To what FDA recognized standard would Method C of DIN/EN 550 (half-cycle) equivalent to? Is it the same as ISO 11135-1:2007 or ISO 11135-1:1994? Would FDA accept EN 550?
Please help!

To what FDA recognized standard would Method C of DIN/EN 550 (half-cycle) equivalent to? Is it the same as ISO 11135-1:2007 or ISO 11135-1:1994? Would FDA accept EN 550?
Please help!


11135:2007 (which replaces ISO 11135:1994) is listed on the FDA web site as a recognized concensus standard. EN 550 is or will soon be reissued as EN ISO 11135. During the three year transition period all of these standards remain valid.

Thank you very much.

Is ISO 11135 equivalent to AAMI TIR 16? I think I've looked it up before and it was, but I get nervous.

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

Hi,

You are correct. You must be in compliance with the ISO 11135. All the rest is guidance.

Does anyone have a documented gap analysis between the 1994 and 2007 standard?

Your help is appreciated
:thanx:
Shira

Our company would like to change ISO 11135-1994 to 2007, but it have difference detail so have anybody advise for gap analysis of them/Many thanks

Our company would like to change ISO 11135-1994 to 2007, but it have difference detail so have anybody advise for gap analysis of them/Many thanks

Hi Sammas,

I have merged your question to this thread where Shira had also asked the same question.

Any one having the gap analysis ?