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
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
Too bad the Annex you cite was removed. I like cross references.