YY/T 0456.1-2003
Replaced
YY/T 0638-2008
Active
Industry standards-Medicine
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 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
Basic Information
Standard Code:
YY/T 0638-2008
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Laboratory medicine
Publish Date:
2008-04-25
Implement Date:
2009-06-01
Pages:
13 pages
Scope
This standard specifies the method of ensuring the metrological traceability of enzymatic concentration calibration products and control substances. These calibration products and control substances are intended to be used for establishing or verifying the accuracy of enzymatic concentration measurements, and are provided by manufacturers as part of or in combination with in vitro diagnostic medical devices.
Development Information
Referenced Standards
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
国际计量学基础和通用术语词汇(VIM) 第2版 日内瓦:ISO 1993
测量不确定度表达指南 第1版 日内瓦:ISO 1993
Adopt standards
ISO 18153:2003
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