There’s been a lot of confusion in the standards-using community over recent EN-ISO revisions just issued on some very popular ISO titles. Some examples? The EN- ISO-10993 series is out in 2009 Editions, while the ISO-10993 series itself hasn’t changed. Another? EN-ISO-11607-1 was upgraded to a 2009 Edition replacing the 2006 Edition, yet still remains identical to the ISO-11607-1 1st Edition from 2006.
How can the EN adoption of the ISO come out in a new edition and still be identical to the original ISO document?
Here’s the reason — The EN (European Union) administrative information has been modified, which has prompted the revision of the document even though the ISO document which it adopts remains the same.
So for the EN-ISO-11607-1, the change is the addition of Annex ZA, which is an informative annex only. This 1 page addition to the document has a table which identifies the relationship between the EN-ISO-11607-1 and the essential requirements of EU Directive 93/42/EEC.
How about the EN-ISO-10993-1? It has the insertion of 2 Annexes, both informative: ZA, again on the relationship between this standard and the EU Directive 93/42/EEC, and ZB, on the relationship of EN-ISO-10993-1 to Directive 90/385/EEC.
The rest of the EN-ISO-10993 series has been revised for the very same insertions.
If you reference the EN-ISO documents in your documentation, you are required to purchase the new revisions or risk being out of compliance.
If you reference the source ISO standards instead, no revisions are necessary, as the underlying ISO documentation remains stable.
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