title status date YY 9706.268-2022 Medical Electrical Equipment Part 2-68: Particular Requirements for Basic Safety and Basic Performance of X-ray Image-guided Radiotherapy Equipment for Electron Accelerators, Light Ion Beam Therapy Equipment and Radionuclide Beam Therapy Equipment Final 20-May YY/T 0296-2022 Disposable Injection Needle Identification Color Code Final 20-May YY/T 0321.1-2022 Disposable Anesthesia Puncture Bag Final 20-May YY/T 0346-2022 Bone Engaging Implants Metal Femoral Neck Fixation Nails Final 20-May YY/T 0593-2022 Ultrasound Transcranial Doppler Flow Analyzer Final 20-May YY/T 0646-2022 Small Pressure Steam Sterilizer Final 20-May YY/T 0681.12-2022 Test Methods for Packaging of Sterile Medical Devices – Part 12: Anti-rubbing Resistance of Soft Barrier Materials Final 20-May YY/T 0719.5-2022 Ophthalmic Optics-Contact Lens Care Products-Part 5: Determination of Physical Compatibility Final 20-May YY/T 0740-2022 Special Technical Conditions for Medical Angiography X-ray Machine Final 20-May YY/T 0794-2022 Special Technical Conditions for Image Plate Imaging Devices for X-ray Photography Final 20-May YY/T 0795-2022 Special Technical Conditions for Oral and Maxillofacial Cone Beam Computed Tomography Equipment Final 20-May YY/T 0803.1-2022 Dentistry – Root Canal Instruments – Part 1: General Requirements Final 20-May YY/T 0809.10-2022 Surgical Implants-Partial and Total Hip Prostheses-Part 10: Determination of Static Load Resistance of Combined Femoral Head Final 20-May YY/T 0871-2022 Ophthalmic optics – Contact lenses – Hygienic handling of multi-patient try-on contact lenses Final 20-May YY/T 0916.3-2022 Small Bore Connectors for Medical Liquids and Gases-Part 3: Connectors for Gastrointestinal Applications Final 20-May YY/T 0916.6-2022 Small-bore Connectors for Medical liquids and Gases-Part 6: Connectors for Shaft Applications Final 20-May YY/T 0933-2022 Medical General Photography Digital X-ray Image Detector Final 20-May YY/T 0934-2022 Medical Dynamic Digital X-ray Image Detector Final 20-May YY/T 0937-2022 Technical Requirements for Ultrasonic Tissue-Mimicking Phantoms Final 20-May YY/T 0967-2022 Dentistry – Rods for Rotating and Reciprocating Instruments Final 20-May YY/T 1011-2022 Dentistry – Nominal Diameter and Designation of Rotary Instruments Final 20-May YY/T 1021.1-2022 Dentistry – Extraction forceps – Part 1: General Requirements Final 20-May YY/T 1226-2022 Human Papillomavirus Nucleic Acid (typing) Detection Kit Final 20-May YY/T 1282-2022 Disposable Intravenous Indwelling Needle Final 20-May YY/T 1629.3-2022 Electric Bone Tissue Surgery Equipment and Cutters-Part 3: Drill Bits Final 20-May YY/T 1769-2022 Medical Devices for Human Assisted Reproductive Technology Artificial Insemination Catheters Final 20-May YY/T 1807-2022 Dentistry-Rapid Non-Destructive Testing of Main Components in Restorative Metal Materials-Hand-held X-ray Fluorescence Spectrometer Method (semi-quantitative method) Final 20-May YY/T 1811-2022 Complement 4 Determination Kit (immunoturbidimetric method) Final 20-May YY/T 1812-2022 Characterization of Physicochemical Properties of Degradable Biomedical Metal Materials Final 20-May YY/T 1813-2022 Method for Collecting and Evaluating Information on Reliability of Use of Medical Electrical Equipment Final 20-May YY/T 1814-2022 Surgical Implants Synthetic Nonabsorbable Mesh Hernia Repair Mesh Final 20-May YY/T 1815-2022 Biological Evaluation of Medical Devices – Application of Threshold of Toxicological Concern (TTC) to Assess the Biocompatibility of Components of Medical Devices Final 20-May YY/T 1816-2022 Surgical implants Synthetic Non-absorbable Patch Dura (spinal) Membrane Patch Final 20-May YY/T 1817-2022 Thyroglobulin Assay Kit (chemiluminescence immunoassay) Final 20-May YY/T 1818-2022 Dentistry-Oral Digital