See the post on Compliance to State of the Art International Standards - EU MDR. I think this sums it up pretty well. And yes I agree state of the art is the proper solution you should be using the latest version of the standards that align.
For IEC or EN 60601 series of standards, you also have an alignment issue to consider in many cases. Realize if you have a Particular standard(s) (i.e. IEC 60601-2-XX or IEC/ISO 80601-2-XX) that apply to you like an Endoscopic Camera System IEC 60601-2-18:2009, for example, which is based on the older version of IEC 60601-1:2005 (3.0 edition) then you will need to do some extra work to conduct a gap assessment of what areas of IEC 60601-2-18 with respect to IEC 60601-1:2005 + A1:2012 + A2:2020 (edition 3.2) you need to identify the risks that weren't addressed previously based on the IEC 60601-1 (edition 3.0 related to the IEC 60601-2-18:2009) that are new and how to address them. Also, you will need to review the collaterals (i.e. IEC 60601-1-XX) that apply to your endoscopic camera system and do the same for the collaterals because they refer to older collaterals references that have gaps, as well. You will want to use your Risk Management File to provide evidence that you demonstrate the acceptable mitigations for the risks identified for the hazards (hazardous situations) are addressed for each and documented in the test report (TRF - test report form for the IEC CB Scheme test report forms that most labs are used to using) applicable. This is what most good test labs and Notified Bodies would expect at least as my experience. I am on the CB scheme Risk Management group for the medical group (ETF-3) was a technical reviewer for a NotifiedBody and have helped clients through this process.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 11-Jan-2024 19:09
From: Anonymous Member
Subject: Electrical safety and EMC standard update
This message was posted by a user wishing to remain anonymous
Hi,
With the updated standards of electrical safety and EMC published , but yet to be harmonized under EU MDR , how important is it to follow these standards for the legacy devices?
thanks,