UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

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

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

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

DIN EN ISO 13408-6

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)

active, Most Current
Buy Now
Organization: DIN
Publication Date: 1 July 2013
Status: active
Page Count: 28
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

May 1, 2019
Aseptic processing of health care products - Part 6: Isolator systems (ISO/DIS 13408-6:2019); German and English version prEN ISO 13408-6:2019
A description is not available for this item.
DIN EN ISO 13408-6
July 1, 2013
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013) (includes Amendment A1:2013)
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...
September 1, 2011
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)
A description is not available for this item.

References

Advertisement