This standard provides guidance for standards writers on how to include safety requirements in the development of medical device safety standards, which are expected to use the risk management framework established in ISO 14971. This guide covers safety-related performance and usability, extending concepts already developed in ISO/IEC Guide 51. This standard is intended for use in conjunction with ISO/IEC Guide 51 and ISO 14971.
YY/T 1473-2016 Referenced Document
GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
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 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 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 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
GB/T 20000.4-2003 Guide for standardization--Part 4: Safety aspects for their inclusion in standards
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
YY/T 0316-2016 Medical devices.Application of risk management to medical devices
YY/T 1473-2016 history
2023YY/T 1473-2023 Medical device standardization work guide involves standard formulation of safety content
2016YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices