GB/T 16886.19

📋 Scope / 适用范围 ai_extracted

GB/T 16886 This part provides the principles for designing and implementing toxicokinetic studies of medical devices. Appendix A presents considerations for toxicokinetic studies in the biological evaluation of medical devices.

📝 Foreword / 前言 ai_extracted

GB/T 16886.16-2003/ISO 10993-16:1997 This part of GB/T 16886 identically adopts the international standard ISO 10993-16:1997 "Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables." The general title of GB/T 16886 is "Biological evaluation of medical devices," and it 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. Standards for other aspects of biological testing will be covered in additional parts. Annex A of this part is a normative annex, and Annex B is an informative annex. This part was proposed by the State Drug 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: Jinan Medical Device Quality Supervision and Inspection Center of the State Drug Administration. Main drafters of this part: Wang Kelei, Wang Ting, You Shaohua, Zhu Xuetao, Huang Jingchun. GB/T 16886.16-2003/ISO 10993-16:1997 Introduction This part of GB/T 16886 provides guidelines and requirements for the design and conduct of toxicokinetic studies. Toxicokinetics describes the absorption, distribution, metabolism, and excretion of foreign substances in the body over time. A key consideration in the safety evaluation of medical devices is the stability of materials in the body and the distribution of leachables and degradation products. Toxicokinetic studies may be of significant value in evaluating the safety of materials used in the development of medical devices and in interpreting the mechanisms of observed adverse effects. The necessity and scope of toxicokinetic studies should be carefully considered based on the nature and duration of contact between the device and the human body. Potential hazards caused by medical devices may arise from interactions between device components or their metabolites and biological systems. Leachables that may be released from medical devices (e.g., residual catalysts, processing aids, residual monomers, fillers, antioxidants, plasticizers) and/or degradation products released from materials may produce adverse effects in the body. There is extensive published literature on the use of toxicokinetic methods to study the fate of chemical substances in the body (see Annex B). This part provides guidance on the methods and techniques used in such studies. Annex A provides instructions for the use of this part of GB/T 16886. GB/T 16886.16-2003/ISO 10993-16:1997 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables

📚 References & Relations / 引用与关联

🔗 Related Standards / 同类标准