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
30.01 , 30.05 , 30.06 , 33.04 , 33.06 , 33.07 , 34.04 , 34.07 , 37.05 , 38.08 , 38.21 , 38.22 , 39.24 , 39.26 , 40.14 , 40.15 , 48.18 , 48.23 , 59.06 , 62.11 , 62.12 , 63.07 , 66.02 , 84.19 , 84.21 , 85.39 , 87.13 , 87.14 , 90.01 , 90.02 , 90.04 , 90.06 , 90.11 , 90.13 , 90.18 , 90.19 , 90.20 , 90.21 , 90.22 , 90.25 , 94.02 , 94.05
HS Range
MRA/Harmonised Regulations related to the Standard
ASEAN Agreement on Medical Device Directive (AMDD)
ASEAN Body responsible for Standard
ASEAN Medical Device Committee (AMDC)
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