[PSES] The Basics of Laser Safety in the Workplace

[John Mcbain]

Hi All -

Our chapter will have a short online presentation on this topic - details
and meeting link below.
Since online presentations can be viewed worldwide (though sometimes at
inconvenient times) we thought we would extend an invitation through the
EMC-PSTC list.
Those interested in seeing slides from previous presentations can check our
website at *https://r6.ieee.org/scv-pses/ <https://r6.ieee.org/scv-pses/> *.

Best regards,
John McBain, PSES SCV Chapter Secretary
===

*The Basics of Laser Safety in the Workplace*May 11 @ 5:00 pm - 6:30 pm PDT

*Speaker: Regan Arndt*

*Time: May 11, 2022 05:00 PM Pacific Time (US and Canada)*

*Presentation: **Laser biological effects and hazards and what to do about
them*

Do you have the right laser safety control program in place? It includes a
lot more than buying a few pairs of laser glasses.

This presentation provides an overview of what the Laser Safety Officer
(LSO) needs to know.

· General knowledge of laser safety fundamentals and terminology.

· Awareness of biological hazards associated with laser processes.

· Understanding of the laser standards applicable to their industry.

· Familiarity with beam – and non-beam – hazards in laser operation.

· How to prevent industrial laser accidents through control
measures.



By the end of the presentation, you will be better informed about how
important implementing laser safety can be.
Perhaps you and your colleagues will “see the light” (or perhaps not!).



*Presenter: Regan Arndt*

Regan Arndt is a Product Compliance Engineer & Laser Safety Officer at
Thermo Fisher Scientific working with high power electron microscopes and
lasers for the semiconductor industry. In the last 28 years, Regan has been
a product safety & EMC engineer for several firms, including some NRTLs, as
well as an IECEE technical auditor and IECEE technical certifier for the CB
scheme. He is currently the Chair of the IEEE PSES SCV Chapter in Northern
California.



*Join Zoom Meeting*

IEEE PSES SCV Chapter is inviting you to a scheduled Zoom meeting.

https://us02web.zoom.us/j/82987430759?pwd=TmhXaGtibnora051UEdDZGg3K0hFZz09

Meeting ID: 829 8743 0759
Passcode: 181195

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Re: [PSES] Laser Safety

[Jim Hulbert]

I should mention that the laser device we are looking at is a Class II laser 
product, certified by the OEM, to be used for bar code scanning, if that makes 
any difference.  I don't think it does make any difference in our obligations 
as a manufacturer incorporating it into our end product.

From: Jim Hulbert
Sent: Tuesday, October 23, 2018 4:16 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Laser Safety

Hi.  I would like to confirm laser safety requirements in an industrial machine 
under the U.S. FDA regulations.   If a Class II laser module (purchased OEM) is 
installed in an industrial type machine, my understanding is that the machine 
manufacturer must adhere to the following requirements:
1. The machine must provide additional enclosure for the device so that the 
operator is not exposed to levels higher than Class I during machine operation.
2. The machine manufacturer would be obligated to test the machine to confirm 
that the Class I levels are indeed not exceeded and submit a report to the FDA.
3. If the additional enclosure for the device can be opened or removed by the 
operator, the enclosure must be safety interlocked.
4. The machine manufacturer would be required to keep records and report unit 
sales to the FDA on an annual basis.
Is my understanding of the 4 points above correct?  If so, am I missing any 
else?
Thanks.
Jim Hulbert
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Re: [PSES] Laser Safety

[Lauren Crane]

Jim,
My two cents...

1.   Beams higher than class I can emit from your products aperture but 
appropriate protections must otherwise be in place. Maintaining class I is 
ideal, but consider things like laser cutters which must emit higher power 
beams. A fundamental criterion is that the emitted beam be no higher than what 
is needed to do what the product is intended to do.

2.   While EN 60825-1 not and CDRH standard, several laser notices accept 
parts of it. It contains the explicit idea that some aspects of product 
classification can be achieved through inspection (e.g. such as demonstrating 
no beam exits your product). However if you are counting on attenuation rather 
than blocking, with a Class II beam source you are probably going to have to 
measure to demonstrate compliance to class I levels.

3.   Safety interlocks are only required in certain circumstances - check 
the laser standard 21CFR1040.10. It, in fact, allows for the possibility (in 
some cases) of a non-interlocked protective housing.

4.   There are several more administrative obligations, such as submitting 
an initial product report and any relevant supplemental reports . Be sure to 
review all of 21CFR subpart J (e.g., part 1000, 1002. Etc...).

Regards,
Lauren Crane

From: Jim Hulbert 
Sent: Tuesday, October 23, 2018 3:16 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [PSES] Laser Safety

Hi.  I would like to confirm laser safety requirements in an industrial machine 
under the U.S. FDA regulations.   If a Class II laser module (purchased OEM) is 
installed in an industrial type machine, my understanding is that the machine 
manufacturer must adhere to the following requirements:
1. The machine must provide additional enclosure for the device so that the 
operator is not exposed to levels higher than Class I during machine operation.
2. The machine manufacturer would be obligated to test the machine to confirm 
that the Class I levels are indeed not exceeded and submit a report to the FDA.
3. If the additional enclosure for the device can be opened or removed by the 
operator, the enclosure must be safety interlocked.
4. The machine manufacturer would be required to keep records and report unit 
sales to the FDA on an annual basis.
Is my understanding of the 4 points above correct?  If so, am I missing any 
else?
Thanks.
Jim Hulbert
This email message may contain confidential, proprietary and/or privileged 
information. It is intended only for the use of the intended recipient(s). If 
you have received it in error, please immediately advise the sender by reply 
email and then delete this message. No one other than the intended recipient 
may disclose, copy, distribute or use the information contained in this message.



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[PSES] Laser Safety

[Jim Hulbert]

Hi.  I would like to confirm laser safety requirements in an industrial machine 
under the U.S. FDA regulations.   If a Class II laser module (purchased OEM) is 
installed in an industrial type machine, my understanding is that the machine 
manufacturer must adhere to the following requirements:
1. The machine must provide additional enclosure for the device so that the 
operator is not exposed to levels higher than Class I during machine operation.
2. The machine manufacturer would be obligated to test the machine to confirm 
that the Class I levels are indeed not exceeded and submit a report to the FDA.
3. If the additional enclosure for the device can be opened or removed by the 
operator, the enclosure must be safety interlocked.
4. The machine manufacturer would be required to keep records and report unit 
sales to the FDA on an annual basis.
Is my understanding of the 4 points above correct?  If so, am I missing any 
else?
Thanks.
Jim Hulbert
This email message may contain confidential, proprietary and/or privileged 
information. It is intended only for the use of the intended recipient(s). If 
you have received it in error, please immediately advise the sender by reply 
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may disclose, copy, distribute or use the information contained in this message.




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Re. laser safety and Li-Po batteries

[Peter Weichel]

Hi guy´s,
 
Thank you very much for all your kind answers, i will study the provide
information carefully.
Have a nice weekend all ;-)
 
Best regards
Peter
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Re: Laser safety and Li-Po batteries

[Paolo Peruzzi]

Hi Peter,

IEC 60825-1 is the reference standard for laser devices labelling. 
In its EN version it is the reference for EU market.
In the US the reference is 21 CFR part 1040.10, but FDA also recognizes IEC
60825-1.

regards,
Paolo




 

--- 
Paolo Peruzzi 
Regulatory Medical R&D 
El.En. S.p.A. 
Via Baldanzese, 17 
50041 Calenzano (FI) 
Italy 
Tel. +39 055 8826807 
FAX  +39 055 8832884  
standa...@elen.it  
http://www.elengroup.com/  



Peter Weichel ha scritto: 

Hi experts,
 
I have two topics for which i need information:
 
a)
Which standard(s) regulate the marking requirements for labels to be 
put on
equipment using Class II laser devices ?
And are there similar requirements for EU and USA ?
 
 
b)
Re. Li-Po batteries shipped inside equipment (internal) i wonder if IATA
regulations or others sets a maximum level of charge on such batteries when
shipped from factory. I.e. may a Li-Po battery be fully charged while shipping
inside equipment ?
 
Thanks and have a nice day,
 
Peter Weichel
Denmark
 
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RE: Laser safety and Li-Po batteries

[Barker, Neil]

Peter
 
I'll decline to answer your question re lasers, as I am sure others are more
knowledgeable than I am.
 
In answer to your question about batteries, I answered a similar question last
week. The reply was:-
 
Lithium batteries may be shipped installed in product. The UN No. is 3091.
IATA regulations apply Packing Instruction 912, which states:-
 
"The General Packing Requirements of 5.0.2 must be met.
 
Lithium batteries (liquid or solid cathode) contained in equipment must meet
all the requirements of Packing Instruction 903 other than those relating to
packaging, be protected against short circuits and be securely held in place.
Cells must not be capable of being discharged during transport to the extent
that the open circuit voltage is less than the lower of:
 
(a) 2 Volts; or
 
(b) 2/3 of the voltage of the undischarged cell.
 
Equipment containing lithium batteries must be contained in strong outer
packaging. The outer packaging must be waterproof or made waterproof through
the use of a liner, such as a plastic bag, unless the equipment is made
waterproof by nature of its construction. the equipmenmt must be secured
against movement within the outer packaging and be packed so as to prevent
accidental operation during air transport.
 
The quantity of lithium metal contained in any piece of equipment must not
exceed 12g per cell and 500g per battery.
 
Not more than 5kg of lithium batteries may be contained in any piece of
equipment."
 

Neil Barker

Manager

Central Quality

 

e2v

106 Waterhouse Lane, Chelmsford, Essex, CM1 2QU, England

Tel: +44 (0)1245 453616

Mobile:   +44 (0)7801 723735

Fax:+44 (0)1245 453571

 www.e2v.com <http://www.e2v.com/> 

 

P Consider the environment: do you really need to print this e mail?

 

-Original Message-
From: Peter Weichel [mailto:r...@weichels.dk]
Sent: 11 September 2008 21:33
To: emc-p...@ieee.org
    Subject: Laser safety and Li-Po batteries


Hi experts,
 
I have two topics for which i need information:
 
a)
Which standard(s) regulate the marking requirements for labels to be 
put on
equipment using Class II laser devices ?
And are there similar requirements for EU and USA ?
 
 
b)
Re. Li-Po batteries shipped inside equipment (internal) i wonder if IATA
regulations or others sets a maximum level of charge on such batteries when
shipped from factory. I.e. may a Li-Po battery be fully charged while shipping
inside equipment ?
 
Thanks and have a nice day,
 
Peter Weichel
Denmark
 

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Sent by E2V TECHNOLOGIES PLC or a member of the E2V group of companies. A
company registered in England and Wales. 

Company number; 04439718. 

Registered address; 106 Waterhouse Lane, Chelmsford, Essex, CM1 2QU, UK.

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Laser safety and Li-Po batteries

[Peter Weichel]

Hi experts,
 
I have two topics for which i need information:
 
a)
Which standard(s) regulate the marking requirements for labels to be put on
equipment using Class II laser devices ?
And are there similar requirements for EU and USA ?
 
 
b)
Re. Li-Po batteries shipped inside equipment (internal) i wonder if IATA
regulations or others sets a maximum level of charge on such batteries when
shipped from factory. I.e. may a Li-Po battery be fully charged while shipping
inside equipment ?
 
Thanks and have a nice day,
 
Peter Weichel
Denmark
 
-  This
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Re: Laser safety officer at test labs

[emc-p...@ieee.org]

It varies by state, but in Massachusetts you are required by state regulation
and the Bureau of Public Health to comply with a set of regulations which
includes a laser safety officer,
http://www.mass.gov/Eeohhs2/docs/dph/regs/105cmr121.pdf
much as you would if you were operating an X ray machine, using radioactive
materials, etc.

Bob Johnson
ITE Safety <http://www.itesafety.com> 

Moshe Valdman wrote: 

Hi all,
 
Test labs test all kinds of equipment in various tests (EMC, safety, HALT etc)
Occasionally there might be high power lasers (class 3B or class 4) as part of
the product tested in the lab
 
Does this require the lab to have an LSO person (laser safety officer) and
other special measures ro reduce risks of injury during the tests?
 
thanks and regards,
Moshe Valdman
QA and reliability Enginner
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RE: Laser safety officer at test labs

[emc-p...@ieee.org]

I am not a laser safety expert either  – but in my opinion it would
constitute the implementation of a Laser Safety Program which requires an LSO.
Class 3B and 4 lasers require use of a LS manual, LS Training, LS processes,
LS inspections and much more. The goal of this is to assure the safety of
others and the operator when the laser is in use from accidental exposure. 

 

Mark Schmidt

 

  _  

From: emc-p...@ieee.org [mailto:emc-p...@ieee.org] On Behalf Of Moshe Valdman
Sent: Friday, April 18, 2008 8:58 AM
To: emc-p...@ieee.org
Subject: Laser safety officer at test labs

 

Hi all,

 

Test labs test all kinds of equipment in various tests (EMC, safety, HALT etc)

Occasionally there might be high power lasers (class 3B or class 4) as part of
the product tested in the lab

 

Does this require the lab to have an LSO person (laser safety officer) and
other special measures ro reduce risks of injury during the tests?

 

thanks and regards,

Moshe Valdman

QA and reliability Enginner

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http://www.ieeecommunities.org/emc-pstc -
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Re: Laser safety officer at test labs

[emc-p...@ieee.org]

Product safety standards typically do not specify the required safety
precautions for performing testing.  The facility safety requirements are
normally based on government regulations and corporate policies.

I don't know the rules for most countries.  In the United States, the basic
rules are set out by the Occupational Safety and Health Administration in
the Department of Labor (OSHA).  In this case, OSHA has guidelines and
references ANSI standards for specific practices.
http://www.osha.gov/SLTC/laserhazards/standards.html

I am not a laser expert and I encourage those who are to correct or amend
the limited information I have provided.

Ted Eckert
APC-MGE
http://www.apc.com/

The items contained in this e-mail reflect the personal opinions of the
writer and are only provided for the assistance of the reader. The writer
is not speaking in an official capacity for APC-MGE or Schneider Electric.
The speaker does not represent APC-MGE's or Schneider Electric's official
position on any matter.


   
 Moshe Valdman 
  To 
 Sent by:  emc-p...@ieee.org   
 emc-p...@ieee.org  cc 
   
   Subject 
 04/18/2008 07:57      Laser safety officer at test labs   
 AM
   
   
   
   
   




Hi all,

Test labs test all kinds of equipment in various tests (EMC, safety, HALT
etc)
Occasionally there might be high power lasers (class 3B or class 4) as part
of the product tested in the lab

Does this require the lab to have an LSO person (laser safety officer) and
other special measures ro reduce risks of injury during the tests?

thanks and regards,
Moshe Valdman
QA and reliability Enginner
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Laser safety officer at test labs

[emc-p...@ieee.org]

Hi all,
 
Test labs test all kinds of equipment in various tests (EMC, safety, HALT etc)
Occasionally there might be high power lasers (class 3B or class 4) as part of
the product tested in the lab
 
Does this require the lab to have an LSO person (laser safety officer) and
other special measures ro reduce risks of injury during the tests?
 
thanks and regards,
Moshe Valdman
QA and reliability Enginner
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Laser Safety Officer Training in Canada

[emc-p...@ieee.org]

We have a few seats left in our laser safety officer training course that is
being offered the week of 18-Jun-07. If you are interested, please visit our
website,  <http://www.qps.ca/> www.qps.ca, and follow the links to the laser
safety registration pages.

-- 
Doug Nix
QPS Evaluation Services Inc.
Mobile: (519) 729-5704 
Fax: (519) 653-1318
Email:  <mailto:d...@qps.ca> d...@qps.ca
Web: qps.ca

 

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RE: Laser safety AEL calculation - angular subtense and C6

[emc-p...@ieee.org]

Kyaw:

It may help to see IEC Technical Report TR 60825-10 "Safety of laser products
Part 10: Application guidelines and explanatory notes to IEC 60825-1,"
Sections 9 Intrabeam Viewing, and 10, Extended Source Viewing.

Also see IEC Technical Report TR 60825-14 "Safety of laser products Part 14: A
user's guide," which is a "guide" to 60825-1, and contain numerous worked
calculation examples, etc.

These were written as informative and educational texts to the normative parts
of IEC 60825-1.

