GB/T 16886.9-2001

📋 Scope / 适用范围 ai_extracted

This part of GB/T 16886 provides general principles for the systematic evaluation of potential and observed biodegradation of medical devices, and offers general principles for the design and conduct of biodegradation studies. This part of GB/T 16886 does not apply to the following situations: a) Engineered living tissue products; b) Methodologies for evaluating or studying degradation products generated by mechanical processes. Methods for generating such degradation products may be specified in specific product standards as appropriate; c) Non-degradable product leachable components. When product standards provide methods for the qualitative and quantitative determination of degradation products applicable to a specific product, those standards take precedence over this part of GB/T 16886.

📝 Foreword / 前言 ai_extracted

This part of GB/T 16886 aims to provide general principles for the qualitative and quantitative study of degradation products of various materials described in GB/T 16886.13 (polymers), ISO 10993-14 (ceramics), and ISO 10993-15 (metals and alloys). This part of GB/T 16886 is identical to the international standard ISO 10993-9:1999, "Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products." Appendix A of this part is a normative appendix, and Appendix B is an informative appendix. This part was proposed by the National Medical Products Administration. This part was consolidated by the National Technical Committee for Standardization of Biological Evaluation of Medical Devices. This part was drafted by: Jinan Medical Device Quality Supervision and Inspection Center of the National Medical Products Administration. Main drafters of this part: Qian Chengyu, Huang Jingchun, Shi Yanping, Bo Huaxian. GB/T 16886.9-2001 ISO Foreword ISO (International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote. International Standard ISO 10993-1 was prepared by ISO/TC 194, Biological evaluation of medical devices. This edition cancels and replaces the first edition (ISO 10993-13:1992). ISO 10993 under the general title "Biological evaluation of medical devices" consists of the following parts: Part 1: Evaluation and testing Part 2: Animal welfare requirements Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Part 4: Selection of tests for interactions with blood Part 5: Tests for in vitro cytotoxicity Part 6: Tests for local effects after implantation Part 7: Ethylene oxide sterilization residuals Part 9: Framework for identification and quantification of potential degradation products Part 10: Tests for irritation and sensitization Part 11: Tests for systemic toxicity Part 12: Sample preparation and reference materials Part 13: Identification and quantification of degradation products from polymeric medical devices Part 14: Identification and quantification of degradation products from ceramics Part 15: Identification and quantification of degradation products from metals and alloys Part 16: Toxicokinetic study design for degradation products and leachables Part 18: Chemical characterization Other parts will cover other aspects of biological testing. Appendix A of this part of ISO 10993 is a normative appendix, and Appendix B is for information only. GB/T 16886.9-2001 Introduction This part of ISO 10993 aims to provide general principles for the qualitative and quantitative study of degradation products of various materials described in ISO 10993-13 (polymers), ISO 10993-14 (ceramics), and ISO 10993-15 (metals and alloys). Information obtained from these studies is used in the biological evaluation in other parts of ISO 10993. Materials used to manufacture medical devices may produce degradation products when placed in a biological environment. These degradation products may exhibit different effects in vivo compared to the parent material. Degradation products can be generated in different ways, either through mechanical action (relative motion between two or more different components), fatigue loading (leading to fracture), release from the device due to interactions between the device and the environment, or a combination of these. Mechanical wear primarily produces particulate fragments, while release of substances from the surface due to leaching, chemical chain scission of structures, or corrosion can produce free ions or different types of reaction products in the form of organic or inorganic compounds. These degradation products may be stable, not undergoing biochemical reactions with their environment, or they may be reactive. However, the accumulation of large quantities of stable degradation products may have a physical effect on surrounding tissues. Degradation products may remain at the site where they are generated or may be transported within the biological environment by various mechanisms. The biologically acceptable level of degradation products depends on their nature and concentration. It is recommended that this be evaluated through clinical experience and specific studies. If new degradation products and/or unknown degradation products are theoretically possible, relevant tests must be conducted. For degradation products that are well-characterized and clinically acceptable, further studies may not be necessary. National Standard of the People's Republic of China Biological evaluation of medical devices Part 9: Framework for identification

📚 References & Relations / 引用与关联

📖 Terms & Definitions / 术语和定义 ai_extracted

降解degradation / degradation

材料的解体。

生物降解biodegradation / biodegradation

生物环境而引起的降解。 GB/T 16886. 1-ISO 10993-1中的定义和下列定义。 注:可用体外试验模拟生物降解 生物可吸收医疗鹅械 bioresorbable medical device 在人体生物环境中能被降解和吸收的医疗器械。 可沥滩物 leachable 从材料中可浸提出的组分，但不是化学降解产物。 腐蚀 corrosion 3 3

Degradation caused by biological environment. Definitions from GB/T 16886.1-ISO 10993-1 and the following definitions. Note: In vitro tests may be used to simulate biodegradation. Bioresorbable medical device A medical device that can be degraded and absorbed in the human biological environment. Leachable A component that can be extracted from a material, but is not a chemical degradation product. Corrosion 3 3

🔗 Related Standards / 同类标准