Testing to IEC 60825-1:2007 vs. IEC 60825-1:2014

[dr1vn]

We currently manufacture a device with a positioning laser. We had it tested to 60825-1:2007. The 2007 version is still a harmonized standard along with the 2014 version. The FDA does not list the 2014 version as a consensus standard. The 2007 version is a consensus standard with the FDA.

I'm not sure of the timings as to when the 2007 version no longer applies in both the EU and FDA. Any idea when we would need to test to the 2014 version?

Thanks in advance!

 

[Marc]

A quick "Bump". My Thanks in advance to anyone who can help with this one.

 

[JPerry]

Bump, bump...

FDA still only lists Ed 2 as recognized. But IEC lists Ed 2 as 'Withdrawn'. I don't think I've ever seen that before (FDA listing a withdrawn standard version).

Always something new to learn - anyone know why Ed 2 is withdrawn, and how best to approach choosing an edition for the US? Just go with Ed 2 since it's the listed consensus version, or go with Ed 3 and 'justify'?

Thanks in advance for anyone who has experience with this!

 

[damnshark]

Laser notice 56 permits the use of IEC 60825-1:2014 (aka Ed 3) for products in the US in lieu of 21 CFR 1040.10.

(since I don't have 5 posts yet I can't share the link to the Federal Register documents/2019/05/08/2019-09381/laser-products-conformance-with-iec-60825-1-ed-3-and-iec-60601-2-22-ed-31-laser-notice-no-56
But a Google search for

laser notice 56

will find it.)


IEC 60825-1:2014 is advantageous if you want to offer your product in world markets.

 

[Marc]

The link is: Laser Products-Conformance With IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56); Guidance for Industry and Food and Drug Administration Staff; Availability