YY/T 0467-2016
Medical devices.Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices (English Version)

Standard No.

YY/T 0467-2016

Language

Chinese, Available in English version

Release Date

2016

Published By

Professional Standard - Medicine

Latest

YY/T 0467-2016

Replace

YY/T 0467-2003

Scope

This standard considers and identifies certain important standards and guidance that are useful in the assessment of conformity to recognized fundamental principles of medical device safety and performance. This standard is intended to be used by manufacturers, standardization bodies and regulatory bodies for conformity assessment.

YY/T 0467-2016 Referenced Document

• GB 18279 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization*， 2023-09-08 Update
• GB 18280 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
• GB 4793 Safety requirements for electronic measuring apparatus
• GB 9706.1 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance*， 2020-04-09 Update
• GB 9706.10 Medical electrical equipment. Part 2: Particular requirements for safety of therapeutic X-ray generators
• GB 9706.103 Medical electrical equipment—Part 1-3: General requirements for basic safety and essential performance—Collateral Standard: Radiation protection in diagnostic X-ray equipment*， 2020-12-24 Update
• GB 9706.11 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis
• GB 9706.12 Medical electrical equipment. Part 1: General requirements for safety 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
• GB 9706.13 Medical electrical equipment.Part 2:Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
• GB 9706.14 Medical electrical equipment--Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
• GB 9706.15 Medical electrical equipment.Part 1:General requirements for safety.1.Collateral standard:Safety requirements for medical electrical systems
• GB 9706.16 Medical electrical equipment.Part 2:Particular requirements for the safety of radiotherapy simulators
• GB 9706.17 Medical electrical equipment.Part 2:Particular requirements for the safety of gamma beam therapy equipment
• GB 9706.18 Medical electrical equipment. Part 2: Particular requirements for the safety of X-ray equipment for computed tomography
• GB 9706.19 Medical electrical equipment-Part 2:Particular requirements for the safety of endoscopic equipment
• GB 9706.2 Medical electrical equipment--Part 2-16: Particular requirements for the safety of haemodialysis,haemodiafiltration and haemofiltration equipment
• GB 9706.20 Medical electrical equipment Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
• GB 9706.201 Medical electrical equipment—Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV*， 2020-12-24 Update
• GB 9706.202 Medical electrical equipment—Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories*， 2021-12-01 Update
• GB 9706.203 Medical electrical equipment—Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment*， 2020-05-29 Update
• GB 9706.204 Medical electrical equipment—Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators*， 2022-07-13 Update
• GB 9706.205 Medical electrical equipment—Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment*， 2020-07-23 Update
• GB 9706.206 Medical electrical equipment—Part 2-6: Particular requirments for the basic safety and essential performence of microwave therapy equipment*， 2020-07-23 Update
• GB 9706.208 Medical electrical equipment –Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV*， 2021-08-10 Update
• GB 9706.21 Medical electrical equipment--Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
• GB 9706.211 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment*， 2020-12-24 Update
• GB 9706.212 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators*， 2020-04-09 Update
• GB 9706.213 Medical electrical equipment—Part 2-13: Particular requirements for the basics safety and essential performance of an anaesthetic workstation*， 2021-12-01 Update
• GB 9706.216 Medical electrical equipment—Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment*， 2021-08-10 Update
• GB 9706.217 Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment*， 2020-12-24 Update
• GB 9706.218 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment*， 2021-12-01 Update
• GB 9706.219 Medical electrical equipment—Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators*， 2021-10-11 Update
• GB 9706.22 Medical electrical equipment--Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
• GB 9706.222 Medical electrical equipment—Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment*， 2022-03-15 Update
• GB 9706.224 Medical electrical equipment—Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers*， 2021-12-01 Update
• GB 9706.225 Medical electrical equipment—Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs*， 2021-12-01 Update
• GB 9706.226 Medical electrical equipment—Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs*， 2021-10-11 Update
• GB 9706.227 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment*， 2021-10-11 Update
• GB 9706.228 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis*， 2020-12-24 Update
