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Chinese National Standard List: Medical apparatus and devices in general

T/CSBME 009-2019 Quality evaluation method of cybersecurity in medical devices 
  Issued on:   Translation Price(USD): 165.0
T/CSBME 064-2022 Quality requirements and evaluation on AI medical equipment for bone age diagnosis―Part 1:Data set 
  Issued on:   Translation Price(USD): 165.0
T/CSBME 017-2020 Disposable protective medical isolation gown 
  Issued on: 2020-04-21   Translation Price(USD): 225.0
GB/T 35533-2017 General technical requirement for chromosomal abnormality detection microarray 
  Issued on:   Translation Price(USD): 100.0
T/GDMDMA 0012.14-2022 Medical device standardized management system in hospital Part 14: Requirements for informatization construction and management 
  Issued on:   Translation Price(USD):
GB 7954-1987 Vocabulary of glass syringes for medical use 
  Issued on:   Translation Price(USD): 184.0
T/CSBME 026-2021 Myoglobin Quantitative Assay （Kit） (fluorescence immunochromatography) 
  Issued on: 2021-01-16   Translation Price(USD): 165.0
DB32/T 4271-2022 Specification for cleanroom (zone) test of medical device plant 
  Issued on: 2022-05-26   Translation Price(USD):
T/CQAP 2002-2022 Vesicular Stomatitis Virus (VSV) vector -derived pseudovirus positive control material for SARS-CoV-2 nucleic acid detection 
  Issued on: 2022-01-26   Translation Price(USD): 165.0
T/CSBME 006-2019 Safety assessment of the magnetic resonance imaging for active implantable medical device—Method of the equivalent tissue-simulating medium 
  Issued on:   Translation Price(USD): 255.0
T/CSBME 027-2021 Creatin Kinase Isoenzyme (CKMB) Quantitative Assay（kit） (fluorescence immunochromatography) 
  Issued on: 2021-01-16   Translation Price(USD):
T/CSBME 031-2021 Specification for disinfection and storage of transesophageal echocardiography probe 
  Issued on: 2021-01-01   Translation Price(USD): 165.0
T/CSBME 018-2020 Disposable regular medical general isolated gown 
  Issued on: 2020-04-21   Translation Price(USD): 165.0
YY 9706.278-2023 Medical electrical equipment--Part 2-78 : Particular requirements forbasic safety and essential performance of medical robots for rehabilitation,assessment, compensation or alleviation 
  Issued on: 2023-03-14   Translation Price(USD): 900.0
GB/T 44585.1-2024 Application of risk management for medical device connecting IT-network—Part 1：Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software 
  Issued on: 2024-09-29   Translation Price(USD): 645.0
YY/T 1833.5-2024 Artificial intelligence medical device - Quality requirements and evaluation - Part 5 : Pre-trained models 
  Issued on: 2024-09-29   Translation Price(USD): 375.0
YY/T 1950-2024 Tissue engineering medical device products - Generic requirement for bio-derived peripheral nerve repair implant 
  Issued on: 2024-09-29   Translation Price(USD): 300.0
YY/T 1940-2024 Medical nickel titanium powders for additive manufacturing 
  Issued on: 2024-09-29   Translation Price(USD): 120.0
MZ/T 238-2025 Monitoring and positioning systems-Millimeter wave radar monitoring alarm 
  Issued on: 2025-02-28   Translation Price(USD):
GB/T 44827-2024 Molecular in vitro diagnostic examinations—Specifications for pre-examination processes in metabolomics in urine, venous blood serum and plasma 
  Issued on: 2024-10-26   Translation Price(USD): 315.0
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