GB/T 16886.18-2011
Biological evaluation of medical devices.Part 18: Chemical characterization of materials (English Version)
- Standard No.
- GB/T 16886.18-2011
- Language
- Chinese, Available in English version
- Release Date
- 2011
- Published By
- General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
- Status
- 2024-01
- Replace By
- GB/T 16886.18-2022
- Latest
- GB/T 16886.18-2022
- Scope
- This part of GB/T 16886 describes the qualitative and quantitative framework for material identification and its chemical composition. The resulting chemical characterization information can be used in some important applications, such as: - As part of the overall biosafety evaluation of medical devices (ISO 10993 -1 and ISO 14971). - By measuring the level of leachable substances in medical devices, to evaluate whether they comply with the allowable limits of the substances based on the health risk assessment (ISO 10993-17). —Determine the equivalence between the proposed material and the clinically established material. - Determine the equivalence of the final device to the prototype device, and check the relevance of the prototype device data used to support the evaluation of the final device. — Screening of new materials suitable for the intended clinical application of medical devices. This part of GB/T 16886 does not involve the characterization and quantification of degradation products. See ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15 for content in this regard. GB/T 16886 applies to materials or devices that come into direct or indirect contact with the human body. (See 4.2.1 of ISO 10993-1:2003) This part of GB/T 16886 is expected to apply to material suppliers and medical device manufacturers when conducting biological safety evaluation.
GB/T 16886.18-2011 Referenced Document
- ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
- YY/T 0316-2008 Medical devices.Application of risk management to medical devices
GB/T 16886.18-2011 history
- 2022 GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process
- 2011 GB/T 16886.18-2011 Biological evaluation of medical devices.Part 18: Chemical characterization of materials
GB/T 16886.18-2011 -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