These medical device standards will be implemented this month!
National standards for medical devices
| Standard Number |
Standard Name |
Implementation Time |
| GBT/T44059.1-2024 | Medical gas piping systems – Part 1: Compressed medical gas and vacuum piping systems | July 1, 2025 |
| GB/T12279.2-2024 | Cardiovascular implantable devices – Artificial heart valves – Part 2: Surgical implantable artificial heart valves | July 1, 2025 |
| GB/T44138-2024 | Cardiovascular implants absorbable implants | July 1, 2025 |
| GB/T12279.1-2024
|
Cardiovascular implantable devices – Artificial heart valves – Part 1: General requirements | July 1, 2025
|
| GB/T43952-2024 | Medical supply equipment | July 1, 2025 |
Medical device industry standards to be implemented on July 20th
| Standard Number |
Standard Name |
Standard Name |
| YY/T0063-2024
|
Medical electrical equipment – Medical diagnostic X-ray tube assemblies – Focal spot sizes and related characteristics | July20, 2025
|
| YY/T0282-2024 | Injection needle | July20, 2025 |
| YY/T0810.1-2024
|
Articular replacement implant devices – Total knee prosthesis – Part 1: Determination of fatigue properties of tibial trays | July20, 2025
|
| YY/T0870.8-2024
|
Genotoxicity tests for medical devices – Part 8: In vivo unscheduled DNA synthesis test in mammalian hepatocytes | July20, 2025
|
| YY/T0923-2024
|
Microbial invasion test method for connectors used in liquid and blood circuits | July20, 2025
|
| YY/T0924.2-2024 | Joint replacement implantable devices – Components of partial and total knee joint prostheses – Part 2: Metal, ceramic and plastic articulating surfaces | July20, 2025 |
| YY/T1117-2024 | Plaster bandage | July20, 2025 |
| YY/T1148-2024 | Lumbar puncture needle | July20, 2025 |
| YY/T1306-2024 | Fumigation Therapy Apparatus | July20, 2025 |
| YY/T1307-2024
|
Detector for medical digital X-ray mammography | July20, 2025
|
| YY/T1535-2024
|
Medical devices for human assisted reproductive technology – Human sperm survival test | July20, 2025
|
| YY/T1550.3-2024
|
Guidelines for the Study of Compatibility between Single – use Infusion Devices and Drugs – Part 3: Study of Leachables – Unknown Substances | July20, 2025
|
| YY/T1754.4-2024
|
Pre – clinical animal studies of medical devices – Part 4: Acute wound models for evaluating the wound – healing promotion of dressings | July20, 2025
|
| YY/T1786-2024
|
Hepatitis B Virus e Antigen Detection Kit (Chemiluminescent Immunoassay) | July20, 2025
|
| YY/T1922-2024
|
Sports medicine implantable devices – Tendon and ligament fixation screws | July20, 2025
|
| YY/T1932-2024
|
Dentistry – Diaphragm – type bracketless orthodontic appliance | July20, 2025
|
| YY/T1933-2024 | Special technical specifications for magnetic resonance imaging injection devices | July20, 2025
|
| YY/T1935-2024
|
Safety requirements and test methods for implantable cardiac pacemakers and cardioverter defibrillators in magnetic resonance environments | July20, 2025
|
| YY/T1936-2024 | Customized fixed denture | July20, 2025 |
| YY/T1937-2024 | Customized removable dentures | July20, 2025 |
| YY/T1939-2024
|
Test Method for Bacterial Endotoxin in Medical Devices – Recombinant Factor C Method | July20, 2025
|
| YY/T1942-2024
|
The form and content of the unique medical device identification | July20, 2025 |
| YY/T1943-2024 | Implementation and application of packaging for Unique Device Identification (UDI) of medical devices | July20, 2025 |
