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BSI - BS EN ISO 14937

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

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Organization: BSI
Publication Date: 31 March 2010
Status: active
Page Count: 52
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 14937
March 31, 2010
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
A description is not available for this item.
BS EN ISO 14937
March 15, 2001
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
A description is not available for this item.
BS EN ISO 14937
March 15, 2001
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
A description is not available for this item.
BS EN ISO 14937
March 15, 2001
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
A description is not available for this item.

References

This document references:
ISO 20857 - Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2010
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of...
This document references:
IEC 61010-2-040 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
Published by IEC on May 1, 2020
Equipment included in scope This part of IEC 61010 specifies safety requirements for electrical equipment intended for sterilization, washing, and disinfection of medical materials in the medical,...
This document references:
AAMI ST67 - Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
Published by AAMI on January 1, 2019
Inclusions This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as “sterile.” Approaches to...
This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
A description is not available for this item.
This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 25539-3 - Cardiovascular implants - Endovascular devices Part 3: Vena cava filters
Published by BSI on March 31, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 25539-2 - Cardiovascular implants - Endovascular devices Part 2: Vascular stents
Published by BSI on October 31, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 25539-1 - Cardiovascular implants — Endovascular devices Part 1: Endovascular prostheses
Published by BSI on March 31, 2017
A description is not available for this item.
This document is referenced by:
BS ISO 11658 - Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
Published by BSI on May 31, 2012
A description is not available for this item.
This document is referenced by:
BS EN ISO 13504 - Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
Published by BSI on July 31, 2012
A description is not available for this item.
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