Is ISO 11135 equivalent to AAMI TIR 16? I think I've looked it up before and it was, but I get nervous.
No they are definitely
not the same. ISO 11135:2007 is the normative standard - the parts you
must comply with if you wish sterilize medical devices using EO. The AAMI TIR series are the "
How to" documents, giving technical guidance about how to comply with elements of the ISO standard, and as such are informative references.
You
must comply with ISO11135; you
may use TIR 14, 15, 16, 19
et al. to provide you with specific methodology to demonstrate compliance.
Does anyone else have a different view?
Jimmy