[PSES] CAN/CSA-C22.2 NO. 60601-1:14 deviations

2018-04-16 Thread Paolo Peruzzi

Hi all,

I'm interested in the last edition of the canadian deviations to IEC 60601-1.
On the CSA website, it seems that you cannot get them without having to buy the 
whole IEC standard, which I already have.
Does anybody know if there is a source just for the deviations?

Also, I have in my hand the deviations to the previous IEC edition (ed. 3 
without A1:2012). Do you know if they are still valid or have been amended?

Thanks,
Best regards,

Paolo Peruzzi
Regulatory Affairs Manager
El. En. S.p.A. - DEKA M.E.L.A. srl
Via Baldanzese, 17 - 50041 Calenzano (FI)
Italy

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

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colposcope

2008-11-13 Thread Paolo Peruzzi
Dear all,
does anybody know which safety standard should apply to a colposcope?

thanks 
-- 


 

Paolo Peruzzi 
Regulatory Medical R&D 
El.En. S.p.A. 
Via Baldanzese, 17 
50041 Calenzano (FI) 
Italy 
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FAX  +39 055 8832884  
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Re: Laser safety and Li-Po batteries

2008-09-12 Thread 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 <mailto:standa...@elen.it> 
http://www.elengroup.com/ <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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EU machinery directive reference in DoC

2008-07-04 Thread Paolo Peruzzi

Dear all,
I have not clear which is the deadline, if there is one, for the change 
of reference to the Machinery Directive in a CE declaration of 
Conformity, from 98/37/EC toward 2006/42/EC.
Thanks,


Paolo Peruzzi
El.En. S.p.A.
Via Baldanzese, 17
50041 Calenzano (FI)
Italy
Tel. +39 055 8826807
FAX  +39 055 8832884 
standa...@elen.it <mailto:standa...@elen.it>
http://www.elengroup.com/

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earthline choke

2003-09-11 Thread Paolo Peruzzi





Dear all,
I'm involved in the design of a mains filter of a trolley and I'm
discussing with my colleagues about the convenience of inserting an
inductance on the protective earth conductor. I'm quite sceptical regarding
EMC advantages of such a solution, but I haven't much experience on that.
Have you any hints on the subject?

best regards,
Paolo Peruzzi

**********
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Esaote S.p.A.
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CISPR 11 vs CISPR 22 antenna to EUT distance

2003-07-28 Thread Paolo Peruzzi





Hi group,
I've heard of a different test set up for radiated emission measurement
between CISPR 22 and CISPR 11, in the sense that the antenna to EUT
distance is defined  with reference  to EUT boundary rather than to EUT
center. I have a copy of both the latest editions of those standards, but I
can't find such a difference.
Did it exist in the past or it's the figment of my imagination?

Thanks,
Paolo

******
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voltage dips

2003-07-22 Thread Paolo Peruzzi





Hi all,

Is there any basic standard concerning voltage dips and short interruptions
immunity for equipment with input current larger than 16 amps per phase?
And more: can a product standard prescribe such test for equipment with
more than 16 amps per phase and still refer to 61000-4-11 as basic
standard?

Thanks,

Paolo Peruzzi
Esaote S.p.A.
Research & Product Development -  Design Quality Control
via di Caciolle, 15   I- 50127 Florence
tel: +39 055 4229469
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Rif: Re: MIL-STD 461 C

2003-06-12 Thread Paolo Peruzzi






thank you to everybody who replied me on the forum and off-list.
Now I have the standard I was looking for.
Paolo

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MIL-STD 461 C

2003-06-12 Thread Paolo Peruzzi





Dear group,
I would like to get the old broadband and narrowband RE limit tables of the
superseded MIL STD 461C, for teaching purposes.
Could anybody tell me where to find a pdf of that standard?
Thanks,
Paolo

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Rif: Re: 60601-1-2:2002

2003-02-17 Thread Paolo Peruzzi




Hi all,

As far as I know, EN 60601-1-2 (2001) is listed on OJ since last december,
see:
http://europa.eu.int/eur-lex/it/dat/2002/c_310/c_31020021213it00040011.pdf

Best regards,
Paolo Peruzzi

**
Paolo Peruzzi
Esaote S.p.A.
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  has...@a-pex.co.jp  
  
  Inviato da:Per: rehel...@mmm.com
  
  owner-emc-pstc@majordo Cc: 
emc-p...@majordomo.ieee.org
  mo.ieee.orgCcr: 
  
 Oggetto: Re:
60601-1-2:2002 
  
  
  17/02/2003 11.56
  
  Per favore, rispondere  
  
  a hasimt
  
  
  
  
  



Hello Bob,

Not, yet.
You can check it below web site.
http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/r
eflist/meddevic.html

But I think you should use new version, if available.

