Standard

NS-EN ISO 11137-1:2015

Published
Preview

Corrigendums and amendments are bought separately.

Language
Services

Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Edition: 2015-06
  • Version: 1
  • Document type: NAT
  • ICS 11.080.01
  • National Committee CEN/TC 204

Legal references

EU law: 93/42/EEC, 90/385/EEC, 2017/746, 2017/745, 98/79/EC

Product Relations

Product life cycle