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CEN - EN ISO 13408-6

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

inactive
Organization: CEN
Publication Date: 1 June 2011
Status: inactive
Page Count: 30
ICS Code (Sterilization and disinfection in general): 11.080.01
scope:

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 isolator systems used for aseptic processing of health care products.

This part of ISO 13408 is focused on the use of isolator systems to maintain aseptic conditions; this may include applications for hazardous materials.

This part of ISO 13408 does not supersede or replace national regulatory requirements, such as Good Manufacturing Practices (GMPs) and/or compendial requirements that pertain in particular to national or regional jurisdictions.

Document History

EN ISO 13408-6
May 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...
EN ISO 13408-6
June 1, 2011
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...
EN ISO 13408-6
June 1, 2011
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 references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO 17665-1 - Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Published by ISO on August 15, 2006
Inclusions This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this...
This document references:
ISO TS 17665-2 - Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
Published by ISO on January 15, 2009
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth...
This document references:
ISO 10648-1 - Containment Enclosures - Part 1: Design Principles
Published by ISO on May 15, 1997
A description is not available for this item.
This document references:
ISO 10648-2 - Containment Enclosures - Part 2: Classification According to Leak Tightness and Associated Checking Methods
Published by ISO on December 15, 1994
A description is not available for this item.
This document is referenced by:
BS EN 556-2 - Sterilization of medical devices - Requirements for medical devices to be designated “STERILE” Part 2: Requirements for aseptically processed medical devices
Published by BSI on September 30, 2015
A description is not available for this item.
This document is referenced by:
CEN/TS 16244 - Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
Published by CEN on April 1, 2018
This Technical Specification sets out the framework and structure for the standard related to ventilation in hospitals. It gives the requirements for the drafting of the parts of the standard,...
This document is referenced by:
BS PD CEN/TS 16244 - Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals
Published by BSI on May 31, 2018
A description is not available for this item.
This document is referenced by:
BS EN 556-2 - TC - Tracked Changes (Redline) - Sterilization of medical devices — Requirements for medical devices to be designated “STERILE” Part 2: Requirements for aseptically processed medical devices
Published by BSI on February 24, 2020
A description is not available for this item.
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