NF EN ISO 13408-2
NF EN ISO 13408-2

NF EN ISO 13408-2

June 2018
Standard Current

Aseptic processing of health care products — Part 2: Sterilizing filtration

Le présent document spécifie les exigences de filtration stérilisante dans le cadre du traitement aseptique des produits de santé, mené conformément à la NF EN ISO 13408-1. Il propose également des préconisations concernant les exigences générales pour la configuration, la validation et les opérations de routine d''un processus de filtration stérilisante aux utilisateurs de filtre.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2018

Number of pages

49 p.

Reference

NF EN ISO 13408-2

ICS Codes

11.080.01   Sterilization and disinfection in general

Print number

1

International kinship

ISO 13408-2:2018

European kinship

EN ISO 13408-2:2018
Sumary
Aseptic processing of health care products — Part 2: Sterilizing filtration

Le présent document spécifie les exigences de filtration stérilisante dans le cadre du traitement aseptique des produits de santé, mené conformément à la NF EN ISO 13408-1. Il propose également des préconisations concernant les exigences générales pour la configuration, la validation et les opérations de routine d''un processus de filtration stérilisante aux utilisateurs de filtre.
Replaced standards (1)
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)

Le présent document spécifie les exigences de filtration stérilisante dans le cadre du traitement aseptique des produits de santé. Il propose également des directives aux utilisateurs de filtre concernant les exigences générales de configuration, de validation et d''opération de routine d''un processus de filtration stérilisante à utiliser pour le traitement aseptique des produits de santé. Il ne concerne pas l''élimination des virus. La filtration stérilisante ne s''applique pas aux fluides contenant des particules dont les principes actifs sont de taille supérieure à la dimension des pores d''un filtre (par exemple vaccins bactériens sur des cellules entières).

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