ISO 11607-1:2009 vs. 2006 - What Changed?

Bonebuilder

Starting to get Involved
#1
Hi Everyone

Has anyone made a comparison of what changes ISO 11607-1:2009 introduces over the 2006 version it replaces?

At a quick look the contents list is the same, save for one less annex; "Annex ZA (Informative) Relationship between this International Standard and the Essentials Requirements of EU Directive 93/42/EEC on medical devices" isn't in the new version.

Despite it seems there being less content BSI still want to charge £142.00 for the update which seems a little rich to me.

Regards

Bonebuilder
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
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#2
I don't know what changed in ISO 11607, but I bet it was akin to the ISO 9001:2000 to 2008 "update" - For all intents and purposes the changes from the 2000 version hardly necessitated a full blown reissue. Follow the money :notme: Too bad the Annex you cite was removed. I like cross references.
 
#3
I'm afraid ISO 11607 is not my specialty but..

The annex ZA is added to an international standard when it becomes a European "harmonised" standard. So ISO 11607:xxxx will not have annex ZA but xx EN 11607:xxxx will.

Often, when looking for a standard from somewhere like the BSi web store, you can find a line such as "relationship to other standards" which will invariably state that the BS EN standard is identical to the IEC/ISO version, so the addition of annex ZA will be the only difference. But that doesn't help to explain the differences in an updated standard.
 
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