Harmonized EN 60601 Z Annexes are Not Useful

Mark Meer

Trusted Information Resource
#1
Curious about the harmonized (EN) versions of the IEC 60601 standards, and their Z annexes, which are supposed to give EU Directive essential requirements coverage by the standard.

But I'm looking, for example, at EN 60601-1-11, and the ZZ annex simply states:
...within its scope the Standard covers all relevant essential requirements given in Annex I of EU Directive 93/42/EEC...
...and that's pretty much all the information given!

This is DRASTICALLY different than other harmonized standards, that go into a lot of detail as to exactly what's covered with cross references between requirements and applicable Standard clauses. In other harmonized standards, these annexes usually take the form of a table of essential requirements, and notes regarding what's covered by the standard, and any deviations/caveats.

Did the authors of these standards just get lazy?
 
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