YY/T 0870.3-2013
Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells (English Version)
- Standard No.
- YY/T 0870.3-2013
- Language
- Chinese, Available in English version
- Release Date
- 2013
- Published By
- Professional Standard - Medicine
- Status
- 2020-08
- Replace By
- YY/T 0870.3-2019
- Latest
- YY/T 0870.3-2019
- Scope
- This part of YY/T 0870 specifies the method for in vitro mammalian cell gene mutation testing of medical devices/materials using mouse lymphoma cell line (L5178Y TK+/-3.7.2C). The test method recommended in this section is the microplate method.
YY/T 0870.3-2013 Referenced Document
- GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
- GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
- GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
- GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
YY/T 0870.3-2013 history
- 2019 YY/T 0870.3-2019 Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
- 2013 YY/T 0870.3-2013 Test for genotoxicity of medical devices.Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
