GB/T 16886.10-2017 English PDF (GBT16886.10-2017)

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GB/T 16886.10-2017: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
GB/T 16886.10-2017
Biological evaluation of medical devices-Part 10. Tests for irritation and skin sensitization
ICS 11.100.20
C30
National Standards of People's Republic of China
Replace GB/T 16886.10-2005
Medical device biology evaluation
Part 10. Stimulation and skin sensitization test
(ISO 10993-10.2010, IDT)
Released on.2017-12-29
2018-07-01 implementation
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China
China National Standardization Administration issued
Foreword
GB/T 16886 "Biological Evaluation of Medical Devices" consists of the following components.
--- 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 leachable allowable limit;
---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 10th part of GB/T 16886.
Other aspects of biological testing will have other parts of the standard.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces GB/T 16886.10-2005 "Medical Device Biological Evaluation Part 10 Stimulation and delayed type hypersensitivity test
Inspection, compared with GB/T 16886.10-2005, the main technical changes are as follows.
--- Modified the standard name;
---Modified terms and definitions (Chapter 3, Chapter 3 of the.2005 edition);
--- Cancellation of "material identification" (see 5.4 of.2005 edition);
--- The intradermal reaction test was adjusted from the appendix to the text (see 6.4, Appendix B of the.2005 edition);
--- Human skin irritation test method is adjusted from the text to the appendix (see Appendix C,.2005 edition 6.4);
--- Skin sensitization test increases the local lymph node test in mice (see 7.2);
--- Increased in vitro skin irritation test (see Appendix D);
--- Added method for preparing polymer test material extract (see Appendix E).
This section uses the translation method equivalent to ISO 10993-10.2010 "Medical Device Biology Evaluation Part 10. Stimulation and Skin
Sensitive test.
The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows.
GB/T 16886.2-2011 Biological evaluation of medical devices - Part 2. Animal welfare requirements (ISO 10993-2..2006, IDT)
GB/T 16886.9-2017 Biological evaluation of medical devices - Part 9. Qualitative and quantitative framework for potential degradation products
(ISO 10993-9.2009, IDT)
GB/T 16886.12-2017 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (ISO 10993-12.
2012, IDT)
GB/T 16886.13-2017 Biological evaluation of medical devices - Part 13. Qualitative analysis of degradation products of polymer medical devices
Quantification (ISO 10993-13.2010, IDT)
GB/T 16886.14-2003 Biological evaluation of medical devices - Part 14. Qualification and quantification of ceramic degradation products
(ISO 10993-14.2001, IDT)
GB/T 16886.15-2003 Biological evaluation of medical devices - Part 15. Qualification and quantification of degradation products of metals and alloys
(ISO 10993-15.2000, IDT)
GB/T 16886.18-2011 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005, IDT)
This part is proposed by the State Food and 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. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center; Shenzhen Medical Device Testing Center.
The main drafters of this section. Wang Wei, Cao Ping, Fan Chunguang, Liu Wei, Xu Wei District.
The previous versions of the standards replaced by this section are.
---GB/T 16886.10-2000;
---GB/T 16886.10-2005.
introduction
This part of GB/T 16886 is used to assess the exposure hazards that may be caused by chemicals released from medical devices, including
Skin and mucous membrane irritation, eye irritation or skin sensitization.
Certain materials contained in medical devices have been tested and their potential skin, mucous membrane irritation or sensitization has been confirmed. other
Some untested materials and their chemical composition may have adverse effects when in contact with human tissue. Therefore, the manufacturer is responsible
Evaluate the potential adverse effects of the device before it is placed on the market.
Traditionally, small animal experiments have to be carried out before human trials to help predict human response. Recently, it has also been added as an auxiliary or
Optional in vitro and human trials. Although much effort has been made in this area and some progress has been made, the results show
The previously designed in vitro tests have not been satisfactory, so it has not been possible to eliminate the in vivo test. When appropriate, this section encourages in vitro pre-testing
The method was used as a screening test before animal testing. In order to reduce the number of animals used, this section proposes a step-by-step evaluation method, which is tested at each stage.
The results are reviewed and analyzed. Animal testing is generally required prior to human testing.
These studies should be conducted in accordance with good laboratory quality management practices and in compliance with animal welfare regulations. Suggested in the right circumstances
Statistical analysis of the data.
This section is used by trained and experienced professionals who are able to interpret the standard requirements and consider all aspects of the device.
The factors, including the intended use of the device, the current knowledge of the medical device given by the review of the scientific literature and prior clinical experience,
Determine the evaluation results of each medical device.
The tests included in this section are important tools for the development of safety products and are tested by trained personnel and explain the test results.
This section is based on a number of standards and guidelines, including OECD guidelines, the United States Pharmacopoeia and the European Pharmacopoeia. This section can be used as a basic text.
Used to select and implement tests that evaluate stimuli and skin sensitization reactions associated with the safety of medical materials and devices.
Medical device biology evaluation
Part 10. Stimulation and skin sensitization test
1 Scope <...