GB/T 16886.16-2013 English PDF (GBT16886.16-2013)

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GB/T 16886.16-2013: Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables
GB/T 16886.16-2013
Biological evaluation of medical devices.Part 16. Toxicokinetic study design for degradation products and leachables
ICS 11.100
C30
National Standards of People's Republic of China
Replace GB/T 16886.16-2003
Medical device biology evaluation
Part 16. Degradation products and leachables
Toxicokinetic study design
Part 16. Toxicokineticstudydesignfordegradationproductsandleachables
(ISO 10993-16.2010, IDT)
Released on.2013-12-17
Implementation of.2014-08-01
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 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 delayed type hypersensitivity test;
--- Part 11. Systemic toxicity test;
---Part 12. Sample preparation and reference samples;
--- Part 13. Qualitative and quantitative determination of polymer degradation products;
--- 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 16th 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 16886.16-2003 "Biological evaluation of medical devices - Part 16. Degradation products and leachables
Dynamics Research Design, compared with GB/T 16886.16-2003, the main technical changes are as follows.
--- Modified "3 terms and definitions";
--- Revised the "5 Test Method Guide";
--- Revised "Appendix A should be considered in the study of toxicokinetics", introducing ISO 10993-17, ISO 10993-18 and
The content of ISO 14971.
This section uses the translation method equivalent to ISO 10993-16.2010 "Medical Device Biological Evaluation Part 16. Degradation Products and
Design of toxicokinetic studies of leaching materials.
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 16886.12-2005 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (ISO 10993-
12.2002, 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, IDT);
---YY/T 0316-2008 Medical device risk management for medical devices (ISO 14971.2007, IDT).
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 Technical Committee for Standardization of Medical Device Biology Evaluation (SAC/TC248).
This section is mainly drafted by. National Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
Participated in the drafting of this section. Shanghai Biomaterials Research and Testing Center, Peking University Frontier Interdisciplinary Research Institute, Biomedical Materials and
Tissue Engineering Research Center.
The main drafters of this section. Yu Shaohua, Sun Wei, Yan Tingfei, Liu Chenghu, Hua Nan, Feng Keran.
introduction
Toxicokinetics describes the absorption, distribution, metabolism, and excretion of foreign compounds in the body over time. Medical device
The key to a full evaluation is to consider the stability of the material in the body as well as the expected and unanticipated leachables and degradation products. Toxic generation
Kinetic studies are valuable in evaluating the safety of materials used in the development of medical devices or in elucidating the mechanisms of observed adverse reactions.
of. Toxicokinetic studies may also be applicable to medical devices containing active components. Should be based on the nature and time of contact between the device and the human body,
Rethink the necessity and scope of conducting toxicokinetic studies (see Appendix A). Existing toxicological literature and toxicokinetic data can be full
This is a consideration in this regard.
The potential hazard caused by medical devices may be due to interactions between the components of the device or its metabolites and biological systems.
Leachables from medical devices that can be released from their materials (eg residual catalysts, processing aids, residual monomers, fillers, antioxidants, plasticization)
The agent and/or the migrating degradation products may have an adverse effect in the body.
There are many published literatures on the use of toxicokinetic methods to study the in vivo orientation of chemicals (see references), which are used in these studies.
The methodology and technology form the basis of this part of the GB/T 16886 guide. Appendix A gives the use of this part of GB/T 16886
Description.
Medical device biology evaluation
Part 16. Degradation products and leachables
Toxicokinetic study design
1 Scope
This part of GB/T 16886 gives the principles for designing and implementing toxicokinetic studies for medical devices. Appendix A describes the medical device
Mechanical biology evaluates the issues that should be considered in the study of toxicokinetics.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalua-
tionofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess)
ISO 10993-2 Medical Device Biology Evaluation Part 2. Animal welfare requirements (Biologicalevaluationofmedical
devices-Part 2.Animalwelfarerequirements)
ISO 10993-12 Biological evaluation of medical devices - Part 12. Sample preparation and reference samples (Biologicalevaluationof
medicaldevices-Part 12. Samplepreparationandreferencematerials)
ISO 10993-17 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (Biological
evaluationofmedicaldevices-Part 1...