NF CEN ISO/TS 11135-2

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.

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Main informations

Collections

National standards and national normative documents

Publication date

November 2008

Number of pages

53 p.

Reference

NF CEN ISO/TS 11135-2

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-101-2

Print number

2 - 01/08/2009

International kinship

ISO/TS 11135-2:2008

European kinship

CEN ISO/TS 11135-2:2008
Sumary
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.

Replaced standards (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

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

Standard replaced by (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

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

Table of contents
View the extract
  • Avant-propos
    v
  • Introduction
    vi
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Termes et définitions
    2
  • 4 Systèmes de management de la qualité
    2
  • 4.1 Documentation
    2
  • 4.2 Responsabilité de la direction
    2
  • 4.3 Réalisation du produit
    3
  • 4.4 Mesurages, analyse et amélioration - Maîtrise du produit non conforme
    3
  • 5 Caractérisation de l'agent stérilisant
    3
  • 5.1 Agent stérilisant
    3
  • 5.2 Efficacité microbicide
    3
  • 5.3 Effets sur les matériaux
    3
  • 5.4 Considérations environnementales
    3
  • 6 Caractérisation du procédé et de l'équipement
    4
  • 6.1 Caractérisation du procédé
    4
  • 6.2 Caractérisation de l'équipement
    4
  • 7 Définition du produit
    5
  • 7.1 Généralités
    5
  • 7.2 Sécurité et performance du produit
    8
  • 7.3 Qualité microbiologique
    9
  • 7.4 Documentation
    9
  • 8 Définition du procédé
    10
  • 9 Validation
    13
  • 9.1 Qualification de l'installation
    13
  • 9.2 Qualification opérationnelle
    15
  • 9.3 Qualification de performance
    16
  • 9.4 Différences de configuration de charge
    20
  • 9.5 Revue et approbation de la validation
    20
  • 10 Surveillance et contrôle périodiques
    21
  • 10.1 Généralités
    21
  • 10.2 Libération paramétrique
    22
  • 11 Libération du produit après stérilisation
    23
  • 12 Maintien de l'efficacité du procédé
    24
  • 12.1 Généralités
    24
  • 12.2 Maintenance de l'équipement
    25
  • 12.3 Requalification
    26
  • 12.4 Évaluation des modifications
    27
  • Annexe A (informative) Directives relatives à l'application de l'ISO 11135-1:2007, Annexe A, détermination du taux de létalité du procédé de stérilisation - Approche indicateur biologique/charge biologique
    28
  • Annexe B (informative) Directives relatives à l'ISO 11135-1:2007, Annexe B - Détermination conservatrice du taux de létalité du procédé de stérilisation - Approche de surextermination
    38
  • Bibliographie
    40
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