The NMPA published eighteen industry standards on August 22, 2022, to guide manufacturers for local type testing and regulatory approval:
- YY/T 0325-2022 Disposable sterile urinary catheter
- YY/T 0334-2022 General requirements for silicone rubber surgical implants
- YY/T 0493-2022 Dentistry elastomeric impression materials
- YY/T 0567.6-2022 Aseptic processing of healthcare products – Part 6: Isolator systems
- YY/T 0642-2022 Ultrasound—Sound field characteristics—Test methods for determining the thermal and mechanical index of medical diagnostic ultrasound fields
- YY/T 0772.4-2022 Surgical implants high molecular weight polyethylene Part 4: Test method for oxidation index
- YY/T 1829-2022 Dentistry-In vitro evaluation method of dentinal tubule occlusion effect
- YY/T 1833.3-2022 Artificial intelligence medical devices-Quality requirements and evaluation Part 3: General requirements for data labeling
- YY/T 1842.6-2022 Medical devices-connectors for medical fluid storage container delivery systems-Part 6: Neurological applications
- YY/T 1851-2022 Medical pure tantalum powder for additive manufacturing
- YY/T 1852-2022 Medical devices for human assisted reproductive technology – Determination of ammonium ion in culture liquid
- YY/T 1853-2022 Ultrasonic bone tissue surgery equipment and tools
- YY/T 1854-2022 Test method for the dissolution of trioctyl trimellitate (TOTM) in polyvinyl chloride medical devices
- YY/T 1858-2022 Artificial intelligence medical devices-Lung image aided analysis software-algorithm performance test method
- YY/T 1864-2022 Human factors design requirements and evaluation methods for spinal internal fixation systems and surgical instruments
- YY/T 1872-2022 Negative pressure drainage sponge
- YY/T 1879-2022 Creation and assignment of unique identifiers for medical devices
- YY/T 0321.3-2022 Disposable filters for anesthesia
The industry recommended standards are not legally binding but recommended by regulatory authorities. For English version of any standards above, please contact us or email info@ChinaMedDevice.com. We charge nominal fees for the translation.
