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Eighteen Standards Issued in One Day

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nmpa guidelines for nanomaterials

The NMPA published eighteen industry recommended standards on July 6, 2022 to guide manufacturers for local type testing and regulatory approval:

  • YY/T 0273-2022 Dentistry-Dental amalgam blender
  • YY/T 0290.4-2022 Ophthalmic optics – Intraocular lenses – Part 4: Labeling and information
  • YY/T 0299-2022 Medical ultrasonic couplant
  • YY/T 0482-2022 Medical Magnetic Resonance Imaging Equipment-Determination of Main Image Quality Parameters
  • YY/T 0519-2022 Dentistry-Testing of bonding with tooth structure
  • YY/T 0612-2022 Disposable human arterial blood sample collector (arterial blood gas needle)
  • YY/T 0634-2022 Ophthalmic instruments Fundus camera
  • YY/T 0793.1-2022 Preparation and quality management of fluids for hemodialysis and related treatments – Part 1: Water treatment equipment for hemodialysis and related treatments
  • YY/T 0793.4-2022 Preparation and quality management of fluids for hemodialysis and related treatments – Part 4: Dialysate quality for hemodialysis and related treatments
  • YY/T 0821-2022 Disposable Dispensing Syringes
  • YY/T 1789.3-2022 In vitro diagnostic test system-performance evaluation method-Part 3: detection limit and quantification limit
  • YY/T 1789.4-2022 In-vitro diagnostic test system-performance evaluation method-Part 4: Linear interval and reportable interval
  • YY/T 1810-2022 Tissue engineering medical products Quantitative detection of sulfated glycosaminoglycans (sGAG) for evaluating cartilage formation
  • YY/T 1833.1-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation Part 1: Terminology
  • YY/T 1833.2-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation-Part 2: General Requirements for Data Sets
  • YY/T 1835-2022 Performance and test methods of breast positron emission tomography devices
  • YY/T 1845-2022 General requirements for surgical guides for orthopedic surgery
  • YY/T 1848-2022 Disposable ureteral occlusion catheter

The industry recommended standards are not legally binding but recommended by regulatory authorities. For English version of any standards above, please contact us any time at info@ChinaMedDevice.com. We charge nominal fees for the translation.

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