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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

Oct 14, 2009

General information

90.20     Oct 15, 2025

ISO

ISO/TC 198

International Standard

11.080.01  

English   French   Russian  

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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WITHDRAWN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WITHDRAWN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
90.20 Standard under periodical review
Oct 15, 2025

CORRIGENDA / AMENDMENTS

PROJECT
ISO 14937:2009/WD Amd 1

National adoptions

delSRPS EN ISO 14937:2023  
ISS

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

40.98   Project deleted

Z076 more

SRPS EN ISO 14937:2011  
ISS

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)

60.60   Standard published

Z076 more

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