GB/T 16886.16-2021
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables (English Version)

Standard No.
GB/T 16886.16-2021
Language
Chinese, Available in English version
Release Date
2021
Published By
国家市场监督管理总局、中国国家标准化管理委员会
Latest
GB/T 16886.16-2021
Replace
GB/T 16886.16-2013
Scope
This document specifies the principles for designing and conducting toxicokinetic studies relevant to medical devices. Appendix A describes issues considered in toxicokinetic studies for the biological evaluation of medical devices. This document is applicable to toxicokinetic studies of degradation products and leachable substances of medical devices.

GB/T 16886.16-2021 Referenced Document

  • ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

GB/T 16886.16-2021 history

  • 2021 GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
  • 2013 GB/T 16886.16-2013 Biological evaluation of medical devices.Part 16: Toxicokinetic study design for degradation products and leachables
  • 2003 GB/T 16886.16-2003 Biological evaluation of medical devices--Part 16: Toxicokinetic study design for degradation products and leachables
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

GB/T 16886.16-2021 -All Parts

GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity GB/T 16886.12-2023 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices GB/T 16886.14-2003 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables GB/T 16886.17-2005 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices GB/T 16886.23-2023 Biological Evaluation of Medical Devices Part 23: Stimulation Test GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals GB/T 16886.9-2022 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products


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