EN ISO 13485 Amended by: Corrigendum No. 1 January 2008.

chris1price

Trusted Information Resource
#1
Hi all

I had a surprise this morning, a new version of ISO13485:2003 dropped on my desk. As far as I can tell, the only changes are to the forward:

a) dropping the references to EN46000 and to the older ISO13485:2001 and ISO15488:2001 which are all now obsolete.

b) Reference to Module E, the basis for Annex VI of drective 93/42/EEC, which allows various exclusions (7.3, 7.5.1, and 7.5.2)

Are there any other changes I have missed?

In practice I dont think these make much difference, however we should be aware of them.

Chris
 
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G

Gert Sorensen

#2
Can't find the corrigendum anywhere. I can only find references to a 2007 corrigendum.

Who printed your version?
 

chris1price

Trusted Information Resource
#4
Hi Gert

You may be right. The coversheet has a date of 31st Jan 2008 and references "Implementation of CEN corrigendum June 2007". This is a BSI document, BS EN ISO13485, other versions may be updated differently.

Chris
 
W

wrodnigg

#5
The "international" standard EN ISO 13485/AC is dated 2007-06-00, there are several national standards, which have a later revision/date...

And yes, the only difference is, that 13485:2003 can now be "officially" applied for Module E, Annex VI MDD.

There is no need to purchase it (not even when you follow Annex VI). (if any certification body asks for it, tell them, you have reviewed it and you do not need it, because there is no substantial change...)

German and Austrian standards institutes have published the whole standard as DIN (ON) EN ISO 13485:2007 (all 100 pages), but I tell all my customers, that they do not need to buy it, because there are no relevant changes in the standard.
 

Marcelo

Inactive Registered Visitor
#6
Hello wrodnigg

The "international" standard EN ISO 13485/AC is dated 2007-06-00, there are several national standards, which have a later revision/date...
EN ISO 13485 is not an inernation standard, it´s the european implementation of the ISO international standard.

that 13485:2003 can now be "officially" applied for Module E, Annex VI MDD.
Are you sure about that? I think that before it can "officially" be used it has to be published in the Official Journal and thus added to the list of harminised standards (altough i cannot see why it could not be used before anyway :))
 
W

wrodnigg

#7
mmantunes,

That's why I wrote "international" and not international (without "..."), and I just distinguish between "international" EN/ISO/IEC/IEEE and "national" like DIN, BS, AAMI, ... (we can discuss about the (un)importance of EN, ISO, IEC... and about the meaning of the Vienna Agreement and so on... but IMHO there are more important topics around)

And yes, I am totally sure about that (I have already issued certificates according Annex VI / 13485 last year) - if you look at the list of the
list of harmonized standards which was amend by OJ C 186 of 2007-08-09 you will find the AC/2007 on the list of harmonized standards (EN 46003:1999 can be applied until 2009-07-31).
 
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