GB/T 16886.10-2005
Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity (English Version)

GB/T 16886.10-2005
Standard No.
GB/T 16886.10-2005
Language
Chinese, Available in English version
Release Date
2005
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status
 2018-07
Replace By
GB/T 16886.10-2017
Latest
GB/T 16886.10-2017
Replace
GB/T 16886.10-2000
Scope
This part of GB/T 16886 describes the evaluation steps for potential irritation and delayed hypersensitivity reactions of medical devices and their constituent materials. This part of GB/T 16886 covers: a) considerations before the test; b) test procedure, and c) key factors for interpretation of results. Appendix A gives instructions for the preparation of specific materials relevant to the above tests. The supplementary tests given in Appendix B specify the requirements for devices suitable for intradermal injections, as well as devices used in the eye, oral cavity, rectum, penis, and vagina.

GB/T 16886.10-2005 Referenced Document

  • GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
  • GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
  • GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
  • GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements *， 2011-12-30 Update

GB/T 16886.10-2005 history

  • 2017 GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
  • 2005 GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
  • 2000 GB/T 16886.10-2000 Biological evaluation of medical devices--Part 10: Tests for irritation and sensitization

GB/T 16886.10-2005 -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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