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BSI - BS EN ISO 11138-1

Sterilization of health care products — Biological indicators Part 1: General requirements

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Organization: BSI
Publication Date: 30 April 2017
Status: active
Page Count: 52
ICS Code (Sterilization and disinfection in general): 11.080.01
ICS Code (Disinfectants and antiseptics): 11.080.20

Document History

BS EN ISO 11138-1
April 30, 2017
Sterilization of health care products — Biological indicators Part 1: General requirements
A description is not available for this item.
BS EN ISO 11138-1
July 31, 2006
Sterilization of health care products Biological indicators Part 1: General requirements
A description is not available for this item.

References

This document references:
11607-1 AMD 1 - Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems AMENDMENT 1: Application of risk management
Published by ISO on September 1, 2023
A description is not available for this item.
This document references:
ISO 11135 - Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on July 15, 2014
Inclusions This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial...
This document references:
ISO 18472 - Sterilization of health care products - Biological and chemical indicators - Test equipment
Published by ISO on August 1, 2018
This document specifies the requirements for test equipment to be used to: — test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the...
This document references:
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
Published by ISO on October 15, 2009
Inclusions 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...
This document is referenced by:
BS EN ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements
Published by BSI on February 28, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 16061 - Instruments for use in association with non-active surgical implants — General requirements
Published by BSI on April 30, 2021
A description is not available for this item.
This document is referenced by:
BS EN 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 BSI on April 30, 2013
A description is not available for this item.
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