| 1 | Accuracy requirements and test methods for electron beam dose calculation of radiotherapy planning software | recommended | formulate | / | / | National Medical Electrical Appliances Standardization Technical Committee Radiation Therapy Nuclear Medicine and Radiation Dosimetry Equipment Subcommittee | |
| 2 | Test method for total leakage rate of medical protective masks | recommended | revise | YY/T 0866-2011 | / | National Medical Protective Equipment Standardization Working Group | |
| 3 | Medical clean bench | recommended | revise | YY/T 1539-2017 | / | National Measurement, Control and Laboratory Electrical Equipment Safety Standardization Technical Committee Medical Equipment Sub-Technical Committee | |
| 4 | Survival Motor Neuron (SMN) Detection Kit | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 5 | Colorectal cancer-related gene methylation detection kit (fluorescent PCR method) | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 6 | flow matrix | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 7 | Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence immunoassay) | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 8 | Tacrolimus Assay Kit | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 9 | 25-Hydroxyvitamin D Assay Kit | recommended | revise | YY/T 1585-2017 | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 10 | Columbia blood agar basal medium | recommended | revise | YY/T 0576-2005 | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 11 | ELISA | recommended | revise | YY/T1529-2017 | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 12 | ELISA Detection Kit | recommended | revise | YY/T 1183-2010 | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 13 | Performance evaluation of pathogen susceptibility testing and antimicrobial susceptibility testing equipment for clinical laboratory testing and in vitro diagnostic systems for infection Part 2: Performance evaluation of antimicrobial susceptibility testing equipment compared to broth microdilution reference methods | recommended | revise | YY/T 0688.2-2010 | ISO 20776-2-2021 | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 14 | Cardiac troponin assay kit (labeled immunoassay) | recommended | revise | YY/T 1233-2014 | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 15 | Aldosterone Assay Kit (Chemiluminescent Immunoassay ) | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | |
| 16 | Technical requirements and test methods for female condoms | recommended | revise | YY/T 1567-2017 | ISO 25841:2017+AMD1:2020 | National Technical Committee on Family Planning Devices of Standardization Administration of China | |
| 17 | Dimensions and test requirements for four-pole connector system for active implantable medical devices and implantable cardiac rhythm control devices | recommended | revise | YY/T 0972-2016 | ISO 27186:2020 | Active Implant Subcommittee of the National Standardization Technical Committee on Surgical Implants and Orthopedic Devices | |
| 18 | Suction catheter for airway | recommended | revise | YY/T 0339-2019 | ISO 8836:2019 | National Standardization Technical Committee of Anesthesia and Respiratory Equipment | |
| 19 | Passive Humidifiers for Anesthesia and Respiratory Equipment | recommended | revise | YY/T 1610-2018 | ISO 20789:2018 | National Standardization Technical Committee of Anesthesia and Respiratory Equipment | |
| 20 | Portable Electric Infusion Pump | recommended | revise | YY/T 1469-2016 | / | National Medical Electrical Appliances Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee | |
| twenty one | Sterile single-use syringes – Part 2: Syringes for power-actuated syringe pumps | recommended | revise | YY/T 0573.2-2018 | ISO 7886-2:2020 | National Medical Syringe (Needle) Standardization Technical Committee | |
| twenty two | Single-use sterile syringes part 3: self-destructing fixed-dose vaccine syringes | recommended | revise | YY/T 0573.3-2019 | ISO 7886-3:2020 | National Medical Syringe (Needle) Standardization Technical Committee | |
| twenty three | Sterile hypodermic syringes for single use Part 4: Preventing re-use of syringes | recommended | revise | YY/T 0573.4-2020 | ISO 7886-4:2018 | National Medical Syringe (Needle) Standardization Technical Committee | |
| twenty four | Cardiac radiofrequency ablation therapy equipment | recommended | revise | YY/T 0860-2011 | / | National Medical Electrical Appliances Standardization Technical Committee Physical Therapy Equipment Sub-Technical Committee | |
| 25 | Passive Surgical Implant Type I Collagen Implant | recommended | revise | YY/T 0954-2015 | / | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | |
| 26 | In Vitro Degradation Test of Polylactide Homopolymers, Copolymers and Blends for Surgical Implants | recommended | revise | YY/T 0474-2004, YY/T 0473-2004 | ISO 13781:2017 | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | |
| 27 | Specific requirements for artificial ligaments of implanted devices in sports medicine | recommended | revise | YY/T 0965-2014 | / | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | |
| 28 | Self-closing intracranial aneurysm clips with implanted neurosurgery devices | recommended | revise | YY/T 0685-2008 | ISO 9713-2022 | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | |
| 29 | Test method for morphology characteristics of porous structure of surgical implants | recommended | formulate | / | / | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | |
| 30 | Wear of implanted total hip prostheses for joint replacement Part 4: Testing of hip prostheses under edge-loaded conditions due to component placement | recommended | formulate | / | ISO 14242-4:2018 | Orthopedic Implant Subcommittee of the National Standardization Technical Committee on Surgical Implants and Orthopedic Devices | |
| 31 | Traditional Chinese medicine scraping equipment | recommended | formulate | / | ISO 20308:2017 | Standardization Technical Unit of Traditional Chinese Medicine Devices | |
| 32 | Tongue image information collection equipment for traditional Chinese medicine equipment | recommended | revise | YY/T 1488-2016 | / | Standardization Technical Unit of Traditional Chinese Medicine Devices | |
| 33 | Chinese medicine equipment glass cupping device | recommended | formulate | / | ISO 22213:2020 | Standardization Technical Unit of Traditional Chinese Medicine Devices | |
| 34 | Medical image display system for medical electrical equipment Part 2: Acceptance and stability test of medical image display system | recommended | formulate | / | IEC 62563-2:2021 | Medical X-ray Equipment and Appliances Subcommittee of National Standardization Technical Committee of Medical Electrical Appliances | |
| 35 | General technical requirements for X-ray computed tomography equipment | recommended | revise | YY/T 0310-2015 | / | Medical X-ray Equipment and Appliances Subcommittee of National Standardization Technical Committee of Medical Electrical Appliances | |
| 36 | Requirements and measurement methods for the sound field of ultrasonic physiotherapy equipment in the frequency range of 0.5MHz to 5MHz | recommended | revise | YY/T 0750-2018 | IEC 61689:2022 | Medical Ultrasound Equipment Subcommittee of National Medical Electrical Appliances Standardization Technical Committee | |
| 37 | Medical Ultrasonic Nebulizer | recommended | revise | YY/T 0109-2013 | / | Medical Ultrasound Equipment Subcommittee of National Medical Electrical Appliances Standardization Technical Committee | |
| 38 | Disposable sterile nerve catheters and accessories | recommended | formulate | / | ISO 20698:2018 | National Medical Syringe (Needle) Standardization Technical Committee | |
| 39 | Infusion Connectors Part 2: Needleless Connectors | recommended | revise | YY/T 0581.2-2011 | / | National Standardization Technical Committee of Medical Infusion Sets | |
| 40 | Test method for microbial intrusion of connectors for fluid and blood circuits | recommended | revise | YY/T 0923-2014 | / | National Standardization Technical Committee of Medical Infusion Sets | |
| 41 | Guidelines for Compatibility Study of Disposable Infusion Sets and Drugs Part 3: Unknowns for Leachables Study | recommended | formulate | / | / | National Standardization Technical Committee of Medical Infusion Sets | |
| 42 | Bacterial endotoxin test method for medical devices Recombinant C factor method | recommended | formulate | / | / | National Medical Device Biological Evaluation Standardization Technical Committee | |