• GB 9706.229 Medical electrical equipment—Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators*， 2021-08-10 Update
• GB 9706.23 Medical electrical equipment-Part 2-43:Particular requirements for the safety of X-ray equipment for interventional procedures
• GB 9706.236 Medical electrical equipment—Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy*， 2021-12-01 Update
• GB 9706.237 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment*， 2020-04-09 Update
• GB 9706.239 Medical electrical equipment—Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment*， 2021-08-10 Update
• GB 9706.24 Medical electrical equipment-Part 2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices
• GB 9706.243 Medical electrical equipment—Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures*， 2021-02-20 Update
• GB 9706.244 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography*， 2020-12-24 Update
• GB 9706.245 Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices*， 2020-12-24 Update
• GB 9706.25 Medical electrrical equipment Part 2: Particular requirements for the safety of electrocardiographic monitoring equipment
• GB 9706.254 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy*， 2020-12-24 Update
• GB 9706.255 Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors*， 2022-12-29 Update
• GB 9706.26 Medical electrical equipment.Part 2: Particular requirements for the safety of electroencephalographs
• GB 9706.260 Medical electrical equipment—Part 2-60: Paticular requirments for the basic safety and essential performance of dental equipment*， 2020-11-17 Update
• GB 9706.263 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment*， 2020-11-17 Update
• GB 9706.265 Medical electrical equipment—Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment*， 2021-02-20 Update
• GB 9706.27 Medical electrical equipments.Part 2-24: Particular requirements for the safety of infusion pumps and controllers
• GB 9706.271 Medical electrical equipment—Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment*， 2022-12-29 Update
• GB 9706.275 Medical electrical equipment—Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment*， 2022-12-29 Update
• GB 9706.28 Medical electrical equipment.Part 2:Particular requirements for the safety of lung ventilators.Critical care ventilators
• GB 9706.283 Medical electrical equipment—Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment*， 2022-12-29 Update
• GB 9706.29 Medical electrical equipment.Part 2:Particular requirements for the safety and essential performance of anaesthetic systems
• GB 9706.290 Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment*， 2022-12-29 Update
• GB 9706.3 Medical electrical equipment-Part 2: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
• GB 9706.39 Medical electrical equipment.Part 2-39:Particular requirements for the safety of peritoneal dialysis equipment
• GB 9706.4 Medical electrical equipment-Part2-2:Particular requirements for the safety of high frequency surgical equipment
• GB 9706.5 Medical electrical equipment.Part 2-1:particular requirements for the safety of electron accelerators in the range 1 MeV to 50 MeV
• GB 9706.6 Medical electrical equipment.Part 2:Particular requirements for the safety of microwave therapy equipment
• GB 9706.7 Medical electrical equipment.Part2-5:Particular requirements for the safety of ultrasonic physiotherapy equipment
• GB 9706.8 Medical electrical equipment-Part2-4:Particular requirements for the safety of cardiac defibrillators
• GB 9706.9 Medical electrical equipment.Part2-37:Particular requirements for the safety of ultrasonic medical diagnosetic and monitoring equipment
• 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 1962.1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.Part 1:General requirement
• GB/T 1962.2 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment Part 2: Lock fittings
• GB/T 19633 Packaging for terminally sterilized medical devices
• GB/T 19973.1 Microbiological methods for sterilization of healthcare products - Part 1: Determination of the total number of microorganisms on products*， 2023-03-17 Update
• GB/T 19973.2 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process*， 2018-03-15 Update
• 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 20000.4-2003 Guide for standardization--Part 4: Safety aspects for their inclusion in standards
• GB/T 5465.2-1996 Graphical symbols for use on electrical equipment
• YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
• YY/T 0297 Clinical investigation of medical devices
• YY/T 0316-2008 Medical devices.Application of risk management to medical devices
• YY/T 0595-2006 Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2003
• YY/T 0771.2-2009 Medical devices utilizing animal tissues and their derivatives.Part 2:Controls on sourcing,collection and handling

YY/T 0467-2016 history

• 2016 YY/T 0467-2016 Medical devices.Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
• 2003 YY/T 0467-2003 Medical devices-Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices