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AAMI TIR14

Contract sterilization using ethylene oxide

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Organization: AAMI
Publication Date: 1 January 2016
Status: active
Page Count: 19
scope:

This AAMI TIR provides guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR addresses how ANSI/AAMI/ISO 11135:2014 applies to contract ethylene oxide (EO) sterilization operations for devices marketed in the United States.

EO contract sterilization guidance for health care providers is not specifically covered in this TIR.

Document History

AAMI TIR14
January 1, 2016
Contract sterilization using ethylene oxide
This AAMI TIR provides guidance that augments ANSI/AAMI/ISO 11135:2014, both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. This TIR...
January 1, 2009
Contract sterilization using ethylene oxide
This AAMI TIR provides additional guidance to augment ANSI/AAMI/IS0 11135-1:2007, both for medical device manufacturers that use contract sterilization facilities and for contract sterilization...
January 1, 1997
Contract Sterilization for Ethylene Oxide
A description is not available for this item.

References

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