  
William T. Sykes
Lucent Technologies EH&S
Product Safety/Conformance Manager
Room 7B-516A
600-700 Mountain Avenue
Murray Hill, NJ  07974-0636 
(908)582-6937
   


From: emc-p...@ieee.org [mailto:emc-p...@ieee.org]On Behalf Of KYAW HTIN
AUNG
Sent: Thursday, June 08, 2006 12:22 PM
To: EMC PSTC
Subject: Laser safety AEL calculation - angular subtense and C6


Dear Good People

Our product is a class II laser scanning engine. The
original source of laser is from a laser diode. It
passes through a lens and strikes two subtended
mirrors before it goes out for scanning. According to
IEC 60825-1, AEL limit is defined as C6x10-3W where C6
is based on angular subtense (alpha). If alpha is less
than or equal to alpha min, C6 = 1. If alpha is
between min and max, C6 is alpha/alpha min where alpha
min is 1.5mrad.

The debate right now is how to define alpha value to
get C6. I was told to consider it is intrabeam viewing
so that alpha is always min and C6=1. I have no
objection that it is intrabeam viewing but I do not
accept that alpha is always min for intrabeam viewing.
In our case, I consider it is an enlarged source, not
a point source. Enlarged source will create enlarged
image at the retina of our eye. So alpha will be
greater than min value of 1.5mrad and C6 will be
greater than 1.

Anybody can shed the light on this topic? Or any
reference to a good info source?

Thanks in advance

Kyaw

Send instant messages to your online friends http://uk.messenger.yahoo.com 

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Laser safety AEL calculation - angular subtense and C6

[emc-p...@ieee.org]

Dear Good People

Our product is a class II laser scanning engine. The
original source of laser is from a laser diode. It
passes through a lens and strikes two subtended
mirrors before it goes out for scanning. According to
IEC 60825-1, AEL limit is defined as C6x10-3W where C6
is based on angular subtense (alpha). If alpha is less
than or equal to alpha min, C6 = 1. If alpha is
between min and max, C6 is alpha/alpha min where alpha
min is 1.5mrad.

The debate right now is how to define alpha value to
get C6. I was told to consider it is intrabeam viewing
so that alpha is always min and C6=1. I have no
objection that it is intrabeam viewing but I do not
accept that alpha is always min for intrabeam viewing.
In our case, I consider it is an enlarged source, not
a point source. Enlarged source will create enlarged
image at the retina of our eye. So alpha will be
greater than min value of 1.5mrad and C6 will be
greater than 1.

Anybody can shed the light on this topic? Or any
reference to a good info source?

Thanks in advance

Kyaw

Send instant messages to your online friends http://uk.messenger.yahoo.com 

-

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Singapore Laser Safety Standards

[emc-p...@ieee.org]

Hi Group,

I am trying to find out about specific laser safety standards employed
in Singapore.

Specifically I need to know whether there are any import
requirements/restrictions for laser products. I am also interested to
know what standard that they have adopted and whether there is any
legislation that references this standard. 

FYI our product is factory process equipment that contains a laser
rotary encoder, that is likely to be a class 1 or class 1M (though I am
not sure whether this will contain an embedded laser of higher class)

Any advice or guidance would be grately appreciated!

Many thanks in advance
Duncan. 
 
Duncan Hobbs, Senior Compliance Engineer 
Product Compliance Laboratory
Xyratex Technology Ltd.
Havant,
Hampshire,
U.K.
PO9 1SA
tel: 02392 496444
fax: 02392 496014
duncan_ho...@xyratex.com

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RE: laser safety label

[richwo...@tycoint.com]

If the light source is an LED, there are no FDA requirements. The
requiremens for lasers can be found in 21 CFR 1000-1010 and 1040. Also see
the many publications and notices from the DHHS. 

http://www.fda.gov/cdrh/


Richard Woods
Sensormatic Electronics
Tyco International


From: Neil Helsby [mailto:nei...@solid-state-logic.com]
Sent: Thursday, June 26, 2003 10:58 AM
To: emc-p...@majordomo.ieee.org
Subject: laser safety label



In the USA, what safety labels and/or manual information is required when a
class 1 (fibre optic) device is fitted to a panel for equipment 
interconnection? Are the requirements the same as those for EN 60825-1?

Many thanks for your assistance.

Regards,

Neil Helsby


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RE: laser safety label

[Frazee, Douglas (Douglas)]

I think you'll find all you need to know here;
http://www.fda.gov/cdrh/comp/guidance/1346.html


Douglas G. Frazee
Regulatory Compliance Manager
Lucent Technologies
PSAX Division
dfra...@lucent.com

 -Original Message-
From:   Neil Helsby [mailto:nei...@solid-state-logic.com] 
Sent:   Thursday, June 26, 2003 10:58 AM
To: emc-p...@majordomo.ieee.org
Subject:    laser safety label


In the USA, what safety labels and/or manual information is required when a
class 1 (fibre optic) device is fitted to a panel for equipment 
interconnection? Are the requirements the same as those for EN 60825-1?

Many thanks for your assistance.

Regards,

Neil Helsby


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laser safety label

[Neil Helsby]

In the USA, what safety labels and/or manual information is required when a
class 1 (fibre optic) device is fitted to a panel for equipment 
interconnection? Are the requirements the same as those for EN 60825-1?

Many thanks for your assistance.

Regards,

Neil Helsby


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RE: Laser safety questions

[David Heald]

Well, 
  In response to question 1, you may want to try for Class 1M.  The new
measurement geometries allow many class 3B lasers to be reclassified as 1M.
I would assume (although I have no direct experience here) that the visible
spectrum lasers would also benefit from the new geometries (BTW, the Class
1M spectrum is 302.5 to 4000nm).  Wouldn't it be wonderful to have all Class
1(M) lasers?!!

Best Regards,
Dave Heald

-Original Message-
From: Gandler, Mark [mailto:mgand...@ciena.com]
Sent: Tuesday, November 12, 2002 1:47 PM
To: 'emc-p...@majordomo.ieee.org'
Subject: Laser safety questions



Hello Group,

 According to the new revision of IEC 60825-1 (2001-08) , there are 
following laser products classes: 1, 1M, 2, 2M , 3R , 3B and 4, instead of
1, 2 , 3A, 3B and 4 per previous revision.

Question # 1 : should we change the labeling, let's say from 3A to 3R? Is it
any timetable for implementation?

The latest revision that I have for IEC 60825-2 is 2000-05 and
classification there still 1,2,3A ,k 3A, 3B and 4.

Question # 2 : is it any newer version of 60825-2 available? and if yes,
what are the classes in it?

Is it correct to assume that if somebody asking for laser power density , so
I need to look for maximum permissible exposure (MPE)?

If not , what it could be? 

If yes, what is the easiest (or only) way to calculate it? 
Let say the wavelength is 1550 nm, located on PCB , than after 10 mm or so
is a connector, exposure is 100s. Any ideas?

The MPE in the IEC table is 1000W/m2.

Thank you in advance, 

Mark Gandler
Ciena


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RE: Laser safety questions

[Richard Hughes]

Mark,

Regarding question #1

Perhaps your question is based on the misconception that in Europe and
elsewhere we use IEC standards directly.  This in fact is not the case.  For
Europe we use ENs agreed by CENELEC and published by national standards
bodies, such as BSI.  These ENs are frequently either based on, or identical
to, IEC standards: however they are not IEC publications per se.  The same
is also true in other parts of the world, such as Australia.

The OJEC list of standards offering a presumption of conformity with the LVD
provides information that the second amendment to EN 60825-1 does provide a
presumption of conformity with the LVD.  Moreover, Amendment 2 (which
contains the newer classifications) supersedes the earlier amendment (A11 -
containing the older classifications) on 1 Jan 2004.  Until 1 Jan 2004 you
can you use the new or the old classifications, at your choice.

Regarding question #2

No there is currently no published version of IEC (or EN) 60825-2 that
references the newer Classes in Amendment 2 of 60825-1.  IEC TC76, the
committee responsible for the IEC 60825-x series of standards is, however,
in the process of preparing such an update.

In the interim the IEC have available an 'Interpretation Sheet' that
explains how you could amend IEC 60825-2 to use the newer class
designations.  However, there is also disagreement regarding the value of
this Interpretation Sheet:  more I will not say.

Finally, IEC 60825-2 does not contain any 'Class' designations.  This
standard has 'Hazard Level' designations which take into account the fact
that optical networks may utilise high optical powers to transmit data along
a contiguous fibre path providing that there is an Automatic Power Reduction
feature (of adequate reliability) to decrease the output to a safe value in
the event of a fault.  Of course, the Hazard Level designations in part 2
refer to the AELs and MPEs for the corresponding Class in part 1.

Opinions as always,

Richard Hughes. 


-Original Message-
From: Gandler, Mark [mailto:mgand...@ciena.com]
Sent: 12 November 2002 18:47
To: 'emc-p...@majordomo.ieee.org'
Subject: Laser safety questions



Hello Group,

 According to the new revision of IEC 60825-1 (2001-08) , there are 
following laser products classes: 1, 1M, 2, 2M , 3R , 3B and 4, instead of
1, 2 , 3A, 3B and 4 per previous revision.

Question # 1 : should we change the labeling, let's say from 3A to 3R? Is it
any timetable for implementation?

The latest revision that I have for IEC 60825-2 is 2000-05 and
classification there still 1,2,3A ,k 3A, 3B and 4.

Question # 2 : is it any newer version of 60825-2 available? and if yes,
what are the classes in it?

Is it correct to assume that if somebody asking for laser power density , so
I need to look for maximum permissible exposure (MPE)?

If not , what it could be? 

If yes, what is the easiest (or only) way to calculate it? 
Let say the wavelength is 1550 nm, located on PCB , than after 10 mm or so
is a connector, exposure is 100s. Any ideas?

The MPE in the IEC table is 1000W/m2.

Thank you in advance, 

Mark Gandler
Ciena


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Re: Laser safety questions

[John Woodgate]

I read in !emc-pstc that Gandler, Mark  wrote (in
<4fb204c0ca96d54aa7805b3715620bdd13b...@w2ksjexg02.oni.com>) about
'Laser safety questions' on Tue, 12 Nov 2002:

> According to the new revision of IEC 60825-1 (2001-08) , there are 
>following laser products classes: 1, 1M, 2, 2M , 3R , 3B and 4, instead of
>1, 2 , 3A, 3B and 4 per previous revision.
>
>Question # 1 : should we change the labeling, let's say from 3A to 3R? Is it
>any timetable for implementation?

There are NO timetables associated with *IEC* standards, which are
purely voluntary. There *IS* a timetable associated with an EN version,
if there is one.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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Laser safety questions

[Gandler, Mark]

Hello Group,

 According to the new revision of IEC 60825-1 (2001-08) , there are 
following laser products classes: 1, 1M, 2, 2M , 3R , 3B and 4, instead of
1, 2 , 3A, 3B and 4 per previous revision.

Question # 1 : should we change the labeling, let's say from 3A to 3R? Is it
any timetable for implementation?

The latest revision that I have for IEC 60825-2 is 2000-05 and
classification there still 1,2,3A ,k 3A, 3B and 4.

Question # 2 : is it any newer version of 60825-2 available? and if yes,
what are the classes in it?

Is it correct to assume that if somebody asking for laser power density , so
I need to look for maximum permissible exposure (MPE)?

If not , what it could be? 

If yes, what is the easiest (or only) way to calculate it? 
Let say the wavelength is 1550 nm, located on PCB , than after 10 mm or so
is a connector, exposure is 100s. Any ideas?

The MPE in the IEC table is 1000W/m2.

Thank you in advance, 

Mark Gandler
Ciena


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Re: LED's and laser safety?

[John Woodgate]

I read in !emc-pstc that Richard Hughes 
wrote (in <6b78f2524cd7d5118a0402204840075b02795...@zhard0jc.europe.nort
el.com>) about 'LED's and laser safety?' on Mon, 28 Oct 2002:

>If I said that the LVD was 'new approach' then you or someone else would 
>feel the necessity to correct me.  Instead I am being castigated for being 
>accurate but hair-splitting.  
>

Oh, sure. You can't win. I would not have contested 'new approach', of
course, but someone else might indeed do so. Anality rules!
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: LED's and laser safety?

[Richard Hughes]

John,

If I said that the LVD was 'new approach' then you or someone else would
feel the necessity to correct me.  Instead I am being castigated for being
accurate but hair-splitting.  

So be it.

Richard Hughes



-Original Message-
From: John Woodgate [mailto:j...@jmwa.demon.co.uk]
Sent: 28 October 2002 12:08
To: emc-p...@majordomo.ieee.org
Subject: Re: LED's and laser safety?



I read in !emc-pstc that Richard Hughes 
wrote (in <6b78f2524cd7d5118a0402204840075b02795...@zhard0jc.europe.nort
el.com>) about 'LED's and laser safety?' on Mon, 28 Oct 2002:
>A product carries a CE marking to show that it complies with the
national 
>implementations of all applicable 'new approach' EU Directives (and the
LVD, 
>which isn't 'new approach').
>
Why do you say that the LVD is not 'new approach'? It refers to
standards, and does not embody the technical provisions itself.

I suppose it's not formally 'new approach' because it dates from 1973,
long before the term 'new approach' was introduced. But that is hair-
splitting.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk

Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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Re: LED's and laser safety?

[John Woodgate]

I read in !emc-pstc that Richard Hughes 
wrote (in <6b78f2524cd7d5118a0402204840075b02795...@zhard0jc.europe.nort
el.com>) about 'LED's and laser safety?' on Mon, 28 Oct 2002:
>A product carries a CE marking to show that it complies with the national 
>implementations of all applicable 'new approach' EU Directives (and the 
> LVD, 
>which isn't 'new approach').
>
Why do you say that the LVD is not 'new approach'? It refers to
standards, and does not embody the technical provisions itself.

I suppose it's not formally 'new approach' because it dates from 1973,
long before the term 'new approach' was introduced. But that is hair-
splitting.
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: LED's and laser safety?

[Richard Hughes]

Warren,

A product carries a CE marking to show that it complies with the national
implementations of all applicable 'new approach' EU Directives (and the LVD,
which isn't 'new approach').

Exactly which EU Directive(s) do you think apply to LEDs as components?  The
LVD certainly does not apply and neither does the R&TTED.  The General
Product Safety Directive does apply but that does not require the CE
marking.

If the legislation in Europe did require LEDs to be CE marked then it would
require an amending EU directive (which would then need to be transposed
into the laws of each Member State) to change things.

What we were discussing was the level of detail required to show whether
certain LEDs came within the category of being inherently Class 1 per IEC/EN
60825-1. Let's not confuse standards with Directives: it is possible to use
a Harmonised Standard to demonstrate conformity with the provisions of
certain EU Directives, but that does not mean that compliance with a
standard confers the right to fit the CE marking where no directive applies.

Regards,

Richard Hughes

-Original Message-
From: Warren Birmingham [mailto:war...@comfortjets.com]
Sent: 27 October 2002 21:40
To: emc-p...@ieee.org
Subject: Re: LED's and laser safety?



I think the confusion came from the different types of lasers, which I 
did not provide any differentiation.  I was speaking about non-focused 
LEDs that are on display panels, not LEDs that are considered Class I 
lasers.

All LEDs were previously subject to approval for a CE Mark, but 
non-focused display types were not required to be by UL.  The Europeans 
have adopted UL viewpoint on these types of LEDs only.  Non-focused 
display LEDs are being dropped from the program, the others continue to 
require approval by both the Europeans and UL.

Sorry about any confusion.

Warren Birmingham
Epsilon-Mu Consultants


On Monday, Oct 14, 2002, at 04:53 US/Pacific, richwo...@tycoint.com 
wrote:

>
> I sure would love to hear that argument.
>
> Richard Woods
> Sensormatic Electronics
> Tyco International
>
>
> -Original Message-
> From: Warren Birmingham [mailto:war...@comfortjets.com]
> Sent: Friday, October 11, 2002 6:06 PM
> To: emc-p...@ieee.org
> Subject: Re: LED's and laser safety?
>
>
>
> Gary, I was recently in conversation with UL about LEDs whereas I am
> now being told that UL has convinced the European counterparts that
> LEDs are no longer considered Class I Lasers and the requirements for
> them to be tested as such has been dropped.  UL no longer treats them
> that way in their CB Reports.
>
> Warren Birmingham
> Epsilon-Mu Consultants
> (510) 793-4806
> email: war...@epsilon-mu.com
> website: http://www.epsilon-mu.com
>
>
> On Thursday, Oct 10, 2002, at 08:53 US/Pacific, Gary McInturff wrote:
>
>>
>>  IEC-825 has incorporated LED's into the safety standard but, from
>> what I can tell, left a great deal of confusion.
>>  I typically deal with the 5 - 10 mcd devices and haven't been
>> required to provide any IEC-825 conformity proof for the Western
>> European test house. We may be jumping up to about 60 mcd and
>> non-focused devices and I don't know where the standard starts to
>> become concerned. I hate to buy the standard if it doesn't provide any
>> clarity for these types of parts.
>>  Could you folks clue me in?
>>  Gary
>>
>
>
> ---
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Re: LED's and laser safety?

