ISO 14937:2009 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.
It applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means and is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
ISO 14937:2009 specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.
Status: PublishedPublication date: 2009-10
Edition: 2Number of pages: 37
Technical Committee: ISO/TC 198 Sterilization of health care products
- ICS :
- 11.080.01 Sterilization and disinfection in general
This standard contributes to the following Sustainable Development Goal:
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|std 1 166|
|std 2 166||Paper|
ISO 14937:2000/Cor 1:2003
A standard is reviewed every 5 years
Stage: 90.93 (Confirmed)
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