GB 18278.1-2015
Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices (English Version)
- Standard No.
- GB 18278.1-2015
- Language
- Chinese, Available in English version
- Release Date
- 2017
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Latest
- GB 18278.1-2015
- Replace
- GB 18278-2000 GB/T 20367-2006
- Scope
- This part of GB18278 specifies the requirements for the development, confirmation and routine control of moist heat sterilization of 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 health-related products. This part includes, but is not limited to, the following moist heat sterilization processes, a) saturated steam-gravity exhaust system; b) saturated steam-powered exhaust system; c) air-steam mixed gas; d) water spray; e) water immersion. Note: See Appendix Wang. This section does not specify requirements for the development, validation and routine control of spongiform encephalopathy (such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease) pathogen inactivation process. Some countries have special regulations for handling materials potentially contaminated with these pathogens. Note: See YY/T0771.1, YY/T0771.2 ISO22442-3. This section does not apply to the sterilization process that uses a combination of moist heat and other sterilizing agents (such as: formaldehyde 7) as a sterilizing factor. This section does not detail the specific requirements for medical devices marked "sterile". Note: It should be noted that different Countries and regions have different requirements for labeling medical devices "sterility", for example, YY/T0615.1 or ANSI LAAMIST67. This part does not specify the quality management system that controls all stages of medical device production. Note: This part is not a manufacturing The requirements of a complete quality management system are required, which are only the basic elements of the minimum quality management system necessary to control the sterilization process, and these elements are normatively referenced at appropriate places in the text (see especially Chapter 4). Attention should be paid to the quality management system (see ISO 13485) that controls all stages of medical device production (including the sterilization process).Some countries and regions may require medical device suppliers to implement a complete quality management system and obtain third-party certification. Assessment. This part does not specify occupational safety requirements related to the design and operation of moist heat sterilization facilities. Note: The requirements for operational safety are specified in GB 4793.4. In addition, some countries have safety regulations.
GB 18278.1-2015 Referenced Document
- GB 18278.1 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
- ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
- ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements*， 2017-02-28 Update
- ISO 11138-3 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes*， 2017-02-28 Update
- ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements
- ISO 11140-3 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test; Technical Corrigendum 1
- ISO 11140-4 Sterilization of health care products - Chemical indicators - Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
- ISO 11140-5 Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
- ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
- ISO 11607-2 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
- ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
- ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update
- ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 17664 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices*， 2017-09-30 Update
GB 18278.1-2015 history
- 2017 GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
- 2006 GB/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities
- 2000 GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices has been changed from GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization.
GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices has been changed from GB/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities.
