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Norm

ISO 14937:2009

Issue date: 2009 10 14

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

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 ...
Valid
Publisher:
International Organization for Standardization
Format:
Digital | 37 Pages
Language:
English

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.

ISO 14937:2009
2009 10 14
Sterilization of health care products — General requirements for characterization of a sterilizing a...
Norm
ISO 14937:2000/Cor 1:2003
2003 06 03
Sterilization of health care products — General requirements for characterization of a sterilizing a...
Norm
ISO 14937:2000
2000 12 21
Sterilization of health care products — General requirements for characterization of a sterilizing a...
Norm