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, including Amd 1:2013)
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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.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
4.1 Documentation
4.2 Management responsibility
4.3 Product realization
4.4 Measurement, analysis and improvement — Control of nonconforming product
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.2 Microbicidal effectiveness
5.3 Material effects
5.4 Environmental considerations
6 Process and equipment characterization
6.1 Process
6.2 Equipment
7 Product definition
8 Process definition
8.1 Establishing the maximum acceptable dose
8.2 Establishing the sterilization dose
8.3 Specifying the maximum acceptable dose and the sterilization dose
8.4 Transference of maximum acceptable, verification or sterilization dose between radiation sources
ISO 10012-1:1992 Quality assurance requirements for measuring equipment -- Part 1: Metrological confirmation system for measuring equipment
ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
ISO 10012-1:1992 Quality assurance requirements for measuring equipment -- Part 1: Metrological confirmation system for measuring equipment
ISO 11137-2:2013 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
ISO 11737-2:2009 Sterilization of medical devices -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes