Version of Medical device safety standard - IEC 60601

P

Pauling

#1
Hi,everybody,

We did the safety test according to IEC 60601-1:1998+A1:1992+A2:1995 to apply CE certificate.Today our client said the the test is not complete and expired.
Since IEC standard is not mandatory,but EN verson is, so i seached the harmonized standard list in EU offical website and found that the version now is EN 60601-1:1900+A1:1993+A2:1995+A13:1996 and except for A13, there are idt IEC version.
What is EN 60601-1 A13 about? Is the test according to IEC 60601-1:1998+A1:1992+A2:1995 expired? And how we could do update test based on the first test result?
Thanks in advance!!
 

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T

temujin

#3
I don´t know the content of A13, but according to the link below(from which the quote is taken) A13 was incorporated into EN 60601-1 in 1996.

If I understand it right, then A13 is already part of EN 60601-1 provided that your copy is dated after 1996. Take a look at the reference number on the front page of your copy.


http://www.eisnersafety.com/Medical_Device_Sfty_Standards.htm

The second edition of IEC 60601-1 was published in 1988 and was adopted as an EN standard in 1990. Amendments A1, A11, and A12 were added to IEC60601-1 in 1990 & 1991 and were adopted as part of the EN standard in 1993. Amendment A2 is the most important Amendment to date because it added all the requirements to align the standard much closer to the Medical Device Directive Essential requirements (Annex I of the MDD). EN60601-1 was adopted with this amendment in 1995. Amendment A13 was incorporated into EN60601-1 in 1996. The Third Edition of IEC 60601-1 was published December 15, 2005 and will likely be adopted by many national standards organizations in 2006. After that occurs the Certification Agencies will determine how they will certify products to that standard.
By the way, neither IEC nor EN standards are mandatory (unless you are doing business in Brazil).

Are you sure your client is not referring to the 3rd edition of 60601-1?

Hope this helped, otherwise I know there are numerous 60601 competent people here that might help you out.

regards
t.
 
P

Pauling

#4
Thanks you so much!
You remind me we did the test in Sep. of 2006 that is late for the date of A13 incorporated into EN60601-1 .
However i still don't know the relationship of EN60601-1.90+A1+A2+A13 and IEC 60601-1:1998+A1:1992+A2:1995. Are they equivalence?
I'm sure our client didn't refer to the 3rd version of 60601-1.
And our product is sold to EU, so we have to get CE mark. According to MDD, i think the harmonized standard EN60601-1.90+A1+A2+A13 is mandatory. Refer to my previous attached file, 3rd version of 60601-1 haven't been harmonized yet.
Thanks again!
 
T

temujin

#5
Hi again,

However i still don't know the relationship of EN60601-1.90+A1+A2+A13 and IEC 60601-1:1998+A1:1992+A2:1995. Are they equivalence?
IEC 60601-1:1988 was published as a European norm in 1990 under EN 60601-1:1990. So IEC 60601-1:1988 = EN 60601-1:1990.

The harmonized standard with amendments are (as you point out)
EN 60601-1:1990
+ A1:1993 to EN 60601-1:1990
+ A2:1995 to EN 60601-1:1990
+ A13:1996 to EN 60601-1:1990

As far as I know, IEC standards are normally adopted as European norms without changes, so it does not really matter if you use IEC or EN.


We did the safety test according to IEC 60601-1:1998+A1:1992+A2:1995 to apply CE certificate.
I think you need to add A13, but you write "IEC 60601-1:1998". Is the "1998" a typo? You might have a consolidated version of the standard. Take a look at the Reference Number on the standards front page...


regards
t.
 
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P

Pauling

#6
Is the "1998" a typo?
:eek: Sorry.
It's my type mistake. It should be "1988".

I think you need to add A13
Do you mean add the A13 directly on the test of IEC version? Since
IEC standards are normally adopted European norms without changes
However just the same reason, I confuse about A13 . I think maybe i should find the standard A13 to compare with IEC version.

You help me a lot. Thanks so much!!
 
T

temujin

#7
Do you mean add the A13 directly on the test of IEC version?
No. A13 might be modifying requirements of the base standard.

Just buy A13 and have a look at it...it costs less than EUR 15. Your Notified Body might also be able to help you out.

t.

PS: I had a typo in the sentence you qouted...I have changed it in the post. This should be right:
IEC standards are normally adopted as European norms without changes
 
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Marcelo

Inactive Registered Visitor
#8
Just a quickie :

IEC 60601 plus it´s two ammendments are almost equivalent to EN 60601-1 plus it´s three amendments. There´s some minor differences, that´s why the EN is not a EN IEC.

Also, EN standards are not mandatory, the same as with the IEC standards.
 
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