ISO 14937:2009

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

Publication date:   Oct 14, 2009

General information

90.93 Standard confirmed   Dec 15, 2020

ISO

ISO/TC 198 Sterilization of health care products

International Standard

11.080.01   Sterilization and disinfection in general

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 14937:2000

WITHDRAWN
ISO 14937:2000/Cor 1:2003

NOW

PUBLISHED
ISO 14937:2009
90.93 Standard confirmed
Dec 15, 2020