NF EN ISO 13408-2

NF EN ISO 13408-2

September 2011
Standard Cancelled

Aseptic processing of health care products - Part 2 : filtration

ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products. ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

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Main informations

Collections

National standards and national normative documents

Publication date

September 2011

Number of pages

25 p.

Reference

NF EN ISO 13408-2

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-2

Print number

1 - 18/08/2011

International kinship

ISO 13408-2:2003

European kinship

EN ISO 13408-2:2011
Sumary
Aseptic processing of health care products - Part 2 : filtration

ISO 13408-2:2003 specifies requirements for sterilizing filtration as part of aseptic processing of health care products. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process, to be used for aseptic processing of health care products.

ISO 13408-2:2003 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids containing particles as effective ingredient larger than the pore size of a filter (e.g. bacterial whole-cell vaccines).

Replaced standards (1)
NF EN 13824
March 2005
Standard Cancelled
Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Le présent document spécifie les exigences relatives à la conception et au fonctionnement des installations de traitement aseptique et à la validation et au contrôle de routine des procédés aseptiques en vue de la préparation de dispositifs médicaux liquides stériles. Il ne s'applique pas aux produits pharmaceutiques pour lesquels les exigences relatives aux bonnes pratiques de fabrication appropriées s'appliquent.

Standard replaced by (1)
NF EN ISO 13408-2
May 2018
Standard Current
Aseptic processing of health care products - Part 2 : sterilizing filtration

ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters. ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    1
  • 4 Exigences générales
    3
  • 5 Sélection des filtres et des filtres complets en fonction des données de leur fabricant
    3
  • 6 Critères de sélection spécifiques au fluide en fonction des données de l'utilisateur du filtre
    3
  • 7 Processus de filtration
    4
  • 7.1 Paramètres du processus
    4
  • 7.2 Validation de la rétention microbienne spécifique au fluide par les filtres
    5
  • 8 Conception du système de filtration
    7
  • 9 Processus de routine
    8
  • 10 Documentation du procédé
    9
  • 11 Maintenance et contrôle des modifications
    9
  • 12 Formation de l'opérateur
    9
  • Annexe A (informative) Informations de base et certificats de qualité des cartouches filtrantes
    10
  • Bibliographie
    11
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