[Warren Birmingham]

I think the confusion came from the different types of lasers, which I 
did not provide any differentiation.  I was speaking about non-focused 
LEDs that are on display panels, not LEDs that are considered Class I 
lasers.


All LEDs were previously subject to approval for a CE Mark, but 
non-focused display types were not required to be by UL.  The Europeans 
have adopted UL viewpoint on these types of LEDs only.  Non-focused 
display LEDs are being dropped from the program, the others continue to 
require approval by both the Europeans and UL.


Sorry about any confusion.

Warren Birmingham
Epsilon-Mu Consultants


On Monday, Oct 14, 2002, at 04:53 US/Pacific, richwo...@tycoint.com 
wrote:




I sure would love to hear that argument.

Richard Woods
Sensormatic Electronics
Tyco International


-Original Message-
From: Warren Birmingham [mailto:war...@comfortjets.com]
Sent: Friday, October 11, 2002 6:06 PM
To: emc-p...@ieee.org
Subject: Re: LED's and laser safety?



Gary, I was recently in conversation with UL about LEDs whereas I am
now being told that UL has convinced the European counterparts that
LEDs are no longer considered Class I Lasers and the requirements for
them to be tested as such has been dropped.  UL no longer treats them
that way in their CB Reports.

Warren Birmingham
Epsilon-Mu Consultants
(510) 793-4806
email: war...@epsilon-mu.com
website: http://www.epsilon-mu.com


On Thursday, Oct 10, 2002, at 08:53 US/Pacific, Gary McInturff wrote:



IEC-825 has incorporated LED's into the safety standard but, from
what I can tell, left a great deal of confusion.
I typically deal with the 5 - 10 mcd devices and haven't been
required to provide any IEC-825 conformity proof for the Western
European test house. We may be jumping up to about 60 mcd and
non-focused devices and I don't know where the standard starts to
become concerned. I hate to buy the standard if it doesn't provide any
clarity for these types of parts.
Could you folks clue me in?
Gary




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RE: LED's and laser safety?

[Richard Hughes]

Folks,

Having now communicated with UL and others on this matter, I understand that
there is no  agreement between UL and their European counterparts that all
LEDs are Class 1 (which is what I infer from the comment below). Even if
such an agreement been in existence, its significance for companies wishing
to use compliance with Harmonised Standards to support their declaration of
conformity with the LVD or R&TTED would be highly questionable.

However, it seems that UL do not (in general - it's impracticable to make a
categorical statement about such large organisations) mention those LEDs
that are of the surface-emitting type (known as SLEDs) in their reports.
However, not all LEDs are of this type and so the generalised statement is
inaccurate.

For further information about the safety of SLEDs and some other types of
semiconductor optical emitter you may be interested in the statement
published by the International Commission on Non-Ionising Radiation
Protection (ICNIRP): http://www.icnirp.de/documents/led.pdf  UL's stance on
the safety of SLEDs can be seen to be in line with this statement by the
international body on non-ionising radiation.

Note also that IEC 60825-1, although mentioning in the Note to Clause 9.1
that single-fault condition testing is not needed for SLEDs, does not go as
far as to say that all SLEDs are inherently Class 1.  

I hope that the above clarifies rather than confuses.

My own opinions as always,

Richard Hughes

-Original Message-
From: Warren Birmingham [mailto:war...@comfortjets.com]
Sent: 11 October 2002 23:06
To: emc-p...@ieee.org
Subject: Re: LED's and laser safety?



Gary, I was recently in conversation with UL about LEDs whereas I am 
now being told that UL has convinced the European counterparts that 
LEDs are no longer considered Class I Lasers and the requirements for 
them to be tested as such has been dropped.  UL no longer treats them 
that way in their CB Reports.

Warren Birmingham
Epsilon-Mu Consultants
(510) 793-4806
email: war...@epsilon-mu.com
website: http://www.epsilon-mu.com


On Thursday, Oct 10, 2002, at 08:53 US/Pacific, Gary McInturff wrote:

>
>   IEC-825 has incorporated LED's into the safety standard but, from 
> what I can tell, left a great deal of confusion.
>   I typically deal with the 5 - 10 mcd devices and haven't been 
> required to provide any IEC-825 conformity proof for the Western 
> European test house. We may be jumping up to about 60 mcd and 
> non-focused devices and I don't know where the standard starts to 
> become concerned. I hate to buy the standard if it doesn't provide any 
> clarity for these types of parts.
>   Could you folks clue me in?
>   Gary
>


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Re: LED's and laser safety?

[John Woodgate]

I read in !emc-pstc that richwo...@tycoint.com wrote (in <846BF526A205F8
4BA2B6045BBF7E9A6A04675859@flbocexu05>) about 'LED's and laser safety?'
on Mon, 14 Oct 2002:

>I sure would love to hear that argument.

Just get a time machine and go back to the meeting of the IEC TC85
working group on the subject. (;-)

Maybe someone on the group will let you read the Minutes; they are not
in the public domain.

It's a very sensible decision, IMHO. 
-- 
Regards, John Woodgate, OOO - Own Opinions Only. http://www.jmwa.demon.co.uk 
Interested in professional sound reinforcement and distribution? Then go to 
http://www.isce.org.uk
PLEASE do NOT copy news posts to me by E-MAIL!

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RE: LED's and laser safety?

[richwoods]

I sure would love to hear that argument.

Richard Woods
Sensormatic Electronics
Tyco International


-Original Message-
From: Warren Birmingham [mailto:war...@comfortjets.com]
Sent: Friday, October 11, 2002 6:06 PM
To: emc-p...@ieee.org
Subject: Re: LED's and laser safety?



Gary, I was recently in conversation with UL about LEDs whereas I am 
now being told that UL has convinced the European counterparts that 
LEDs are no longer considered Class I Lasers and the requirements for 
them to be tested as such has been dropped.  UL no longer treats them 
that way in their CB Reports.

Warren Birmingham
Epsilon-Mu Consultants
(510) 793-4806
email: war...@epsilon-mu.com
website: http://www.epsilon-mu.com


On Thursday, Oct 10, 2002, at 08:53 US/Pacific, Gary McInturff wrote:

>
>   IEC-825 has incorporated LED's into the safety standard but, from 
> what I can tell, left a great deal of confusion.
>   I typically deal with the 5 - 10 mcd devices and haven't been 
> required to provide any IEC-825 conformity proof for the Western 
> European test house. We may be jumping up to about 60 mcd and 
> non-focused devices and I don't know where the standard starts to 
> become concerned. I hate to buy the standard if it doesn't provide any 
> clarity for these types of parts.
>   Could you folks clue me in?
>   Gary
>


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Re: LED's and laser safety?

[Warren Birmingham]

Gary, I was recently in conversation with UL about LEDs whereas I am 
now being told that UL has convinced the European counterparts that 
LEDs are no longer considered Class I Lasers and the requirements for 
them to be tested as such has been dropped.  UL no longer treats them 
that way in their CB Reports.


Warren Birmingham
Epsilon-Mu Consultants
(510) 793-4806
email: war...@epsilon-mu.com
website: http://www.epsilon-mu.com


On Thursday, Oct 10, 2002, at 08:53 US/Pacific, Gary McInturff wrote:



	IEC-825 has incorporated LED's into the safety standard but, from 
what I can tell, left a great deal of confusion.
	I typically deal with the 5 - 10 mcd devices and haven't been 
required to provide any IEC-825 conformity proof for the Western 
European test house. We may be jumping up to about 60 mcd and 
non-focused devices and I don't know where the standard starts to 
become concerned. I hate to buy the standard if it doesn't provide any 
clarity for these types of parts.

Could you folks clue me in?
Gary




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RE: LED's and laser safety?

[Richard Hughes]

Folks,

IEC 60825-1:2001 has an Annex G "Information to be provided by manufacturers
of LEDs".  This is an informative annex, the purpose for which is explained
in the above title.

I suggest that you start with asking your LED vendor to send you data in
conformity with the above.  If you're lucky you'll get some useful info.  If
you're unlucky you'll get "but IEC 60825-1 says it's for laser products" -
tell such suppliers to go read the scope, which states "Throughout this part
1 light emitting diodes (LED) are included whenever the word "laser" is
used."

If enough users of LEDs ask their LED suppliers for Annex G data then
eventually those suppliers will twig that this is an important marketing
requirement so they had better start providing the info.

Before anyone complains, yes it is known that the latest version of EN
60950-1 only cross-refers to the older version of 60825-1, but we're working
to correct this in IEC TC108 (now responsible for IEC 60950-x).  Reason? -
difficulty of balancing revision dates within multiple standards - both
revised documents were published the same year. 

It is therefore for users in this forum to satisfy themselves that an LED
that is e.g. Class 1 per IEC 60825-1:2001 also meets the national
implementations of IEC 60825-1 for the countries they wish to supply into.

End of personal views...

Regards,

Richard Hughes



-Original Message-
From: Peter L. Tarver [mailto:peter.tar...@sanmina-sci.com]
Sent: 10 October 2002 22:44
To: EMC-PSTC (E-mail)
Subject: RE: LED's and laser safety?



Gary -

IEC60825-1 uses units of energy, energy/unit area, power and
power/unit area (regardless of any "special" names
associated with them) rather than candela or lumens, which
are typical for simple LEDs.  You'd need some formula to
convert the units to those compatible with IEC60825-1.
However, you might also want to look into IEC TS60825-6,
Safety of Laser Products - Part 6: Safety of Products with
Optical Sources, Exclusively Used for Visible Information
Transmission to the Human Eye.

A Technical Specification doesn't hold the same sway as a
standard, but it is a useful reference for indicator LEDs.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

> -Original Message-
> From: Gary McInturff
> Sent: Thursday, October 10, 2002 8:53 AM
>
>   IEC-825 has incorporated LED's into the
> safety standard but, from what I can tell, left a
> great deal of confusion.
>   I typically deal with the 5 - 10 mcd
> devices and haven't been required to provide any
> IEC-825 conformity proof for the Western European
> test house. We may be jumping up to about 60 mcd
> and non-focused devices and I don't know where
> the standard starts to become concerned. I hate
> to buy the standard if it doesn't provide any
> clarity for these types of parts.
>   Could you folks clue me in?
>   Gary
>


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RE: LED's and laser safety?

[Peter L. Tarver]

Gary -

IEC60825-1 uses units of energy, energy/unit area, power and
power/unit area (regardless of any "special" names
associated with them) rather than candela or lumens, which
are typical for simple LEDs.  You'd need some formula to
convert the units to those compatible with IEC60825-1.
However, you might also want to look into IEC TS60825-6,
Safety of Laser Products - Part 6: Safety of Products with
Optical Sources, Exclusively Used for Visible Information
Transmission to the Human Eye.

A Technical Specification doesn't hold the same sway as a
standard, but it is a useful reference for indicator LEDs.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

> -Original Message-
> From: Gary McInturff
> Sent: Thursday, October 10, 2002 8:53 AM
>
>   IEC-825 has incorporated LED's into the
> safety standard but, from what I can tell, left a
> great deal of confusion.
>   I typically deal with the 5 - 10 mcd
> devices and haven't been required to provide any
> IEC-825 conformity proof for the Western European
> test house. We may be jumping up to about 60 mcd
> and non-focused devices and I don't know where
> the standard starts to become concerned. I hate
> to buy the standard if it doesn't provide any
> clarity for these types of parts.
>   Could you folks clue me in?
>   Gary
>


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RE: LED's and laser safety?

[richwoods]

Gary, I have to be concerned about LEDs also and have found that I need to
consult EN 60825-1 in order to determine the design and documentation
requirements for Class II LEDs. Our EU safety agency requires that we
demonstrate compliance even with Class 1 devices. For the lower emission
LEDs, compliance can usually be demonstrated by a review of the LED
specifications and perhaps a fault test. Otherwise the emissions must be
measured. The standard was an requirement for us in one situation where we
used a high intensity Class 2 LED inside the product in order to obtain the
necessary light outside the product. The external emission was Class 1, but
labels and documentation was required for service.

Regards,

Richard Woods
Sensormatic Electronics
Tyco International
 

Original Message-
From: Gary McInturff [mailto:gary.mcintu...@worldwidepackets.com]
Sent: Thursday, October 10, 2002 11:53 AM
To: EMC-PSTC (E-mail)
Subject: LED's and laser safety?



IEC-825 has incorporated LED's into the safety standard but, from
what I can tell, left a great deal of confusion. 
I typically deal with the 5 - 10 mcd devices and haven't been
required to provide any IEC-825 conformity proof for the Western European
test house. We may be jumping up to about 60 mcd and non-focused devices and
I don't know where the standard starts to become concerned. I hate to buy
the standard if it doesn't provide any clarity for these types of parts.
Could you folks clue me in?
Gary
 

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LED's and laser safety?

[Gary McInturff]

IEC-825 has incorporated LED's into the safety standard but, from what 
I can tell, left a great deal of confusion. 
I typically deal with the 5 - 10 mcd devices and haven't been required 
to provide any IEC-825 conformity proof for the Western European test house. We 
may be jumping up to about 60 mcd and non-focused devices and I don't know 
where the standard starts to become concerned. I hate to buy the standard if it 
doesn't provide any clarity for these types of parts.
Could you folks clue me in?
Gary
 

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RE: Two Questions concerning the subject of Laser Safety

[Chris Maxwell]

Josh,

I agree with your message below.  It may not have been clear in my first email.

The FDA's Laser Notice 50 allows the use of EN 60825-1 for the "technical" 
aspects of laser safety, such as:  determination of the laser classification, 
how to label the device, what information to put in the manual...

However, as you state below, the FDA/CDRH still demands that manufacturers meet 
the documentation,  reporting and tracking requirements (units tracked by 
serial number, model number, reports to the CDRH...) listed in CFR 21, Part 
1040.  

Chris
> -Original Message-
> From: Joshua Wiseman [SMTP:jwise...@printronix.com]
> Sent: Wednesday, June 19, 2002 6:27 PM
> To:   Chris Maxwell; John Juhasz; Davis, Mike; Emc-Pstc (E-mail)
> Subject:  RE: Two Questions concerning the subject of Laser Safety 
> 
> Chris, 
> 
> As I recall Laser Notice 50 does not exempt you from the record keeping and 
> report of the CFR 21, only the qualification aspects.
> 
> Regards, 
> Josh 
> 
> 
> 

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RE: Two Questions concerning the subject of Laser Safety

[Joshua Wiseman]

Chris,

As I recall Laser Notice 50 does not exempt you from the record keeping and
report of the CFR 21, only the qualification aspects.

Regards,
Josh


-Original Message-
From: Chris Maxwell [mailto:chris.maxw...@nettest.com]
Sent: Wednesday, June 19, 2002 1:24 PM
To: John Juhasz; Davis, Mike; Emc-Pstc (E-mail)
Subject: RE: Two Questions concerning the subject of Laser Safety 



As a follow up to John's reply below:

If you are considering taking some kind of class or hiring a consultant for
laser safety; you may want to consider buying a copy of the latest version
of EN 60825-1.  The standard is very thorough, providing methods to
determine the class of laser devices either by measurement or calculation.
It also has tables of requirements for labeling, manual information,
interlocking...requirements for different classes of lasers.

The good thing is, the CDRH has issued Laser Notice 50 which essentially
states that you can use EN 60825-1 to meet the technical aspects (laser
classification, labeling...) of the CDRH requirements.  This greatly
simplifies the technical aspects of laser compliance.  It also means that
your copy of EN 60825 will help you with foreign and US laser safety
compliance. 

Chris Maxwell | Design Engineer - Optical Division
email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 



> -Original Message-
> From: John Juhasz [SMTP:john.juh...@ge-interlogix.com]
> Sent: Wednesday, June 19, 2002 12:57 PM
> To:   'Davis, Mike'; Emc-Pstc (E-mail)
> Subject:  RE: Two Questions concerning the subject of Laser Safety 
> 
> 
> Mike,
> 
> Go to the following link of the CDRH (Center for Devices and Radiological
> Health). They're the ones to whom the
> reports will be sent. There are further links to information that will be
> very useful to you and should answer most
> of the questions you posed below.
> 
> http://www.fda.gov/cdrh/radhlth/index.html
> 
> Simply put, at this moment in the US LEDs are not regulated. But the CDRH
> will be aligning the regs with Europe (EN 60825) where
> verification that the LEDs are safe is required.
> 
> GE Interlogix
> 
> John A. Juhasz
> 
> Fiber Options Div.
> Bohemia, NY 
> 
> 
> 
> 

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RE: Two Questions concerning the subject of Laser Safety

[Chris Maxwell]

As a follow up to John's reply below:

If you are considering taking some kind of class or hiring a consultant for 
laser safety; you may want to consider buying a copy of the latest version of 
EN 60825-1.  The standard is very thorough, providing methods to determine the 
class of laser devices either by measurement or calculation.  It also has 
tables of requirements for labeling, manual information, 
interlocking...requirements for different classes of lasers.

