NF EN ISO 11137-1

NF EN ISO 11137-1

January 2016
Standard Current

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

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.ISO 11137-1:2006 does not:specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.

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Main informations

Collections

National standards and national normative documents

Publication date

January 2016

Number of pages

56 p.

Reference

NF EN ISO 11137-1

ICS Codes

11.080.01   Sterilization and disinfection in general

Classification index

S98-103-1

Print number

1

International kinship

ISO 11137-1:2006

European kinship

EN ISO 11137-1:2015
Sumary
Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.

ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator.

ISO 11137-1:2006 does not:

  • specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;
  • detail specified requirements for designating a medical device as sterile;
  • specify a quality management system for the control of all stages of production of medical devices;
  • specify requirements for occupational safety associated with the design and operation of irradiation facilities;
  • specify requirements for the sterilization of used or reprocessed devices.
Replaced standards (2)
NF EN ISO 11137-1
July 2006
Standard Cancelled
Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices

ISO 11137-1:2006 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices. Although the scope of ISO 11137-1:2006 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment. ISO 11137-1:2006 covers radiation processes employing irradiators using the radionuclide 60Co or 137Cs, a beam from an electron generator or a beam from an X-ray generator. ISO 11137-1:2006 does not: specify requirements for development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease;detail specified requirements for designating a medical device as sterile;specify a quality management system for the control of all stages of production of medical devices;specify requirements for occupational safety associated with the design and operation of irradiation facilities;specify requirements for the sterilization of used or reprocessed devices.

NF EN ISO 11137-1/A1
September 2013
Standard Cancelled
Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices

Le présent document est l'amendement 1 à la norme homologuée NF EN ISO 11137-1 de juillet 2006. Il modifie l'Article 2, les paragraphes 3.29, 3.31, 6.2.5, 7.4, 8.2.2, 12.1.1, 12.1.2.5, 12.1.3.1 12.1.3.2, 12.1.3.5 et l'Annexe A.

Table of contents
  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Éléments du système de management de la qualité
  • 5 Caractérisation de l'agent stérilisant
  • 6 Caractérisation du procédé et de l'équipement
  • 7 Définition du produit
  • 8 Définition du procédé
  • 9 Validation
  • 10 Surveillance et contrôle de routine
  • 11 Libération du produit de la stérilisation
  • 12 Maintien de l'efficacité du procédé
  • Annexe (normative)
  • Annexe A (informative)Directives
  • 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 diagnostic in vitro
  • Bibliographie
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