Article 1: principles of biological evaluation of medical devices and general requirements for testing.
Chapter 1 Test Selection Guide
Chapter II Requirements for Animal Protection
Chapter III Selection and Qualitative Guidance of Standard Samples for Biological Experiments
Chapter IV Sample Preparation and Reference Samples
The second biological experiment and its evaluation
Chapter V Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests
Chapter VI Selection of Blood Interaction Test
Chapter VII Cytotoxicity Test
Chapter VIII Local Reaction Test after Implantation
Chapter 9 Stimulation and sensitization test
Chapter 10 Systemic Toxicity Test
Chapter XI Toxicological Kinetics Research and Design of Degradation Products and Soluble Substances
Chapter XII Formulation of Allowable Limits of Medical Device Processing and Sterilization Residues
The third degradation test and evaluation
Chapter XIII General Rules for Qualitative and Quantitative Analysis of Potential Degradation Products
Chapter XIV Qualitative and Quantitative Analysis of Degradation Products of Polymer Medical Devices
Chapter 15 Qualitative and Quantitative Analysis of Ceramic Degradation Products
Chapter XVI Qualitative and Quantitative Analysis of Degradation Products of Metals and Alloys
Section 4 Physical and Chemical Inspection and Evaluation
Chapter 17 Residues of Ethylene Oxide Sterilization
Chapter 18 chemical characteristics of materials
Article 5 Pre-clinical evaluation of biocompatibility of oral medical devices
Article 6 Clinical research of medical devices
Attachment 1 GB/t16886.1-1997 Biological evaluation of medical devices Part1:Guide to trial selection.
Appendix 2 GB/T16886.3-1997 Biological Evaluation of Medical Devices Part 3: Genotoxicity, Carcinogenicity and Reproductive Toxicity Tests
Appendix 3 GB/T16886.5-1997 Biological evaluation of medical devices Part 5: Cytotoxicity test in vitro.
Appendix 4 GB/T16886.6-1997 Biological evaluation of medical devices Part 6: Local reaction test after implantation.
Appendix 5 GB/T16886.1-1997 Biological Evaluation of Medical Devices Part 1 1: General Toxicity Test.
Appendix 6 ISO 10993-2: 1992 Biological Evaluation of Medical Devices-Part 2: Animal Protection Requirements
Appendix 7 ISO 10993-10:1995 Biological Evaluation of Medical Devices-Part10: Stimulation and Sensitization Tests
Appendix 8 ISO10993-12:1996 Biological Evaluation of Medical Devices-Part12: Sample Preparation and Reference Samples