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 China 'GB/T 21415-2008 ' standard english version summary:

 

NATIONAL STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA

GB/T 21415-2008

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性

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Issued by:   The Standardization Administration of the People's Republic of China
 
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GB Standard Code GB/T 21415-2008
Standard Category China National Standards
GB Standard English Title In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
GB Standard Chinese Title 体外诊断医疗器械 生物样品中量的测量 校准品和控制物质赋值的计量学溯源性
Chinese Version Price $15 USD per 50 pages
English Translation Fee About $15  per 1 page (1,000 words)
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Standard  Code GB Standard Title Cart
  • YY/T 1441-2016
  • (Performance evaluation of In vitro diagnostic medical devices General requirements)
  • YY/T 1454-2016
  • (Self-vitro diagnostic medical devices for detecting the basic requirements)
  • GB/T 29791.2-2013
  • In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
  • GB/T 29791.4-2013
  • In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting
  • GB/T 29791.5-2013
  • In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for selftesting
  • GB/T 29791.3-2013
  • In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
  • GB/T 29791.1-2013
  • In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
  • YY/T 0638-2008
  • In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials
  • YY/T 0639-2008
  • In vitro diagnostic medical devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
  • GB/T 21415-2008
  • In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
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