60601-1:2024 and 60601-2-6:2024 - What’s changed and how deep do I need to go?

[AngelRose]

Hi all,

during our annual audits, a reviewer recently flagged the need to conform to the latest editions of IEC 60601-1 and IEC 60601-2-6 (also updated in 2024) for particular requirements for the basic safety and essential performance of microwave therapy equipment.

Before I rush into buying the full standards (they are certainly not cheap) or engaging an accredited testing laboratory, I’d like to ask the community:
- What are the main changes introduced in the 2024 iterations of IEC 60601-1 and -2-6?
- Can conformance be addressed through technical rationale and gap analysis in certain cases, or are the updates typically non-trivial and requiring full re-test?

Thanks in advance everyone, I'm trying to budget wisely without cutting corners out here.

 

[Hi_Its_Matt]

I believe (although I encourage others chime in) the 2024 amendment was to the European standard only, and was to add the Z-Annexes that show how the standard relates to the MDR and IVDR requirements.

What is the Amendment 13 of IEC 60601-1?

Recently, CENELEC has published to the national standardization bodies an Amendment 13 to the Edition 3.2 of IEC 60601-1.

www.linkedin.com

https://cdn.standards.iteh.ai/samples/77530/a68b1e6868684f04aa5e3ebbc0a9ebd3/SIST-EN-60601-1-2007-A13-2024.pdf

As to the price: you can buy the standards quite inexpensively from the Estonian National Standards Organization at evs.ee.
A multi-user license for the 2024 amendment to 60601-2-6 is a whopping 11€ (13 USD at current exchange rates).

EVS-EN 60601-2-6:2015/A2:2024

Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment

www.evs.ee

The full 60601-1, including 2024 amendment, can be purchased for ~81€ (95 USD).

EVS-EN 60601-1:2006+A1+A12+A2+A13:2024

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + IEC 60601-1:2005/A1:2012 + IEC 60601-1:2005/A2:2020)

www.evs.ee

 

[AngelRose]

Thanks Matt, that's exactly what I needed. Good to know the 2024 updates are mainly about EU alignment and not full technical overhauls. Also, great tip on EVS... huge cost saver.

If anyone has done a gap assessment against A13 or -2-6:2024, did your NB accept it without full re-testing?

 

[Benjamin Weber]

I also wanted to point to EVS for saving money, but Hi_Its_Matt was faster

But I have an important general note to this:
EVS sells the national Estonian EVS standard versions of the European EN versions. Usually those are literally the same as the international IEC versions. You can see this in the so called "Endorsement notice saying "the "(...) approved (...) without any modification", even in the case when the Z-Annexes are added. This is actually the case for the current 60601-1 edition.

But beware: There are cases, where the EN or even the nationally specific EVS editions may differ from the IEC version.