The NMPA released the Medical Devices Standards Annual Report on February 18, 2022. In the year of 2021, 35 national standards and 146 industry standards for medical devices were published.
Among the national standards are 18 electrical equipment standards related to GB 9706.1, six clinical laboratory quality and capability standards and two biological evaluation standards.
By indications, laboratory equipment, imaging, orthopedic surgery, microsurgery, and dental equipment are among the most standards.
International harmonization also achieves the success. Two international standards are published:
- Medical Devices Related to COVID-19 Prevention and Control ISO 80601-2-90:2021
- Cardiovascular Implants – Cardiac Occluders ISO 22679-2021
Five international standards are proposed:
- Energy spectral imaging performance evaluation method of computed tomography equipment
- Surgical instruments – Staplers – Part 1: Terms and Definitions
- Surgical instruments – Staplers – Part 2: General requirements
- Standard for the quantitative determination of collagen characteristic peptides
- Standard for quantitative determination of residual DNA in acellular matrix scaffolds
National Standards 2021
| Number | Title | Issue Date |
| GB9706.202-2021 | Medical Electrical Equipment Part 2-2: Particular Requirements for Basic Safety and Basic Performance of High-Frequency Surgical Equipment and High-Frequency Accessories | 1-Jan |
| GB9706.208-2021 | Medical Electrical Equipment Part 2-8: Particular Requirements for Basic Safety and Essential Performance of Therapeutic X-Ray Equipment with an Energy of 10Kv to 1Mv | 10-Aug |
| GB9706.213-2021 | Medical Electrical Equipment Part 2-13: Particular Requirements for Basic Safety and Essential Performance of Anesthesia Workstations | 1-Dec |
| GB9706.216-2021 | Medical Electrical Equipment Part 2-16: Particular Requirements for Basic Safety and Essential Performance of Hemodialysis, Hemodiafiltration and Hemofiltration Equipment | 10-Aug |
| GB9706.218-2021 | Medical Electrical Equipment Part 2-18: Particular Requirements for Basic Safety and Essential Performance of Endoscopic Equipment | 1-Dec |
| GB9706.219-2021 | Medical Electrical Equipment Part 2-19: Particular Requirements for Basic Safety and Essential Performance of Infant Incubators | 11-Oct |
| GB9706.224-2021 | Medical Electrical Equipment Part 2-24: Particular Requirements for Basic Safety and Essential Performance of Infusion Pumps and Infusion Controllers | 1-Dec |
| GB9706.225-2021 | Medical Electrical Equipment Part 2-25: Particular Requirements for Basic Safety and Essential Performance of Electrocardiographs | 1-Dec |
| GB9706.226-2021 | Medical Electrical Equipment Part 2-26: Particular Requirements for Basic Safety and Essential Performance of Electroencephalography Machines | 11-Oct |
| GB9706.227-2021 | Medical Electrical Equipment Part 2-27: Particular Requirements for Basic Safety and Essential Performance of Cardiac Monitoring Equipment | 11-Oct |
| GB9706.229-2021 | Medical Electrical Equipment Part 2-29: Particular Requirements for Basic Safety and Essential Performance of Radiotherapy Simulators | 10-Aug |
| GB9706.236-2021 | Medical Electrical Equipment Part 2-36: Particular Requirements for Basic Safety and Essential Performance of In Vitro Lithotripsy Devices | 1-Dec |
| GB9706.239-2021 | Medical Electrical Equipment Part 2-39: Particular Requirements for Basic Safety and Essential Performance of Peritoneal Dialysis Equipment | 10-Aug |
| GB9706.243-2021 | Medical Electrical Equipment Part 2-43: Particular Requirements for Basic Safety and Essential Performance of Interventional X-Ray Equipment | 20-Feb |
| GB9706.265-2021 | Medical Electrical Equipment Part 2-65: Particular Requirements for Basic Safety and Essential Performance of Dental X-Ray Machines for Intraoral Imaging | 20-Feb |
| GB/T16886.16-2021 | Biological Evaluation of Medical Devices Part 16: Design of A Toxokinetic Study of Degradation Products and Leachables | 26-Nov |
| GB/T16886.11-2021 | Biological Evaluation of Medical Devices Part 11: Systemic Toxicity Testing | 26-Nov |
| GB/T19634-2021 | In Vitro Diagnostic Testing System – General Technical Requirements for Blood Glucose Monitoring Systems for Self-Testing | 11-Oct |
| GB/T19702-2021 | In Vitro Diagnostic Medical Devices – Measurement of Quantities in Samples of Biological Origin – Requirements for The Presentation and Content of Reference Measurement Procedures | 9-Mar |
| GB/T22576.2-2021 | Medical Laboratory Quality and Competence Requirements Part 2: Requirements in Field of Clinical Hematology Testing | 21-May |
| GB/T22576.3-2021 | Medical Laboratories Requirements for Quality and Competence Part 3: Requirements in the Field of Urine Testing | 21-May |
| GB/T22576.4-2021 | Requirements for Quality and Competence of Medical Laboratories Part 4: Requirements in Field of Clinical Chemistry Testing | 21-May |
| GB/T22576.5-2021 | Medical Laboratories Requirements for Quality and Competence Part 5: Requirements in Field of Clinical Immunology Testing | 21-May |
| GB/T22576.6-2021 | Requirements for Quality and Competence of Medical Laboratories Part 6: Requirements in field of Clinical Microbiology Testing | 21-May |
| GB/T22576.7-2021 | Medical Laboratories Requirements for Quality and Competence Part 7: Requirements in Field of Transfusion Medicine | 21-May |
| GB/T25440.1-2021 | Removal and Analysis of Surgical Implants Part 1: Removal and Handling | 26-Nov |
| GB/T25440.2-2021 | Removal and Analysis of Surgical Implants Part 2: Analysis of Removal of Surgical Implants | 26-Nov |
| GB/T40672-2021 | Clinical Laboratory Testing Antimicrobial Susceptibility Test Dehydrated Mh Agar and Broth Acceptable Lot Criteria | 11-Oct |
| GB/T40983-2021 | Requirements For Quality Evaluation of Novel Coronavirus Igg Antibody Detection Kits | 26-Nov |
| GB/T40982-2021 | Requirements for Quality Evaluation of Novel Coronavirus Nucleic Acid Detection Kits | 26-Nov |
| GB/T40966-2021 | Requirements for Quality Evaluation of Novel Coronavirus Antigen Detection Kits | 26-Nov |
| GB/T40984-2021 | Requirements for Quality Evaluation of Novel Coronavirus Igm Antibody Detection Kits | 26-Nov |
| GB/T40999-2021 | Requirements for Quality Evaluation of Novel Coronavirus Antibody Detection Kits | 26-Nov |
| GB11236-2021 | Copper-Containing Intrauterine Device Technical Requirements and Test Methods | 1-Dec |
| GB14232.4-2021 | Bag-Type Plastic Containers for Human Blood and Blood Components – Part 4: Apheresis Bag Systems with Special Components | 1-Dec |
Industry Standards 2021
| Number | Title | Issue 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 Orthopaedic 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 |
For the English version of the six Safety Standards for Medical Electrical Equipment, please email us at info@ChinaMedDevice.com. We charge nominal fees for the translation.