NF EN ISO 11135-1

NF EN ISO 11135-1

August 2007
Standard Cancelled

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

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2007

Number of pages

57 p.

Reference

NF EN ISO 11135-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-101-1

Print number

1 - 27/08/2007

International kinship

ISO 11135-1:2007

European kinship

EN ISO 11135-1:2007
Sumary
Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11135-1:2007 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices.

Sterilization processes validated and controlled in accordance with the requirements of ISO 11135-1:2007 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Replaced standards (1)
NF EN 550
October 1994
Standard Cancelled
Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization.

Ce document spécifie les exigences relatives à la mise au point, à la validation, au contrôle et à la surveillance du procédé de stérilisation de dispositifs médicaux par l'oxyde d'éthylène.

Standard replaced by (2)
NF EN ISO 11135
July 2014
Standard Current
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO 11135:2014 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.

NF CEN ISO/TS 11135-2
November 2008
Standard Cancelled
Sterilization of health care products - Ethylene oxide - Part 2 : guidance on the application of ISO 11135-1

ISO/TS 11135-2:2008 provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification. This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    2
  • 3 Termes et définitions
    2
  • 4 Systèmes de management de la qualité
    9
  • 4.1 Documentation
    9
  • 4.2 Responsabilité de la direction
    9
  • 4.3 Réalisation du produit
    10
  • 4.4 Mesurages, analyse et amélioration - Maîtrise du produit non conforme
    10
  • 5 Caractérisation de l'agent stérilisant
    10
  • 5.1 Agent stérilisant
    10
  • 5.2 Efficacité microbicide
    10
  • 5.3 Effets sur les matériaux
    10
  • 5.4 Considérations environnementales
    11
  • 6 Caractérisation du procédé et de l'équipement
    11
  • 6.1 Caractérisation du procédé
    11
  • 6.2 Caractérisation de l'équipement
    11
  • 7 Définition du produit
    12
  • 7.1 Généralités
    12
  • 7.2 Sécurité et performance du produit
    13
  • 7.3 Qualité microbiologique
    13
  • 7.4 Documentation
    13
  • 8 Définition du procédé
    13
  • 9 Validation
    14
  • 9.1 Qualification de l'installation
    14
  • 9.2 Qualification opérationnelle
    15
  • 9.3 Qualification de performance
    15
  • 9.4 Différences de configuration de la charge
    17
  • 9.5 Revue et approbation de la validation
    17
  • 10 Surveillance et contrôle de routine
    19
  • 11 Libération du produit après stérilisation
    20
  • 12 Maintien de l'efficacité du procédé
    20
  • 12.1 Généralités
    20
  • 12.2 Maintenance de l'équipement
    20
  • 12.3 Requalification
    21
  • 12.4 Évaluation des modifications
    21
  • Annexe A (normative) Détermination du taux de létalité du procédé de stérilisation - Approche indicateur biologique/charge biologique
    22
  • Annexe B (normative) Détermination conservatrice du taux de létalité du procédé de stérilisation - Approche de surextermination
    25
  • Annexe C (normative) Directives générales
    27
  • Bibliographie
    44
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