Use of Harmonised Standards (Full or Partial)


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Cove Users,

Could anybody give me good examples of when a (Harmonised) standard is used in full, and when one is used partially?

And what defines Full & Partial

Many Thanks


Re: Use of Standards (Full or Partial)

One example of what may be regarded as 'partial' is for bubble humidifiers. The standard ISO 8185 is based on ISO 60601-1 i.e. for electrical medical equipment. Simple bubble humidifiers do not have any electrical components, therefore most of the standard does not apply for that reason. Trying to explain this to a particular moronic NB auditor caused me a lot of issues. Basically in the product dossier I had to rewrite it to indicate clause by clause that it did not apply because it was not electrical. For other standards though it is likely that the standard be applied in full - unless you can supply a good reason not to imo.

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