Medical Device Standards - Difference between IEC and EN Standards

BTW, the transition from IEC (or ISO) to EN is not necessarily an adoption per-se, but it can involves modifications.

Click to expand...

Not technical ones. If there are modifications to requirements, the standard cannot be labeled IEC/ISO.

mmantunes said:

Not technical ones. If there are modifications to requirements, the standard cannot be labeled IEC/ISO.

Click to expand...

Thanks for the clarification. I still think my comment had some value, as for instance IEC 60601-1 was seemingly matched by EN 60601-1 (not "EN IEC..."). According to your comment there could be technical differences because there's no "IEC" in the title.

Cheers,
Ronen.

Thanks for the clarification. I still think my comment had some value, as for instance IEC 60601-1 was seemingly matched by EN 60601-1 (not "EN IEC..."). According to your comment there could be technical differences because there's no "IEC" in the title.

Click to expand...

Yes, both versions of EN 60601 (1990 and 2006) have technical diferences in which there's a normative Annex ZA (and a normative Annex ZD in the 1990 version).

Not exactly what you wanted but this thread points to standards which are "harmonised" with the "MDD". It includes EN,ISO,IEC etc standards
https://elsmar.com/Forums/showthread.php?t=41113
Rob