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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
14 tet 2009

General information

90.60     5 mar 2026

ISO

ISO/TC 198

International Standard

11.080.01  

anglisht   frëngjisht   rusisht  

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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WITHDRAWN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WITHDRAWN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
90.60 Close of review
5 mar 2026

CORRIGENDA / AMENDMENTS

IN_DEVELOPMENT
ISO 14937:2009/WD Amd 1