| 43 | Genotoxicity Tests for Medical Devices Part 8: In Vivo Mammalian Hepatocyte Unscheduled DNA Synthesis Test | recommended | formulate | / | / | National Medical Device Biological Evaluation Standardization Technical Committee | |
| 44 | Preclinical Animal Studies of Medical Devices Part 4: Acute Wound Models for the Evaluation of Dressings for Healing | recommended | formulate | / | / | National Medical Device Biological Evaluation Standardization Technical Committee | |
| 45 | Reconstituted Collagen Dressing | recommended | formulate | / | / | National Medical Protective Equipment Standardization Working Group | |
| 46 | α-cyanoacrylate medical adhesive | recommended | formulate | / | / | National Medical Protective Equipment Standardization Working Group | |
| 47 | plaster bandage | recommended | revise | YY/T 1117-2001, YY/T 1118-2001 | / | National Medical Protective Equipment Standardization Working Group | |
| 48 | Ophthalmic Instruments Corneal Topographer | recommended | revise | YY/T 0787-2010 | ISO 19980:2021 | National Medical Optics and Instrument Standardization Sub-Technical Committee | |
| 49 | Dental Contra Angle Filler | recommended | formulate | / | ISO 19715:2017 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | |
| 50 | Dental Trephine | recommended | formulate | / | ISO 20569:2018 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | |
| 51 | Dentistry Oral Surgery Knife Handles | recommended | formulate | / | ISO 20570:2018 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | |
| 52 | Materials for dental instruments in dentistry – Part 1: Stainless steel | recommended | formulate | / | ISO 21850-1:2020 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | |
| 53 | Dental multi-function spray gun | recommended | formulate | / | ISO 22569:2020 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | |
| 54 | Portable dental equipment for use in non-permanent medical settings in dentistry – Part 1: General requirements | recommended | formulate | / | ISO 23402-1:2020 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | |
| 55 | Peritoneal Dialysis Equipment | recommended | revise | YY/T 1274-2016, YY/T 1493-2016 | / | National Standardization Technical Committee of Medical Extracorporeal Circulation Equipment | |
| 56 | Handling of Medical Devices Information from Medical Device Manufacturers Part 1: Medium to High Risk Medical Devices | recommended | revise | YY/T 0802-2020 | ISO 17664.1:2021 | National Standardization Technical Committee on Disinfection Technology and Equipment | |
| 57 | Handling of Medical Devices Information from Medical Device Manufacturers Part 2: Low Risk Medical Devices | recommended | revise | YY/T 0802-2020 | ISO 17664.2:2021 | National Standardization Technical Committee on Disinfection Technology and Equipment | |
| 58 | Steam formaldehyde sterilizer | recommended | revise | YY/T 0679-2016 | / | National Standardization Technical Committee on Disinfection Technology and Equipment | |
| 59 | Dentistry Magnetic Attachments | recommended | revise | YY/T 1637-2018 | ISO 13017:2020 | National Standardization Technical Committee of Dental Materials and Devices | |
| 60 | Dynamic fatigue test of zirconia dental implants in dentistry | recommended | formulate | / | / | National Standardization Technical Committee of Dental Materials and Devices | |
| 61 | Test methods for corrosion of metallic materials in dentistry | recommended | revise | YY/T 0528-2018 | ISO 10271:2020 | National Standardization Technical Committee of Dental Materials and Devices | |
| 62 | In vitro degradation test method for degradable magnesium-based metal implants | recommended | formulate | / | / | National Standardization Technical Committee of Dental Materials and Devices | |
| 63 | Dental orthodontic brackets and buccal tubes | recommended | revise | YY/T 0915-2015 | ISO 27020:2019 | National Standardization Technical Committee of Dental Materials and Devices | |
| 64 | Information provided by medical device manufacturers | recommended | formulate | / | ISO 20417:2021 | National Medical Device Quality Management and General Requirements Standardization Technical Committee | |
| 65 | Quality and Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents | recommended | formulate | / | / | National medical device clinical evaluation standardization technical unit | |
