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BSI - BS EN ISO 13408-1 - TC

Tracked Changes (Redline) - Aseptic processing of healthcare products Part 1: General requirements

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Organization: BSI
Publication Date: 26 February 2020
Status: active
Page Count: 120
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

BS EN ISO 13408-1 - TC
February 26, 2020
Tracked Changes (Redline) - Aseptic processing of healthcare products Part 1: General requirements
A description is not available for this item.

References

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 14644-5 - Cleanrooms and associated controlled environments Part 5: Operations
Published by ISO on August 15, 2004
This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on...
This document references:
ISO 14644-3 - Cleanrooms and associated controlled environments — Part 3: Test methods
Published by ISO on August 1, 2019
This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions....
This document references:
ISO 14698-2 - Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
Published by ISO on September 15, 2003
This part of ISO 14698 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for...
This document references:
ISO 14698-2 - Cleanrooms and associated controlled environments — Biocontamination control — Part 2: Evaluation and interpretation of biocontamination data
Published by ISO on September 15, 2003
This part of ISO 14698 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for...
This document references:
ISO 14644-3 - Cleanrooms and associated controlled environments — Part 3: Test methods
Published by ISO on August 1, 2019
This document provides test methods in support of the operation for cleanrooms and clean zones to meet air cleanliness classification, other cleanliness attributes and related controlled conditions....
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 14644-5 - Cleanrooms and associated controlled environments Part 5: Operations
Published by ISO on August 15, 2004
This part of ISO 14644 specifies basic requirements for cleanroom operations. It is intended for those planning to use and operate a cleanroom. Aspects of safety that have no direct bearing on...
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