DS/EN ISO 11137-1:2015/A2:2019

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices – Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)

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Harmonized under:
  • Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices

  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices

  • Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

Harmonized standards:


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.

Number of pages: 24

Published: 2019-11-28

Date of approval: 2019-11-25

International relationships : EN ISO 11137-1:2015/A2:2019 IDT ISO 11137-1:2006/Amd 2:2018 IDT

ICS: 11.080.01 - Sterilization and disinfection in general

Item number: M318969



  • CEN/TC 204
  • ISO/TC 198
  • ISO/TC 198/WG 2

Danish committee