Impression Instrument Final 20-May YY/T 1819-2022 Dentistry – Diaphragms for Orthodontic Appliances Final 20-May YY/T 1821-2022 Calculation Method of Body Size-specific Dose Estimation for X-ray Computed Tomography Equipment Final 20-May YY/T 1822-2022 Dentistry Mouth Mirror Final 20-May YY/T 1823-2022 Cardiovascular Implants-Nitinol Alloy Nickel Ion Release Test Method Final 20-May YY/T 1827.1-2022 Medical ElectricalEequipment – Radiation Dose Documentation – Part 1: Structured Report on Radiation Dose for Photographic and Fluoroscopic Equipment Final 20-May YY/T 1830-2022 Electro-pneumatic Hemostatic Device Final 20-May YY/T 1832-2022 Sports Medicine Implanted Devices-suture Tensile Test Method Final 20-May YY/T 1834-2022 X-ray Blood Irradiation Equipment Final 20-May YY/T 1837-2022 Medical electrical equipment General requirements for reliability Final 20-May YY/T 1838-2022 Disposable Peripheral Blood Collection Device Final 20-May YY/T 1839-2022 Cardiopulmonary Bypass System Venous Bubble Trap Final 20-May YY/T 1841-2022 Cardiac Electrophysiological Mapping System Final 20-May YY/T 1842.1-2022 Medical devices—Connectors for Medical Fluid Storage Container Delivery System—Part 1: General Requirements and General Test Methods Final 20-May YY/T 1842.8-2022 Medical devices—Connectors for Medical Fluid Storage Container Delivery Systems—Part 8: Application of Apheresis Citrate Anticoagulant Final 20-May YY/T 1843-2022 Basic Requirements for Network Security of Medical Electrical Equipment Final 20-May YY/T 1846-2022 Endoscopic Surgical Instruments Reusable Abdominal Aspirator Final 20-May YY/T 1847-2022 Globulin Detection Card (column agglutination method) Final 20-May YY/T 1833.1-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation Part 1: Terminology Final 6-Jul YY/T 1833.2-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation-Part 2: General Requirements for Data Sets Final 6-Jul YY/T 0273-2022 Dentistry-Dental Amalgam Blender Final 6-Jul YY/T 0290.4-2022 Ophthalmic Optics – Intraocular lenses – Part 4: Labeling and Information Final 6-Jul YY/T 0299-2022 Medical Ultrasonic Couplant Final 6-Jul YY/T 0482-2022 Medical Magnetic Resonance Imaging Equipment-Determination of Main Image Quality Parameters Final 6-Jul YY/T 0519-2022 Dentistry-Testing of Bonding with Tooth Structure Final 6-Jul YY/T 0612-2022 Disposable Human Arterial Blood Sample Collector (Arterial Blood Gas Needle) Final 6-Jul YY/T 0634-2022 Ophthalmic Instruments Fundus Camera Final 6-Jul YY/T 0793.1-2022 Preparation and Quality Management of Fluids for Hemodialysis and Related Treatments – Part 1: Water Treatment Device for Hemodialysis and Related Treatments Final 6-Jul 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 Final 6-Jul YY/T 0821-2022 Disposable Dispensing Syringes Final 6-Jul YY/T 1789.3-2022 In Vitro Diagnostic Test System-Performance Evaluation Method-Part 3: Detection Limit and Quantification Limit Final 6-Jul YY/T 1789.4-2022 In Vitro Diagnostic Test System-Performance Evaluation Method-Part 4: Linear Interval and Reportable Interval Final 6-Jul YY/T 1810-2022 Tissue Engineering Medical Products Quantitative Detection of Sulfated Glycosaminoglycans (sGAG) for Evaluating Cartilage Formation Final 6-Jul YY/T 1835-2022 Performance and Test Methods of Breast Positron Emission Tomography Devices Final 6-Jul YY/T 1845-2022 General Requirements for Surgical Guides for Orthopedic Surgery Final 6-Jul YY/T 1848-2022 Disposable Ureteral Occlusion Catheter Final 6-Jul YY/T 0325-2022 Disposable Sterile Urinary Catheter Final 22-Aug YY/T 0334-2022 General Requirements for Silicone Rubber Surgical Implants Final 22-Aug YY/T 0567.6-2022 Aseptic Processing of Healthcare Products – Part 6: Isolator Systems Final 22-Aug YY/T 0642-2022 Ultrasound—Sound Field Characteristics—Test Methods