The good thing is, the CDRH has issued Laser Notice 50 which essentially states 
that you can use EN 60825-1 to meet the technical aspects (laser 
classification, labeling...) of the CDRH requirements.  This greatly simplifies 
the technical aspects of laser compliance.  It also means that your copy of EN 
60825 will help you with foreign and US laser safety compliance. 

Chris Maxwell | Design Engineer - Optical Division
email chris.maxw...@nettest.com | dir +1 315 266 5128 | fax +1 315 797 8024

NetTest | 6 Rhoads Drive, Utica, NY 13502 | USA
web www.nettest.com | tel +1 315 797 4449 | 



> -Original Message-
> From: John Juhasz [SMTP:john.juh...@ge-interlogix.com]
> Sent: Wednesday, June 19, 2002 12:57 PM
> To:   'Davis, Mike'; Emc-Pstc (E-mail)
> Subject:  RE: Two Questions concerning the subject of Laser Safety 
> 
> 
> Mike,
> 
> Go to the following link of the CDRH (Center for Devices and Radiological
> Health). They're the ones to whom the
> reports will be sent. There are further links to information that will be
> very useful to you and should answer most
> of the questions you posed below.
> 
> http://www.fda.gov/cdrh/radhlth/index.html
> 
> Simply put, at this moment in the US LEDs are not regulated. But the CDRH
> will be aligning the regs with Europe (EN 60825) where
> verification that the LEDs are safe is required.
> 
> GE Interlogix
> 
> John A. Juhasz
> 
> Fiber Options Div.
> Bohemia, NY 
> 
> 
> 
> 

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RE: Two Questions concerning the subject of Laser Safety

[Peter Tarver]

Mike -

See below.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
San Jose, CA
peter.tar...@sanmina-sci.com

>  -Original Message-
> From: Davis, Mike
> Sent: Wednesday, June 19, 2002 6:59 AM
>
> 1.Are manufacturers required by the FDA to record serial
numbers of Laser modules.  Where is this requirement
located? Does this apply to photodiodes also?

A)  Not in so few words.  The requirements imply the need
for a tracking method by way of a QC program, but nothing is
specifically identified.  Also, if there's a field incident,
traceability to a manufacturing lot would likely become an
issue, especially if the field incident is serious enough to
warrant a recall (you would, no doubt, prefer to recall only
some modules from the field, rather than all of them).  S/Ns
are the most common method I've seen used for this.

B) photodiodes are not controlled by the FDA; neither are
noncoherent LED sources



> 2.I have a concern of what I need to know about Laser
safety but was afraid to ask (because it would cost more
than my compliance budget ($0) would allow without manager
approval). In other words (what is the second question?... I
am getting there.) I am looking to hire a consultant or take
a course. My supervisor wants me to create for him a
proposal answering the type of questions that support the
need to either attend a course or have a consultant educate
me or our professionals here so that he can decide whether
or not we need to hire a consultant, etc, etc. To keep this
short, I will paraphrase by saying that the type of
questions he would like to have answered is it worth the
expense to getting smart, as engineers and a manufacturer of
ITE, in the manufacturing of laser systems?

I believe it's worth "getting smart."  I recommend (you just
missed the last one):

International Laser Safety Conference
March 10-13, 2003
Jacksonville, FL
http://www.laserinstitute.org/conferences/ilsc2003/index2003
.htm


> Here is my question...
> Is there information available that summarizes the
responsibilities to Laser Safety of Compliance, Design,
Manufacturing, and Test Engineers that manufacture laser
systems?

Refer to 21CFR and the CDRH web site for all of this.
You'll find copies of the initial and annual reports and
links to 21CFR.  Some of the information you want is in
early sections of Section 1040 (1040.01, .02) so don't
ignore them and only review 1040.10.


http://www.fda.gov/cdrh/



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RE: Two Questions concerning the subject of Laser Safety

[John Juhasz]

Mike,

Go to the following link of the CDRH (Center for Devices and Radiological
Health). They're the ones to whom the
reports will be sent. There are further links to information that will be
very useful to you and should answer most
of the questions you posed below.

http://www.fda.gov/cdrh/radhlth/index.html

Simply put, at this moment in the US LEDs are not regulated. But the CDRH
will be aligning the regs with Europe (EN 60825) where
verification that the LEDs are safe is required.

GE Interlogix

John A. Juhasz

Fiber Options Div.
Bohemia, NY 




>  -Original Message-
> From: Davis, Mike [mailto:mda...@c-cor.net] 
> Sent: Wednesday, June 19, 2002 9:59 AM
> To:   Emc-Pstc (E-mail)
> Subject:  Two Questions concerning the subject of Laser Safety 
> 
> 1.Are manufacturers required by the FDA to record serial numbers of
> Laser modules.  Where is this requirement located? Does this apply to
> photodiodes also?
> 
> 2.I have a concern of what I need to know about Laser safety but was
> afraid to ask (because it would cost more than my compliance budget ($0)
> would allow without manager approval). In other words (what is the second
> question?... I am getting there.) I am looking to hire a consultant or
> take a course. My supervisor wants me to create for him a proposal
> answering the type of questions that support the need to either attend a
> course or have a consultant educate me or our professionals here so that
> he can decide whether or not we need to hire a consultant, etc, etc. To
> keep this short, I will paraphrase by saying that the type of questions he
> would like to have answered is it worth the expense to getting smart, as
> engineers and a manufacturer of ITE, in the manufacturing of laser
> systems? 
> 
> Here is my question...
> Is there information available that summarizes the responsibilities to
> Laser Safety of Compliance, Design, Manufacturing, and Test Engineers that
> manufacture laser systems? 
> 
> You may respond either on or off line. Thanks in Advance!
> 
> 
>   Michael S. Davis
>   Compliance Engineer
>   C-C0R.net 
>   Tel: 203.630.5788
>   Fax: 203.630.5762
>   mike.da...@c-cor.net
> 
> 

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Two Questions concerning the subject of Laser Safety

[Davis, Mike]

1.  Are manufacturers required by the FDA to record serial numbers of
Laser modules.  Where is this requirement located? Does this apply to
photodiodes also?

2.  I have a concern of what I need to know about Laser safety but was
afraid to ask (because it would cost more than my compliance budget ($0)
would allow without manager approval). In other words (what is the second
question?... I am getting there.) I am looking to hire a consultant or take
a course. My supervisor wants me to create for him a proposal answering the
type of questions that support the need to either attend a course or have a
consultant educate me or our professionals here so that he can decide
whether or not we need to hire a consultant, etc, etc. To keep this short, I
will paraphrase by saying that the type of questions he would like to have
answered is it worth the expense to getting smart, as engineers and a
manufacturer of ITE, in the manufacturing of laser systems? 

Here is my question...
Is there information available that summarizes the responsibilities to Laser
Safety of Compliance, Design, Manufacturing, and Test Engineers that
manufacture laser systems? 

You may respond either on or off line. Thanks in Advance!


>   Michael S. Davis
>   Compliance Engineer
>   C-C0R.net 
>   Tel: 203.630.5788
>   Fax: 203.630.5762
>   mike.da...@c-cor.net
> 
> 
<>

Laser Safety Verification

[georgea]

One way to generate a form of compliance to laser safety standards
is to obtain a CB Report based on, or including IEC 60825-1.  Although
this is used largely as a means of proving conformity to the EU Directives,
I suspect it would be acceptable to concerned buyers world-wide.

George Alspaugh
Lexmark International Inc.



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RE: ( More) Laser Safety Questions

[Peter Tarver]

Doug -

I was in no way implying the flaw was yours.  The flaw lies
in the practical implementation of the system.

Peter

> -Original Message-
> From: Massey, Doug C. [mailto:masse...@ems-t.com]
> Sent: Thursday, March 21, 2002 10:40 AM
>
> Peter - I humbly submit that there is no 'flaw'
> in reminding folks that
> audits do happen and that they may be subject to
> one, however rare they may
> be.
>
> Doug Massey


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RE: ( More) Laser Safety Questions

[Massey, Doug C.]

Peter - I humbly submit that there is no 'flaw' in reminding folks that
audits do happen and that they may be subject to one, however rare they may
be. I don't argue that the agency is understaffed and overworked, and is
more concerned with laser light shows and medical device lasers than with
low-power, visible laser devices.

Regards,

Doug Massey
Lead Regulatory Engineer
LXE, Inc.

-Original Message-
From: Peter Tarver [mailto:peter.tar...@sanmina-sci.com]
Sent: Thursday, March 14, 2002 11:52 AM
To: emc-p...@ieee.org
Cc: Massey, Doug C.
Subject: RE: ( More) Laser Safety Questions


All -

The only flaw with this is that, based on my previous
discussions with CDRH folks, they have very few auditors and
no budget to hire more (this was a few years ago).
Therefore, by their admission, the primary methods of
keeping manufacturers and importers honest is

1) trust in the manufacturer's basic honesty

2) complaints from competitors, customers, etc.

3) field incidents

Their primary concern was keeping up with the laser light
shows, which they said they could not set aside auditing on
(and for good reason).

As a test of the presumption, has anyone on this list ever
had a CDRH auditor in their facility, other than related to
a laser light show?


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com

> -Original Message-
> From: Massey, Doug C.
> Sent: Wednesday, March 13, 2002 6:51 AM
>
> Hi Jeffrey,
> I've seen answers to this post regarding
> enforcement of the IEC standard, as
> well as to the CDRH rules. However, no one has
> mentioned FDA audits.
>
> The FDA does conduct periodic audits at the
> manufacturer's location as
> reported in the Product Reports and Annual
> Reports submitted to them. The
> auditor will check record keeping, quality
> control, and product design
> aspects such as proper labeling. My company has
> been producing laser
> products for many years, and only one audit has
> been conducted, that anyone
> can remember. I was the representative during
> that audit, and I commend the
> auditor on his professionalism and thoroughness.
> The auditor was a pleasure
> to work with, but he was very thorough. Rather
> than a 'let me see what I can
> nail you on' attitude, the auditor I dealt with
> had a 'let me see if I can
> help you improve your compliance process'
> attitude. The auditor will call
> ahead and let you know the date for the audit -
> an appreciated courtesy, but
> the date is not negotiable.
>
> Note that the FDA only has jurisdiction over
> manufacturing locations within
> the US. That's why it falls largely to customs to
> enforce imported goods, I
> presume. It is also noteworthy that the FDA has a
> very broad scope and
> generally has much bigger fish to fry than a
> manufacturer of low-power laser
> devices - I think that's why the frequency of
> audits for manufacturers like
> us is so low. You may never have the pleasure.
>
> For complete information about penalties and
> other administrative topics,
> check
> http://www.fda.gov/cdrh/radhlth/fdcact5c.html ,
> the Electronic Product
> Radiation Control section of the Federal Food,
> Drug, and Cosmetic Act.
> Section 360pp covers Enforcement and Penalties.
>
> Hope this helps.
>
> Doug Massey
> Lead Regulatory Engineer
> LXE, Inc.

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RE: ( More) Laser Safety Questions

[Peter Tarver]

All -

The only flaw with this is that, based on my previous
discussions with CDRH folks, they have very few auditors and
no budget to hire more (this was a few years ago).
Therefore, by their admission, the primary methods of
keeping manufacturers and importers honest is

1) trust in the manufacturer's basic honesty

2) complaints from competitors, customers, etc.

3) field incidents

Their primary concern was keeping up with the laser light
shows, which they said they could not set aside auditing on
(and for good reason).

As a test of the presumption, has anyone on this list ever
had a CDRH auditor in their facility, other than related to
a laser light show?


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com

> -Original Message-
> From: Massey, Doug C.
> Sent: Wednesday, March 13, 2002 6:51 AM
>
> Hi Jeffrey,
> I've seen answers to this post regarding
> enforcement of the IEC standard, as
> well as to the CDRH rules. However, no one has
> mentioned FDA audits.
>
> The FDA does conduct periodic audits at the
> manufacturer's location as
> reported in the Product Reports and Annual
> Reports submitted to them. The
> auditor will check record keeping, quality
> control, and product design
> aspects such as proper labeling. My company has
> been producing laser
> products for many years, and only one audit has
> been conducted, that anyone
> can remember. I was the representative during
> that audit, and I commend the
> auditor on his professionalism and thoroughness.
> The auditor was a pleasure
> to work with, but he was very thorough. Rather
> than a 'let me see what I can
> nail you on' attitude, the auditor I dealt with
> had a 'let me see if I can
> help you improve your compliance process'
> attitude. The auditor will call
> ahead and let you know the date for the audit -
> an appreciated courtesy, but
> the date is not negotiable.
>
> Note that the FDA only has jurisdiction over
> manufacturing locations within
> the US. That's why it falls largely to customs to
> enforce imported goods, I
> presume. It is also noteworthy that the FDA has a
> very broad scope and
> generally has much bigger fish to fry than a
> manufacturer of low-power laser
> devices - I think that's why the frequency of
> audits for manufacturers like
> us is so low. You may never have the pleasure.
>
> For complete information about penalties and
> other administrative topics,
> check
> http://www.fda.gov/cdrh/radhlth/fdcact5c.html ,
> the Electronic Product
> Radiation Control section of the Federal Food,
> Drug, and Cosmetic Act.
> Section 360pp covers Enforcement and Penalties.
>
> Hope this helps.
>
> Doug Massey
> Lead Regulatory Engineer
> LXE, Inc.


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RE: ( More) Laser Safety Questions

[Massey, Doug C.]

Hi Jeffrey,
I've seen answers to this post regarding enforcement of the IEC standard, as
well as to the CDRH rules. However, no one has mentioned FDA audits.

The FDA does conduct periodic audits at the manufacturer's location as
reported in the Product Reports and Annual Reports submitted to them. The
auditor will check record keeping, quality control, and product design
aspects such as proper labeling. My company has been producing laser
products for many years, and only one audit has been conducted, that anyone
can remember. I was the representative during that audit, and I commend the
auditor on his professionalism and thoroughness. The auditor was a pleasure
to work with, but he was very thorough. Rather than a 'let me see what I can
nail you on' attitude, the auditor I dealt with had a 'let me see if I can
help you improve your compliance process' attitude. The auditor will call
ahead and let you know the date for the audit - an appreciated courtesy, but
the date is not negotiable. 

Note that the FDA only has jurisdiction over manufacturing locations within
the US. That's why it falls largely to customs to enforce imported goods, I
presume. It is also noteworthy that the FDA has a very broad scope and
generally has much bigger fish to fry than a manufacturer of low-power laser
devices - I think that's why the frequency of audits for manufacturers like
us is so low. You may never have the pleasure. 

For complete information about penalties and other administrative topics,
check http://www.fda.gov/cdrh/radhlth/fdcact5c.html , the Electronic Product
Radiation Control section of the Federal Food, Drug, and Cosmetic Act.
Section 360pp covers Enforcement and Penalties.

Hope this helps.

Re: (More) Laser Safety Questions

[John Juhasz]

With regards to EN-60825, I would tend to believe (I did not want to say
'assume') that the
enforcement parallels the that for CE marking - customs, market
surveillance, customer/competitor
complaints, etc. 

In the US I would say it's 'the Feds'  -  21CFR 1040 is a 'Code of Federal
Regulations'. In this
case it would be agents from the FDA. But taking Doug McKean's response into
consideration,
focusing on OFCS, we can also include NRTLs in enforcement of compliance -
at least with
respect to the 'initial' compliance of the product. 

In the ITE standards (950, 1950, 60950) section 4.3.12 references lasers,
and notes that
equipment "shall be so designed that harmful effects to persons and
materials affecting
safety are prevented " . . .or something of that sort. In this case the NRTL
(at least the
big one that I use) would want to verify this - using 21CFR 1040 and EN
60825 as
their guide. I have had to provide not only the 'document received' letter
with accession
number from the CDRH, but also with the report that I filed. My listing was
contingent upon providing that supporting info. If you going to incorporate,
and not
modify an already classified laser, you would have submit that component
manufacturer's
supporting data.

