YY/T 0663.1-2014 Cardiovascular implant—Endovascular devices—Part 1:Endovascular prostheses

YY/T 0663.1-2021 Cardiovascular implants—Endovascular devices—Part 1:Endovascular prostheses

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices 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 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables 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 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials 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 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices 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/T 18279.2-2015 Sterilization of health care products—Part 2:Guidance on the application of GB 18279.1 GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization 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 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices GB 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19974-2005 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices GB/T 19974-2018 Sterilization of health care products—General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices YY 0285.1-2004 Sterile,single-use intravascular catheters—Part 1:General requirements YY 0285.1-2017 Intravascular catheters—Sterile and single-use catheters—Part 1:General requirements YY 0285.1-1999 Disposable sterile intravascular catheter - Part 1: General requirements YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0287-2017 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0297-1997 Clinical investigation of medical devices YY/T 0297-2026 General requirements for clinical investigation of medical devices YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis YY 0500-2004 Cardiovasular implants—Tubular vascular prostheses YY/T 0640-2008 Non-active surgical implants—General requirements YY/T 0693-2008 Standard guide for characterization and presentation of the dimensional attributes of vascular stents YY/T 0694-2008 Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents ISO 14160 ASTM D638-03

ISO 25539-1:2003 ISO 25539-1:2003/Amd 1:2005