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, IDT)
This Malaysian Standard specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
NOTE: Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
This standard covers radiation processes employing irradiators using:
a) the radionuclide 60 CO or 137 CS;
b) a beam from an electron generator; or
c) a beam from an X-ray generator.
This Malaysian Standard 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. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
This standard does not:
- detail specified requirements for des
Published
• (none) / (none) / (none)
PDF
26/01/2021
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NSC 18 - Medical Devices and Facilities for Healthcare
