Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
1 Scope
1.1 This part of GB 18280 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
Note: Although the scope of this part is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other products and equipment.
This part covers radiation processes employing irradiators using:
a) the radionuclide 60Co or 137Cs;
b) a beam from an electron generator;
c) a beam from an X-ray generator.
1.2 This part of 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 Creutzfeld-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Examples: ISO 22442-1, ISO 22442-2, and ISO 22442-3.
1.2.1 This part does not detail specified requirements for designating a medical device as sterile.
Note: Attention shall be drawn to regional and national requirements for designating medical devices as “sterile.” See, for example, EN 556-1 or ANSI/AAMI ST67.
1.2.2 This part does not specify a quality management system for the control of all stages of production of medical devices.
Note: It is not a requirement of this part to have a complete quality management system during manufacture, but the elements of a quality management system that are the minimum necessary to control the sterilization process are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see YY/T 0287) that control all stages of production of medical devices, including the sterilization process. Regional and national regulations for the provision of medical devices might require implementation of a complete quality management system and the assessment of that system by a third party.
1.2.3 This part does not require that biological indicators be used for validation or monitoring of radiation sterilization, nor does it require that a pharmacopoeial test for sterility be carried out for product release.
1.2.4 This part does not specify requirements for occupational safety associated with the design and operation of irradiation facilities.
Note: Attention shall also be drawn to the existence, in some countries, of regulations laying down safety requirements for occupational safety related to radiation.
1.2.5 This part does not specify requirements for the sterilization of used or reprocessed devices.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 18280.2-2015 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2: 2006, IDT)
YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485: 2003, IDT)
ISO 10012-1 Quality assurance requirements for measuring equipment - Part 1: Metrological confirmation system for measuring equipment
ISO 117373-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2 Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
Foreword i
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system elements
5 Sterilizing agent characterization
6 Process and equipment characterization
7 Product definition
8 Process definition
9 Validation
10 Routine monitoring and control
11 Product release from sterilization
12 Maintaining process effectiveness
Annex A (Informative) Guidance
Bibliography
