Re: CNS3376

2011-04-04 Thread emc-p...@ieee.org
Please ignore the first paragraph.  My mistake. -Grace


On Mon, Apr 4, 2011 at 5:53 PM, Grace Lin  wrote:


Jay,
 

As I know, the best person in our office to design antennas is Philip.  
The
person in charge of analog group, including all the transmitters/radios, is
Esteban.  I have constantly contact with them as all the transmitters must be
certified. -Grace

 

According to cnsonline.com.tw  , CNS 3376 
(General
Rules for Explosion-proof Construction of Electric Machineries and Apparatuses
of General Use) is obsoleted.  The replacement seems CNS 3376-0 (Explosive
atmospheres - Part 0: Equipment - General requirements, IEC 60079-0), 59
pages, no English version.

 

Please feel free to contact me if I can of any further assistance.

 

With regards,

Grace Lin




On Sun, Apr 3, 2011 at 2:39 PM, Sotherden, James
 wrote:


Hello,
I was wondering if anyone was familiar with the new standards 
CNS3376.

Thank You

Jay Sotherden
Certification Specialist
Cooper Crouse-Hinds  - Syracuse, NY
Phone: 315-477-5392
Fax: 315-477-5118

C3 - "Business Made Easy"
Check Stock, Pricing, Order Status, Tracking and More...
Experience C3 by visiting: www.CooperC3.com 
 
james.sother...@cooperindustries.com 

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Re: CNS3376

2011-04-04 Thread emc-p...@ieee.org
Jay,
 

As I know, the best person in our office to design antennas is Philip.  The
person in charge of analog group, including all the transmitters/radios, is
Esteban.  I have constantly contact with them as all the transmitters must be
certified. -Grace

 

According to cnsonline.com.tw, CNS 3376 (General Rules for Explosion-proof
Construction of Electric Machineries and Apparatuses of General Use) is
obsoleted.  The replacement seems CNS 3376-0 (Explosive atmospheres - Part 0:
Equipment - General requirements, IEC 60079-0), 59 pages, no English version.

 

Please feel free to contact me if I can of any further assistance.

 

With regards,

Grace Lin



On Sun, Apr 3, 2011 at 2:39 PM, Sotherden, James
 wrote:


Hello,
I was wondering if anyone was familiar with the new standards CNS3376.

Thank You

Jay Sotherden
Certification Specialist
Cooper Crouse-Hinds  - Syracuse, NY
Phone: 315-477-5392
Fax: 315-477-5118

C3 - "Business Made Easy"
Check Stock, Pricing, Order Status, Tracking and More...
Experience C3 by visiting: www.CooperC3.com  
james.sother...@cooperindustries.com 

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Indonesia and wireless access points

2011-04-04 Thread emc-p...@ieee.org
Dear Members

Does anyone have an official document stating that 2.4 and 5.8 Ghz radios
cannot be integrated in the same device?

Peter Merguerian

Sent from my iPhone

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Re: Best general safety certifications?

2011-04-04 Thread emc-p...@ieee.org
In message 
, 
dated Mon, 4 Apr 2011, lauren_cr...@amat.com writes:

> Is EUR ING a significant feather to have in one's cap for Europe?

It's not a safety certification. Professional qualifications are very 
different between USA and Europe, and even within Europe. In Britain, 
the prominent electrical (and electronic) engineering qualification is 
MIET, which allows one to achieve Chartered Engineer status through the 
Engineering Council and apply to FEANI for the Eur Ing designation. I 
haven't seen any evidence of value that would prompt me to pay the 
subscription.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
Plural: data, criteria, phenomena. Singular: datum (different meaning: use
'data element' for a single item), criterion, phenomenon. 'Effect' is a noun,
'affect' is a verb (except in psychiatry).

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Best general safety certifications?

2011-04-04 Thread emc-p...@ieee.org
Does anyone know of a website with an opinion ranking for general safety
certifications based on impact/reputation? 

For example, is it more meaningful to have PE or CSP or iNARTE PSE as a
credential. Is EUR ING a significant feather to have in one's cap for Europe? 

