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35 National Standards and 146 Industry Standards Issued in 2021

Date:

YY/T 0061-2021 Specific Electromagnetic Wave Therapy Device 9-Mar YY/T 0286.5-2021 Special Infusion Sets – Part 5: Disposable Bottle and Bag Infusion Sets 9-Mar YY 0290.2-2021 Ophthalmic Optics – Intraocular Lenses – Part 2: Optical Properties and Test Methods 9-Mar YY/T 0321.2-2021 Disposable Anesthesia Needles 9-Mar YY/T 0567.2-2021 Aseptic Processing of Healthcare Products Part 2: Sterile Filtration 9-Mar YY/T 0629-2021 Dentistry Central Suction Source Equipment 9-Mar YY/T 0636.1-2021 Medical Suction Equipment Part 1: Electric Suction Equipment 9-Mar YY/T 0636.2-2021 Medical Suction Equipment Part 2: Manually Actuated Suction Equipment 9-Mar YY/T 0636.3-2021 Medical Suction Equipment Part 3: Suction Equipment Powered by Vacuum or Positive Pressure Source 9-Mar YY/T 0681.4-2021 Test Methods for Packaging of Sterile Medical Devices – Part 4: Determination of Seal Leakage of Breathable Packaging by Dye Penetration Method 9-Mar YY/T 0696-2021 Measurement of Output Characteristics of Nerve and Muscle Stimulators 9-Mar YY/T 0724-2021 Special Technical Conditions for Dual Energy X-Ray Absorptiometry 9-Mar YY/T 0742-2021 Special Technical Conditions for Gastrointestinal X-Ray Machines 9-Mar YY/T 0746-2021 Special Technical Conditions for On-Board Medical X-Ray Diagnostic Equipment 9-Mar YY 0838-2021 Microwave Thermosetting Equipment 9-Mar YY/T 0868-2021 Electrodes for Nerve and Muscle Stimulators 9-Mar YY/T 1014-2021 Dentistry Dental Probe 9-Mar YY/T 1035-2021 Stethoscope 9-Mar YY/T 1120-2021 Dentistry Dental Lights 9-Mar YY/T 1416.5-2021 Determination of Dose Addition in Single-Use Human Venous Blood Sample Collection Containers Part 5: Glycine 9-Mar YY/T 1416.6-2021 Determination of Dose Addition in Single-Use Human Venous Blood Sample Collection Containers Part 6: Imidazolidinyl Ureas 9-Mar YY/T 1465.7-2021 Methods for Evaluating Immunogenicity of Medical Devices Part 7: Flow-Liquid-Liquid Multiplex Protein Quantification Techniques 9-Mar YY/T 1679-2021 Guidelines for The Preclinical Evaluation of Bone Defects of Critical Size In Vivo for Tissue-Engineered Medical Device Products 9-Mar YY/T 1688-2021 Medical Devices for Human Assisted Reproductive Technology-Methods for Staining and Counting Blastocyst Cells 9-Mar YY/T 1712-2021 Assistive Surgical Devices and Assisted Surgical Systems Using Robotics 9-Mar YY/T 1728-2021 Clinical Laboratory Tests And In Vitro Diagnostic Systems Reference Methods for In Vitro Activity Detection of Yeast-Like Fungi Antibacterial Agents Associated with Infectious Diseases 9-Mar YY/T 1735-2021 Hepatitis C Virus Antibody Detection Reagent (Box) (Chemiluminescence Immunoassay) 9-Mar YY/T 1740.1-2021 Medical Mass Spectrometers Part 1: Liquid Chromatography-Mass Spectrometry 9-Mar YY 1741-2021 Antithrombin Ⅲ Assay Kit 9-Mar YY/T 1742-2021 Adenosine Deaminase Assay Kit 9-Mar YY/T 1743-2021 Anesthesia and Respiratory Equipment Nebulization Systems and Components 9-Mar YY/T 1755-2021 Dentistry Sandblasting Handpieces and Sandblasting Powders 9-Mar YY/T 1756-2021 Dentistry Reusable Periodontal Ligament Injection Rack 9-Mar YY/T 1757-2021 Medical Freezer 9-Mar YY/T 1763-2021 Medical Electrical Equipment Medical Light Ion Beam Equipment Performance Characteristics 9-Mar YY/T 1766.1-2021 Image Quality Evaluation Method for X-Ray Computed Tomography Equipment Part 1: Modulation Transfer Function Evaluation 9-Mar YY/T 1766.2-2021 Methods for Evaluating Image Quality of X-Ray Computed Tomography Equipment—Part 2: Evaluation of Low-Contrast Resolution 9-Mar YY/T 1767-2021 Ultrasound Power Measurement High Intensity Therapeutic Ultrasound (Hitu) Transducers and Systems 9-Mar YY/T 1768.1-2021 Needle Injection Systems for Medical Use – Requirements and Test