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BSI - BS EN ISO 13408-5

Aseptic processing of health care products Part 5: Sterilization in place

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Organization: BSI
Publication Date: 30 October 2011
Status: active
Page Count: 28
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 13408-5
October 30, 2011
Aseptic processing of health care products Part 5: Sterilization in place
A description is not available for this item.

References

This document references:
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
Published by BSI on March 31, 2010
A description is not available for this item.
This document references:
ISO TR 22442-4 - Medical devices utilizing animal tissues and their derivatives — Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy (TSE) agents and validation assays for those processes
Published by ISO on December 1, 2010
This Technical Report offers suggestions for designing and conducting validation assays to help determine if processes used in the manufacture of medical devices derived from non-viable animal...
This document references:
ISO 22442-2 - Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
Published by ISO on September 1, 2020
This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices...
This document references:
ISO 11138-3 - Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
Published by ISO on March 1, 2017
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization...
This document references:
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
Published by BSI on March 31, 2010
A description is not available for this item.
This document references:
BS EN ISO 13408-1 - Aseptic processing of health care products Part 1: General requirements
Published by BSI on August 31, 2015
A description is not available for this item.
This document references:
BS EN ISO 13408-1 - Aseptic processing of health care products Part 1: General requirements
Published by BSI on August 31, 2015
A description is not available for this item.
This document references:
BS EN ISO 13408-1 - Aseptic processing of health care products Part 1: General requirements
Published by BSI on August 31, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 13408-6 - Aseptic processing of health care products Part 6: Isolator systems
Published by BSI on May 31, 2021
A description is not available for this item.
This document is referenced by:
BS EN ISO 13408-3 - Aseptic processing of health care products Part 3: Lyophilization
Published by BSI on October 30, 2011
A description is not available for this item.
This document is referenced by:
BS EN ISO 14644-7 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Published by BSI on October 14, 2004
A description is not available for this item.
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