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ISO 13408-6:2021

Aseptic processing of health care products — Part 6: Isolator systems
13. 4. 2021.

Опште информације

60.60     13. 4. 2021.

ISO

ISO/TC 198

Međunarodni standard

11.080.01  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 13408-6:2005

POVUČEN
ISO 13408-6:2005/Amd 1:2013

TRENUTNO

OBJAVLJEN
ISO 13408-6:2021
60.60 Standard objavljen
13. 4. 2021.

Nacionalna preuzimanja

SRPS EN ISO 13408-6:2021  
ISS

Aseptična obrada proizvoda za zaštitu zdravlja – Deo 6: Izolatorski sistemi

60.60   Standard objavljen

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