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Std ID |
Description (Standard Title) |
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YY/T 1960-2025
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Medical devices - Information to be supplied by the manufacturer
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YY/T 0870.8-2024
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Test for genotoxicity of medical devices - Part 8: Unscheduled DNA synthesis test with mammalian liver cells in vivo
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YY/T 0916.7-2024
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Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
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YY/T 1535-2024
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Medical devices for human assisted reproductive technology - Human sperm viability assay(HSVA)
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YY/T 1754.4-2024
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Preclinical animal study of medical devices - Part 4: Acute trauma model for evaluating the healing promoting performance of dressing
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YY/T 1939-2024
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Test for bacterial endotoxins of medical devices - Recombinant factor C method
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YY/T 1942-2024
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Form and content of the unique device identifier
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YY/T 1943-2024
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UDI implementation and application in medical device package levels
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YY/T 1686-2024
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Medical electrical equipment employing robotic technology - Terminology, definitions and classification
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YY/T 1833.5-2024
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Artificial intelligence medical device - Quality requirements and evaluation - Part 5: Pre-trained models
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YY/T 1930-2024
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Medical device clinical evaluation - Terms and definitions
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YY/T 1940-2024
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Medical nickel titanium powders for additive manufacturing
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YY/T 1949-2024
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Artificial intelligence medical device - Specific requirement for datasets: color fundus images of diabetic retinopathy
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YY/T 1950-2024
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Tissue engineering medical device - Silk fibroin
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YY/T 0870.7-2023
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Technical specifications for pollution control of deactivated denitration catalyst regeneration
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YY/T 1473-2023
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Aqueous Urea Solution Dispensers
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YY/T 1789.6-2023
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(In vitro diagnostic test systems - Performance evaluation methods - Part 6: Precision, diagnostic sensitivity and specificity of qualitative reagents)
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YY/T 1842.7-2023
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Testing Specification for Vapor Recovery Systems of Gasoline Dispensing Facilities
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YY/T 1888-2023
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Calibration Specification for Half-value Layer Meters of(20~150)kV X-ray beam
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YY 9706.278-2023
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Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
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YY/T 0688.1-2023
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Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobi
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YY/T 1789.5-2023
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In vitro diagnostic test systems - Performance evaluation method - Part 5: Analytical specificity
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YY/T 1437-2023
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Medical devices - Guidance on the application of GB/T 42062
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YY/T 1754.3-2023
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Preclinical animal study of medical devices - Part 3: Animal ventral incisional hernia model for evaluating the histological reaction and biomechanical performance of the hernia repair patch
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YY/T 1897-2023
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Biological evaluation of nanomedical devices Genotoxicity test In vitro mammalian cell micronucleus test
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YY/T 1899-2023
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Method of tissue histological sample preparation and evaluation for absorbable medical devices after implantation
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YY/T 0841-2023
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Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
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YY/T 1833.4-2023
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Artificial intelligence medical device - Quality requirements and evaluation - Part 4: Traceability
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YY/T 1907-2023
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Artificial intelligence medical device - Coronary CT image processing software - Algorithm performance test methods
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YY/T 1909-2023
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Additive manufacturing for medical applications - Requirements for control and validation of metal powder-bed electron beam fusion process
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YY/T 1910-2023
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Medical-grade beta-tricalcium phosphate powder for additive manufacturing
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YY/T 1911-2023
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Test method of coagulation for medical devices
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YY/T 1912-2023
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Biological evaluation and testing of medical devices for soft tissue regeneration
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YY/T 1914-2023
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Medical devices for human assisted reproductive technology - General requirements of apparatus products
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YY/T 1915-2023
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General requirements for laboratory testing of immunochromatographic kits
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YY/T 1928-2023
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Terminology and classification of medical electrical equipment intended for use in the magnetic resonance environment
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YY/T 1805.3-2022
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Tissue engineering medical device products - Collagen protein - Part 3: Quantification of collagen based on marker peptide detection - Liquid chromatography-mass spectrometry
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YY/T 1849-2022
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Recombinant collagen protein
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YY/T 0916.3-2022
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Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
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YY/T 0916.6-2022
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Small-bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
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YY/T 1812-2022
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Characterization of physical and chemical properties of degradable biomedical metallic materials
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YY/T 1813-2022
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Methods for operational reliability information collection and evaluation of medical electrical equipment
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YY/T 1815-2022
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Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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YY/T 1837-2022
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Medical electrical equipment - General requirements for reliability
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YY/T 1838-2022
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Disposable capillary blood collection device
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YY/T 1842.1-2022
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Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods
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YY/T 1842.8-2022
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Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 8: Citrate-based anticoagulant solution for apheresis applications
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YY/T 1843-2022
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Basic requirements of cybersecurity for medical electrical equipment
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YY/T 1789.3-2022
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(In-vitro diagnostic test systems - Methods for evaluating performance - Part 3: Limits of detection and limits of quantification)
