Skip to product information
1 of 5

PayPal, credit cards. Download editable-PDF and invoice in 1 second!

GB/T 16886.9-2017 English PDF (GBT16886.9-2017)

GB/T 16886.9-2017 English PDF (GBT16886.9-2017)

Regular price $150.00 USD
Regular price Sale price $150.00 USD
Sale Sold out
Shipping calculated at checkout.
Quotation: In 1-minute, 24-hr self-service. Click here GB/T 16886.9-2017 to get it for Purchase Approval, Bank TT...

GB/T 16886.9-2017: Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products

GB/T 16886.9-2017
Biological evaluation of medical devices--Part 9. Framework for identification and quantification of potential degradation products ICS 11.100.20
C30
National Standards of People's Republic of China
Replace GB/T 16886.9-2001
Medical device biology evaluation
Part 9. Qualitative and potential degradation products
Quantitative framework
Biologicalevaluationofmedicaldevices-Part 9. Frameworkforidentification (ISO 10993-9.2009, 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 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 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 ninth 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 16886.9-2001 "Biological evaluation of medical devices - Part 9. Qualitative and quantitative analysis of potential degradation products Framework, compared with GB/T 16886.9-2001, the main technical changes are as follows. --- Revised the "scope" (see Chapter 1, Chapter 1 of the.2001 edition); --- Revised the "Degradation Research Design Principles" (see Chapter 4, Chapter 4 of the.2001 edition); --- Increased flow chart for degradation studies (see Figure A.1).
This section uses the translation method equivalent to ISO 10993-9.2009 "Medical Device Biological Evaluation Part 9. Potential Degradation Products Qualitative and Quantitative Framework.
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 16886.12-2017 Medical Device Biology Evaluation Part 12. Sample Preparation and Reference Samples (ISO 10993- 12.2012, IDT);
--- GB/T 16886.13-2017 Biological evaluation of medical devices - Part 13. Qualification and quantification of polymer degradation products (ISO 10993-13.2010, IDT);
--- GB/T 16886.14-2003 Biological evaluation of medical devices - Part 14. Qualification and quantification of ceramic degradation products (idt, ISO 10993-14.2001);
--- GB/T 16886.15-2003 Biological evaluation of medical devices - Part 15. Qualification and determination of degradation products of metals and alloys Quantity (idt, ISO 10993-15.2000);
--- GB/T 16886.16-2003 Biological evaluation of medical devices - Part 16. The toxic kinetics of degradation products and solubles Research design (ISO 10993-16.1997, IDT);
--- GB/T 16886.17-2005 Biological evaluation of medical devices - Part 17. Establishment of allowable limits for leachables (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);
---GB/T 16886.19-2011 Biological evaluation of medical devices - Part 19. Physical chemistry, morphological and surface Sexual characterization (ISO 10993-19.2006, 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 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. The main drafters of this section. Guo Lijuan, Liu Lili, Peng Jian.
The previous versions of the standards replaced by this section are.
---GB/T 16886.9-2001.
introduction
This part of GB/T 16886 is intended to be GB/T 16886.13 (polymer), GB/T 16886.14 (ceramic) and GB/T 16886.15 Qualitative and quantitative studies of various material degradation products described by (metals and alloys) provide general principles. The information obtained from these studies can be used for the biological evaluation described in other sections of GB/T 16886. Materials used in the manufacture of medical devices may be degraded in the biological environment, and these degradation products may be present in the body. The main material has a different role.
Mechanical wear mainly produces particulate debris, which can be produced by leaching, chemical structure damage or corrosion caused by substances released from the surface. Free radicals or different kinds of reaction products in the form of organic or inorganic compounds. These degradation products may react or may be stable and do not biochemically react with the environment. But a large number of stable degradation products Aggregation can have a physical impact on surrounding tissues. Degradation products may remain in the position at the time of their formation, or in the biological environment The mechanism is migrated.
The biologically acceptable level of degradation products depends on their nature and concentration and should be evaluated first through clinical experience and special studies. Such as Theoretically there may be new degradation products and/or unknown degradation products, and it is necessary to carry out relevant tests. Fully and clinically connectable The degradation products received may not require further study.
Note that the safety and effectiveness of a medical device may be adversely affected by degradation, so in the risk management of the device The role of degradation should be considered.
Medical device biology evaluation
Part 9. Qualitative and potential degradation products
Quantitative framework
1 Scope
This part of GB/T 16886 is a systematic review of the potential and observed biodegradation and biodegradation studies of medical devices. The basic principles are provided by the calculation and implementation. This part of GB/T 16886 does not apply to.
a) evaluation of degradation caused solely by mechanical processes; methodologies for generating such degradation products may be subject to specific product standards Provision
