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 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2016

Number of pages

67 p.

Reference

NF EN ISO 13408-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-117-1

Print number

1

International kinship

ISO 13408-1:2008

European kinship

EN ISO 13408-1:2015
Sumary
Aseptic processing of health care products - Part 1 : general requirements

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.

ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

Replaced standards (2)
NF EN ISO 13408-1
September 2011
Standard Cancelled
Aseptic processing of health care products - Part 1 : general requirements

ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products. ISO 13408-1:2008 includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in other parts of ISO 13408.

NF EN ISO 13408-1/A1
July 2013
Standard Cancelled
Aseptic processing of health care products - Part 1 : general requirements - Amendment 1

Le présent document liste les modifications qui seront appliquées à la NF EN ISO 13408-1:2011 et prend en compte les exigences liées aux Directives 90/385/CEE "Dispositifs médicaux implantables actifs", 93/42/CEE "Dispositifs médicaux" et 98/79/CEE "Dispositifs médicaux de diagnostic in vitro" par l'ajout des annexes ZA, ZB et ZC.

Standard replaced by (1)
NF EN ISO 13408-1
April 2024
Standard Current
Aseptic processing of health care products - Part 1 : general requirements

This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Specific requirements and guidance on various specialized processes and methods related to sterilizing filtration, lyophilization, clean-in place (CIP) technologies, sterilization in place (SIP) and isolator systems are given in the other parts of the ISO 13408 series.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Éléments du système qualité
  • 5 Définition d'un traitement aseptique
  • 6 Environnement de fabrication
  • 7 Équipement
  • 8 Personnel
  • 9 Fabrication du produit
  • 10 Simulation de procédé
  • 11 Essai de stérilité
  • Annexe (normative)
  • Annexe (normative)
  • Annexe A(informative) Exemple de logigramme
  • Annexe B(informative) Éléments types de la définition d'un procédé aseptique
  • Annexe C(informative) Exemples de risques spécifiques
  • Annexe D(informative) Comparaison de la classification des chambres stériles
  • Annexe E(informative) Spécifications relatives à l'eau utilisée dans le procédé
  • Annexe F(informative) Zone de traitement aseptique
  • Annexe ZA(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 90/385/CEE relative aux dispositifs médicaux implantables actifs
  • Annexe ZB(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEE relative aux dispositifs médicaux
  • Annexe ZC(informative) Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 98/79/CE relative aux dispositifs médicaux de diagnosticin vitro
  • Bibliographie
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