GB/T 16886.12-2017 English PDF (GBT16886.12-2017)

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GB/T 16886.12-2017: Biological evaluation of medical devices -- Part 12: Sample preparation and reference materials
GB/T 16886.12-2017
Biological evaluation of medical devices--Part 12. Sample preparation and reference materials
ICS 11.100.20
C30
National Standards of People's Republic of China
Replace GB/T 16886.12-2005
(ISO 10993-12..2012, 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 toxicokinetics of degradation products and solubles;
--- 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 12th 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 16886.12-2005 "Biological evaluation of medical devices Part 12. Sample preparation and reference samples". versus
The main technical changes compared with GB/T 16886.12-2005 are as follows.
--- Amend the standard name to "Medical Device Biological Evaluation Part 12. Sample Preparation and Reference Materials";
--- Added the terms "limit leaching", "leachables" and "leachables"; (see Chapter 3);
--- Added general requirements (see Chapter 4);
--- Revised the extraction conditions and methods (see 10.3, 10.3 of the.2009 edition);
--- Revised the relevant content of the test sample extraction principle (see Appendix C, Appendix C of the.2009 edition);
--- Increased limit leaching for the biological evaluation of polymeric materials (see Appendix D).
This section uses the translation method equivalent to ISO 10993-12.2012 "Medical Device Biological Evaluation Part 12. Sample Preparation and Reference
According to the material.
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 16886.3-2008 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
(ISO 10993-3.2003, IDT)
GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4. Selection of test for interaction with blood (ISO 10993-4.
2002, IDT)
GB/T 16886.5-2017 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (ISO 10993-5.2009,
IDT)
GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6. Post-implantation partial response test (ISO 10993-6.
1994, IDT)
GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Resin residues from ethylene oxide (ISO 10993-7.
1995, 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 16886.10-2017 Medical Device Biology Evaluation Part 10. Stimulation and delayed type hypersensitivity test
(ISO 10993-10.2010, IDT)
GB/T 16886.11-2011 Biological evaluation of medical devices - Part 11. Systemic toxicity test (ISO 10993-11.2006,
IDT)
2012, IDT)
GB/T 16886.13-2017 Biological evaluation of medical devices - Part 13. Qualification and determination of degradation products of polymer medical devices
Quantity (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 16886.16-2013 Biological evaluation of medical devices - Part 16. Toxic kinetics of degradation products and solubles
Design (ISO 10993-16.2010, IDT)
GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (ISO 10993-
17.2002, IDT)
GB/T 16886.18-2011 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (ISO 10993-18.2005)
GB/T 16886.19-2011 Biological evaluation of medical devices - Part 19. Physical chemistry, morphological and surface properties
Expropriation (ISO 10993-19.2006)
YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.2007, IDT)
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 Food and Drug Administration.
This part is under the jurisdiction of the National Medical Device Biology Evaluation Standardization Technical Committee (TC428).
This section drafted by. State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
The main drafters of this section. Hou Li, Sun Likui, Liu Chenghu.
The previous versions of the standards replaced by this section are.
---GB/T 16886.12-2005.
introduction
This part of GB/T 16886 specifies guidelines for the preparation of sample preparation methods and reference materials for the biological evaluation of medical devices. sample
The preparation method should take into account the biological evaluation method and the material to be evaluated. Each biological test method requires the selection of materials and extraction
Solvents and conditions.
This section is based on current national and international norms, procedures and standards and will be reviewed and revised periodically.
Medical device biology evaluation
Part 12. Sample preparation and reference materials
1 Scope
This part of GB/T 16886 specifies that medical devices are tested in accordance with the biological systems specified in other parts of GB/T 16886.
The sample preparation and reference material selection requirements to be followed are given, and a program guide is given.
This section specifically proposes.
---Test sample selection;
--- Select a representative part from the device;
---Test sample preparation;
---Test control;
---Selection and requirements for reference materials;
--- Preparation of extract.
This section does not apply to living cells, but can be applied to m...