ISO 14937:2000
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

Standard No.

ISO 14937:2000

Release Date

2000

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 14937:2000/Cor 1:2003

Latest

ISO 14937:2009

Scope

1 This International Standard specifies general requirements for the characterization of a sterilizing agent, and for the development, validation and routine control of a sterilization process for medical devices. 2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. 3 This International Standard does not apply to processes that rely solely on physical removal of microorganisms (for example, filtration). 4 This International Standard does not describe detailed test procedures for assessing microbial inactivation. 5 This International Standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized and the organization with responsibility for sterilizing the medical device. 6 This International Standard does not supersede or modify published International Standards for particular sterilization processes. NOTE 1 Although the scope of this International Standard is limited to medical devices, the principles described may also be applied to other health care products. NOTE 2 Sterilization processes validated and controlled in accordance with the requirements of this International Standard should not be assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

ISO 14937:2000 Referenced Document

• IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*， 2017-01-01 Update
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
• ISO 13485 *， 2018-05-15 Update
• ISO 13488 Quality systems - Medical devices - Particular requirements for the application of ISO 9002

ISO 14937:2000 history

• 2009 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
• 2003 ISO 14937:2000/Cor 1:2003 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; Technical Corrigendum 1
• 2000 ISO 14937:2000 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