Notice! 40 Medical Device Standards Will Be Implemented Soon!
Standards to be implemented in March.
| Serial Number |
Standard Number |
Standard Name |
|
1 |
YY/T 167-2020 | Ultrasound Probe Puncture Holder |
| 2 | GB/T40966-2021 | Requirements for Quality Assessment of New Coronavirus Nucleic Acid Test Kits |
| 3 | GB/T40982-2021 | Requirements for Quality Assessment of New Coronavirus Nucleic Acid Test Kits |
| 4 | GB/T40983-2021 | Requirements for Quality Assessment of New Coronavirus IgG Antibody Test Kits |
| 5 | GB/T40984-2021 | Requirements for Quality Assessment of New Coronavirus IgM Antibody Test Kits |
| 6 | GB/T40999-2021 | Requirements for Quality Assessment of New Coronavirus Antibody Test Kits |
| 7 | YY/T 0629-2021 | Dental Science Central Suction Source Equipment |
| 8 | YY/T 0724-2021 | Special Technical Condition for Dual-energy X-ray Bone Densitometer |
| 9 | YY/T 0742 2021 | Special Specification for Gastrointestinal X-ray Machine |
| 10 | YY/T 0746-2021 | Special Specification for on-board Medical X-ray Diagnostic Equipment |
| 11 | YY/T 1014-2021 | Dentistry Dental Probe |
| 12 | YY/T 1035-2021 | Stethoscope |
| 13 | YY/T 1679-2021 | Tissue Engineering Medical Device Products
Guidelines for Preclinical Evaluation of Critical Size Bone Defects in Vivo |
| 14 | YY/T 1688-2021 | Medical Instruments for Human Assisted Reproductive Technology – Methods for Staining and Counting Blastocyst Cells |
| 15 | YY/T 1728-2021 | Clinical Laboratory Testing and In Vitro Diagnostic System: Reference Methods for In Vitro Activity Detection of Yeast Like Fungi Antimicrobial Agents for Infectious Diseases |
| 16 | YY/T 1735-2021 | Hepatitis C virus Antibody DetectionReagent (kit) (Chemiluminescence Immunoassay |
| 17 | YY/T 1755-2021 | Dentistry Sandblasting Handpieces and Sandblasting Points |
| 18 | YY/T 1756-2021 | Dentistry -Reusable Periodontal Ligament Injection Stand |
| 19 | YY/T 1756-2021 | Dentistry Reusable Periodontal Membrane Injection Frame Ultrasound Power Measurement High Intensity Therapeutic Ultrasound (hitu) Transducers and Systems |
| 20 | YY/T 1771-2021 | Transformation Temperature of Nitinol Shape Memory Alloys Tested by Bending Free Recovery Method |
| 21 | YY/T 1772-2021 | Test Methods for Galvanic Corrosion in Surgical Implants Electrolyte |
| 22 | YY/T 1776-2021 | Determination of Lactide Monomer Content in Polylactic Acid Materials of Surgical Implants |
| 23 | YY/T 1779-2021 | Dentistry – Orthodontic Anchorage Nails |
| 24 | YY/T 1783-2021 | Endoscopic Surgical Instruments – Reusable Abdominal Trocars |
| 25 | YY/T 1794-2021 | General Technical Requirements for Air Collagen Membranes |
| 26 | YY/T 19702-2021 | In Vitro Diagnostic Medical Devices – Measurement of Quantities in Samples of Biological Origin – Requirements for the Presentation and Content of Reference Measurement Procedures |
| 27 | YY/T 0286.5-2021 | Dedicated Infusion Sets – Part V -Single Use Hanging and Bag Infusion Sets |
| 28 | YY/T 0321.2-2021 | Disposable Anesthesia Needles |
| 29 | YY/T 0567.2-2021 | Aseptic Processing of Healthcare Products – Part 2: Bactericidal Filtration |
| 30 | YY/T 0636.2-2021 | Medical Suction Equipment – Part 2: Artificially Driven Suction Equipment |
| 31 | YY/T 0681.4 | Sterile Medical Device Packaging Test Methods – Part 4: Determination of Sealing Leakage from Breathable Packs by Dye Fluid Penetration |
| 32 | YY-T 1416.5-2021 | Method for the Determination of Added Doses in Single Use Human Venous Blood Sample Collection Containers – Part 5: Glycine |
| 33 | YY-T 1416.6-2021 | Method for the Determination of Added Doses in Single Use Human Venous Blood Sample Collection Containers – Part 6: Imidazolium Alkyl |
| 34 | YY-T 1465.7-2021 | Methods for Immunogenicity Evaluation of Medical Devices – Part 7: Flow Cytometric Multiplex Protein Quantification |
| 35 | YY-T 1766.1-2021 | Image Quality Evaluation Methods for X-ray Computed Tomography Equipment – Part 1: Modulation Transfer Function Evaluation |
| 36 | YY-T 1766.2-2021 | Methods for Evaluating Image Quality of X-ray Computed Tomography Equipment – Part 2: Evaluation of Low Contrast Resolution |
| 37 | YY-T 1768.1-2021 | Needle Injection Systems for Medical Use – Requirements and Experimental Methods – Part 1: Needles Injection System |
| 38 | YY-T 1768.2-2021 | Needle Injection Systems for Medical Use – Requirements and Test Methods: Needles |
| 39 | YY-T 17701 2021 | Medical Device Thrombosis Testing – Part 1: In Vivo Thrombosis Testing in Dogs |
|
40 |
YY-T 1775.1-2021 |
Biological Evaluation of Absorbable Medical Devices – Part 1: Guidelines for Absorbable Implants |