Perhaps a more equitable way of asking the question is do different general
safety certifications have different sway in certain arena's or industries? 


Thanks in advance for any insight. 

Regards, 
-- 
Lauren Crane (mr.) 
Product Regulatory Analyst | Corporate Product EHS | Applied Materials 
Office 512.272.6540 | Mobile 512.736.7201 | America - Europe - Asia 

external use 

** Save paper and trees! Please consider the environment before printing this
e-mail. 
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Re: CE Marking Applicability for Spare Parts

2011-04-04 Thread emc-p...@ieee.org
In message 
<8ae4315f4873f64691ed634747bd56560d19b...@alpmlvem07.e2k.ad.ge.com>, 
dated Mon, 4 Apr 2011, "Momcilovic, Nick (GE Healthcare)" 
 writes:

>- Does Device A shipped in 2013, strictly to replace a defective 
>identical unit, need to be compliant to 60601-1 3rd Ed?  If so, why? -

  I don't think so. Why, indeed?

>If not, should the device continue to bear the CE Marking and DoC to 
>2nd Ed even though the OJ will show 3rd Ed at this time?

Yes.

> If not, will there be issues in customs with the device not bearing 
>the CE Marking (i.e., should the packaging be clearly marked as for 
>replacement use only?)?

Yes, and it would be good to put an explanation, citing the New Approach 
Directive Guide (2.1), on the DoC itself.
-- 
OOO - Own Opinions Only. Try www.jmwa.demon.co.uk and www.isce.org.uk
John Woodgate, J M Woodgate and Associates, Rayleigh, Essex UK
Plural: data, criteria, phenomena. Singular: datum (different meaning: use
'data element' for a single item), criterion, phenomenon. 'Effect' is a noun,
'affect' is a verb (except in psychiatry).

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CE Marking Applicability for Spare Parts

2011-04-04 Thread emc-p...@ieee.org
Dear fellow list members,

I would like some opinions on the scenario described below.  This
happens to be related to medical devices and specifically the MDD in the
EU but I think the same scenario can be played out for any type of
product governed by an EU CE Marking Directive

Background Info:
- Device A is compliant to 2nd Ed of 60601-1 and has its own DoC.
- Device A has been sold in the EU for years.
- Device A is considered a medical device but is always used as part of
a larger medical system, Deice B, which is also compliant to 60601-1 and
has its own DoC.
- Device A is discontinued and no longer produced and sold as a new
product but still is produced only to replace defective units in the
field that are used on Device B systems.  Device A still bears CE
Marking and has original DoC.
- MDD will require all products "placed on the market" sometime after
Jun-2012 (dependent on 60601-2-xx date in OJ) to be compliant to 3rd Ed
of 60601-1.
- New Approach Directive Guide indicates (2.1): "Products which have
been repaired (for example following a defect), without changing the
original performance, purpose or type, are not to be considered as new
products according to New Approach directives.  Thus, such products need
not undergo conformity assessment, whether or not the original product
was placed on the market before or after the directive entered into
force.  This applies even if the product has been temporarily exported
to a third county for the repair operations.  Such operations are often
carried out by replacing a defective or worn item by a spare part, which
either is identical, or at least similar, to the original spare part
(for example modifications may have taken place due to technical
progress, or discontinued production of the old part)."

Scenario:
- Device A fails in the field in the EU in 2013 and needs to be replaced
(repair not possible).  New identical replacement unit is manufactured
and sent to the EU to replace defective unit.
- The system (Device B) that Device A is used on in the field in the EU,
is still 2nd Ed compliant.

Questions:
- Does Device A shipped in 2013, strictly to replace a defective
identical unit, need to be compliant to 60601-1 3rd Ed?  If so, why?
- If not, should the device continue to bear the CE Marking and DoC to
2nd Ed even though the OJ will show 3rd Ed at this time?  If not, will
there be issues in customs with the device not bearing the CE Marking
(i.e., should the packaging be clearly marked as for replacement use
only?)?


Regards,

Nick Momcilovic
Regulatory Engineering Leader
GE Healthcare
www.gehealthcare.com

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