2024-11-21 3.22.70.169
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Code of China
Chinese National Standard List: Medical apparatus and devices in general

T/CSBME 009-2019 Quality evaluation method of cybersecurity in medical devices 
  Issued on:   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:   Price(USD): 165.0
T/CSBME 017-2020 Disposable protective medical isolation gown 
  Issued on: 2020-04-21   Price(USD): 225.0
GB/T 35533-2017 General technical requirement for chromosomal abnormality detection microarray 
  Issued on:   Price(USD): 100.0
GB 7954-1987 Vocabulary of glass syringes for medical use 
  Issued on:   Price(USD): 184.0
T/CSBME 026-2021 Myoglobin Quantitative Assay （Kit） (fluorescence immunochromatography) 
  Issued on: 2021-01-16   Price(USD): 165.0
DB32/T 4271-2022 Specification for cleanroom (zone) test of medical device plant 
  Issued on: 2022-05-26   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   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:   Price(USD): 255.0
T/CSBME 027-2021 Creatin Kinase Isoenzyme (CKMB) Quantitative Assay（kit） (fluorescence immunochromatography) 
  Issued on: 2021-01-16   Price(USD):
T/CSBME 031-2021 Specification for disinfection and storage of transesophageal echocardiography probe 
  Issued on: 2021-01-01   Price(USD): 165.0
T/CSBME 018-2020 Disposable regular medical general isolated gown 
  Issued on: 2020-04-21   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   Price(USD): 900.0
GB/T 42984.1-2023 Health software—Part 1: General requirements for product safety 
  Issued on: 2023-9-7   Price(USD): 400.0
YY/T 1910-2023 Medical-grade beta-tricalcium phosphate powder for additive manufacturing 
  Issued on: 2023-09-05   Price(USD): 165.0
YY/T 1911-2023 Test method of coagulation for medical devices 
  Issued on: 2023-09-05   Price(USD): 165.0
YY/T 1909-2023 Additive manufacturing for medical applications―Requirements for control and validation of metal powder-bed electron beam fusion process 
  Issued on: 2023-09-05   Price(USD): 225.0
YY/T 1833.4-2023 Artificial intelligence medical device-Quality requirements and evaluation-Part 4:Traceability  
  Issued on: 2023-09-05   Price(USD): 195.0
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products 
  Issued on: 2023-09-05   Price(USD): 105.0
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration 
  Issued on: 2023-09-05   Price(USD): 225.0
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