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 email info@ChinaMedDevice.com. We charge nominal fees for the translation.