NF EN ISO 13408-5
NF EN ISO 13408-5

NF EN ISO 13408-5

September 2011
Standard Current

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

Le présent document spécifie les exigences générales relatives à la stérilisation sur place(SSP) appliquée aux surfaces de l''équipement utilisé pour la fabrication de produits de santé stériles et se trouvant en contact avec le produit, et cela en procédant à un traitement aseptique. Il propose également des directives relatives à la qualification, à la validation, à l''exploitation et au contrôle.

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Main informations

Collections

National standards and national normative documents

Publication date

September 2011

Number of pages

29 p.

Reference

NF EN ISO 13408-5

ICS Codes

11.080.01   Sterilization and disinfection in general

European kinship

EN ISO 13408-5:2011
Sumary
Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

Le présent document spécifie les exigences générales relatives à la stérilisation sur place(SSP) appliquée aux surfaces de l''équipement utilisé pour la fabrication de produits de santé stériles et se trouvant en contact avec le produit, et cela en procédant à un traitement aseptique. Il propose également des directives relatives à la qualification, à la validation, à l''exploitation et au contrôle.
Replaced standards (1)
NF EN 13824
NF EN 13824
January 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.

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