| 66 | Quality and Technical Specifications for Clinical Trials of Medical Devices | recommended | formulate | / | / | National medical device clinical evaluation standardization technical unit | |
| 67 | Packaging Implementation and Application of Unique Identification for Medical Devices | recommended | formulate | / | / | Device Standardization Center | |
| 68 | The form and content of the unique identification of medical devices | recommended | formulate | / | / | Device Standardization Center | |
| 69 | Tissue engineering medical device product peripheral nerve implant repair and regeneration performance evaluation test method | recommended | formulate | / | / | National Surgical Implants and Orthopedic Devices Standardization Technical Committee Organization Engineering Medical Device Products Sub-Technical Committee | |
| 70 | General requirements for quality evaluation and quality control of acellular matrix materials for tissue engineering medical devices | recommended | formulate | / | / | National Surgical Implants and Orthopedic Devices Standardization Technical Committee Organization Engineering Medical Device Products Sub-Technical Committee | |
| 71 | Residual detection of chemical reagents in biological source materials of tissue engineering medical device products Sodium dodecyl sulfate | recommended | formulate | / | / | National Surgical Implants and Orthopedic Devices Standardization Technical Committee Organization Engineering Medical Device Products Sub-Technical Committee | |
| 72 | Detection of Residual α-Gal Antigen in Animal-derived Scaffold Materials of Tissue Engineering Medical Devices | recommended | revise | YY/T 1561-2017 | / | National Surgical Implants and Orthopedic Devices Standardization Technical Committee Organization Engineering Medical Device Products Sub-Technical Committee | |
| 73 | Antibacterial performance test for biological evaluation of nanomedical devices | recommended | formulate | / | / | National Medical Device Biological Evaluation Standardization Technical Committee Nano Medical Device Biological Evaluation Sub-Technical Committee | |
| 74 | Human sperm survival test for medical devices used in human assisted reproductive technology | recommended | revise | YY/T 1535-2017 | / | Standardization technology unit for medical devices used in human assisted reproductive technology | |
| 75 | Special requirements for artificial intelligence medical device datasets: fundus color photos of diabetic retinopathy | recommended | formulate | / | / | Artificial intelligence medical device standardization technical unit | |
| 76 | Terms, definitions, classifications for medical electrical equipment using robotics | recommended | revise | YY/T 1686-2020 | / | Medical Robot Standardization Technology Coordinator Unit | |
| 77 | Laparoscopic Surgical System Using Robotics | recommended | formulate | / | / | Medical Robot Standardization Technology Coordinator Unit | |
| 78 | Medical lower extremity exoskeleton robot | recommended | formulate | / | / | Medical Robot Standardization Technology Coordinator Unit | |
| 79 | Tumor tissue gene mutation detection kit (high-throughput sequencing method) | recommended | formulate | / | / | Medical high-throughput sequencing standardization technology centralized unit | |
| 80 | Preimplantation Chromosomal Aneuploidy Analysis Software | recommended | formulate | / | / | Medical high-throughput sequencing standardization technology centralized unit | |
| 81 | Disposable sterile incision protector | recommended | formulate | / | / | National Standardization Technical Committee of Surgical Instruments | Enterprise-led standard projects |
| 82 | Materials for Surgical Instruments Part 1 Metallic Materials | recommended | revise | YY/T 0294.1-2016 | ISO 7153-1:2016 | National Standardization Technical Committee of Surgical Instruments | Enterprise-led standard projects |
| 83 | Medical Nitinol Powders for Additive Manufacturing | recommended | formulate | / | / | Medical Additive Manufacturing Technology Medical Device Standardization Technology Coordinator | Enterprise-led standard projects |
| 84 | Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 5: Pre-trained Model | recommended | formulate | / | / | Artificial intelligence medical device standardization technical unit | Enterprise-led standard projects |