Methods – Part 1: Needle Injection Systems 9-Mar YY/T 1768.2-2021 Needle Injection Systems for Medical Use – Requirements and Test Methods – Part 2: Needles 9-Mar YY/T 1770.1-2021 Medical Device Thrombosis Test Part 1: In Vivo Thrombosis Test in Dogs 9-Mar YY/T 1771-2021 Determination of Phase Transition Temperature of Niti Shape Memory Alloy by Bending-Free Recovery Method 9-Mar YY/T 1772-2021 Surgical Implants — Test Methods for Galvanic Corrosion in Electrolytes 9-Mar YY/T 1773-2021 Disposable External Peritoneal Dialysis Tubing 9-Mar YY/T 1775.1-2021 Biological Evaluation of Absorbable Medical Devices Part 1: Guidelines for Absorbable Implants 9-Mar YY/T 1776-2021 Determination of Lactide Monomer Content in Polylactic Acid Materials for Surgical Implants 9-Mar YY/T 1779-2021 Dentistry Orthodontic Anchorage Nails 9-Mar YY/T 1783-2021 Endoscopic Surgical Instruments Reusable Abdominal Trocar 9-Mar YY 9706.102-2021 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility Requirements and Tests 9-Mar YY/T 9706.106-2021 Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance Collateral Standard: Availability 9-Mar YY 9706.108-2021 Medical Electrical Equipment Part 1-8: General Requirements for Basic Safety and Essential Performance Collateral Standard: General Requirements, Tests and Guidelines for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems 9-Mar YY/T 9706.110-2021 Medical Electrical Equipment Part 1-10: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for The Development of Physiological Closed-Loop Controllers 9-Mar YY 9706.111-2021 Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems for Use in Home Care Environments 9-Mar YY 9706.112-2021 Medical Electrical Equipment Part 1-12: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Intended for Use in Emergency Medical Services Environments 9-Mar YY 9706.210-2021 Medical Electrical Equipment – Part 2-10: Particular Requirements for Basic Safety and Essential Performance of Nerve and Muscle Stimulators 9-Mar YY 9706.220-2021 Medical Electrical Equipment – Part 2-20: Particular Requirements for Basic Safety and Essential Performance of Infant Transport Incubators 9-Mar YY9706.233-2021 Medical Electrical Equipment Part 2-33: Particular Requirements for Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnostics 9-Mar YY 9706.235-2021 Medical Electrical Equipment – Part 2-35: Particular Requirements for Basic Safety and Essential Performance of Medical Blanket, Pad or Mattress Heating Equipment 9-Mar YY 9706.240-2021 Medical Electrical Equipment – Part 2-40: Particular Requirements for Basic Safety and Essential Performance of Electromyography and Evoked Response Equipment 9-Mar YY 9706.250-2021 Medical Electrical Equipment – Part 2-50: Particular Requirements for Basic Safety and Essential Performance of Infant Phototherapy Equipment 9-Mar YY 9706.257-2021 Medical Electrical Equipment – Part 2-57: Particular Requirements for Basic Safety and Essential Performance of Non-Laser Light Source Equipment for Therapeutic, Diagnostic, Monitoring and Plastic/Medical Cosmetic Use 9-Mar YY 9706.262-2021 Medical Electrical Equipment Part 2-62: Particular Requirements for Basic Safety and Essential Performance of High-Intensity Ultrasound Therapy (Hitu) Equipment 9-Mar YY 9706.269-2021 Medical Electrical Equipment – Part 2-69: Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrators 9-Mar YY/T 1794-2021 General Technical Requirements for Oral Collagen Membranes 10-Mar YY/T 0106-2021 General Technical Conditions for Medical Diagnostic X-Ray Machines 6-Sep YY/T 0290.1-2021 Ophthalmic Optics – Intraocular Lenses – Part 1: Terminology 6-Sep YY/T 0290.6-2021 Ophthalmic Optics – Intraocular Lenses – Part 6: Shelf Life and Shipping Stability 6-Sep YY/T 0314-2021 Disposable Human Venous Blood Sample Collection Container 6-Sep YY/T 