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ISO 13408-6

Aseptic processing of health care products - Part 6: Isolator systems AMENDMENT 1

inactive
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Organization: ISO
Publication Date: 15 March 2013
Status: inactive
Page Count: 10
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

ISO 13408-6
April 1, 2021
Aseptic processing of health care products — Part 6: Isolator systems
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related...
ISO 13408-6
March 15, 2013
Aseptic processing of health care products - Part 6: Isolator systems AMENDMENT 1
A description is not available for this item.
ISO 13408-6
June 15, 2005
Aseptic processing of health care products - Part 6: Isolator systems
This part of ISO 13408 specifies the requirements for isolator systems used for aseptic processing and offers guidance on qualification, bio-decontamination, validation, operation and control of...

References

This document is referenced by:
EN ISO 13408-1 - Aseptic processing of health care products - Part 1: General requirements
Published by CEN on June 1, 2015
This p art of I SO 13408 specifies t he general r equirements for, a nd offers g uidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing...
This document is referenced by:
AAMI 13408-1 - Aseptic processing of health care products - Part 1: General requirements
Published by AAMI on January 1, 2008
This part of ISO 13408 specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of the manufacturing process...
This document is referenced by:
DIN ISO 13022 - Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
Published by DIN on June 1, 2014
This International Standard specifies requirements and guidance for processing practices and managing risk associated with viable cellular components of products regulated as medicinal products,...
This document is referenced by:
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
Published by BSI on February 29, 2008
A description is not available for this item.
This document is referenced by:
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.
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