While perhaps a definitive enforcement 'Agency X' does not exist, there are
hurdles that
need to be cleared. And considering today's economy, I wouldn't think any of
our employers would want to have trouble with 'the Feds'.

Just my own opinions . . . .

John Juhasz
Fiber Options
Div. of GE Interlogix
Bohemia, NY

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RE: ( More) Laser Safety Questions

[Peter Tarver]

Jeffery -

I have no answer to the enforcement question for the US, but
I suspect it's complaint and incident driven, as the EMC
regulations historically have been.

For NRTLs, the acceptance of previously certified Class I
lasers incorporated into other equipment is based on CDRH
Laser Notice 42, available as a part of all Laser Notices at

http://www.fda.gov/cdrh/radhlth/pdf/laspol01.pdf

Links to other useful information is available at

http://www.fda.gov/cdrh/radhlth/index.html


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com

> -Original Message-
> From: Collins, Jeffrey
> Sent: Monday, March 11, 2002 7:32 PM
>
> Hello Group,
>
> There was a lot of good dialog recently regarding
> laser safety. Thanks to
> all that participated
>
> Questions:
>
> Who enforces the FDA CDRH 1040.1 laser safety
> standards in the US?
>
> How is it enforced?
>
> What are the penalties for noncompliance?
>
> Who enforces the IEC or EN 60825 laser safety
> standards in Europe /
> Globally?
>
> How is it enforced?
>
> What are the penalties for noncompliance?
>
>
> My questions are stemming from the Class 1 or 1M
> laser safety requirements
> particularly in Telecom networks.
> Some NRTL's and CAB's do not require or do not
> enforce their clients doing a
> submittal ( To the FDA ) for installing these
> types of laser products in
> your equipment. Their decision was based on your
> company using a class 1
> laser that carries a current NRTL / CAB safety
> certification which was not
> modified from it's original design when installed
> into your products.
>
> Thanks in advance,
>
> Jeffrey Collins


---
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Re: ( More) Laser Safety Questions

[Doug McKean]

I don't know.  That's a very interesting question. 

For each separate title in the CFRs there's a 
separate federal enforcement agency. 
CFR Title 47 Telecommunications is the FCC. 
CFR Title 29 Labor (or workplace stuff) is OSHA, etc ... 
and thus CFR Title 21 Food and Drugs is FDA. 

That's what happens when new laws come into 
effect - they try to determine if an enforcement 
agency already exists.  If there is none, then they 
have to start up a whole new agency. That's why 
the FCC was started (as were others) when the 
law was passed regarding telecommunications. 
So that's why CFR Title 47 is FCC country and 
CFR Title 21 is FDA country and the two don't mix. 

Keep in mind that although the laser laws are 
obviously written for laser safety, much of it is 
actually for the medical field as well as experimental 
scientific stuff where the potential for immediate 
and permanent harm is present. 

The OSHA requirement specifically addresses 
equipment being approved by an NRTL. But, 
with laser products and systems, you apply to 
the FDA. The FDA is not an NRTL. And it 
will never be since NRTLs are approved by 
OSHA.  The FDA and OSHA are enforcement 
federal agencies in parallel with each other and 
don'tapprove each other's methods. 

And you get nothing back from the FDA except some 
letter acknowledging your submittal.  Nothing else. 
There's no "approval" to speak of.  Certainly if you 
misrepresent your laser product or system and some 
unfortunate incident were to happen, you would most 
likely be charged with something from the FDA itself. 
But not limited to the FDA. 

The radiological side of things are also touched on 
by something like 1950 which probably does borrow 
from the FDA.  And since 1950 is used by NRTLs 
for product compliance, maybe that's how OSHA 
might also get involved. 

It sounds as though if you're unfortunate to have 
some accident befall you, you could potentially get 
multiple hits from several different federal agencies. 

I don't know Jeff.  Like to hear the others about this. 

Regards, Doug McKean 



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Re: ( More) Laser Safety Questions

[CherryClough]

Don't forget the European Product Liability Directive (85/374/EEC amended by 
99/34/EC) and General Product Safety Directive (92/59/EEC).

Neither of these require any approvals or markings, but both require that the 
state of the art in safety engineering is applied, and this implies the use 
of all relevant standards, whether harmonised or not, and world-class expert 
knowledge where international standards are incomplete or inappropriate.

Note that both of them include civil liability requirements that can see 
companies held liable for unlimited financial penalties without the injured 
party having to prove that the product actually caused the injury. 
This is variously known as "no-fault liability" or "strict liability", and 
the larger your company is, the more likely it is to be a target for no-win 
no-fee lawyers.

Whether you complied with these directives or not is determined by a court 
while you are being sued. It is getting more and more difficult, I am told, 
for manufacturer to make a successful defence.

The UK's implementation of the Product Liability directive is the 1987 
Consumer Protection Act. A useful guide to this used to be found at: 
http://www.lowpay.gov.uk/access/consumer/intro.html. 

The UK's implementation of the GPSD is the 'General Product Safety 
Regulations 1994', and a guide used to be available at: 
http://www.dti.gov.uk/access/safreg94/foreword.html#1 .

All the very best!
Keith Armstrong
www.cherryclough.com

In a message dated 12/03/02 15:30:57 GMT Standard Time, 
andrew_car...@uk.xyratex.com writes:

> Subj:RE: ( More) Laser Safety Questions
> Date:12/03/02 15:30:57 GMT Standard Time
> From:andrew_car...@uk.xyratex.com (Andrew Carson)
> Sender:owner-emc-p...@majordomo.ieee.org
> Reply-to:  HREF="mailto:andrew_car...@uk.xyratex.com";>andrew_car...@uk.xyratex.com 
> (Andrew Carson)
> To:jcoll...@ciena.com (Collins, Jeffrey), emc-p...@ieee.org
> 
> Jeff
> 
> In response the second part of your question on who enforces EN60825
> within Europe. If the laser device is used on a product that falls under
> on of the CE (or New Approach Directives ) eg. The LVD. Then the
> enforcement will be like any other CE marked goods. Which varies from
> country to country, bt for the UK the CE mark is watched over by the
> Depeartment of Trade and Industy and the The Office of Trading
> Standards. 
> 
> Now complaice to a CE marking directive carries penalities ranging from
> Finess, porduct recal and worst case upto 2 years jail time for the
> person signing the DOC. The enforcement is made agaist the perosn, not
> the company.
> 
> Starngely though, if your Laser porduct does not fall under a CE
> directive, there is no piece of European legistation saying it needs to
> meet EN60825, beyond the old Product Safety Directive (Which does not
> require a CE mark).
> 
> In your case, if you are incororating an already CDRH registered Class 1
> device into your product without alteration. Then you do not need to re
> register your overall product. This is covered by a CDRH notice to the
> laser industry No. 42.
> 
> Andrew Carson - Senior Compliance Engineer, Xyratex, UK
> 
> Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014
> 
> 
> -----Original Message-
> From: Chris Maxwell [mailto:chris.maxw...@nettest.com] 
> Sent: 12 March 2002 13:22
> To: Collins, Jeffrey; emc-p...@ieee.org
> Subject: RE: ( More) Laser Safety Questions
> 
> 
> I believe that OSHA enforces the CDRH laser safety guidelines in the
> workplace.  I'm not sure about consumer goods...Possibly the Consumer
> Product Safety Commission?
> 
> Penalties for non-compliance would be the typical fines, recalls ...
> handed out by OSHA or CPSC.
> 
> > -Original Message-
> > From:Collins, Jeffrey [SMTP:jcoll...@ciena.com]
> > Sent:Monday, March 11, 2002 10:32 PM
> > To:'emc-p...@ieee.org'
> > Subject:( More)  Laser Safety Questions
> > 
> > 
> > Hello Group,
> > 
> > There was a lot of good dialog recently regarding laser safety. Thanks
> > to
> > all that participated 
> > 
> > Questions:
> > 
> > Who enforces the FDA CDRH 1040.1 laser safety standards in the US?  
> > 
> > How is it enforced? 
> > 
> > What are the penalties for noncompliance?
> > 
> > Who enforces the IEC or EN 60825 laser safety standards in Europe /
> > Globally?
> > 
> > How is it enforced? 
> > 
> > What are the penalties for noncompliance? 
> > 
> > 
> > My questions are stemming from the Class 1 or 1M laser safety
> > requirements
> > particularly in Telecom networks.
> > Some NRTL&

RE: ( More) Laser Safety Questions

[Chris Maxwell]

Great point regarding customs.  One that I hadn't thought of since we
are a "homegrown" manufacturer.

> -Original Message-
> From: Andrew Carson [SMTP:andrew_car...@uk.xyratex.com]
> Sent: Tuesday, March 12, 2002 10:08 AM
> To:   Chris Maxwell; Collins, Jeffrey; emc-p...@ieee.org
> Subject:  RE: ( More)  Laser Safety Questions
> 
> As an Importer of Laser good into the states, it is US Customs who
> enforce the CDRH requirements. Penalties will range from refusal of
> entry to fines for false declaration of your goods.
> 
> Once in the US it falls to State and Local laws to enforce compliance.
> I
> do not think the Product Safety Commission has any real power's in
> this
> area, beyond if the good's are unsafe.
> 
> I have attached a pdf which covers the various state regulation's
> above
> and beyond the requirements of the CDRH. Hope this helps.
> 
> Andrew Carson - Senior Compliance Engineer, Xyratex, UK
> 
> Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014
> 
> 
> -Original Message-
> From: Chris Maxwell [mailto:chris.maxw...@nettest.com] 
> Sent: 12 March 2002 13:22
> To: Collins, Jeffrey; emc-p...@ieee.org
> Subject: RE: ( More) Laser Safety Questions
> 
> 
> I believe that OSHA enforces the CDRH laser safety guidelines in the
> workplace.  I'm not sure about consumer goods...Possibly the Consumer
> Product Safety Commission?
> 
> Penalties for non-compliance would be the typical fines, recalls ...
> handed out by OSHA or CPSC.
> 
> > -Original Message-
> > From:   Collins, Jeffrey [SMTP:jcoll...@ciena.com]
> > Sent:   Monday, March 11, 2002 10:32 PM
> > To: 'emc-p...@ieee.org'
> > Subject:( More)  Laser Safety Questions
> > 
> > 
> > Hello Group,
> > 
> > There was a lot of good dialog recently regarding laser safety.
> Thanks
> > to
> > all that participated!!!! 
> > 
> > Questions:
> > 
> > Who enforces the FDA CDRH 1040.1 laser safety standards in the US?  
> > 
> > How is it enforced? 
> > 
> > What are the penalties for noncompliance?
> > 
> > Who enforces the IEC or EN 60825 laser safety standards in Europe /
> > Globally?
> > 
> > How is it enforced? 
> > 
> > What are the penalties for noncompliance? 
> > 
> > 
> > My questions are stemming from the Class 1 or 1M laser safety
> > requirements
> > particularly in Telecom networks.
> > Some NRTL's and CAB's do not require or do not enforce their clients
> > doing a
> > submittal ( To the FDA ) for installing these types of laser
> products
> > in
> > your equipment. Their decision was based on your company using a
> class
> > 1
> > laser that carries a current NRTL / CAB safety certification which
> was
> > not
> > modified from it's original design when installed into your
> products. 
> > 
> > 
> > 
> > Thanks in advance,
> > 
> > Jeffrey Collins
> > Sr. HW Engineering Manager 
> > EMC/ NEBS/ Safety/ Reliability
> > CIENA  Core Switching Division
> > 10480 Ridgeview Court, Cupertino, CA. 95014
> > (408) 366-4806, Fax (408) 366-4866
> > jcoll...@ciena.com
> > http://www.ciena.com
> > 
> > 
> > 
> > 
> > 
> > 
> > 
> > 
> > 
> > ---
> > This message is from the IEEE EMC Society Product Safety
> > Technical Committee emc-pstc discussion list.
> > 
> > Visit our web site at:  http://www.ewh.ieee.org/soc/emcs/pstc/
> > 
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> > Click on "browse" and then "emc-pstc mailing list"
> 
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RE: ( More) Laser Safety Questions

[Andrew Carson]

Jeff

In response the second part of your question on who enforces EN60825
within Europe. If the laser device is used on a product that falls under
on of the CE (or New Approach Directives ) eg. The LVD. Then the
enforcement will be like any other CE marked goods. Which varies from
country to country, bt for the UK the CE mark is watched over by the
Depeartment of Trade and Industy and the The Office of Trading
Standards. 

Now complaice to a CE marking directive carries penalities ranging from
Finess, porduct recal and worst case upto 2 years jail time for the
person signing the DOC. The enforcement is made agaist the perosn, not
the company.

Starngely though, if your Laser porduct does not fall under a CE
directive, there is no piece of European legistation saying it needs to
meet EN60825, beyond the old Product Safety Directive (Which does not
require a CE mark).

In your case, if you are incororating an already CDRH registered Class 1
device into your product without alteration. Then you do not need to re
register your overall product. This is covered by a CDRH notice to the
laser industry No. 42.

Andrew Carson - Senior Compliance Engineer, Xyratex, UK

Phone: +44 (0)23 9249 6855 Fax: +44 (0)23 9249 6014


-Original Message-
From: Chris Maxwell [mailto:chris.maxw...@nettest.com] 
Sent: 12 March 2002 13:22
To: Collins, Jeffrey; emc-p...@ieee.org
Subject: RE: ( More) Laser Safety Questions


I believe that OSHA enforces the CDRH laser safety guidelines in the
workplace.  I'm not sure about consumer goods...Possibly the Consumer
Product Safety Commission?

Penalties for non-compliance would be the typical fines, recalls ...
handed out by OSHA or CPSC.

> -Original Message-
> From: Collins, Jeffrey [SMTP:jcoll...@ciena.com]
> Sent: Monday, March 11, 2002 10:32 PM
> To:   'emc-p...@ieee.org'
> Subject:  ( More)  Laser Safety Questions
> 
> 
> Hello Group,
> 
> There was a lot of good dialog recently regarding laser safety. Thanks
> to
> all that participated 
> 
> Questions:
> 
> Who enforces the FDA CDRH 1040.1 laser safety standards in the US?  
> 
> How is it enforced? 
> 
> What are the penalties for noncompliance?
> 
> Who enforces the IEC or EN 60825 laser safety standards in Europe /
> Globally?
> 
> How is it enforced? 
> 
> What are the penalties for noncompliance? 
> 
> 
> My questions are stemming from the Class 1 or 1M laser safety
> requirements
> particularly in Telecom networks.
> Some NRTL's and CAB's do not require or do not enforce their clients
> doing a
> submittal ( To the FDA ) for installing these types of laser products
> in
> your equipment. Their decision was based on your company using a class
> 1
> laser that carries a current NRTL / CAB safety certification which was
> not
> modified from it's original design when installed into your products. 
> 
> 
> 
> Thanks in advance,
> 
> Jeffrey Collins
> Sr. HW Engineering Manager 
> EMC/ NEBS/ Safety/ Reliability
> CIENA  Core Switching Division
> 10480 Ridgeview Court, Cupertino, CA. 95014
> (408) 366-4806, Fax (408) 366-4866
> jcoll...@ciena.com
> http://www.ciena.com
> 
> 
> 
> 
> 
> 
> 
> 
> 
> ---
> This message is from the IEEE EMC Society Product Safety
> Technical Committee emc-pstc discussion list.
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RE: ( More) Laser Safety Questions

[Chris Maxwell]

I believe that OSHA enforces the CDRH laser safety guidelines in the
workplace.  I'm not sure about consumer goods...Possibly the Consumer
Product Safety Commission?

Penalties for non-compliance would be the typical fines, recalls ...
handed out by OSHA or CPSC.

