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

Aseptisk behandling av medicintekniska produkter - Del 6: Isolatorsystem (ISO 13408-6:2021)

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

Aseptisk behandling av medicintekniska produkter - Del 6: Isolatorsystem (ISO 13408-6:2021)
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Omfattning
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.

Ämnesområden

Sterilisering och desinficering allmänt (11.080.01) Farmakopéprodukter allmänt (11.120.01)


Köp denna standard

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

Aseptisk behandling av medicintekniska produkter - Del 6: Isolatorsystem (ISO 13408-6:2021)
Prenumerera på standarden - Läs mer Dölj
Pris: 1 349 SEK
standard ikon pdf

PDF

Pris: 1 349 SEK
standard ikon

Papper

Pris: 2 158,40 SEK
standard ikon pdf + standard ikon

PDF + papper

Fler alternativ Färre alternativ

Produktinformation

Språk: Engelska

Framtagen av: Rengöring, desinfektion och sterilisering, SIS/TK 349

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

Artikelnummer: STD-80029389

Utgåva: 2

Fastställd: 2021-05-24

Antal sidor: 52

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