EN ISO 11137-1:2006

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)

Publication date:   Aug 10, 2006

General information

99.60 Withdrawal effective   Jun 10, 2015

CEN

CEN/TC 204 Sterilization of medical devices

European Norm

11.080.01   Sterilization and disinfection in general

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Scope

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 552:1994

WITHDRAWN
EN 552:1994/A1:1999

WITHDRAWN
EN 552:1994/A2:2000

NOW

WITHDRAWN
EN ISO 11137-1:2006
99.60 Withdrawal effective
Jun 10, 2015

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN ISO 11137-1:2006/A1:2013

REVISED BY

PUBLISHED
EN ISO 11137-1:2015