Note 1. Pure mechanical degradation mainly produces particulate debris. Although not within the scope of this part of GB/T 16886, this degradation product can be cited Biological reactions are required, so biological evaluations are required in accordance with the requirements of other parts of GB/T 16886. b) leaching components resulting from non-degradation;
c) Medical devices or components that do not directly or indirectly contact the patient's body. Note 2. This part of GB/T 16886 applies to the degradation of materials used in any product defined in GB/T 16886.1 “Medical Devices”, even if such The product is different from the applicable regulations for medical devices. Such as a stent for tissue engineering medical products, or a carrier for releasing a drug or biological agent. 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 materials (Biologicalevaluationof medicaldevices-Part 12. Samplepreparationandreferencematerials)
ISO 10993-13 Biological evaluation of medical devices - Part 13. Qualification and quantification of polymer degradation products (Biologicaleval- uationofmedicaldevices-Part 13.IdentificationandquantificationofdegradationProductsfrompol- Ymericmedicaldevices)
ISO 10993-14 Biological evaluation of medical devices - Part 14. Qualification and quantification of ceramic degradation products (Biologicalevalua- tionofmedicaldevices-Part 14.Identificationandquantificationofdegradationproductsfromceram- Ics)
ISO 10993-15 Biological evaluation of medical devices - Part 15. Qualification and quantification of metal and alloy degradation products (Biological eveluationofmedicaldevices-Part 15.Identificationandquantificationofdegradationproductsfrom Metalsandaloys)
ISO 10993-16 Biological evaluation of medical devices - Part 16. Design and analysis of toxic kinetics of degradation products and solubles (Biologicalevaluationofmedicaldevices-Part 16. Toxicokineticstudydesignfordegradationproducts Andleachables)
ISO 10993-17 Biological evaluation of medical devices - Part 17. Establishment of leaching allowances (Biological evaluationofmedicaldevices-Part 17.Establishmentofalowablelimitsforleachablesubstances) ISO 10993-18 Biological evaluation of medical devices - Part 18. Chemical characterization of materials (Biologicalevaluationofmedical devices-Part 18.Chemical characterizationofmaterials)
ISO /T S10993-19 Biological evaluation of medical devices - Part 19. Physical chemistry, morphological and surface characterization of materials (Bi- ologicalevaluationofmedicaldevices-Part 19. Physico-chemical, morphologicalandtopographical Attributeofmaterials)
3 Terms and definitions
The following terms and definitions defined by ISO 10993-1 apply to this document. 3.1
Degradation
Disintegration of materials.
3.2
Biodegradation biodegradation
Degradation caused by the biological environment (3.1).
3.3
Bioresorbable medical device bioresorbablemedicaldevice
Medical devices that can be degraded (3.1) and absorbed in the human biological environment. 3.4
Leachable leachable
The leached component of the material, but not the degradation product. 3.5
Corrosion corrosion
Erosion of metallic materials caused by chemical or electrochemical reactions. Note. This term is sometimes used to refer to the deterioration of other materials in a broad sense. This part of GB/T 16886 refers to metal materials. 3.6
Substance
A single chemical element or compound, or a composite structure of a compound. 3.7
Device component
One of the different components that make up a device.
3.8
Degradation product
Any particle or chemical produced by chemical cracking of the original material. 3.9
Application environment serviceenvironment
The anatomical site that the device is intended to use, including surrounding body fluids, tissues, and biomolecules. 4 Degradation research design principles
4.1 General
The evaluation method of degradation varies depending on the characteristics of the test material, the medical device, and the anatomical site used for the specific device. Selected The evaluation model should represent the application environment of the device. Research may not require a biological environment, but simulate biological environmental conditions. Some degradation processes have shown that in vitro models may not fully reflect the application environment, such as mechanical processes that affect biodegradation, This should be considered when specifying a simulated application environment. In the design of degradation studies, specific materials or product degradation criteria involving qualitative and quantitative degradation products should be considered. If not Applicable specific material standards should be ISO 10993-13 (for polymers), ISO 10993-14 (for ceramics) or ISO 10993-15 (for metals and alloys). All relevant degradation criteria should be considered for instruments consisting of two or more materials. ISO 10993-13, ISO 10993-14 and ISO 10993-15 only consider degradation products produced by the chemical action of the final product, therefore These three criteria do not apply to degradation due to mechanical stress, wear or electromagnetic radiation in the intended use of the device. For the above drop Other methods should be considered for the solution.
4.2 Preliminary considerations