> -Original Message-
> From: Collins, Jeffrey [SMTP:jcoll...@ciena.com]
> Sent: Monday, March 11, 2002 10:32 PM
> To:   'emc-p...@ieee.org'
> Subject:  ( More)  Laser Safety Questions
> 
> 
> Hello Group,
> 
> There was a lot of good dialog recently regarding laser safety. Thanks
> to
> all that participated 
> 
> Questions:
> 
> Who enforces the FDA CDRH 1040.1 laser safety standards in the US?  
> 
> How is it enforced? 
> 
> What are the penalties for noncompliance?
> 
> Who enforces the IEC or EN 60825 laser safety standards in Europe /
> Globally?
> 
> How is it enforced? 
> 
> What are the penalties for noncompliance? 
> 
> 
> My questions are stemming from the Class 1 or 1M laser safety
> requirements
> particularly in Telecom networks.
> Some NRTL's and CAB's do not require or do not enforce their clients
> doing a
> submittal ( To the FDA ) for installing these types of laser products
> in
> your equipment. Their decision was based on your company using a class
> 1
> laser that carries a current NRTL / CAB safety certification which was
> not
> modified from it's original design when installed into your products. 
> 
> 
> 
> Thanks in advance,
> 
> Jeffrey Collins
> Sr. HW Engineering Manager 
> EMC/ NEBS/ Safety/ Reliability
> CIENA  Core Switching Division
> 10480 Ridgeview Court, Cupertino, CA. 95014
> (408) 366-4806, Fax (408) 366-4866
> jcoll...@ciena.com
> http://www.ciena.com
> 
> 
> 
> 
> 
> 
> 
> 
> 
> ---
> This message is from the IEEE EMC Society Product Safety
> Technical Committee emc-pstc discussion list.
> 
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( More) Laser Safety Questions

[Collins, Jeffrey]

Hello Group,

There was a lot of good dialog recently regarding laser safety. Thanks to
all that participated 

Questions:

Who enforces the FDA CDRH 1040.1 laser safety standards in the US?  

How is it enforced? 

What are the penalties for noncompliance?

Who enforces the IEC or EN 60825 laser safety standards in Europe /
Globally?

How is it enforced? 

What are the penalties for noncompliance? 


My questions are stemming from the Class 1 or 1M laser safety requirements
particularly in Telecom networks.
Some NRTL's and CAB's do not require or do not enforce their clients doing a
submittal ( To the FDA ) for installing these types of laser products in
your equipment. Their decision was based on your company using a class 1
laser that carries a current NRTL / CAB safety certification which was not
modified from it's original design when installed into your products. 



Thanks in advance,

Jeffrey Collins
Sr. HW Engineering Manager 
EMC/ NEBS/ Safety/ Reliability
CIENA  Core Switching Division
10480 Ridgeview Court, Cupertino, CA. 95014
(408) 366-4806, Fax (408) 366-4866
jcoll...@ciena.com
http://www.ciena.com









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RE: Laser Safety

[Davis, Mike]

I also thank you all that have responded. 


--- Begin Message ---


Thanks, I appreciate the input.

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
USA
(616) 257 2469
mschm...@xrite.com  


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Laser Safety

[Mark Schmidt]

Thanks, I appreciate the input.

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
USA
(616) 257 2469
mschm...@xrite.com  


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RE: Laser Safety

[Peter Tarver]

Mark & John -

Since 21CFR is based on ANSI Z136.1, it seems the best of
references.  However, 21CFR is the ultimate judge for the
US.

ANSI Z136.2 is for fiber optic systems, rather than
products, but is still a good reference.

Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com

> -Original Message-
> From: John Juhasz
> Sent: Tuesday, March 05, 2002 12:28 PM
>
> Your best bet in classifying your 'system' is to
> look at ANSI Z136.1 and .2 specs. In my opinion
> (some may disagree)
> it's a good guide.
>
> John Juhasz
> Fiber Options
> Bohemia, NY


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RE: Laser Safety

[Peter Tarver]

Mark -

My first inclination is to ask: do you need Class I?  In the
US, the higher classes of laser products primarily require
labeling and additional information in instruction manuals.
As stated by Doug McKean, 21CFR allows the fiber optic
system connections to provide a level of safety, in the
sense that an open or broken fiber is not considered.

If the product will be marketing internationally,
IEC60825-1, Class 3B does have some potential design
requirements, but is otherwise significantly similar to
21CFR.  For IEC60825-1, fiber disconnection (as a
maintenance/service activity) and breakage (as a fault
condition) is considered in determination of laser class.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com


> -Original Message-
> From: Mark Schmidt
> Sent: Tuesday, March 05, 2002 11:17 AM
>
> I am trying to gain a better understanding of
> lasers and I have had some
> discussion and been told some things that don’t
> make much sense to me so
> I am asking the group for some guidance. Here is
> my question.
>
> If the unexpanded raw beam of a Class III b laser
> was incorporated into
> a larger system, is then expanded and used in
> this same system reducing
> the beam intensity to Class I levels. Would the
> overall system be
> classified as Class I ?
>
> Thanks.
>
> Mark Schmidt
> Regulatory Compliance
> X-Rite Incorporated
> U.S.A.
> (616) 257 2469
> mschm...@xrite.com 


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RE: Laser Safety

[Peter Tarver]

All -

ANSI standards are not free, but some may be purchased in
soft copy form and those standards are downloadable.

If IEC60825-1 requirements are used for a product, you must
review CDRH Laser Notice 50 to see how you are effected.
This can't be a "markings only" type of thing; you have to
use the whole standard.  The certification marking mentioned
in Laser Notice 50 is more verbose than the plain old 21CFR
marking.  Other marking differences exist for higher laser
classes where the ANSI based logotype is replaced by
IEC60825-1 markings.

The harmonization project between IEC TC76 and 21CFR is
ongoing.  I don't know the status, but it's not completed.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina-SCI Homologation Services
peter.tar...@sanmina-sci.com

> -Original Message-
> From: John Juhasz
> Sent: Wednesday, March 06, 2002 6:47 AM
>
> I tried looking real hard for free downloadable ANSI specs
> and couldn't find them - I had to buy them.
>
> Regarding labelling, there have been efforts (not sure
> of the status at this time - is there anyone out
> there who knows?) to harmonize the EN 60825 and
> 21CFR1040 to make it easier on manufacturers.
> As the final laser classifications are parallel
> (it's the methodology that has differences)
> the FDA, in the interest of manufacturer satisfaction(?)
> has been allowing the use of the Classification/Warning
> labels as described in EN 60825. But you still have to
> add the FDA-CDRH label "This product complies with FDA
> Radiation Performance Standard 21 CFR Subpart J"
>
> Hope this helps.
>
> John Juhasz
> Fiber Options
> Bohemia, NY


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RE: Laser Safety

[Robert Wilson]

Regarding the comment John made (snipped below), I think that in some
regards, regulatory warnings are partially to blame for installers/users
not paying proper attention to safety requirements. 

In North America, the tendency is to require verbose, rambling warnings
that tend to include so much redundant or even irrelevant information
that the user just ignores them. This is in general contrast to the
tendency in Europe, where warnings are kept short and "punchy", or even
totally replaced by eye-catching symbols.

One can imagine ol' "Bubba" the installer faced with a warning
containing a paragraph of legalistic run-on sentences that cannot seem
to get to the point in a concise manner. He is simply going to ignore
the whole thing.

A case in point is the FCC Class B warning on consumer electronic
equipment. Is there anyone on the planet who has actually bothered to
fully read this warning? Seems to me that this is a general problem that
ought to be addressed.

Bob Wilson
TIR Systems Ltd.
Vancouver.

-Original Message-
From: John Juhasz [mailto:jjuh...@fiberoptions.com] 
Sent: March 6, 2002 6:17 AM
To: 'Mark Schmidt'; emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


[Snip]

In my opinion, whether or not the installers/service/end-user
is trained or not (sometimes the trained are worse because
they tend to be over-confident and throw caution to the wind)
it's worth marking the areas on/in the product as well as 
putting references in the manual.


John Juhasz
Fiber Options
Bohemia, NY



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RE: Laser Safety

[Peter Merguerian]

Hello All,

Yes, the FDA permits the use of IEC 825 labelling in lieu of CFR1040
labelling. 

However, note that IEC 825 permits the Class 1 label to be in the
instructions rather than on the product. The FDA requires you to have the
Class 1 labelling on the product.

This e-mail message may contain privileged or confidential information. If
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received this e-mail message in error, please return by forwarding the
message and its attachments to the sender.


PETER S. MERGUERIAN
Technical Director
I.T.L. (Product Testing) Ltd.
26 Hacharoshet St., POB 211
Or Yehuda 60251, Israel
Tel: + 972-(0)3-5339022  Fax: + 972-(0)3-5339019
Mobile: + 972-(0)54-838175
http://www.itl.co.il
http://www.i-spec.com





-Original Message-
From: John Juhasz [mailto:jjuh...@fiberoptions.com]
Sent: Wednesday, March 06, 2002 4:47 PM
To: 'Davis, Mike'; 'Doug Mckean'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety



I tried looking real hard for free downloadable ANSI specs
and couldn't find them - I had to buy them.

Regarding labelling, there have been efforts (not sure
of the status at this time - is there anyone out
there who knows?) to harmonize the EN 60825 and
21CFR1040 to make it easier on manufacturers. 
As the final laser classifications are parallel
(it's the methodology that has differences)
the FDA, in the interest of manufacturer satisfaction(?) 
has been allowing the use of the Classification/Warning
labels as described in EN 60825. But you still have to
add the FDA-CDRH label "This product complies with FDA
Radiation Performance Standard 21 CFR Subpart J" 

Hope this helps.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 9:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?



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Re: Laser Safety

[Doug McKean]

Gary, agreed.  It must be clearly stated. 
As Jon Curtis mentioned, this is a very 
tricky declaration but one I've done. 
Also, in another post, I mentioned that 
some agencies will challange disconnect 
of the receive end leaving the fiber live. 

- Doug McKean 



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Re: Laser Safety

[Doug McKean]

Yes, Jon, thanks. Again, I was being very specific 
about the caveats for this declaration. 

Also, not only breaks with fiber, but there are 
some European agencies which have challanged 
the fact that if the fiber connection to the receiver 
end of the fiber is disconnected, there is a "live" 
end of the fiber capable of Class IIIb exposure. 

Proceed with caution. 

- Doug McKean 



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RE: Laser Safety

[Joshua Wiseman]

This message is in MIME format. Since your mail reader does not understand
this format, some or all of this message may not be legible.
You may be interested in this.  It is Laser Notice 50 from CDRH allowing
conformance to the EN60825-1 Am2.  There are still CDRH requirements you
must follow but this certainly lightens the load.

Regards,
Josh



-Original Message-
From: John Juhasz [mailto:jjuh...@fiberoptions.com]
Sent: Wednesday, March 06, 2002 6:47 AM
To: 'Davis, Mike'; 'Doug Mckean'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety



I tried looking real hard for free downloadable ANSI specs
and couldn't find them - I had to buy them.

Regarding labelling, there have been efforts (not sure
of the status at this time - is there anyone out
there who knows?) to harmonize the EN 60825 and
21CFR1040 to make it easier on manufacturers. 
As the final laser classifications are parallel
(it's the methodology that has differences)
the FDA, in the interest of manufacturer satisfaction(?) 
has been allowing the use of the Classification/Warning
labels as described in EN 60825. But you still have to
add the FDA-CDRH label "This product complies with FDA
Radiation Performance Standard 21 CFR Subpart J" 

Hope this helps.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 9:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?



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fda.pdf
Description: Binary data

Re: Laser Safety

[Doug McKean]

Hi Mark, 

I was very specific about the conditions of the declaration. 
Scuse me for being a lawyer, but in order to do the type 
of declaration I mentioned, you must clearly state that 
all laser ports be populated even during service or 
maintainance. 

Regards, Doug McKean 



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Re: Laser Safety

[Jon Curtis]

See laser notice 50 from the FDA. 
http://www.fda.gov/cdrh/radhlth/laser.html


It's allowed, but you have to change the certification statement to 
indicate that you are using the notice.


Jon Curtis
Curtis-Straus LLC

John Juhasz wrote:


I tried looking real hard for free downloadable ANSI specs
and couldn't find them - I had to buy them.

Regarding labelling, there have been efforts (not sure
of the status at this time - is there anyone out
there who knows?) to harmonize the EN 60825 and
21CFR1040 to make it easier on manufacturers. 
As the final laser classifications are parallel

(it's the methodology that has differences)
the FDA, in the interest of manufacturer satisfaction(?) 
has been allowing the use of the Classification/Warning

labels as described in EN 60825. But you still have to
add the FDA-CDRH label "This product complies with FDA
Radiation Performance Standard 21 CFR Subpart J" 


Hope this helps.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 9:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?



---
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--
Jon D. Curtis, P.E.

Director of Engineering
Curtis-Straus LLC NRTL TCB

One Stop Laboratory for NEBS, EMC, 
Product Safety, and Telecom Testing.

527 Great Road
Littleton, MA 01460 USA
Voice 978-486-8880  Fax 978-486-8828
email: jcur...@curtis-straus.com
WWW.CURTIS-STRAUS.COM




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Re: Laser Safety

[Doug McKean]

Hi Mark, 

Absolutely. The thing is to do with this type of 
declaration to the FDA, which I've done, you have 
to state that any connection or disconnection of fiber 
cables shall be done only when the equipment is 
powered off AND that prior to power up for any 
service maintainance and/or normal use that ALL 
fiber connections to the laser transceivers be made. 

In other words, during normal use, service or maintainance, 
the intent of the product is to have ALL lasing be in 
the fiber - i.e. all laser transceiver ports are populated 
with fiber.  All this has to be clearly stated to the 
end user in the documentation. 

Regards, Doug McKean 




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RE: Laser Safety

[JMurphy]

This message is in MIME format. Since your mail reader does not understand
this format, some or all of this message may not be legible.
Attached is Laser Notice 50 issued by the CDRH in 2001.  It allows you to
use comparable sections from IEC 60825-1/A2 which includes labeling.

Jack

-Original Message-
From: John Juhasz [mailto:jjuh...@fiberoptions.com]
Sent: Wednesday, March 06, 2002 9:47 AM
To: 'Davis, Mike'; 'Doug Mckean'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety



I tried looking real hard for free downloadable ANSI specs
and couldn't find them - I had to buy them.

Regarding labelling, there have been efforts (not sure
of the status at this time - is there anyone out
there who knows?) to harmonize the EN 60825 and
21CFR1040 to make it easier on manufacturers. 
As the final laser classifications are parallel
(it's the methodology that has differences)
the FDA, in the interest of manufacturer satisfaction(?) 
has been allowing the use of the Classification/Warning
labels as described in EN 60825. But you still have to
add the FDA-CDRH label "This product complies with FDA
Radiation Performance Standard 21 CFR Subpart J" 

Hope this helps.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 9:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?



---
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laser_notice_50.pdf
Description: Binary data

RE: Laser Safety

[Joshua Wiseman]

My experience with labeling is as long as all the required information is
available you can use a single label.  In fact on my product I have two
labels the first indicates the opening with "AVOID EXPOSURE - Laser Light
Emitted From This Aperture".  The second has the IEC label information, FDA
information, model number, date code, address, and other useless
information.




-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 6:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?

Re: Laser Safety

[Jon Curtis]

 Use caution once again.  IEC 60825-2 is NOT single fault.  You need to 
go further and consider if a condition is "reasonable foreseeable" even 
if you need multiple faults to get there.  Often there is congruence 
between single fault and reasonably foreseeable, but not always.


>From 60825-2:
reasonably foreseeable event
event the occurrence of which under given circumstances can be predicted 
fairly accurately,

and the occurrence probability or frequency of which is not low or very low.
Examples of reasonably foreseeable events might include the following: 
component failure,
fibre cable break, optical connector disconnection, operator error or 
inattention to safe

working practices.
Reckless use or use for completely inappropriate purposes is not to be 
considered as a

reasonably foreseeable event

The assessment of hazard levels shall always consider worst case 
conditions, including
reasonably foreseeable fault conditions (see 4.4.3). Consequently, it 
may be necessary to
include multiple fault conditions, the probability of which shall be 
judged by the

responsible organization.
NOTE Whereas IEC 60825-1 refers to single fault conditions, it may be 
reasonably foreseeable that more

than one fault will combine to cause a dangerous situation.

FDA laser notice 50 issued in July of 2001 allows you to harmonize with 
IEC 60825-1, so as long as you slightly modify your FDA certification 
statement label to note that you are using the deviations in Notice 50 
you can use the IEC 60825 labels.  The FDA is contemplating a rule 
making to adopt the IEC versions and has therefore put manufacturers on 
notice that they will not take enforcement action against those choosing 
to use the IEC standards.  Note that you still have additional 
administrative requirements under the CDRH rules.


Jon Curtis
Curtis-Straus LLC

Davis, Mike wrote:


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?





Subject:

Re: Laser Safety
From:

Doug Mckean 
Date:

Tue, 5 Mar 2002 17:16:54 -0500
To:

emc-p...@majordomo.ieee.org


Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 




---
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--
Jon D. Curtis, P.E.

Director of Engineering
Curtis-Straus LLC NRTL TCB

One Stop Laboratory for NEBS, EMC, 
Product Safety, and Telecom Testing.

