What are the IEC 60601-1-2 Collateral and "Particular" standards

[occounty]

Hi,
Almost all medical devices use one or more either Collateral and particular standards. Some of the collateral and particular standards are referenced in the NORMATIVE REFERENCE section of 60601-1-2 standard, so it is clear what version of the standard to use.
But for the Collateral or particular standards that are NOT listed in this section, where to or how to determine which version of the specific standard will be acceptable?

Much thanks!

 

[Marcelo]

Acceptability of the standards really depends on the way the standards are recognized by regulatory requirements, so you would need to verify in each regulatory requirement of each target country how it does that.

In the case of the text of the standard in itself, 1.3 defines that "Applicable collateral standards become normative at the date of their publication and shall apply together with this standard" so it means all the last versions of the collateral standards. But again, regulatory requirements supersedes this comment.

For example, although IEC 60601-1-2 has a fourth edition, worldwide the third edition is still used, and the fourth edition will be used depending on the regulatory system (in Europe, for example, the target date is 31/12/2018, as defined here: Medical devices - European Commission. In Brazil, the third edition will be used for some years still).