GB 18279.1-2015
Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices (English Version)
- Standard No.
- GB 18279.1-2015
- Language
- Chinese, Available in English version
- Release Date
- 2015
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- Latest
- GB 18279.1-2015
- Replace By
- GB 18279-2023
- Replace
- GB 18279-2000
- Scope
- This part of GB 18279 specifies the requirements for the development, validation and routine control of the ethylene oxide sterilization process for medical devices. The sterilization process confirmed and controlled in accordance with the requirements of this part cannot be presumed to effectively inactivate the pathogenic agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Some countries have developed detailed recommendations for handling substances that may be contaminated by such agents. This section does not detail the specific requirements for medical devices labeled as sterile. This standard does not specify a quality management system for the control of all stages of medical device production. This section does not specify occupational safety requirements related to the design and operation of ethylene oxide sterilization facilities. This section does not cover sterilization of ethylene oxide or mixtures containing ethylene oxide injected directly into individual product packaging, or continuous sterilization processes. This section does not include analytical methods for determining residual levels of ethylene oxide and/or its reaction products.
GB 18279.1-2015 Referenced Document
- GB 18281.1-2015 Sterilization of health care products.Biological indicators.Part 1:General requirements
- GB 18281.2-2015 Biological indicators for sterilization of healthcare products - Part 2: Biological indicators for ethylene oxide sterilization*， 2017-01-01 Update
- GB 18282.1-2015 Chemical indicators for sterilization of healthcare products - part 1: general rules*， 2017-01-01 Update
- GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
- GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
- GB/T 19022-2003 Measurement management systems-Requirements for measurement processes and measruing equipment
- GB/T 19972-2005 Sterilization of health care products.Biological indicators.Guidance for the selection, use and interpretation of results
- GB/T 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
- GB/T 19973.2-2005 Sterilization of medical devices.Microbiological methods.Part 2: Tests of sterility performed in the validation of a sterilization process
- GB/T 19974-2005 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
- YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
GB 18279.1-2015 history
- 2015 GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
- 2000 GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization
GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices was changed to GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization.
