Partial Compliance to an ISO Standard for Medical Device CE Marking

[robert.beck]

I have an odd question that came up - if part of a standard isn't applicable, do you have to claim partial compliance?

I would say no to this question. if you comply to all applicable parts, you are fully compliant.

 

[Sullen-gent]

I have been in similar situation as described in this thread whereby we apply most of the standard but not all of it, as it is not applicable. However we would list the standard in the ERC and would not say partial compliance.

I suspect partial compliance is important when clauses of the standard do apply but you have alternative solutions in place (ERC and presumption issues).

I was once asked to state partially compliance as so few of the clauses were applicable that the engineer was not comfortable saying we met the standard.

 

[robert.beck]

I can understand that the engineering viewpoint might differ from the regulatory/business viewpoint. it depends who gets to approve the ERC document.

 

[rob73]

Ask the person in question if they had an all electric car whether they would expect it to comply with exhaust emissions standards?