18 medical device industry standards have been approved and are now published, including:

  1. 1. YY/T 0273-2022 “Dentistry - Dental Amalgamators”
  2. 2. YY/T 0290.4-2022 “Ophthalmology - Intraocular Lens Part 4: Labelling and Data”
  3. 3. YY/T 0299-2022 “Medical Ultrasound Coupling Agent”
  4. 4. YY/T 0482-2022 “Magnetic Resonance Equipment for Medical Imaging - Determination of Essential Image Quality Parameters”
  5. 5. YY/T 0519-2022 “Dentistry - Testing of Adhesion to Tooth Structure”
  6. 6. YY/T 0612-2022 “Single-use Receptacles for Human Arterial Blood Specimen Collection”
  7. 7. YY/T 0634-2022 “Ophthalmic Instruments - Fundus Cameras”
  8. 8. YY/T 0793.1-2022 “Making and Quality Management of Liquid for Haemodialysis Applications and Related Therapies Part 1: Water Treatment Equipments for Haemodialysis Applications and Related Therapies”
  9. 9. YY/T 0793.4-2022 “Making and Quality Management of Liquid for Haemodialysis Applications and Related Therapies Part 4: Quality of Dialysing Fluid for Haemodialysis Applications and Related Therapies”
  10. 10. YY/T 0821-2022 “Dispensing Syringe for Single Use”
  11. 11. YY/T 1789.3-2022 “In Vitro Diagnostic Test Systems - Method for Performance Evaluation Part 3: Limit of Detection and Quantitation”
  12. 12. YY/T 1789.4-2022 “In Vitro Diagnostic Test Systems - Method for Performance Evaluation Part 4: Linear Interval and Reportable Interval”
  13. 13. YY/T 1810-2022 “Tissue Engineering Medical Device Products - Quantitative Examination of sGAG for Evaluating Cartilage Formation”
  14. 14. YY/T 1833.1-2022 "Artificial Intelligence Medical Devices - Quality Requirements and Evaluation Part 1: Terminology"
  15. 15. YY/T 1833.2-2022 “Artificial Intelligence Medical Devices - Quality Requirements and Evaluation Part 2: General Requirements for Data Set“
  16. 16. YY/T 1835-2022 “Characteristics and Test Methods for Breast Positron Emission Tomography
  17. 17. YY/T 1845-2022 “General Requirements for Orthopedic Surgical Template”
  18. 18. YY/T 1848-2022 “Ureteral Occlusion Catheters for Single Use”

 

Attachment: Information Table of Medical Device Industry Standards

 

 

Reference:  

NMPA’s Announcement on Releasing 18 Medical Device Industry Standards Including YY/T 1833.1-2022 "Artificial Intelligence Medical Devices - Quality Requirements and Evaluation Part 1: Terminology" (No. 52 of 2022)

 

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