Best regards,
Tetsuya Hashimoto
A-PEX International Co.Ltd.
www.a-pex.co.jp

> Is EN 60601-1-2:2002 listed in the OJ? I can only find reference to the
> 1993 version. Can we officially use the latest version?
>
> Bob Heller
> 3M EMC Laboratory, 76-1-01
> St. Paul, MN 55107-1208
> Tel:  651- 778-6336
> Fax:  651-778-6252
> ===
>
>




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Rif: Re: Measuring AC Line Impedance

2002-11-06 Thread Paolo Peruzzi

I think Don is right: the resistive load measurement is not useful; yo need
to measure the e.m.f. and to perform two reactive load measurements in
order to solve the equations.


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ESAOTE S.p.A. Paolo Peruzzi
Research & Product DevelopmentDesign Quality Control
Via di Caciolle,15tel:+39.055.4229306
I- 50127 Florence fax:+39.055.4223305
e-mail: paolo.peru...@esaote.com



I read in !emc-pstc that don_borow...@selinc.com wrote (in
) about 'Measuring
AC Line Impedance' on Tue, 5 Nov 2002:
>Part 1. This measurement will NOT give just the resistive part of the
>source impedance.

Your post is so long that it is not clear what you are trying to
correct. Also, by top-posting you make it more difficult to understand
how your comments relate to previous texts.

If we measure the voltage developed across a resistive load, we have one
equation with three unknowns, e.m.f., source inductance and source
resistance. If we measure the voltage developed across a pure capacitive
load (or one with known losses), we also have one equation with three
unknowns. If we measure the *open-circuit* voltage, we immediately have
the value of one unknown, the e.m.f. or Thevenin equivalent source
voltage. That leaves us with two equations and two unknowns, which are
soluble.
--
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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PCB floating area layout

2002-02-25 Thread Paolo Peruzzi

Hi all,
I'm dealing with a PCB that has a floating section isolated from the rest
of the board for safety purposes (patient applied part).
I found out some problems with emissions, due to the coupling between the
floating part and of the PCB and the earthed one.

My questions are concerning the layout design of the floating area:

1) Is it best to minimize the HF capacitive coupling between the earthed
ground and the floating ground or to maximize it?
2) Is it best to reduce the amount of the floating ground or to increase
it?

Does it depend on the goodness of the "main ground", i.e. how much it is
"cold" ?  (I see the board as a dipole with one end connected to earth, and
the other floating).

Thanks,
p.p.

-
ESAOTE S.p.A.     Paolo Peruzzi
Research & Product DevelopmentDesign Quality Control
Via di Caciolle,15tel:+39.055.4229306
I- 50127 Florence fax:+39.055.4223305
e-mail: paolo.peru...@esaote.com




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RE: EMC for cardio : which standard apply?

2002-01-09 Thread Paolo Peruzzi


Jim,
thanks for your suggestions.
Our product will be sold at least in Europe and US, so we need CE marking,
but not only that, I suppose.
Though there are some similarities between 60601-2-25 +A1 and 60601-1-2 2nd
ed, I think there are important differences too, to the extent that the
latter is in general more severe (more tests prescribed).
Best regards,
p.p.

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ESAOTE S.p.A. Paolo Peruzzi
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EMC for cardio : wich standard apply?

2002-01-03 Thread Paolo Peruzzi

hello,

I have to test an electrocardiograph for EMC , but I'm in trouble with the
standard to apply.
There is IEC 60601-2-25 -A1, "Particular requirements for the safety of
elecrocardiographs", that deals with EMC, and refers to IEC 60601-1-2 1st
ed.(1993, now superseded) and is still valid, as far as I know.
But now we have the new edition of IEC 60601-1-2, and its requirements are
very different from 60601-2-25-A1 ones.
The old edition is replaced by the new one, but what about those particular
standards based on it?
So I don't know which standard I have to apply.
Can anybody out of there dispel my doubts?

Best regards
p.p.

-
ESAOTE S.p.A.         Paolo Peruzzi
Research & Product DevelopmentDesign Quality Control
Via di Caciolle,15tel:+39.055.4229306
I- 50127 Florence fax:+39.055.4223305
e-mail: paolo.peru...@esaote.com







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Medical devices radiated immunity

2001-12-06 Thread Paolo Peruzzi

Hi all,

The second edition of IEC 60601-1-2 (EMC for medical electrical equipments)
sets out a radiated immunity test between 80 MHz and 2.5 GHz. For test
methods it refers to IEC 61000-4-3, which covers frequencies up to 2 GHz.
So what about the test method? Can you follow the procedure described in
Annex J of new 61000-3-4 ( FDIS version) as "indipendent windows method" up
to 2.5 GHz?

Thanks in advance,
p.

-
ESAOTE S.p.A.     Paolo Peruzzi
Research & Product DevelopmentDesign Quality Control
Via di Caciolle,15tel:+39.055.4229306
I- 50127 Florence fax:+39.055.4223305
e-mail: paolo.peru...@esaote.com



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