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BSI - BS EN ISO 13408-2 - TC

Tracked Changes (Redline) - Aseptic processing of health care products Part 2: Sterilizing filtration

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Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 96
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 13408-2 - TC
February 25, 2020
Tracked Changes (Redline) - Aseptic processing of health care products Part 2: Sterilizing filtration
A description is not available for this item.

References

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 11137-1 - Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices AMENDMENT 2: Revision to 4.3.4 and 11.2
Published by ISO on November 1, 2018
A description is not available for this item.
This document references:
11139 AMD 1 - Sterilization of health care products — Vocabulary of terms used in sterilization and related equipment and process standards AMENDMENT 1: Amended and additional terms and definitions
Published by ISO on January 1, 2024
A description is not available for this item.
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
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:
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.
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