GB/T 18279.2-2015
Sterilization of health care products.Part 2:Guidance on the application of GB 18279.1 (English Version)
- Standard No.
- GB/T 18279.2-2015
- 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/T 18279.2-2015
- Replace By
- GB 18279-2023
- Replace
- GB 18279-2000
- Scope
- This part of GB 18279 provides guidance for implementing the requirements of GB 18279.1-2015. This section does not restate these requirements, nor is it a guideline for independent application. The terms that are not applicable in GB 18279.1 are also not applicable in this part. For the convenience of reference, the clause numbers of this part correspond to those of GB 18279.1-2015. Appendix C of GB 18279.1-2015 already contains detailed guidelines for the requirements of GB 18279.1, and should be applied in conjunction with this part. This part is mainly applicable to those who have mastered the basic principles of ethylene oxide sterilization, but need help in better meeting the requirements of GB 18279.1-2015. This section is not applicable to persons who lack basic knowledge of ethylene oxide sterilization.
GB/T 18279.2-2015 Referenced Document
- 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
- 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 19973.1-2015 Sterilization of medical devices.Microbiological methods.Part 1:Determination of a population of microorganisms on products
- YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
- YY/T 0802-2010 Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
GB/T 18279.2-2015 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/T 18279.2-2015 Sterilization of health care products.Part 2:Guidance on the application of GB 18279.1 has been changed from GB 18279-2000 Medical devices--Validation and routine control of ethylene oxide sterilization.
GB/T 18279.2-2015 Sterilization of health care products.Part 2:Guidance on the application of GB 18279.1 was changed to GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization.