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ANSI/AAMI/ISO 14937:2009/(R)2013
Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
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Summary
This document specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. Applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. Intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of products to be sterilized and organizations responsible for sterilizing medical devices. Annex 3
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2009 |
| Confirmation Date | 01/01/2013 |
| Page Count | 0 |
| Themes | Sterilization—Industrial |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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