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Report
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AAMI TIR14:2016/(R)2024
Contract sterilization using ethylene oxide
Summary
This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered. No annex
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2016 |
| Confirmation Date | 01/01/2024 |
| Page Count | 20 |
| Themes | Sterilization—Industrial |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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01/01/2016
Active
, Reaffirmed
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