AAMI/ANSI 11135-1:2007, EO Sterilization



AAMI for many years has been the US party with responsibility for sterilization-related standards.

Anyone have any info on the politics or organizational relations underlying that no longer being the case, such that the latest AAMI version of the above standard is not current with the latest ISO version and US FDA no longer recognizes the AAMI version as authoritative?

This was brought to mind today by FDA's publication of a December-issued Warning Letter to Customed, a Puerto Rico kit packer, for (along other things) having their sterilization process validated to AAMI/ANSI 11135-1:2007 instead of ISO 11135:2014.

Clearly FDA regards the 2014 version as effective now. Interestingly, this is not universally known among contract sterilization houses...a Michigan company that we use was not aware of it, for instance, and thinks that there is a three year transition period.
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We've now had two FDA-Registered-Establishment, ISO13485/11135-certified EO sterilization providers tell us that they think 11135:2014 doesn't go into effect until 2017.

11135-1:2007 definitely no longer is in the Recognized Consensus Standards list, though.

I was told today by one of the FDA Technical Contacts for ISO 11135:2014 that as far as FDA is concerned, ISO 11135:2014 became effective for FDA purposes as soon as it was included in the Recognized Consensus Standards database.

I've sent an email to our Certification Body, which also is the CB for the two EO sterilization providers mentioned above, asking whether they have provided information to EO sterilization providers regarding effectivity of the new standard.
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Do you have any update re FDA recognition of ISO 11135:2014 and withdrawal of AAMI /ISO11135-1:2007?

The common understanding is yes there is a transition period but I assume this does not apply for new applications with the FDA?

Any further insights would be appreciated.

Thank you.


I do not. I've had no response from our Certification Body.

They have a history of not responding when I ask them a question for which they do not have an answer, so I'm not totally surprised.


My understanding of the FDA Recognized standards is if it is on the list it is what the FDA requires you test against. No transition exists.

Transitions are to allow you to change your system to meet the new changed requirements of the standard. The FDA tends not to add things to the list immediately (60601 3rd ed. was years behind general acceptance), but when it does you can't look back.


FDA sometimes in the past has retained an old version beyond its addition of a new version, specifically to allow for a gradual period of adoption. This is a different approach than that used by ISO and EU, but achieves a similar end-goal.

This time, however, they did not do that.

big boss

Starting to get Involved
ear all
i have aquestion ,as per the iso 11135:2014 in OQ part
1- do we need to run humidity mapping ?? as in this phrase in standarad it refer to table C1 which releate to number of data logger for temp only , also is it make sense as humidity injected to be 60 % as an example so in empty chamber this not suposed to be decreased or increased !!!so can any one help to clearify this point
2- also i need to understand ((
In empty chamber OQ exercises, the recorded temperature range, within the usable chamber
volume during EO or inert gas exposure, of ± 3 °C of the average recorded chamber temperature
at each time point should be obtained after an equilibration period)) as this not clear for me
also do any one can provide copies of AAMI TRI16 and 28
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