GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
Sterilization of health care products -
General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
1 Scope
1.1 Inclusions
1.1.1 This standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.
Note: Although the scope of this standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.
1.1.2 This standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.
1.1.3 This standard is intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices.
1.1.4 This standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine monitoring and control of a sterilization process.
Note: It is not a requirement of this standard to have a full quality management system. The necessary elements 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 or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.
1.2 Exclusions
1.2.1 This standard does not apply to sterilization processes that rely solely on physical removal of microorganisms (for example, filtration).
1.2.2 This standard does not describe detailed procedures for assessing microbial inactivation.
1.2.3 This standard does not specify requirements for characterization of an agent or 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.
Note: See also ISO 22442-1, ISO 22442-2 and ISO 22442-3.
1.2.4 This standard does not supersede or modify published standards for particular sterilization processes.
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 18281.1-2015 Sterilization of health care products-Biological indicators-Part 1:General requirements (ISO 11138-1: 2006, IDT)
YY/T 0287-2003 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485: 2003, IDT)
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-17 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
ISO 11737-1 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 per-formed in the definition，validation and maintenance of a sterilization process
IEC 61010-2-040 Safety requirements for electrical equipment for measurement，control and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfcetors used to treat medical materials
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
bioburden
population of viable microorganisms on or in product and/or sterile barrier system
[GB/T 19971-2015, definition 2.2]
3.2
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[GB/T 19971-2015, definition 2.3]
3.3
change control
assessment and determination of the appropriateness of a proposed alteration to product or procedure
[GB/T 19971-2015, definition 2.5]
3.4
chemical indicator
non-biological indicator
GB/T 19974-2018 The following standards are cited：
