NF EN ISO 13408-1
NF EN ISO 13408-1

NF EN ISO 13408-1

May 2024
Standard Current

Aseptic processing of health care products - Part 1: General requirements

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Main informations

Collections

National standards and national normative documents

Publication date

May 2024

Number of pages

102 p.

Reference

NF EN ISO 13408-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Print number

1

International kinship

ISO 13408-1:2023

European kinship

EN ISO 13408-1:2024
Replaced standards (1)
NF EN ISO 13408-1
NF EN ISO 13408-1
January 2016
Standard Cancelled
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

Le présent document spécifie des exigences générales et propose des directives en matière de méthodes, de programmes et de modes opératoires pour le développement, la validation et le contrôle de produits de santé soumis à un traitement aseptique. Il comprend des exigences et des directives relatives au domaine général du traitement aseptique. Des exigences et des directives spécifiques sur les divers procédés et méthodes spécialisés de filtration, de lyophilisation, de nettoyage in situ, de stérilisation in situ et de systèmes isolateurs sont indiquées dans les différentes parties de l''ISO 13408.

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