Standard Swedish standard · SS-EN ISO 13408-6:2021

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

Status: Valid

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Standard Swedish standard · SS-EN ISO 13408-6:2021

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
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Scope
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products.
This document does not specify requirements for restricted access barrier systems (RABS).
This document does not supersede or replace national regulatory requirements such as Good Manufacturing Practices (GMPs) and/or compendia requirements that pertain in particular to national or regional jurisdictions.
This document does not specify requirements for isolators used for sterility testing; however, some of the principles and information in this document could be applicable to this application.
This document does not define biosafety containment requirements.

Subjects

Sterilization and disinfection in general (11.080.01) General (11.120.01)


Buy this standard

Standard Swedish standard · SS-EN ISO 13408-6:2021

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)
Subscribe on standards - Read more Dölj
Price: 1 487 SEK
standard ikon pdf

PDF

Price: 1 487 SEK
standard ikon

Paper

Price: 2 379,20 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-80029389

Edition: 2

Approved: 5/24/2021

No of pages: 52

Replaces: SS-EN ISO 13408-6:2011 , SS-EN ISO 13408-6:2011/A1:2013