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IEC 81001-5-1 was added to the list of recognized consensus standards

The FDA added late December 2022 IEC 81001-5-1 to the list of recognized consensus standards.
That's it. After beating around the bush on this blog on whether UL 2900-x or IEC 81001-5-1 would be applicable to 510(k) submissions and other regulatory clearances, we now have the answer.

We can use IEC 81001-5-1 as:

A good way to make thing (a bit) more simple.

Remark: UL 2900-x can still be applied in the US!



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