0480-2021 Diagnostic X-Ray Imaging Equipment General Purpose and Mammography Anti-Scatter Grid Characteristics 6-Sep YY/T 0616.6-2021 Disposable Medical Gloves – Part 6: Test Method for Evaluating Permeability of Chemotherapeutic Drugs 6-Sep YY/T 0617-2021 Disposable Human Peripheral Blood Sample Collection Container 6-Sep YY/T 0663.1-2021 Cardiovascular Implants – Endovascular Devices – Part 1: Endovascular Prostheses 6-Sep YY 0671-2021 Medical Devices Sleep Apnea Treatment Masks & App Accessories 6-Sep YY/T 0719.9-2021 Ophthalmic Optics – Contact Lens Care Products – Part 9: Determination of Chelating Agents 6-Sep YY/T 0758-2021 General Requirements for Medical Laser Fibers 6-Sep YY/T 0811-2021 High-Dose Radiation Cross-Linked Ultra-High Molecular Weight Polyethylene Products for Surgical Implants 6-Sep YY/T 0910.1-2021 Medical Electrical Equipment – Medical Image Display System – Part 1: Evaluation Method 6-Sep YY/T 0916.1-2021 Small Bore Connections for Medical Liquids and Gases – Part 1: General Requirements 6-Sep YY/T 0962-2021 Cross-Linked Sodium Hyaluronate Gel for Plastic Surgery 6-Sep YY/T 0988.3-2021 Surgical Implant Coatings Part 3: Mussel Mucin Materials 6-Sep YY/T 1012-2021 Dental Handpiece Coupling Dimensions 6-Sep YY 1045-2021 Dentistry Handpieces and Motors 6-Sep YY/T 1181-2021 Immunohistochemistry Kit 6-Sep YY/T 1629.6-2021 Electric Bone Tissue Surgery Equipment Knives Part 6: Files 6-Sep YY/T 1704.3-2021 Disposable Cervical Dilators Part 3: Balloon 6-Sep YY/T 1708.3-2021 Basic Requirements for Connectivity Compliance of Medical Diagnostic X-Ray Imaging Equipment – Part 3: Digital Photographic X-Ray Machines 6-Sep YY/T 1708.4-2021 Basic Requirements for Connectivity Compliance of Medical Diagnostic X-Ray Imaging Equipment Part 4: Digital Subtraction Angiography X-Ray Machine 6-Sep YY/T 1708.5-2021 Basic Requirements for Connectivity Compliance of Medical Diagnostic X-Ray Imaging Equipment Part 5: Mammography Machine 6-Sep YY/T 1708.6-2021 Basic Requirements for Connectivity Compliance of Medical Diagnostic X-Ray Imaging Equipment Part 6: Oral X-Ray Machine 6-Sep YY/T 1740.2-2021 Medical Mass Spectrometers Part 2: Matrix-Assisted Laser Desorption Ionization Time-Of-Flight Mass Spectrometers 6-Sep YY/T 1745-2021 Automatic Stool Analyzer 6-Sep YY/T 1748-2021 Neurovascular Implants Intracranial Coils 6-Sep YY/T 1760-2021 Disposable Peritoneal Dialysis Drain 6-Sep YY/T 1761-2021 Dialysis Tubing Disinfectant 6-Sep YY/T 1764-2021 Test Method For In Vitro Axial, Bending and Torsional Durability of Vascular Stents 6-Sep YY/T 1774-2021 Male Condoms – Guidelines for The Use of Gb/T 7544 And Yy/T 1777 In Condom Quality Management 6-Sep YY/T 1777-2021 Male Condoms – Technical Requirements and Test Methods for Synthetic Condoms 6-Sep YY/T 1778.1-2021 Biocompatibility Evaluation of Respiratory Gas Pathways in Medical Applications Part 1: Evaluation and Testing During Risk Management 6-Sep YY/T 1780-2021 Medical Personal Protection System 6-Sep YY/T 1781-2021 Test Method for Mechanical Properties of Metal Staples 6-Sep YY/T 1782-2021 Test Method for Mechanical Properties of Orthop
aedic External Fixator 6-Sep YY/T 1785-2021 Amino Acid and Carnitine Detection Kit (Tandem Mass Spectrometry) 6-Sep YY/T 1787-2021 Cardiovascular Implants Heart Valve Repair Devices and Delivery Systems 6-Sep YY/T 1788-2021 Surgical Implants – General Requirements for Patch Products Of Animal Origin 6-Sep YY/T 1789.1-2021 In Vitro Diagnostic Test Systems – Methods for Evaluating Performance – Part 1: Precision 6-Sep YY/T 1790-2021 Fibrin/Fibrinogen Degradation Product Assay Kit (Latex Immunoturbidimetry) 6-Sep YY/T 1792-2021 Fluorescence Immunochromatography Analyzer 6-Sep YY/T 1793-2021 Bacterial Endotoxin Assay Kit 6-Sep YY/T 1795-2021 Sperm Quality Analyzer 6-Sep YY/T 1796-2021 Special Technical Conditions for