Full consideration of the possibility of expected degradation or unintended degradation of materials is a fundamental focus of biosafety evaluation of medical devices. To test Considering the evaluation of chemical properties and the known degradation mechanism, then consider the necessity of designing and evaluating the experimental study of biodegradation. Degradation studies on all medical devices are neither necessary nor realistic, and the need for degradation studies is considered in Appendix A. Degradation experiment Evaluation of the necessity of the study should include clinical experience in document review and/or documentation, as shown in ISO 10993-1 for applicable literature review. Aspect of the guide. The results of this study may lead to the conclusion that if the product under consideration has proven acceptable clinical experience, New data, published data and similar to known instruments, materials and degradation products eliminate the need for testing. ISO 10993-1, ISO 10993-16 and ISO 10993-17 give guidelines for the biological evaluation of degradation products and leachables, medical devices Guidance for the extraction of mechanical leachables can be found in ISO 10993-12. The chemical characterization of materials used in medical devices and their leachables can be found in ISO 10993-18. The material physicochemical, morphological and surface characterization guidelines are given in ISO 10993-19. Consider these criteria before proceeding with degradation studies. Helps distinguish between degradation products and leachables.
Note. Despite the differences between leachables and degradation products, it is also possible to combine degradation product studies with leachables studies. Further creature Academic evaluation studies do not require discrimination between degradation products and leachables. However, when it is considered necessary to reduce the level of leachables as a risk control When measuring, it is important to distinguish the degradation products from the leachables. 4.3 Test design
Biodegradation research protocols containing research objectives shall be designed and documented in accordance with the principles set out in 4.1, approved research protocols Analytical methods for the following characteristics of degradation products should be clearly studied. a) chemical and physicochemical properties;
b) surface topography;
c) Biochemical properties.
Methods for the formation of degradation products should also be described in approved research protocols, which should be most suitable for the determination of degradable materials, and This is explained.
For multi-component devices, an approved research protocol should consider each component/material and should consider the combined effects of different components on degradation. And the possibility of a secondary reaction between the degradation products. Note. In vitro tests can simulate biodegradation.
4.4 Characterization of degradation products from medical devices
The degradation products produced during the study may be microparticles or solubles or ions. These methods should be characterized using appropriate analytical methods The method used to confirm and report in the research report. If particles are generated, the particle size, shape, surface area and other related properties need to be Line representation.
Note 1. Due to the physical and chemical properties of particulate materials at the nanoscale, this can affect toxicological properties. If biological evaluation of degradation products is required, the design of the degradation study should be carefully considered to ensure that it does not interfere with biological testing. See Appendix B for aspects to consider in biodegradation studies. The program should include. a) identification and characterization of the device and/or material and its intended use; b) identification and characterization of possible degradation mechanisms; c) identification and characterization of known, possible and potential degradation products; d) Test methodology.
Note 2. The extent and rate of release of degradation products depends on various factors, such as the process of changing the composition and structure of the surface, the migration from the interior to the surface of the material, Solubility in a physiological environment and chemical composition of a physiological environment. 5 Research report
The research report should include the following information.
a) description of the material or device (see B.2), including the intended use and the nature of human exposure; b) description of degradation evaluation and degradation evaluation;
c) description of degradation test methods, test conditions, test materials and test procedures (including controls); d) description of the analytical method, including quantitative limits and controls; e) statements in accordance with appropriate good laboratory practices and/or testing laboratory quality management systems (eg ISO /IEC 17025); f) qualitative and quantitative degradation products (eg the form and state of the degradation products and their stability and the controls used); g) summary of results;
h) Interpretation and discussion of the results.
Appendix A
(normative appendix)
Consideration of the necessity of degradation research
A.1 Degradation studies should be considered in one of the following cases. a) the device is designed to be bioabsorbable;
b) the device is expected to be implanted in the body for more than 30 days; c) Extensive research in material systems has shown that toxic substances may be released during contact with the human body. A.2 Degradation studies may not be carried out in the following cases.
a) Possible degradation products are in a range of expected quantities and at similar rates and classes to devices with a history of safe clinical applications The same applicat...

View full details