for Determining the Thermal and Mechanical Index of Medical Diagnostic Ultrasound Fields Final 22-Aug YY/T 0772.4-2022 Surgical Implants High Molecular Weight Polyethylene Part 4: Test Method for Oxidation Index Final 22-Aug YY/T 1829-2022 Dentistry-In Vitro Evaluation Method of Dentinal Tubule Occlusion Effect Final 22-Aug YY/T 1833.3-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling Final 22-Aug YY/T 1842.6-2022 Medical Devices-Connectors for Medical Fluid Storage Container Delivery Systems-Part 6: Neurological Applications Final 22-Aug YY/T 1851-2022 Medical Pure Tantalum Powder for Additive Manufacturing Final 22-Aug YY/T 1852-2022 Medical Devices for Human Assisted Reproductive Technology – Determination of Ammonium Ion in Culture Liquid Final 22-Aug YY/T 1853-2022 Ultrasonic Bone Tissue Surgery Equipment and Tools Final 22-Aug YY/T 1854-2022 Test Method for the Dissolution of Trioctyl Trimellitate (TOTM) in Polyvinyl Chloride Medical Devices Final 22-Aug YY/T 1858-2022 Artificial Intelligence Medical Devices-Lung Image Aided Analysis Software-Algorithm Performance Test Method Final 22-Aug YY/T 1864-2022 Human Factors Design Requirements and Evaluation Methods for Spinal Internal Fixation Systems and Surgical Instruments Final 22-Aug YY/T 1872-2022 Negative Pressure Drainage Sponge Final 22-Aug YY/T 1879-2022 Creation and Assignment of UDIs for Medical Devices Final 22-Aug YY/T 0321.3-2022 Disposable Filters for Anesthesia Final 22-Aug YY/T 0493-2022 Dentistry Elastomeric Impression Materials Final 22-Aug YY 0719.2-2022 Ophthalmic Optics – Contact Lens Care Products – Part 2: Basic Requirements Final 17-Oct YY 0290.8-2022 Ophthalmic Optics – Intraocular Lenses – Part 8: Basic Requirements Final 17-Oct YY 0650-2022 General Technical Requirements for Radiofrequency Ablation Device Final 17-Oct YY 1289-2022 Laser Therapy Equipment Ophthalmic Laser Photocoagulation Apparatus Final 17-Oct YY/T 0633-2022 Ophthalmic Instruments Indirect Ophthalmoscope Final 17-Oct YY/T 0698.2-2022 Packaging Materials for Terminally Sterilized Medical Devices – Part 2: Sterilization Packaging Materials – Requirements and Test Methods Final 17-Oct YY/T 0719.10-2022 Ophthalmic Optics-Contact Lens Care Products-Part 10: Determination of Moisturizing Lubricants Final 17-Oct YY/T 0952-2022 Medical Temperature Controller Final 17-Oct YY/T 0989.5-2022 Surgical Implants Active Implantable Medical Devices Part 5: Circulatory Support Devices Final 17-Oct YY/T 1043.1-2022 Dentistry-Non-mobile Dental Treatment Machines and Dental Patient Chairs-Part 1: General Requirements Final 17-Oct YY/T 1293.2-2022 Contact Wound Dressings-Part 2: Polyurethane Foam Dressings Final 17-Oct YY/T 1464-2022 Sterilization of Health Care Products – Low Temperature Steam Formaldehyde – Requirements for the Development, Validation and Routine Control of Medical Device Sterilization Processes Final 17-Oct YY/T 1844-2022 Anesthesia and Respiratory Equipment – General Requirements for Airway and Related Equipment Final 17-Oct YY/T 1855-2022 Test Method for Fatigue Performance of Combined Ceramic Femoral Head Final 17-Oct YY/T 1857-2022 Dentistry Digging Spoons and Bone Curettes Final 17-Oct YY/T 1859-2022 Anti-Calcification Evaluation of Animal-Derived Cardiovascular Implants Subcutaneous Implantation Test in Rats Final 17-Oct YY/T 1865-2022 General Technical Requirements for BRCA Gene Mutation Detection Kits and Databases (High-throughput Sequencing Method) Final 17-Oct YY/T 1877-2022 Method for the Determination of Bisphenol-based Propane (BPA) Residues in Extracorporeal Circulation Devices Final 17-Oct YY/T 1880-2022 Serum Amyloid A Assay Kit Final 17-Oct YY/T 1064-2022 Dentistry – General Requirements for Drills for Dental Implant Surgery Final 17-Oct

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