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Attention! 15 National Standards Coming Soon!

2022-05-16

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

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