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BSI - BS EN ISO 25424

Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

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Organization: BSI
Publication Date: 30 November 2019
Status: active
Page Count: 66
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 25424 + A1
November 30, 2019
Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
A description is not available for this item.
BS EN ISO 25424
November 30, 2019
Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
A description is not available for this item.
BS EN ISO 25424
August 31, 2011
Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
A description is not available for this item.

References

This document references:
EN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Published by CEN on May 1, 2014
A description is not available for this item.
This document references:
EN 556-1 - Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
Published by CEN on October 1, 2001
This European Standard specifies the requirements for a terminally-sterilized medical device to be designated "STERILE". Part 2 of this European Standard specifies the requirements for an aseptically...
This document references:
EN 867-5 - Non-Biological Systems for Use in Sterilizers - Part 5: Specification for Indicator Systems and Process Challenge Devices for Use in Performance Testing for Small Sterilizers Type B and Type S
Published by CEN on August 1, 2001
A description is not available for this item.
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:
BS EN 556-1 - Sterilization of Medical Devices - Requirements for Medical Devices to Be Designated "Sterile" - Part 1: Requirements for Terminally Sterilized Medical Devices
Published by BSI on December 11, 2001
A description is not available for this item.
This document is referenced by:
BS EN 12182 - Assistive products for persons with disability - General requirements and test methods
Published by BSI on June 30, 2012
A description is not available for this item.
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