AAMI ANSI/AAMI/ISO 14937:2009/(R)2013

Current Revision
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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AAMI 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

PUBLISH DATE 2009
AAMI ANSI/AAMI/ISO 14937:2009/(R)2013
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.
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