UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - BS EN ISO 13408-6

Aseptic processing of health care products Part 6: Isolator systems

active, Most Current
Organization: BSI
Publication Date: 31 May 2021
Status: active
Page Count: 48
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 13408-6
May 31, 2021
Aseptic processing of health care products Part 6: Isolator systems
A description is not available for this item.
BS EN ISO 13408-6
October 30, 2011
Aseptic processing of health care products Part 6: Isolator systems
A description is not available for this item.
BS EN ISO 13408-6
October 30, 2011
Aseptic processing of health care products Part 6: Isolator systems
A description is not available for this item.

References

This document references:
ISO 18362 - Manufacture of cell-based health care products - Control of microbial risks during processing
Published by ISO on February 1, 2016
This International Standard specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of...
This document references:
ISO 14644-7 - Cleanrooms and associated controlled environments Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Published by ISO on October 1, 2004
This part of ISO 14644 specifies the minimum requirements for the design, construction, installation, test and approval of separative devices, in those respects where they differ from cleanrooms as...
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 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 - 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.
This document is referenced by:
BS EN ISO 13408-1 - TC - Tracked Changes (Redline) - Aseptic processing of healthcare products Part 1: General requirements
Published by BSI on February 26, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 14534 - TC - Tracked Changes (Redline) - Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
Published by BSI on February 26, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 13408-2 - TC - Tracked Changes (Redline) - Aseptic processing of health care products Part 2: Sterilizing filtration
Published by BSI on February 25, 2020
A description is not available for this item.
View Less
View All
Advertisement