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Access 75 Chinese Medical Device Standards for Free
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China is one of the few regulatory markets where medical device standards, including GB and YY standards, are available free of charge from the relevant authorities.
On this page, you can find 75 Chinese medical device standards. Manufacturers can use tools such as Kimi (Kimi AI) to translate these standards into English for an initial understanding and reference.
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1. YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods
2. YY/T 0681.12-2022 Test methods for sterile medical device packaging – Part 12: Flex-crack resistance of flexible barrier materials
3. YY/T 1812-2022 Characterization of physicochemical properties of degradable biomedical metallic materials
4. YY/T 1813-2022 Methods for the collection and evaluation of reliability information for medical electrical equipment in use
5. YY/T 1815-2022 Biological evaluation of medical devices – Assessment of the biocompatibility of medical device constituents using the Threshold of Toxicological Concern (TTC)
6. YY/T 1837-2022 Medical electrical equipment – General requirements for reliability
7. YY/T 1843-2022 Medical electrical equipment – Basic requirements for cybersecurity
8. YY/T 1833.1-2022 Artificial intelligence medical devices – Quality requirements and evaluation – Part 1: Terminology
9. YY/T 1833.2-2022 Artificial intelligence medical devices – Quality requirements and evaluation – Part 2: General requirements for datasets
10. YY/T 0567.6-2022 Aseptic processing of health care products – Part 6: Isolator systems
11. YY/T 1833.3-2022 Artificial intelligence medical devices – Quality requirements and evaluation – Part 3: General requirements for data annotation
12. YY/T 1854-2022 Test method for the leaching of trioctyl trimellitate (TOTM) from polyvinyl chloride (PVC) medical devices
13. YY/T 1879-2022 Creation and Assignment of Unique Device Identification (UDI) for Medical Devices;
14. YY 9706.277-2023 Medical electrical equipment – Part 2-77: Particular requirements for the basic safety and essential performance of robot-assisted surgical equipment;
15. YY/T 0870.7-2023 Genotoxicity testing of medical devices – Part 7: In vivo alkaline comet assay in mammals;
16. YY/T 1473-2023 Guidelines for medical device standardization – Development of standards involving safety aspects;
17. YY/T 1268-2023 Ethylene oxide sterilization – Product adoption and process equivalence;
18. YY/T 1897-2023 Biological evaluation of nanomedical devices – Genotoxicity testing: In vitro mammalian cell micronucleus test;
19. YY/T 0466.1-2023 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements;
20. YY/T 0841-2023 Medical electrical equipment – Periodic testing and testing after repair of medical electrical equipment;
21. YY/T 1833.4-2023 Artificial intelligence medical devices – Quality requirements and evaluation – Part 4: Traceability;
22. YY/T 1911-2023 Test methods for coagulation in medical devices;
23. YY/T 0698.5-2023 Packaging materials for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction – Requirements and test methods;
24. YY/T 1928-2023 Terminology and classification for medical electrical equipment intended for use in the magnetic resonance environment;
25. YY 0970-2023 Sterilization of health care products Liquid chemical sterilants for single-use medical devices of animal origin; requirements for the characterization, development, validation, and routine control of the sterilization process for medical devices.
26. YY/T 1876-2023: Tissue-engineered medical products – Determination of residual DNA in biomaterials of animal origin – Fluorescent staining method.
27. YY/T 0726-2020: Passive surgical implants – Implants with an ancillary substance – General requirements.
28. YY/T 0660-2008: Standard specification for polyetheretherketone (PEEK) polymers for surgical implants.
29. YY/T 1707-2020: Surgical implants – Differential scanning calorimetry (DSC) for polyetheretherketone (PEEK) polymers and their composites used in implantable medical devices.
30. YY/T 1701-2020: Medical-grade Ti-6Al-4V/Ti-6Al-4V ELI powders for additive manufacturing.
31. YY/T 0772.3-2009: Surgical implants – Ultra-high-molecular-weight polyethylene (UHMWPE) – Part 3: Accelerated aging methods. 32. YY/T 0772.4-2009: Surgical implants – Ultra-high-molecular-weight polyethylene (UHMWPE) – Part 4: Oxidation index test method. 33. GB/T 19701.1-2016: Surgical implants – Ultra-high-molecular-weight polyethylene (UHMWPE) – Part 1: Powder form.
34. GB/T 19701.2-2016: Surgical implants – Ultra-high-molecular-weight polyethylene (UHMWPE) – Part 2: Molded forms.
35. GB/T 12417.1-2008: Passive surgical implants – Implants for osteosynthesis and joint replacement – Part 1: Particular requirements for osteosynthesis implants.
