NF EN ISO 13408-6

NF EN ISO 13408-6

May 2021
Standard Current

Aseptic processing of health care products - Part 6 : isolator systems

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.

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Main informations

Collections

National standards and national normative documents

Publication date

May 2021

Number of pages

46 p.

Reference

NF EN ISO 13408-6

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-6

Print number

1

International kinship

ISO 13408-6:2021

European kinship

EN ISO 13408-6:2021
Sumary
Aseptic processing of health care products - Part 6 : isolator systems

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.

Replaced standards (2)
NF EN ISO 13408-6
September 2011
Standard Cancelled
Aseptic processing of health care products - Part 6 : isolator systems

Le présent document spécifie les exigences en matière de systèmes isolateurs utilisés pour le traitement aseptique et indique les lignes directrices relatives à la qualification, la biodécontamination, la validation, le fonctionnement et le contrôle des systèmes isolateurs utilisés pour le traitement aseptique des produits de santé. Il se concentre sur l'utilisation des systèmes isolateurs afin de maintenir les conditions aseptiques. Cela peut inclure les applications pour les matières dangereuses.

NF EN ISO 13408-6/A1
May 2013
Standard Cancelled
Aseptic processing of health care products - Part 6 : isolator systems - Amendment 1

Le présent amendement modifie la norme NF EN ISO 13408-6, de septembre 2011.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Éléments du système qualité
  • 5 Principe de base des systèmes isolateurs
  • 6 Spécification des systèmes isolateurs
  • 7 Conception des systèmes isolateurs
  • 8 Validation
  • 9 Surveillance et contrôle de routine
  • 10 Formation du personnel
  • Annexe A (informative) Dispositifs agissant comme des ports de transfert pour appareils mobiles et portables
  • Annexe B (informative) Système isolateur - Explication des termes utilisés, de l'écoulement de l'air et des flux de matériaux
  • Annexe C (informative) Système isolateur - Surfaces en contact direct/indirect avec le produit
  • Annexe ZA (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Annexe ZB (informative) Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/746
  • Bibliographie
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