GB/T 16886.1-2001
Biological evaluation of medical devices--Part 1: Evaluation and testing (English Version)

Standard No.
GB/T 16886.1-2001
Language
Chinese, Available in English version
Release Date
2001
Published By
General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Status
 2011-12
Replace By
GB/T 16886.1-2011
Latest
GB/T 16886.1-2022
Scope
This part of GB/T 16886 describes: a) the basic principles guiding the biological evaluation of medical devices; b) classification according to the nature and time of contact between machinery and the human body; c) selection of relevant tests. This part of GB/T 16886 does not involve materials and devices that do not come into direct or indirect contact with the patient's body, nor does it involve biological hazards caused by mechanical failures. Other parts of the GB/T16886-ISO.10993 standard include various special tests, as stated in the ISO preface. (see note in A2).

GB/T 16886.1-2001 history

  • 2022 GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
  • 2011 GB/T 16886.1-2011 Biological evaluation of medical devices.Part 1: Evaluation and testing within a risk management process
  • 2001 GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
Biological evaluation of medical devices--Part 1: Evaluation and testing

GB/T 16886.1-2001 -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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