527 Great Road
Littleton, MA 01460 USA
Voice 978-486-8880  Fax 978-486-8828
email: jcur...@curtis-straus.com
WWW.CURTIS-STRAUS.COM

RE: Laser Safety

[wayne . d . thomas]

John,

The CDRH web site has "Laser Notice No. 50" that covers "Laser Products -
Conformance with IEC60825-1, - - " that is believe is the document you are
looking for.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/topindx
.cfm?alpha=l


Wayne Thomas
Product Safety Engineering
Customer Quality Assurance
Tektronix Inc.
503 - 627 - 4058

 -Original Message-
From:   John Juhasz [mailto:jjuh...@fiberoptions.com] 
Sent:   Wednesday, March 06, 2002 6:47 AM
To: 'Davis, Mike'; 'Doug Mckean'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject:RE: Laser Safety


I tried looking real hard for free downloadable ANSI specs
and couldn't find them - I had to buy them.

Regarding labelling, there have been efforts (not sure
of the status at this time - is there anyone out
there who knows?) to harmonize the EN 60825 and
21CFR1040 to make it easier on manufacturers. 
As the final laser classifications are parallel
(it's the methodology that has differences)
the FDA, in the interest of manufacturer satisfaction(?) 
has been allowing the use of the Classification/Warning
labels as described in EN 60825. But you still have to
add the FDA-CDRH label "This product complies with FDA
Radiation Performance Standard 21 CFR Subpart J" 

Hope this helps.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 9:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?



---
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RE: Laser Safety

[Gary McInturff]

Doug, 
I don't think this is accurate, unless you had a signal detect etc that 
shut the beam off when the interconnecting cable is removed. These cables are 
typically removable SC, LC or TC, or TNC type connectors. Removing them just 
leaves an open aperture for folks to stare into. So I would think that you 
would need some sort of interlock.
Gary

-Original Message-
From: Doug Mckean [mailto:dmck...@corp.auspex.com]
Sent: Tuesday, March 05, 2002 2:17 PM
To: emc-p...@majordomo.ieee.org
Subject: Re: Laser Safety



Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 



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RE: Laser Safety

[John Juhasz]

Yes indeed, Jon makes a good point which I should've mentioned
in my response as well (as I have been down this road).

If you are fortunate enough to have input with regard to 
cabling consider specifying fiber optic cables which comply with 
IEC 794-2 with inherent mechanical protection are considered
less likely to break. 

John Juhasz
FIber Options
Bohemia, NY

-Original Message-
From: Jon Curtis [mailto:j...@curtis-straus.com]
Sent: Wednesday, March 06, 2002 9:23 AM
To: Doug Mckean
Cc: emc-p...@ieee.org
Subject: Re: Laser Safety



Use caution with this approach.  IEC 60825-2 is specifically for Optical 
Fiber Communications Systems (OFCS) and requires the consideration of 
fiber breaks exposing humans to the laser energy contained within. 
 60825-2 is referenced in 60825-1 and must be considered for OFCS. 
 Additionally, you need to consider where the fiber goes as a break 
might occur downstream and expose not only direct users of the equipment.

Jon Curtis
Curtis-Straus LLC

Doug Mckean wrote:

>Do the acid test type question ... 
>
>During normal use, what are you exposing the end user to? 
>
>For instance, with a laser pointer using a Class IIIb 
>laser that emits unprotected from the pointer, the 
>pointer is Class IIIb. 
>
>If instead, you are using a Class IIIb laser for fiber optic 
>communication and the entire beam is contained within 
>the fiber, no lasing is emitted from the product during 
>normal operation and/or service or maintainance, then 
>you *could* declare the telco product as Class I. 
>
>- Doug McKean 
>
>
>
>---
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-- 
Jon D. Curtis, P.E.

Director of Engineering
Curtis-Straus LLC NRTL TCB

One Stop Laboratory for NEBS, EMC, 
Product Safety, and Telecom Testing.
527 Great Road
Littleton, MA 01460 USA
Voice 978-486-8880  Fax 978-486-8828
email: jcur...@curtis-straus.com
WWW.CURTIS-STRAUS.COM




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RE: Laser Safety

[John Juhasz]

I tried looking real hard for free downloadable ANSI specs
and couldn't find them - I had to buy them.

Regarding labelling, there have been efforts (not sure
of the status at this time - is there anyone out
there who knows?) to harmonize the EN 60825 and
21CFR1040 to make it easier on manufacturers. 
As the final laser classifications are parallel
(it's the methodology that has differences)
the FDA, in the interest of manufacturer satisfaction(?) 
has been allowing the use of the Classification/Warning
labels as described in EN 60825. But you still have to
add the FDA-CDRH label "This product complies with FDA
Radiation Performance Standard 21 CFR Subpart J" 

Hope this helps.

John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Davis, Mike [mailto:mda...@c-cor.net]
Sent: Wednesday, March 06, 2002 9:26 AM
To: 'Doug Mckean'; 'John Juhasz'; 'Mark Schmidt';
emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety


I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?



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RE: Laser Safety

[Davis, Mike]

This message is in MIME format. Since your mail reader does not understand
this format, some or all of this message may not be legible.
I agree with Doug and with John but, I have the same question. And I will
add, Doug is speaking of the FDA-CDRH requirement for the US. But, to
ascertain what the European mode is, this requires a single-fault condition
for classification as described by John Juhasz. That, I understand. John, is
there a free downloadable copy of ANSI Z136.1 and .2 specs?

I have used the calculations to determine the classification of a laser
based on the no fault and a single fault mode. These lasers are operating in
a pulsed mode at a 50% duty cycle. I have attached a sample calculation of a
1310nmn and a 1550nm laser that I used to determine that the lasers either
do or do not fall within the Class 1 laser classification. Another
question...

Can the same label be used for FDA as for IEC? Has anyone had any feedback
or problems with laser labels that deviated from recommended markings by the
21 CFR or IEC 825-1?


--- Begin Message ---

Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 



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--- End Message ---


Laser Class calculation.doc
Description: MS-Word document

Re: Laser Safety

[Jon Curtis]

Use caution with this approach.  IEC 60825-2 is specifically for Optical 
Fiber Communications Systems (OFCS) and requires the consideration of 
fiber breaks exposing humans to the laser energy contained within. 
60825-2 is referenced in 60825-1 and must be considered for OFCS. 
Additionally, you need to consider where the fiber goes as a break 
might occur downstream and expose not only direct users of the equipment.


Jon Curtis
Curtis-Straus LLC

Doug Mckean wrote:

Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 




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--
Jon D. Curtis, P.E.

Director of Engineering
Curtis-Straus LLC NRTL TCB

One Stop Laboratory for NEBS, EMC, 
Product Safety, and Telecom Testing.

527 Great Road
Littleton, MA 01460 USA
Voice 978-486-8880  Fax 978-486-8828
email: jcur...@curtis-straus.com
WWW.CURTIS-STRAUS.COM




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RE: Laser Safety

[John Juhasz]

Mark,

The ANSI spec (in Z136.2) provides specific info
for OFCS (Optical Fiber Communications Systems).
This specific information relates to, among other
things, installation location/product accessibility
and personnel exposure/training and marking.
ANSI developed 'Service Group'(SG) classifications,
with the previously mentioned items lumped-in
with the laser Class. For the most
part the SG classification tracks the laser
Class - Class I = SG1 . . Class 3b = SG3b.

Are the installation/service personnel also
the end-user/operator? Is there a possibility
for the end-user, at any time, access the 3b without
much difficulty? If yes, the manual
would indeed be an additional place for a
statement relating to 3b.. ANSI specifies that in
SG3b areas (even if it's inside the product itself)
must be marked with a DANGER statement
see the spec for details). 

Also worth noting is that those who will be exposed
to Class IIIb - installation or service personnel
(which puts the product in the SG3b category)
as you noted have to be trained.
"Only authorized trained personnel shall be permitted
to install or perform service on SG3a, SG3b, or SG4
OFCS."

In my opinion, whether or not the installers/service/end-user
is trained or not (sometimes the trained are worse because
they tend to be over-confident and throw caution to the wind)
it's worth marking the areas on/in the product as well as 
putting references in the manual.


John Juhasz
Fiber Options
Bohemia, NY

-Original Message-
From: Mark Schmidt [mailto:mschm...@xrite.com]
Sent: Wednesday, March 06, 2002 8:09 AM
To: Doug Mckean; emc-p...@majordomo.ieee.org
Subject: RE: Laser Safety



Hi Doug,

During normal use the operator could be exposed to Class I. Service
personnel and installation would require potential exposure to Class
IIIb. Should the operators manual make reference to this. Also, wouldn't
you have to warn the operator and service personnel with text in the
manual and warning signs in the IIIb compartment of the system ?

Thank you,

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
USA
(616) 257 2469
mschm...@xrite.com


 -Original Message-
From:   Doug Mckean [mailto:dmck...@corp.auspex.com] 
Sent:   Tuesday, March 05, 2002 5:17 PM
To: emc-p...@majordomo.ieee.org
Subject:Re: Laser Safety


Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 



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RE: Laser Safety

[Mark Schmidt]

Hi Doug,

During normal use the operator could be exposed to Class I. Service
personnel and installation would require potential exposure to Class
IIIb. Should the operators manual make reference to this. Also, wouldn't
you have to warn the operator and service personnel with text in the
manual and warning signs in the IIIb compartment of the system ?

Thank you,

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
USA
(616) 257 2469
mschm...@xrite.com


 -Original Message-
From:   Doug Mckean [mailto:dmck...@corp.auspex.com] 
Sent:   Tuesday, March 05, 2002 5:17 PM
To: emc-p...@majordomo.ieee.org
Subject:    Re: Laser Safety


Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 



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Re: Laser Safety

[Doug Mckean]

Do the acid test type question ... 

During normal use, what are you exposing the end user to? 

For instance, with a laser pointer using a Class IIIb 
laser that emits unprotected from the pointer, the 
pointer is Class IIIb. 

If instead, you are using a Class IIIb laser for fiber optic 
communication and the entire beam is contained within 
the fiber, no lasing is emitted from the product during 
normal operation and/or service or maintainance, then 
you *could* declare the telco product as Class I. 

- Doug McKean 



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RE: Laser Safety

[John Juhasz]

While it is technically possible to have a Class IIIb-capable component
laser in a Class I 'system' the path there is not clear cut.

Besides the emitter's technical issues (AEL, exposure time, radiant
power, wavelength, to name only a few) you have to take in 
consideration the failure modes of the laser driver circuitry - that
Class I limits can be exceeded in event of failure, whether the system
is a closed system (beam accessibility during service/normal use),
the products installation location and acessbility to unauthorized
personnel etc. 

Your best bet in classifying your 'system' is to
look at ANSI Z136.1 and .2 specs. In my opinion (some may disagree)
it's a good guide. 

John Juhasz
Fiber Options
Bohemia, NY


-Original Message-
From: Mark Schmidt [mailto:mschm...@xrite.com]
Sent: Tuesday, March 05, 2002 2:17 PM
To: emc-p...@majordomo.ieee.org
Subject: Laser Safety




I am trying to gain a better understanding of lasers and I have had some
discussion and been told some things that don’t make much sense to me so
I am asking the group for some guidance. Here is my question.

If the unexpanded raw beam of a Class III b laser was incorporated into
a larger system, is then expanded and used in this same system reducing
the beam intensity to Class I levels. Would the overall system be
classified as Class I ?

Thanks.

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
U.S.A.
(616) 257 2469
mschm...@xrite.com <mailto:mschm...@xrite.com> 




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Laser Safety

[Mark Schmidt]

I am trying to gain a better understanding of lasers and I have had some
discussion and been told some things that don’t make much sense to me so
I am asking the group for some guidance. Here is my question.

If the unexpanded raw beam of a Class III b laser was incorporated into
a larger system, is then expanded and used in this same system reducing
the beam intensity to Class I levels. Would the overall system be
classified as Class I ?

Thanks.

Mark Schmidt
Regulatory Compliance 
X-Rite Incorporated 
U.S.A.
(616) 257 2469
mschm...@xrite.com  




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Re: Laser Safety

[Doug McKean]

"Matt Kilkenny" 
>
> I have a question on lasers for ITE concerning IEC-825 and FDA
requirements.
> According to IEC, class 3b lasers have to have safety doors
(interlocks).
> Can automatic power reduction be used if you are not pumping the
laser to a
> 3b class level of power.  In other words, can we not put interlocks
on the
> system if the 3b laser power has been reduced to a 3a or class 1
level
> through microprocessor limitating it?  Or is their single fault
concerns if
> the microprocessor fails?
>
> Thanks for any help,

Doesn't this then make the microprocessor an interlock device and, as
such, you'd have to go through every single state of the
microprocessor
for single fault analysis?

- Doug McKean



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[Fwd: Re: Laser Safety]

[David Heald]

Forwarded for Bert Planting.

 Original Message 
Subject: Re: Laser Safety
List-Post: emc-pstc@listserv.ieee.org
Date: Mon, 18 Jun 2001 06:59:41 +0200
From: Bert Planting 
Organization: ASML
To: Matt Kilkenny 
CC: emc-p...@majordomo.ieee.org
References: <0954d2e4fe26d411909100b0d022a345191...@mail.opthos.com>

Matt,

Because you are using a microprocessor limitating it this is not seen as
sufficient safe solution for reduction of the output by "safety" people
(based on my experience with US third parties). 
Reduction should only be done by hardware and not by fault sensitive
microprocessor.

In this case you should use an interlock.

regards,

Bert Planting
Prodct safety ASML




Matt Kilkenny wrote:
> 
> I have a question on lasers for ITE concerning IEC-825 and FDA requirements.
> According to IEC, class 3b lasers have to have safety doors (interlocks).
> Can automatic power reduction be used if you are not pumping the laser to a
> 3b class level of power.  In other words, can we not put interlocks on the
> system if the 3b laser power has been reduced to a 3a or class 1 level
> through microprocessor limitating it?  Or is their single fault concerns if
> the microprocessor fails?
> 
> Thanks for any help,
> 
> Matt Kilkenny
> mkilke...@opthos.com

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Re: Laser Safety

[126344 - Yuriy Zygovskiy]

Sorry, simple test.
-Original Message-
From: Matt Kilkenny 
To: emc-p...@majordomo.ieee.org 
List-Post: emc-pstc@listserv.ieee.org
Date: Friday, June 15, 2001 2:08 PM
Subject: Laser Safety


>
>
>I have a question on lasers for ITE concerning IEC-825 and FDA
requirements.
>According to IEC, class 3b lasers have to have safety doors (interlocks).
>Can automatic power reduction be used if you are not pumping the laser to a
>3b class level of power.  In other words, can we not put interlocks on the
>system if the 3b laser power has been reduced to a 3a or class 1 level
>through microprocessor limitating it?  Or is their single fault concerns if
>the microprocessor fails?
>
>Thanks for any help,
>
>Matt Kilkenny
>mkilke...@opthos.com
>
>
>---
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>
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>
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Re: Laser Safety

[126344 - Yuriy Zygovskiy]

Matt:
In this case only interlocks can be applicable because practically somebody
can get
in danger with 3b laser (worse case).

Yuriy Vygovskiy
Engineering Design Compliance

-Original Message-
From: Matt Kilkenny 
To: emc-p...@majordomo.ieee.org 
List-Post: emc-pstc@listserv.ieee.org
Date: Friday, June 15, 2001 2:08 PM
Subject: Laser Safety


>
>
>I have a question on lasers for ITE concerning IEC-825 and FDA
requirements.
>According to IEC, class 3b lasers have to have safety doors (interlocks).
>Can automatic power reduction be used if you are not pumping the laser to a
>3b class level of power.  In other words, can we not put interlocks on the
>system if the 3b laser power has been reduced to a 3a or class 1 level
>through microprocessor limitating it?  Or is their single fault concerns if
>the microprocessor fails?
>
>Thanks for any help,
>
>Matt Kilkenny
>mkilke...@opthos.com
>
>
>---
>This message is from the IEEE EMC Society Product Safety
>Technical Committee emc-pstc discussion list.
>
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RE: Laser Safety

[Gary McInturff]

Matt,
Yes, There is a concern on the failure at least a single fault - but
I believe the IEC 825 requires a double fault protection, but others may
know more.
You would have to know what the faults of the micro are fail, on
fail off, is there a software routine that can cause the problem (and trust
me you don't want to go there.
If you knew how the micro failed and how it causes the laser to
exceed  your permissible limits then rather than trying to figure out all
the ways the system could fail in a "laser hazardous mode", you may be able
to produce in your circuitry  methods for fault protection. This circuitry
and the components that make it up would then become critical and controlled
components which would require tracking and verification.
Gary

-Original Message-
From: Matt Kilkenny [mailto:mkilke...@opthos.com]
Sent: Friday, June 15, 2001 11:21 AM
To: emc-p...@majordomo.ieee.org
Subject: Laser Safety




I have a question on lasers for ITE concerning IEC-825 and FDA requirements.
According to IEC, class 3b lasers have to have safety doors (interlocks).
Can automatic power reduction be used if you are not pumping the laser to a
3b class level of power.  In other words, can we not put interlocks on the
system if the 3b laser power has been reduced to a 3a or class 1 level
through microprocessor limitating it?  Or is their single fault concerns if
the microprocessor fails?