| 85 | blood thawing equipment | recommended | formulate | / | / | National Measurement, Control and Laboratory Electrical Equipment Safety Standardization Technical Committee Medical Equipment Sub-Technical Committee | Enterprise-led standard projects |
| 86 | 17α-Hydroxyprogesterone Assay Kit ( Labeled Immunoassay) | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | Enterprise-led standard projects |
| 87 | Microalbumin assay kit (immunoturbidimetric method) | recommended | formulate | / | / | National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee | Enterprise-led standard projects |
| 88 | Anesthesia and Respiratory Equipment Peak Expiratory Flow Meter for Evaluation of Pulmonary Function in Spontaneously Breathing Persons | recommended | revise | YY/T 1438-2016 | ISO 23747:2015 | National Standardization Technical Committee of Anesthesia and Respiratory Equipment | Enterprise-led standard projects |
| 89 | EEG electrodes | recommended | formulate | / | / | National Medical Electrical Appliances Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee | Enterprise-led standard projects |
| 90 | Disposable sterile insulin syringe | recommended | revise | YY/T 0497-2018 | ISO 8537:2016 | National Medical Syringe (Needle) Standardization Technical Committee | Enterprise-led standard projects |
| 91 | Far Infrared Magnetic Therapy Sticker (Bag) | recommended | formulate | / | / | National Medical Electrical Appliances Standardization Technical Committee Physical Therapy Equipment Sub-Technical Committee | Enterprise-led standard projects |
| 92 | Orthopedic drills – Part 1: Drills, taps and countersinks | recommended | revise | YY/T 0958.1-2014 | ISO 9714-1:2012 | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | Enterprise-led standard projects |
| 93 | Sports Medicine Implantable Device Meniscus Suture System | recommended | formulate | / | / | National Technical Committee on Surgical Implants and Orthopedic Devices of Standardization Administration of China | Enterprise-led standard projects |
| 94 | Special technical requirements for intraoral digital X-ray imaging system | recommended | formulate | / | / | Medical X-ray Equipment and Appliances Subcommittee of National Standardization Technical Committee of Medical Electrical Appliances | Enterprise-led standard projects |
| 95 | Special technical conditions for medical X-ray high voltage generator | recommended | formulate | / | / | Medical X-ray Equipment and Appliances Subcommittee of National Standardization Technical Committee of Medical Electrical Appliances | Enterprise-led standard projects |
| 96 | Ophthalmology Type A Ultrasonic Measuring Instrument | recommended | revise | YY/T 0107-2015 | / | Medical Ultrasound Equipment Subcommittee of National Medical Electrical Appliances Standardization Technical Committee | Enterprise-led standard projects |
| 97 | Contact Wound Dressings Part 7: Carboxymethylcellulose Dressings | recommended | formulate | / | / | National Medical Protective Equipment Standardization Working Group | Enterprise-led standard projects |
| 98 | Medical Sodium Hyaluronate Dressing | recommended | formulate | / | / | National Medical Protective Equipment Standardization Working Group | Enterprise-led standard projects |
| 99 | Ophthalmic Instruments Projection and Electronic Eye Charts for Measuring Visual Acuity | recommended | revise | YY/T 0764-2009 | ISO 10938:2016 | National Medical Optics and Instrument Standardization Sub-Technical Committee | Enterprise-led standard projects |
| 100 | Dentistry Dental Forceps | recommended | revise | YY/T 1284.1-2015, YY/T 1284.2-2015, YY/T 1284.3-2015 | ISO 15098:2020 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | Enterprise-led standard projects |
| 101 | Dental Soft Tissue Circumcision Knife | recommended | formulate | / | ISO 23445:2021 | National Dental Materials and Devices Standardization Technical Committee Dental Equipment and Devices Sub-Technical Committee | Enterprise-led standard projects |
| 102 | Negative Pressure Washer Disinfector | recommended | formulate | / | / | National Standardization Technical Committee on Disinfection Technology and Equipment | Enterprise-led standard projects |
