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

standard by Association for the Advancement of Medical Instrumentation/International Org. for Standardization , 10/14/2009

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Full Description

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.

Product Details

Published:: 10/14/2009
ISBN(s):: 1570203695
ANSI:: ANSI Approved
Number of Pages:: 53
File Size:: 1 file , 320 KB
Part of:: AAMI STBK10-3
Note:: This product is unavailable in Ukraine, Russia, Belarus