NF EN 550

NF EN 550

October 1994
Standard Cancelled mandatory application standard
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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.

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Main informations

Collections

National standards and national normative documents

Publication date

October 1994

Number of pages

37 p.

Reference

NF EN 550

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-101

Print number

1 - 01/10/1994

European kinship

EN 550:1994
Sumary
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 (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
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  • Avant-propos
    3
  • Introduction
    4
  • 1
    Domaine d'application 5
  • 2
    Références normatives 5
  • 3 Définitions
    6
  • 4 Généralités
    9
  • 5 Validation
    11
  • 6
    Maîtrise et surveillance du procédé 13
  • 7
    Libération du produit après stérilisation 14
  • Annexe A
    (normative) Méthode de calcul des valeurs D par la méthode B de qualification opérationnelle microbiologique 17
  • Annexe B
    (informative) Guide d'application de l'EN 550 19
  • Annexe C
    (informative) Bibliographie 35
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