GB/T 16886.13-2001

📋 Scope / 适用范围 ai_extracted

GB/T 16886 This part provides guidance for the design of qualitative and quantitative tests for degradation products of finished polymer medical devices intended for clinical use. GB/T 16886 This part describes two test methods for generating degradation products: one is an accelerated degradation test as a screening method, and the other is a real-time degradation test. For materials that are polymerized at the time of use, cured polymers are used in the tests. The data obtained from the tests are used for the biological evaluation of the polymers. GB/T 16886 This part only addresses degradation products resulting from chemical changes in finished polymer medical devices; it does not cover degradation of polymer devices caused by mechanical stress, friction, or electromagnetic radiation. GB/T 16886 This part does not address the biological activity of fragments and soluble degradation products; for this, evaluation is recommended in accordance with the principles of GB/T 16886.1 and ISO 10993-17. Due to the wide range of polymer materials used in medical devices, no specific analytical techniques are specified or prescribed. GB/T 16886 This part does not specify specific requirements for acceptable levels of degradation products.

📝 Foreword / 前言 ai_extracted

GB/T 16886 This part of the standard is identical to the international standard ISO 10993-13:1998 "Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices". Annex A of this part is an informative annex. This part was proposed by the National Medical Products Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Biological Evaluation of Medical Devices. This part was drafted by the Jinan Medical Device Quality Supervision and Inspection Center of the National Medical Products Administration. Main drafters of this part: Pan Huaxian, Wang Kelei, Qin Dongli, Wang Ting. GB/T 16886.13-2001 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 10993-13 was prepared by ISO/TC 194, Biological evaluation of medical devices. 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 [Technical Report] 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 Annex A of this standard is for information only. GB/T 16886.13-2001 Introduction This International Standard ISO 10993-13 has been developed from ISO/TR 10993-9. The degradation products covered in this part of ISO 10993 refer primarily to those formed by the cleavage of chemical bonds due to hydrolysis and/or oxidation processes in an aqueous environment. It is recognized that other biological factors, such as enzymes, proteins, and cellular activity, can alter the rate and nature of degradation. It should be noted that polymeric devices may contain residues and leachables such as monomers, oligomers, solvents, catalysts, additives, fillers, and processing aids. If these components are present, they may interfere with the identification and quantification of degradation products, and their content needs to be considered and accounted for. It is recognized that residual monomers may be identical to degradation products generated from the polymer. The identification and quantification of degradation products serve as a basis for biological evaluation according to ISO 10993-1, risk analysis according to ISO 14538, and toxicokinetic studies according to ISO 10993-16. National Standard of the People's Republic of China Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2001 idt ISO 10993-13:1998

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