Attention! 15 National Standards Coming Soon!
Standards to be implemented in June, 15 items:
| Serial Number |
Standard Number |
Standard Name |
| 1 | YY0899-2020 | General Requirements for Accessories of Medical Microwave Equipment |
| 2 | YY/T 1711-2020 | Gating Interfaces For Radiotherapy |
| 3 | YY/T 1713-2020 | Colloidal Gold Immunochromatographic Assay Kit |
| 4 | YY 1727-2020 | Human Immunodeficiency Virus Antibody Assay Kit from Exudate of Oral( MucosaColloidal Gold Immunochromatography) |
| 5 | 5YY/T 1733-2020 | Guidelines for Dose Distribution Testing of Irradiated Devices for Radiation Sterilization of Medical Devices |
| 6 | YY 0341.1-2020 | Passive Surgical Implants Osteosynthesis and Spinal Implants Part 1: Special Requirements for Osteosynthesis Implants |
| 7 | YY 0341.2-2020 | Passive Surgical Implants Osteosynthesis and Spinal Implants Part 2:Special Requirements for Spinal Implants |
| 8 | GB 8369.2-2020 | Single Use Blood Transfusion Devices Part 2: Pressure Transfusion |
| 9 | GB/T 22576.2 2021 | Requirements for Quality and Competence in Medical Laboratories Part 2: Requirements in the Field of Clinical Hematology Testing |
| 10 | GB / T 22576.3-2021 | Requirements for Quality and Competence in Medical Laboratories Part 3: Requirements in the Field of Urine Tests |
| 11 | GB / T 22576.4 -2021 | Requirements for Quality and Competence in Medical Laboratories Part 4: Requirements for Competency in Clinical Chemistry Testing |
| 12 | GB/T 22576.5-2021 | Requirements for Quality and Competence in Medical Laboratories Part 5: Requirements in the Field of Clinical Immunology Testing |
| 13 | GB/T 22576.6-2021 | Requirements for Quality and Competence in Medical Laboratories Part 6: Requirements in the Field of Clinical Microbiology Testing |
| 14 | GB/T 22576.7-2021
|
Requirements for Quality and Competence in Medical Laboratories Part 7: Requirements in the Field of Transfusion Medicine |
| 15 | GB/T 39367.1-2020 | Qualitative in Vitro Testing of Nucleic Acids for Identification Procedures Part 1: General Requirements, Terminology and Definitions |
BradyKnows provides turn-key solutions to help overseas manufacturers facing the regulatory challenges in China. Pls contact us for any questions via info@bradyknowsmedical.com