Medical Dry Film 6-Sep YY/T 1797-2021 Endoscopic Surgical Instruments Laparoscopic Cutting Staplers and Components 6-Sep YY/T 1798-2021 Disposable Intrauterine Compression Balloon 6-Sep YY/T 1800-2021 Deafness Gene Mutation Detection Kit 6-Sep YY/T 1802-2021 Additively Manufactured Medical Products – Evaluation Method for Metal Ion Precipitation Of 3D Printed Titanium Alloy Implants 6-Sep YY/T 1803-2021 Polyvinyl Alcohol Hemostatic Sponge 6-Sep YY/T 1804-2021 Anesthesia And Respiratory Equipment Spirometers for Measuring Human Time Forced Expiratory Volume 6-Sep YY/T 1805.2-2021 Tissue Engineering Medical Device Products Collagen Part 2: Molecular Weight Detection of Type I Collagen-Sodium Lauryl Sulfate Polyacrylamide Gel Electrophoresis 6-Sep YY/T 1806.1-2021 Evaluation Method For In Vitro Degradation Performance of Biomedical Materials-Part 1: Degradable Polyesters 6-Sep YY/T 1806.2-2021 Evaluation Method Of In Vitro Degradation Performance of Biomedical Materials Part 2: Mussel Mucin 6-Sep YY/T 1808-2021 In Vitro Skin Irritation Test for Medical Devices 6-Sep YY/T 1809-2021 Medical Additive Manufacturing Powder Bed Fusion Forming Process Metal Powder Cleaning and Cleaning Effect Verification Method 6-Sep YY 9706.221-2021 Medical Electrical Equipment – Part 2-21: Particular Requirements for Basic Safety and Essential Performance of Radiant Warmers for Infants 6-Sep YY 9706.234-2021 Medical Electrical Equipment – Part 2-34: Particular Requirements for Basic Safety and Essential Performance of Invasive Blood Pressure Monitoring Equipment 6-Sep YY 9706.247-2021 Medical Electrical Equipment Part 2-47: Particular Requirements for Basic Safety and Essential Performance of Holter Monitoring Systems 6-Sep YY 9706.252-2021 Medical Electrical Equipment – Part 2-52: Particular Requirements for Basic Safety and Essential Performance of Medical Beds 6-Sep YY 9706.270-2021 Medical Electrical Equipment Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnea Therapy Equipment 6-Sep YY 9706.272-2021 Medical Electrical Equipment – Part 2-72: Particular Requirements for Basic Safety And Essential Performance of Domestic Ventilators Used By Ventilator-Dependent Patients 6-Sep YY/T 0500-2021 Cardiovascular Implants Vascular Prostheses Tubular Vascular Grafts & Vascular Patches 6-Dec YY/T 0647-2021 Passive Surgical Implants – Specific Requirements for Breast Implants 6-Dec YY/T 0701-2021 Calibrators For Hematology Analyzers 6-Dec YY/T 1160-2021 Carcinoembryonic Antigen (Cea) Assay Kit 6-Dec YY/T 1164-2021 Human Chorionic Gonadotropin (Hcg) Detection Kit (Colloidal Gold Immunochromatography) 6-Dec YY/T 1180-2021 Human Leukocyte Antigen (Hla) Genotyping Kit 6-Dec YY/T 1204-2021 Total Bile Acid Assay Kit (Enzyme Cycle Method) 6-Dec YY/T 1747-2021 Neurovascular Implants Intracranial Arterial Stents 6-Dec YY/T 1784-2021 Blood Gas Analyzer 6-Dec YY/T 1789.2-2021 In-Vitro Diagnostic Test Systems – Performance Evaluation Methods – Part 2: Accuracy 6-Dec YY/T 1791-2021 Hepatitis B Virus E Antibody Detection Kit (Luminescence Immunoassay) 6-Dec YY/T 1801-2021 Fetal Chromosomal Aneuploidy Trisomy 21, Trisomy 18 And Trisomy 13 Detection Kit (High-Throughput Sequencing Method) 6-Dec YY/T 1820-2021 Specific Antinuclear Antibody Igg Detection Kit (Western Blotting) 6-Dec YY/T 1824-2021 Eb Virus Nucleic Acid Detection Kit (Fluorescent Pcr Method) 6-Dec YY/T 1825-2021 Red And White Blood Cell Count Reference Measurement Procedures 6-Dec YY/T 1826-2021 Group B Streptococcus Nucleic Acid Detection Kit (Fluorescent Pcr Method) 6-Dec YY/T 1828-2021 Anti-Mullerian Hormone Assay Kit (Chemiluminescence Immunoassay) 6-Dec YY/T 1831-2021 Treponema Pallidum Antibody Detection Kit (Immunochromatography) 6-Dec YY/T 1836-2021 Respiratory Virus Multiplex Nucleic Acid Detection Kit 6-Dec
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