Thanks for any help,

Matt Kilkenny 
mkilke...@opthos.com 


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Laser Safety

[Matt Kilkenny]

I have a question on lasers for ITE concerning IEC-825 and FDA requirements.
According to IEC, class 3b lasers have to have safety doors (interlocks).
Can automatic power reduction be used if you are not pumping the laser to a
3b class level of power.  In other words, can we not put interlocks on the
system if the 3b laser power has been reduced to a 3a or class 1 level
through microprocessor limitating it?  Or is their single fault concerns if
the microprocessor fails?

Thanks for any help,

Matt Kilkenny 
mkilke...@opthos.com 


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RE: [Fwd: System Laser Safety questions]

[Doug McKean]

Remote interlocks are for operating procedures that 
have the operator disconnect live fiber during 
"normal" operation.  

Is that what users of your equipment will be doing? 

I've done registration with the FDA on systems which 
ran Class IIIb lasers.  "Normal" or "maintenance" 
modes of operation required all the cables to be 
connected containing any and all emissions from 
the lasers within the cables making the entire 
product device Class I which flew with the FDA. 

Regards, Doug McKean 


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RE: [Fwd: System Laser Safety questions]

[Peter Tarver]

Hello, Marko.

A remote interlock connector is required when there is
potential human exposure to laser radiation, as might be
found in labs or industrial environments where the laser is
cutting something or marking a product (there may be other
applications).  In such an environment, there is a need to
have the operator's station remote from the laser and its
target.

The remote interlock connector is intended to allow the
operator's station to connect to the lasing system to
start/interrupt lasing.  Some stations might have a dead-man
switch/key switch combination that provides a contact
opening/closure on the cable connected to the remote
interlock connector.

The key lock feature is separate from the remote interlock
connector.  One can not be substituted for the other.

I have a hard time imagining the need for a remote interlock
connector on an optical networking product.  You should
double check the laser class definitions and other
requirements applicable to your system.  You will probably
be pleasantly surprised (relieved).

The beam stop requirements apply to your output.  You're
right about the input fiber, though, and there's not a lot
that can be done, other than to follow the guidelines in
IEC60825-2 and ANSI Z136.2, as well as complying with
IEC60825-1 and 21CFR.


Regards,

Peter L. Tarver, PE
Product Safety Manager
Sanmina Homologation Services
355 E. Trimble Rd.
San Jose, CA 95131-1218
V: 408-474-1322
F: 408-474-1318
M: 408-234-3529
peter.tar...@sanmina.com


> -Original Message-
> From: marko.radoji...@mapleoptical.com
> Subject: [Fwd: System Laser Safety questions]
>
> Greetings,
>
> We have class IIIb lasers in a communication
> system box and are trying
> to
> meet the FDA 1040.10 and EN60825-2 requirements.
> Both standards call for
> a
> "Remote interlock connector". What exactly is
> that thing? Can it be
> satisfied with a key control feature that is also
> called out?
>
> Also we have a patch panel incorporated into the
> product which can
> accept,
> in the worst (almost stupid) case, a Class IIIb
> input. Are we
> responsible
> for meeting the beam stop requirement from the
> output of the connector
> patch
> panel? It seems to me that this would be no
> different than pulling the
> cable
> and looking into the fiber directly.
>
> All comments would be appreciated.
>
> Thanks,
> Marko
>
> Marko Radojicic
> ma...@mapleoptical.com


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[Fwd: System Laser Safety questions]

[Dave Heald]

Forwarded for Marko Radojicic.  Please include Marko in any replies.
Dave Heald

 Original Message 
Subject: System Laser Safety questions
List-Post: emc-pstc@listserv.ieee.org
Date: Tue, 24 Apr 2001 14:50:36 -0700
From: Marko Radojicic 
To: "EMC-PSTC (E-mail)" 

Greetings,

We have class IIIb lasers in a communication system box and are trying
to
meet the FDA 1040.10 and EN60825-2 requirements. Both standards call for
a
"Remote interlock connector". What exactly is that thing? Can it be
satisfied with a key control feature that is also called out?

Also we have a patch panel incorporated into the product which can
accept,
in the worst (almost stupid) case, a Class IIIb input. Are we
responsible
for meeting the beam stop requirement from the output of the connector
patch
panel? It seems to me that this would be no different than pulling the
cable
and looking into the fiber directly.

All comments would be appreciated.

Thanks,
Marko

Marko Radojicic
Manager, Hardware Design Assurance
Maple Optical Systems
ma...@mapleoptical.com
Phone: 408/545-1263
FAX: 408/434-9209

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Re: Laser Safety Product Labeling

[Peter Merguerian]

Thomas,

You need consulting from a renowned laser specialist. I recommend you
contact my colleague at TUV Rheinland of North America Woody Strzelecki at
TUV Rheinland of North America; he will guide you to exactly what is
required. His e-mail is wstrzele...@us.tuv.com.

One note I have to mention is that classification is made based on normal
conditions and single fault conditions.

Good luck and do not look into that fiber!


At 11:27 21/11/2000 -0800, Courtland Thomas wrote:
>
>Hello group,
>
>Does anyone have any experience with product labeling equipment, that use
>lasers. I have a situation where a Class 3B laser is used, however after the
>power attenuation through the fiber cable, the output power is only 800uW
>max. This power actually could be considered Class 2, however the wavelength
>is 1300nm, which falls into the invisible light spectrum. Therefore, I plan
>to label the product Class 3A. If there are any errors in my reasoning,
>please let me know. I want to place a caution label (all that is required
>for this output level) on the top of the product, but my marketing people
>don't want it displayed there because they feel that it may hamper sales.
>Unfortunately, marketing has too much authority, so I am looking for a
>standard that mandates where the label should go. Everything I have read
>only makes suggestions, but I need more than that.
>
>Thanks in advance,
>
>Courtland Thomas
>Patton Electronics
>
>
>---
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>
Peter Merguerian
Managing Director
Product Testing Division
I.T.L. (Product Testing) Ltd.
Hacharoshet 26, POB 211
Or Yehuda 60251, Israel

Tel: 972-3-5339022 Fax: 972-3-5339019
e-mail: pmerguer...@itl.co.il
website: http://www.itl.co.il 

TO LEARN ABOUT AUSTRALIAN AND NEW ZEALAND REQUIREMENTS, CONTACT ME AT THE
EARLIEST STAGES OF YOUR DESIGN; REQUIREMENTS CAN BE TRICKY!






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RE: Laser Safety Product Labeling

[John Juhasz]

Courtland . . . 

With regards to the fiber optic cable that you make reference to, is that
the 'pigtail' from
the laser device? Or is that the actual installation fiber? 

If the output power is from the far end of an installed fiber, then I would
not 
make that classification. The output power is what is available at the
product itself
without the fiber installed. Someone can turn the unit on without a fiber
installed 
and look into the connector (although one would assume that people would
know better.
But you know where assupmtions get you . . . ).
The other consideration is the location of where the product will ultimately
be installed. Is it 
in a 'restricted access' location? Or is it in an 'unrestricted location'
where any 
idiot can mess with it? That is another variable in determining
classification and what
engineering controls are/are not required.

With specific reference to the label, I would put it near the 'aperture'
from which
the beam is accessible. That makes the most sense. Once again, the CDRH will

check that in the report you file wiht them.
The argument from your marketing dept. has 'some' merit. Personally, I don't
think it's going to affect sales. If your product is 'commercial' equipment
as 
opposed to consumer, then I would like to think (I am assuming again)that
your
customer base is educated about such products. Obviously your customers know
that 
they're buying a laser product? 
The alternative is getting a lawsuit from the customer because there was no
warning
and someone now has retinal damage.Then the CDRH will definitely be reviewng
your file.

John Juhasz
Fiber Options
Bohemia, NY


-Original Message-
From: Courtland Thomas [mailto:ctho...@patton.com]
Sent: Tuesday, November 21, 2000 2:27 PM
To: emcpost
Subject: Laser Safety Product Labeling



Hello group,

Does anyone have any experience with product labeling equipment, that use
lasers. I have a situation where a Class 3B laser is used, however after the
power attenuation through the fiber cable, the output power is only 800uW
max. This power actually could be considered Class 2, however the wavelength
is 1300nm, which falls into the invisible light spectrum. Therefore, I plan
to label the product Class 3A. If there are any errors in my reasoning,
please let me know. I want to place a caution label (all that is required
for this output level) on the top of the product, but my marketing people
don't want it displayed there because they feel that it may hamper sales.
Unfortunately, marketing has too much authority, so I am looking for a
standard that mandates where the label should go. Everything I have read
only makes suggestions, but I need more than that.

Thanks in advance,

Courtland Thomas
Patton Electronics


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Laser Safety Product Labeling

[Courtland Thomas]

Hello group,

Does anyone have any experience with product labeling equipment, that use
lasers. I have a situation where a Class 3B laser is used, however after the
power attenuation through the fiber cable, the output power is only 800uW
max. This power actually could be considered Class 2, however the wavelength
is 1300nm, which falls into the invisible light spectrum. Therefore, I plan
to label the product Class 3A. If there are any errors in my reasoning,
please let me know. I want to place a caution label (all that is required
for this output level) on the top of the product, but my marketing people
don't want it displayed there because they feel that it may hamper sales.
Unfortunately, marketing has too much authority, so I am looking for a
standard that mandates where the label should go. Everything I have read
only makes suggestions, but I need more than that.

Thanks in advance,

Courtland Thomas
Patton Electronics


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RE: Laser Safety-Thanks

[Maxwell, Chris]

Group,

Of course I'll share! 

A few people have contacted me offline, and I have sent them the 4 pdf files
that I have found.  

I'm not going to post them to the whole group because there are 4 pdf
(Adobe) files which would hog up all sorts of server space at the good old
IEEE.  

BUT, ANYONE INTERESTED IN GETTING THESE APP NOTES IS INVITED TO EMAIL ME
DIRECTLY AT chr...@gnlp.com.  I WILL FORWARD THE PDF FILES TO YOU.

If you want to go fishing for yourself, three of the pdf files (AB I-008, AB
I-009 and AB I-015) are at the Agilent website at:

http://www.semiconductor.agilent.com/led_lamps/app_index.html

See y'all later,

Chris
> -Original Message-
> From: Joe Finlayson [SMTP:jfinlay...@telica.com]
> Sent: Wednesday, October 18, 2000 3:20 PM
> To:   'Maxwell, Chris'
> Subject:  RE: Laser Safety-Thanks
> 
> Hi Chris,
> 
>   Any chance of forwarding this app note to the group?
> 
> Thx,
> 
> 
> Joe
> 
> 
> Joe Finlayson
> Manager, Compliance Engineering
> Telica, Inc.
> 734 Foster Street, Bldg. G, Suite 100
> Marlboro, MA 01752
> Tel:  (508) 480-0909 x212
> Fax:  (508) 480-0922
> Email:jfinlay...@telica.com
> 
> 
> 
> -Original Message-
> From: Maxwell, Chris [mailto:chr...@gnlp.com]
> Sent: Wednesday, October 18, 2000 8:20 AM
> To: 'EMC-PSTC Internet Forum'
> Subject: Laser Safety-Thanks
> 
> 
> 
> All,
> 
> Thank you to all who have responded to my inquiry regarding laser safety
> calculations.  I want to publicly stress my appreciation to the guys at
> Agilent who went the extra mile to forward an app note.  
> 
> I really appreciate that because our company and Agilent make some
> products
> that compete with one another.  I think that it speaks really well of
> their
> company that they would offer me some assistance.  Overall, I think it
> speaks well of the group, showing that we're just as concerned about
> quality
> products and public safety as we are about our company's bottom line.
> 
> Thanks
> 
> Chris Maxwell, Design Engineer
> GN Nettest Optical Division
> 6 Rhoads Drive, Building 4  
> Utica, NY 13502
> PH:  315-797-4449
> FAX:  315-797-8024
> EMAIL:  chr...@gnlp.com
> 
> 
> 
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> 
> For policy questions, send mail to:
>  Richard Nute:   ri...@ieee.org

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Laser Safety-Thanks

[Maxwell, Chris]

All,

Thank you to all who have responded to my inquiry regarding laser safety
calculations.  I want to publicly stress my appreciation to the guys at
Agilent who went the extra mile to forward an app note.  

I really appreciate that because our company and Agilent make some products
that compete with one another.  I think that it speaks really well of their
company that they would offer me some assistance.  Overall, I think it
speaks well of the group, showing that we're just as concerned about quality
products and public safety as we are about our company's bottom line.

Thanks

Chris Maxwell, Design Engineer
GN Nettest Optical Division
6 Rhoads Drive, Building 4  
Utica, NY 13502
PH:  315-797-4449
FAX:  315-797-8024
EMAIL:  chr...@gnlp.com



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RE: Laser Safety Calculations

[George Sparacino]

Hi Rich,

Sounds reasonable.  Actually, it sounds like a tool that a transciever
vendor would offer on a webpage to assist their customers in development
using that vendors' component...  Has anyone come across such a thing ?

Regards,
George



-Original Message-
From: Rich Nute [mailto:ri...@sdd.hp.com]
Sent: Tuesday, October 17, 2000 3:28 PM
To: george.sparac...@bostonacoustics.com; chr...@gnlp.com
Cc: emc-p...@majordomo.ieee.org
Subject: Re: Laser Safety Calculations





Hi George and Chris:


Better still, TC76 should provide a spreadsheet such
that, upon entering all the data, the spreadsheet does
the calculations and gives you the emission level and
the emission Class.


Regards,
Rich

Re: Laser Safety Calculations

[Rich Nute]

Hi George and Chris:


Better still, TC76 should provide a spreadsheet such
that, upon entering all the data, the spreadsheet does
the calculations and gives you the emission level and
the emission Class.


Regards,
Rich




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RE: Laser Safety Calculations

[George Sparacino]

Chris,

Try contacting Donald Drozdenko at HP (Aligent) at 408-435-5807.  Don headed
the testing / certification efforts for HP's Laser & Led products back when
825 first emerged.  Another person who may be able to help is Dr. Joseph
Tajnai (408)435-6331, also from HP and member of TC76.

Good Luck,
George

-Original Message-
From: Maxwell, Chris [mailto:chr...@gnlp.com]
Sent: Tuesday, October 17, 2000 11:34 AM
To: 'EMC-PSTC Internet Forum'
Subject: Laser Safety Calculations



All,

I too share the sentiments of another member of the group that the
calculations for laser safety in EN 60825-1 are made somewhat more difficult
to follow due to the difficulty of reading the diagrams and the symbols.  I
myself have looked at the diagrams a few times and can't figure out what
symbol is representing what angle ...

I would love to see a few examples and more complete descriptions of the
nomenclature.
Is there a text out there, either commercial or from IEC that goes through
these calculations in more detail?  

Thanks in advance

Chris Maxwell, Design Engineer
GN Nettest Optical Division
6 Rhoads Drive, Building 4  
Utica, NY 13502
PH:  315-797-4449
FAX:  315-797-8024
EMAIL:  chr...@gnlp.com



---
This message is from the IEEE EMC Society Product Safety
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 majord...@ieee.org
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 unsubscribe emc-pstc

For help, send mail to the list administrators:
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 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org

Laser Safety Calculations

[Maxwell, Chris]

All,

I too share the sentiments of another member of the group that the
calculations for laser safety in EN 60825-1 are made somewhat more difficult
to follow due to the difficulty of reading the diagrams and the symbols.  I
myself have looked at the diagrams a few times and can't figure out what
symbol is representing what angle ...

I would love to see a few examples and more complete descriptions of the
nomenclature.
Is there a text out there, either commercial or from IEC that goes through
these calculations in more detail?  

Thanks in advance

Chris Maxwell, Design Engineer
GN Nettest Optical Division
6 Rhoads Drive, Building 4  
Utica, NY 13502
PH:  315-797-4449
FAX:  315-797-8024
EMAIL:  chr...@gnlp.com



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This message is from the IEEE EMC Society Product Safety
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 Michael Garretson:pstc_ad...@garretson.org

For policy questions, send mail to:
 Richard Nute:   ri...@ieee.org