GB 18280.2-2015
Sterilization of health care products.Radiation.Part 2: Establishing the sterilization dose (English Version)
- Standard No.
- GB 18280.2-2015
- 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
- Latest
- GB 18280.2-2015
- Replace
- GB 18280-2000
- Scope
- This part of GB 18280 stipulates the setting method of the minimum dose used to meet the special requirements for sterility and the method of confirming 25 kGy or 15 kGy as the sterilization dose capable of reaching 10 -6 sterility assurance level (SAL) method. This section also specifies the method of dose audit in order to prove that the sterilization dose continues to be effective. This section defines product families for dose establishment and dose auditing.
GB 18280.2-2015 Referenced Document
- GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
- GB/T 19973.1-2005 Sterilization of medical devices.Microbiological methods.Part 1: Estimation of 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 18280.2-2015 history
- 2015 GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
- 2000 GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
