YY/T 0456.1-2003
Replaced
YY/T 0701-2008
Replaced
Industry standards-Medicine
YY/T 0701-2008 Calibrator for hematology analyzer
YY/T 0701-2008 Calibrator for hematology analyzer
Basic Information
Standard Code:
YY/T 0701-2008
Standard Type:
Industry standards
Standard Status:
Replaced
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2008-10-17
Implement Date:
2010-01-01
Pages:
11 pages
Scope
This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, inspection rules, marking, labels and instructions, packaging, transportation, and storage of calibrators used in blood cell analyzers (hereinafter referred to as calibrators).
This standard applies to calibrators used in blood cell analyzers. These calibrators are used to calibrate the five parameters of WBC, RBC, HGB, MCV/HCT, and PLT in blood cell analyzers (also known as hematology analyzers), thereby establishing the metrological traceability of the measurement results of blood cell analyzers.
Development Information
Superseded by the following standards
Referenced Standards
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
JJF 1001-1988
JJF 1005-2005/ISO 指南 30:1992
WS/T 124-1999 Inspection criteria of the quality of clinical chemistry in vitro diagnostic kits—General guideline
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
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active