ISO13485:2012 & 21 CFR 820
Generally speaking, none of them mandates compliance with specific ISO standards.
As of now, ISO 11135:2014 is on the FDA's recognized consensus standards list (since 4.4.2016), and previous versions are not recognized.
In the EU, EN ISO 11135-1:2007 is currently harmonized and ISO 11135:2014 is not. ISO 11135-2 is also not harmonized.
Last edited: