YY/T 0701-2008
Calibrator for hematology analyzer (English Version)
- Standard No.
- YY/T 0701-2008
- Language
- Chinese, Available in English version
- Release Date
- 2008
- Published By
- Professional Standard - Medicine
- Status
- 2023-05
- Replace By
- YY/T 0701-2021
- Latest
- YY/T 0701-2021
- Scope
- This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, inspection rules, signs, labels and instructions, packaging, transportation and storage of calibrators (products) for hematology analyzers (hereinafter referred to as calibrators). This standard applies to calibrators for hematology analyzers. This calibrator is used to calibrate the five parameters of WBC, RBC, HGB, MCV/HCT, and PLT of the blood cell analyzer (also known as the blood analyzer), thereby establishing the metrological traceability of the blood cell analyzer measurement results.
YY/T 0701-2008 Referenced Document
- GB 9969.1-1998 General principles for preparation of instructions for use of industrial products
- GB/T 19703-2005 In vitro diagnostic medical devices-Measurement of quantities in samples of biological origin-Description of reference materials
- 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
- JJF 1005-2005 Terms and Definitions Used in Reference Materials
- WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits.General guideline
YY/T 0701-2008 history
- 2021 YY/T 0701-2021 Calibrators for blood analyzers
- 2008 YY/T 0701-2008 Calibrator for hematology analyzer