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YY/T 1789.4-2022
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(In vitro diagnostic test systems - Performance evaluation methods - Part 4: Linear interval and reportable interval)
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YY/T 1833.1-2022
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Artificial intelligence medical device - Quality requirements and evaluation - Part 1: Terminology
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YY/T 1833.2-2022
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Artificial intelligence medical device - Quality requirements and evaluation - Part 2: General requirements for datasets
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YY/T 1833.3-2022
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Artificial intelligence medical device - Quality requirements and evaluation - Part 3: General requirement for data annotation
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YY/T 1842.6-2022
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Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications
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YY/T 1879-2022
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Creation and placement of unique device identifier
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YY 9706.108-2021
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Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
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YY 9706.111-2021
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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 used in the home healthcare environment
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YY 9706.112-2021
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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 the emergency medical service
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YY/T 1465.7-2021
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Immunogenic evaluation method of medical devices - Part 7: Liquid phase multiplex protein quantification technique by flow cytometry
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YY/T 1770.1-2021
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Test method for thrombogenicity study - Part 1: Thrombogenicity study in dogs in vivo
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YY/T 1775.1-2021
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Biological evaluation of absorbable medical devices - Part 1: Guidance for absorbable implants
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YY/T 9706.106-2021
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
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YY/T 9706.110-2021
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Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
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YY 9706.102-2021
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
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YY/T 1688-2021
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Medical devices for human assisted reproductive technology - A method for blastocyst cell staining and counting
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YY/T 0916.1-2021
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(Small-aperture connectors for medical drugs and gases - Part 1: General requirements)
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YY/T 1764-2021
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(Test method of axial, bending and torsion durability of blood vessel stent in vitro)
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YY/T 1789.1-2021
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(Accurate inspection and diagnosis system performance evaluation method - Part 1: Precision)
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YY/T 1805.2-2021
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(Tissue engineering medical device products Collagen - Part 2: Detection of molecular weight of type I collagen Sodium lauryl sulfate polyacrylamide gel electrophoresis)
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YY/T 1806.1-2021
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(Evaluation method for in vitro degradation performance of biomedical materials - Part 1: Degradable polyesters)
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YY/T 1806.2-2021
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(Evaluation method of in vitro degradation performance of biomedical materials - Part 2: Mussel mucin)
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YY/T 1808-2021
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(In vitro skin irritation test for medical devices)
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YY/T 1809-2021
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(Medical additive manufacturing powder bed molding metal powder molding and effect verification)
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YY/T 1789.2-2021
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In vitro diagnostic test systems - Performance evaluation method - Part 2: Trueness
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YY/T 0771.2-2020
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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YY/T 1686-2020
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Medical electrical equipment employing robotic technology - Classification
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YY/T 1695-2020
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Medical devices for human assisted reproductive technology--Determination of amino acids in human assisted reproductive media
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YY/T 1718-2020
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Medical devices for human assisted reproductive technology in vitro--Embryo transfer catheters
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YY/T 0595-2020
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Medical devices - Quality management systems - Guidance on the application of YY/T 0287-2017
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YY/T 0771.1-2020
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
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YY 1727-2020
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Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)
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YY/T 1698-2020
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(Medical devices for assisted reproductive technology in vitro for humans)
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YY/T 1701-2020
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Medical grade Ti-6Al-4V/Ti-6Al-4V ELI powder used for additive manufacturing
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YY/T 1723-2020
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(High-throughput gene sequencer)
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YY/T 1725-2020
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Multiplex nucleic acid detection kit for infection of microorganisms
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YY/T 1752-2020
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Basic Data Set of Unique Device Identification Database
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YY/T 1753-2020
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Reporting Guide of Unique Device Identification Database
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YY/T 0616.7-2020
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Medical gloves for single use - Part 7: Test method for the immunological measurement of antigenic protein
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YY/T 0664-2020
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Medical device software - Software life cycle processes
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YY/T 1738-2020
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Energy consumption measurement methods for medical electrical equipment
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YY/T 1746-2020
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Absorbable surgical suture - Test method for breaking strength in vitro hydrolytic degradation
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YY/T 1754.1-2020
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Preclinical animal study of medical devices - Part 1: General considerations
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YY/T 1754.2-2020
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Preclinical animal study of medical devices - Part 2: Model of skin defect in induced diabetic rats
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YY/T 1758-2020
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Cardiovascular implants - Pulmonary valve conduit
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YY/T 1759-2020
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Guide for Design and Evaluation of Primary Flexible Packaging for Medical Devices
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YY/T 0639-2019
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In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology
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YY/T 1649.2-2019
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Test method for interactions of medical devices with platelet -- Part 2: In vitro platelet activation products(β-TG, PF4 and TxB2)assay
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YY/T 1678-2019
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Test method for molecular weight averages and molecular weight distribution of polylactic acid and its copolymers for surgical implants
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YY/T 1592-2018
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ABO forward blood grouping and RhD typing reagents(column agglutination technique, CAT)
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YY/T 1593-2018
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Growth hormone testing kit
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