GB/T 16886.5-2003
Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity (English Version)

Standard No.
GB/T 16886.5-2003
Language
Chinese, Available in English version
Release Date
2003
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status
 2018-07
Replace By
GB/T 16886.5-2017
Latest
GB/T 16886.5-2017
Replace
GB/T 16886.5-1997
Scope
This part of GB/T 16886 describes the test methods for evaluating the in vitro cytotoxicity of medical devices. These methods specify that the following test articles be contacted and incubated with the cultured cells, either directly or by diffusion: a) with the leach solution of the device, and/or b) in contact with the device. These methods measure the in vitro biological response of mammalian cells with corresponding biological parameters.

GB/T 16886.5-2003 history

  • 2018 GB/T 16886.5-2017 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests
  • 2003 GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
  • 0000 GB/T 16886.5-1997
Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity

GB/T 16886.5-2003 -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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