Webstore

RS 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

Abstract

1.1.1 This International Standard 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.
NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified
herein can also be applied to sterilization processes for other health care products.
1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated
by physical and/or chemical means.
1.1.3 This International Standard 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.
1.1.4 This International Standard 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.
NOTE It is not a requirement of this International Standard to have a full quality management system. The necessary
elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to
the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of
medical devices. National and/or regional regulations for the provision of medical devices might require the
implementation of a full quality management system and the assessment of that system by a third party.
1.2 Exclusions
1.2.1 This International Standard does not apply to sterilization processes that rely solely on physical
removal of microorganisms (for example, filtration).
1.2.2 This International Standard does not describe detailed procedures for assessing microbial inactivation.
1.2.3 This International Standard does not specify requirements for characterization of an agent or for
development, validation and routine control of a process for inactivating the causative agents of spongiform
encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease.
Specific recommendations have been produced in particular countries for the processing of materials
potentially contaminated with these agents.
NOTE See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.4 This International Standard does not supersede or modify published International Standards for
particular sterilization processes.

General Information

Code	Classification	Theme	Pages	Publisher	Availability
RS ISO 14937: 2009	ADOPTED ISO STANDARDS	Electrical engineering	47	Second Edition Jul 2026	Available