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BSI - BS EN ISO 22442-3

Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents

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Organization: BSI
Publication Date: 29 February 2008
Status: active
Page Count: 34
ICS Code (Biological evaluation of medical devices): 11.100.20
ICS Code (Medical science): 11.020.20

Document History

BS EN ISO 22442-3
February 29, 2008
Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
A description is not available for this item.

References

This document references:
BS EN ISO 22442-1 - Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
Published by BSI on December 31, 2020
A description is not available for this item.
This document references:
ISO 13408-2 - Aseptic processing of health care products - Part 2: Sterilizing filtration
Published by ISO on January 1, 2018
This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users...
This document references:
ISO 13408-5 - Aseptic processing of health care products Part 5: Sterilization in place
Published by ISO on November 15, 2006
A description is not available for this item.
This document references:
ISO 13408-6 - Aseptic processing of health care products — Part 6: Isolator systems
Published by ISO on April 1, 2021
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related...
This document references:
ISO 13408-3 - Aseptic processing of health care products Part 3: Lyophilization
Published by ISO on September 15, 2006
This part of ISO 13408 specifies requirements for, and offers guidance on, equipment, processes, programmes and procedures for the control and validation of lyophilization as an aseptic process. It...
This document references:
ISO 13408-1 - Aseptic processing of health care products - Part 1: General requirements AMENDMENT 1
Published by ISO on May 1, 2013
A description is not available for this item.
This document references:
BS EN ISO 14160 - Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2011
A description is not available for this item.
This document references:
BS EN ISO 14160 - Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2011
A description is not available for this item.
This document references:
BS EN ISO 22442-1 - Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
Published by BSI on December 31, 2020
A description is not available for this item.
This document references:
BS EN ISO 14160 - Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2011
A description is not available for this item.
This document is referenced by:
BS PD 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 BSI on February 28, 2011
A description is not available for this item.
This document is referenced by:
BS EN ISO 22794 - Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
Published by BSI on September 30, 2009
A description is not available for this item.
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