GB/T 16886.3-2019 English PDF (GBT16886.3-2019)

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GB/T 16886.3-2019: Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-2019
Biological evaluation of medical devices--Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
ICS 11.100
C30
National Standards of People's Republic of China
Replace GB/T 16886.3-2008
Medical device biology evaluation
Part 3. Genotoxicity, carcinogenicity and
Reproductive toxicity test
(ISO 10993-3..2014, IDT)
Published on.2019-06-04
2020-01-01 implementation
State market supervision and administration
China National Standardization Administration issued
Foreword
GB/T 16886 "Biological Evaluation of Medical Devices" consists of the following parts.
--- Part 1. Evaluation and testing in the risk management process;
--- Part 2. Animal welfare requirements;
--- Part 3. Genotoxicity, carcinogenicity and reproductive toxicity test;
--- Part 4. Test options for interaction with blood;
---Part 5. In vitro cytotoxicity test;
--- Part 6. Post-implantation local reaction test;
---Part 7. Ethylene oxide sterilization residue;
---Part 9. Qualitative and quantitative frameworks for potential degradation products;
--- Part 10. Stimulation and skin sensitization test;
--- Part 11. Systemic toxicity test;
--- Part 12. Sample preparation and reference materials;
--- Part 13. Qualitative and quantitative determination of degradation products of polymer medical devices;
--- Part 14. Qualitative and quantitative determination of ceramic degradation products;
---Part 15. Qualitative and quantitative determination of metal and alloy degradation products;
---Part 16. Design of toxicokinetic studies of degradation products and leachables;
--- Part 17. The establishment of a limitable amount of leachables;
---Part 18. Chemical characterization of materials;
---Part 19. Physical chemistry, morphological and surface characterization of materials;
--- Part 20. Principles and methods for immunological toxicology testing of medical devices.
This part is the third part of GB/T 16886.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 16886.3-2008 "Medical evaluation of medical devices - Part 3. Genotoxicity, carcinogenicity and reproductive toxicity
Sex test. Compared with GB/T 16886.3-2008, the main technical changes except editorial changes are as follows.
--- Change the test strategy by increasing in vivo testing and subsequent evaluation;
--- Add Appendix A "Guidelines for selecting suitable sample preparation procedures in genotoxicity tests";
--- Add further in vitro and in vivo tests to assess the genotoxic potential of medical devices;
--- Added Appendix B "Follow-up Evaluation Flow Chart";
--- The original Appendix C was changed to Appendix E, "Implantation studies for consideration of carcinogenicity studies" and developed specifications;
--- Added Appendix F "In vitro Embryonic Toxicity Test".
This section uses the translation method equivalent to ISO 10993-3.2014 "Medical Device Biological Evaluation Part 3. Genotoxicity, Carcinogenicity
Sexual and reproductive toxicity test.
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
--- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management
(ISO 10993-1.2009, IDT)
--- GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2. Animal welfare requirements (ISO 10993-2..2006, IDT)
--- GB/T 16886.6-2015 Biological evaluation of medical devices - Part 6. Post-implantation partial response test (ISO 10993-6.
2007, IDT)
--- GB/T 16886.12-2017 Medical Device Biology Evaluation Part 12. Sample Preparation and Reference Materials (ISO 10993-
12.2012, IDT)
--- GB/T 16886.18-2011 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005)
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Sichuan University.
The main drafters of this section. Hou Li, Sun Xiaoxia, Liang Jie, Yuan Wei, Li Qiu.
The previous versions of the standards replaced by this section are.
---GB/T 16886.3-1997, GB/T 16886.3-2008.
introduction
Medical device biology evaluations are usually based on experience, and attention to human safety is the driving force behind their development. Such as cancer
The risk of serious and irreversible effects such as the second-generation malformation is particularly noticeable to the public. In the process of providing safe medical devices,
Such risks are minimized to the minimum. Assessment of mutagenic, carcinogenic and reproductive risks (sources) is an essential component of such risk control
section. At present, the test methods for genotoxicity, carcinogenicity or reproductive toxicity assessment have not been well developed, and in medical devices
The effectiveness of the mechanical test has also not been fully confirmed.
Due to the controversy in the size and preparation of the test sample, the scientific understanding of the disease process and the confirmation of the test, the existing
The method has limitations. For example, little is known about the biological significance of solid carcinogenicity, and it is expected that with advances in science and medical technology,
It will change the understanding and understanding of these important toxicological effects. In the development of this document, the recommended test method is in many ways.
Most acceptable. Other alternative tests are acceptable as long as they are scientifically relevant for safety assessment.
When it is necessary to evaluate a specific medical device and choose a test, it can only be used between the intended human application and the device and various biological systems.
A detailed assessment of potential interactions is particularly important in the field of reproductive and developmental toxicology.
This part of GB/T 16886 gives test methods for testing specific biological hazards (sources) and test selection strategies.
In some cases it helps to identify hazards (sources). Testing is not always necessary for the management of toxicological risks in contact with medical device materials.
Or useful, but when appropriate, it is important to achieve maximum test sensitivity.
There are many factors that may occur and many important factors affecting the results, such as the degree of contact with the test sample, species differences, and machinery.
Or physical factors, so the results need to be assessed according to the specific situation.
Medical device biology evaluation
Part 3. Genotoxicity, carcinogenicity and
Reproductive toxicity test
1 Scope
This part of GB/T 16886 specifies risk estimation, selection of hazard (source) identification tests and risk management strategies, as well as
The possibility of touching the following potentially irreversible biological effects caused by medical devices.
---Genetic toxicity;
--- Carcinogenicity;
--- Reproductive and developmental toxicity.
This section applies to the evaluation of medical devices that have been identified as having potential genotoxic, carcinogenic or reproductive toxicity.
Note. A test selection guide is given in ISO 10993-1.
2 Normative...