NF EN ISO 17665-1

NF EN ISO 17665-1

November 2006
Standard Cancelled

Sterilization of health care products - Moist heat - Part 1 : requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:saturated steam venting systems;saturated steam active air removal systems;air steam mixtures;water spray;water immersion.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2006

Number of pages

54 p.

Reference

NF EN ISO 17665-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-105

Print number

1 - 13/11/2006

International kinship

ISO 17665-1:2006

European kinship

EN ISO 17665-1:2006
Sumary
Sterilization of health care products - Moist heat - Part 1 : requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:

  • saturated steam venting systems;
  • saturated steam active air removal systems;
  • air steam mixtures;
  • water spray;
  • water immersion.
Replaced standards (1)
NF EN 554
October 1994
Standard Cancelled
Sterilization of medical devices. Validation and routine control of sterilization by moist heat.

Le présent document spécifie les exigences relatives à la mise au point, à la validation, au contrôle et à la surveillance du procédé de stérilisation des dispositifs médicaux à la vapeur d'eau.

Standard replaced by (1)
NF EN ISO 17665
May 2024
Standard Current
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.

Table of contents
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 1.1 Éléments inclus
    1
  • 1.2 Éléments exclus
    1
  • 2 Références normatives
    2
  • 3 Termes et définitions
    3
  • 4 Éléments du système de management de la qualité
    10
  • 4.1 Documentation
    10
  • 4.2 Responsabilité du management
    10
  • 4.3 Réalisation du produit
    10
  • 4.4 Mesurage, analyse et amélioration - Maîtrise du produit non conforme
    11
  • 5 Caractérisation de l'agent stérilisant
    11
  • 5.1 Agent stérilisant
    11
  • 5.2 Efficacité microbicide
    11
  • 5.3 Effets sur les matériaux
    11
  • 5.4 Considération environnementale
    11
  • 6 Caractérisation du procédé et de l'équipement
    11
  • 6.1 Procédé
    11
  • 6.2 Équipement
    13
  • 7 Définition du produit
    15
  • 8 Définition du procédé
    16
  • 9 Validation
    17
  • 9.1 Généralités
    17
  • 9.2 Qualification de l'installation (QI)
    18
  • 9.3 Qualification opérationnelle (QO)
    18
  • 9.4 Qualification de performance (QP)
    19
  • 9.5 Revue et approbation de la validation
    20
  • 10 Surveillance et contrôle de routine
    21
  • 11 Libération du produit après stérilisation
    22
  • 12 Maintien de l'efficacité du procédé
    22
  • 12.1 Démonstration de la continuité de l'efficacité
    22
  • 12.2 Réétalonnage
    22
  • 12.3 Maintenance de l'équipement
    23
  • 12.4 Requalification
    23
  • 12.5 Évaluation des modifications
    23
  • Annexe A (informative) Directives
    24
  • Annexe B (informative) Définition du procédé basé sur l'inactivation de la population microbienne à l'état naturel (méthode basée sur la charge biologique)
    29
  • Annexe C (informative) Définition du procédé basé sur l'inactivation d'un micro-organisme de référence et la connaissance de la charge biologique sur des articles de produit appelés à être stérilisés (méthode combinée basée sur l'indicateur biologique/charge biologique)
    30
  • Annexe D (informative) Définition du procédé conservateur basé sur l'inactivation des micro-organismes de référence (méthode de surextermination)
    31
  • Annexe E (informative) Cycles opérationnels
    33
  • Bibliographie
    38
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