Title Of Document

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

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.

Category of Standards

Category 1

Document number assigned by ASEAN

ISO 11137-1:2006

ICS

HS

30.0130.0530.0633.0433.0633.0734.0434.0737.0538.0838.2138.2239.2439.2640.1440.1548.1848.2359.0662.1162.1263.0766.0284.1984.2185.3987.1387.1490.0190.0290.0490.0690.1190.1390.1890.1990.2090.2190.2290.2594.0294.05

HS Range

MRA/Harmonised Regulations related to the Standard

ASEAN Agreement on Medical Device Directive (AMDD)

ASEAN Body responsible for Standard

Medical Device Product Working Group (MDPWG)

Member States

 ID   TH 

Date of harmonisation in ASEAN

Date of Latest Review

Links :

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