36. YY/T YY/T 0772.4-2022 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Test methods for oxidation index;
37. YY/T 1909-2023 Additive manufacturing for medical applications — Requirements for process control and validation of electron beam melting (EBM) using metal powder beds;
38. YY/T 0772.4-2022 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Test methods for oxidation index;
39. YY/T 1909-2023 Additive manufacturing for medical applications — Requirements for process control and validation of electron beam melting (EBM) using metal powder beds;
40. YY/T 0772.4-2022 Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 4: Test methods for oxidation index;
41. YY/T 0987.1-2016 Implants for surgery — Magnetic resonance compatibility — Part 1: Marking for safety;
42. YY/T 0987.2-2016 Implants for surgery — Magnetic resonance compatibility — Part 2: Test methods for magnetically induced displacement force;
43. YY/T 0987.3-2016 Implants for surgery — Magnetic resonance compatibility — Part 3: Methods for evaluation of image artifacts;
44. YY/T 0987.4-2016 Implants for surgery — Magnetic resonance compatibility — Part 4: Test methods for RF-induced heating;
45. YY/T 0987.5-2016 Implants for surgery — Magnetic resonance compatibility — Part 5: Test methods for magnetically induced torque;
46. YY/T 0695-2008 Standard test method for the corrosion susceptibility of small implantable devices by cyclic potentiodynamic polarization;
47. YY/T 1960-2025 Medical devices Information to be supplied by the manufacturer;
48. YY/T 1982-2025: Surgical implants — Test methods for the morphological characteristics of porous structures;
49. YY/T 1924-2025: Surgical implants — Nickel-titanium shape memory alloy wire/cable;
50. YY/T 1934-2025: Human factors design requirements and evaluation methods for orthopedic implants and surgical instruments;
51. GB/T 42061-2022: Medical devices — Quality management systems — Requirements for regulatory purposes;
52. GB/T 42062-2022: Medical devices — Application of risk management to medical devices;
53. GB/Z 42217-2022: Medical devices — Validation of software used in medical device quality management systems;
54. GB/T 19633.1-2024: Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems, and packaging systems;
55. GB/T 19633.2-2024: Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing, and assembly processes;
56. GB/T 16886.10-2024: Biological evaluation of medical devices — Part 10: Tests for skin sensitization;
57. GB/T 16886.17-2025: Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents;
58. GB/T 43278-2023: Medical laboratories — Application of risk management to medical laboratories;
59. GB/Z 43280-2023: Medical laboratories — Guidance on the evaluation of measurement uncertainty;
60. GB/T 16292-2025 Test Methods for Airborne Particles in Cleanrooms (Clean Zones) for the Pharmaceutical Industry;
61. GB/T 16293-2025 GB/T 16293-2025 Test methods for airborne viable particles in cleanrooms (clean zones) for the pharmaceutical industry
62. GB/T 16294-2025 Test methods for settling viable particles in cleanrooms (clean zones) for the pharmaceutical industry
63. GB/T 42984.1-2023 Health Software – Part 1: General Requirements for Product Safety;
64. GB/T 44585.1-2024 Application of Risk Management to Medical Devices Connected to IT Networks – Part 1: Safety, Effectiveness, and Cybersecurity of Connected Medical Devices or Health Software During Implementation and Use;
65. GB 19781-2005 Medical Laboratories – Safety Requirements;
66. YY/T 1752-2020 Basic Data Set for the Unique Device Identification (UDI) Database;
67. YY/T 1437-2023 Medical Devices – Guidance on the Application of GB/T 42062;
68. YY/T 0802.1-2024 Processing of Medical Devices – Information to be Provided by the Medical Device Manufacturer – Part 1: Medium- and High-Risk Medical Devices;
69. YY/T 0802.2-2024 Processing of Medical Devices – Information to be Provided by the Medical Device Manufacturer – Part 2: Low-Risk Medical Devices;
70. YY/T 1930-2024 Clinical Evaluation of Medical Devices – Terms and Definitions;
71. YY/T 0910.2-2025 Medical Electrical Equipment – Medical Image Display Systems – Part 2: Acceptance and Constancy Tests for Medical Image Display Systems;
72. YY/T 1670.2-2025 Neurotoxicity Evaluation of Medical Devices Part 2: Neurocytotoxicity Test;
73. YY/T 1992-2025: Surgical Assistance Equipment Using Robotic Technology – Summative Usability Testing Methods;
74. YY/T 1993-2025: Surgical Assistance Equipment Using Robotic Technology – Reliability Verification Methods;
75. YY/T 0648-2025: Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use – Part 2-101: Particular Requirements for In Vitro Diagnostic (IVD) Medical Equipment; 76. YY/T 1987-2025: Medical Devices Using Brain-Computer Interface (BCI) Technology – Terminology.
