YY/T 1245-2014Automatic blood grouping analyzer (English PDF)
自动血型分析仪
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Issued by
China Food and Drug Administration
Level / Type
Industry · Recommended
Issue date
June 17, 2014
Implementation date
July 1, 2015
Scope
YY/T 1245-2014 is the English-translated version of 自动血型分析仪.
YY/T 1245-2014 is the Chinese pharmaceutical industry standard for automatic blood grouping analyzers.
It specifies requirements, test methods, labelling and instructions for use, and packaging, transportation and storage for automatic analyzers used for human red blood cell blood grouping, antibody screening and similar tests, and covers only instruments based on the column agglutination and microplate methods.
The requirements include the accuracy of ABO and Rh(D) grouping, stability over 8 h of operation, incubation temperature control within ±2.0 °C of the set value and, for centrifugal analyzers, a centrifuge speed within ±2.5% of the set value.
Issued on 17 June 2014 by the China Food and Drug Administration, it has been in force since 1 July 2015. Classification: ICS 11.100, CCS C 44.
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Document preview — YY/T 1245-2014
National Standard of the People's Republic of China
- ICS
- 11.100
- Classification
- C 44
Issued by: China Food and Drug Administration
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Requirements
- 3.1 Accuracy of blood grouping
- 3.2 Stability
- 3.3 Temperature control
- 3.4 Centrifuge speed
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration and is under the jurisdiction of the National Technical Committee on Clinical Laboratory Testing and In Vitro Diagnostic Systems of Standardization Administration of China (SAC/TC 136).
Drafting organizations: Beijing Institute of Medical Device Testing, Beckman Coulter Commercial Enterprise (China) Co., Ltd., Johnson & Johnson (Shanghai) Medical Equipment Co., Ltd., among others.
1 Scope
This standard specifies the requirements, test methods, labelling and instructions for use, and packaging, transportation and storage of automatic blood grouping analyzers.
This standard applies to automatic analyzers for human red blood cell blood grouping, antibody screening and similar tests (hereinafter referred to as analyzers).
This standard specifies technical requirements only for analyzers using the column agglutination method or the microplate method.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191, Packaging - Pictorial marking for handling of goods
GB 4793.1, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements
GB/T 14710, Environmental requirement and test methods for medical electrical equipment
YY/T 0466.1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY 0648, Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
3.1 Accuracy of blood grouping
3.1.1 ABO blood group determination: after the blood sample has been loaded and has reacted with the corresponding dedicated forward and reverse grouping reagents, the analyzer shall automatically report the correct ABO group.
3.1.2 Rh blood group determination: after the blood sample has been loaded and has reacted with the corresponding dedicated reagent, the analyzer shall automatically report the correct Rh(D) negative or positive result.
3.2 Stability
Blood samples of known group are tested 30 min and 8 h after the analyzer is switched on. The results shall agree with the known results.
3.3 Temperature control
The incubation temperature shall be within ±2.0 °C of the set value.
3.4 Centrifuge speed
Under working conditions, the deviation of the measured speed from the set value shall be within ±2.5%.
Note: applies to analyzers using the centrifugation method.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191Graphical symbols marking for handling and storage of packages
- GB 4793.1Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
- GB/T 14710The environmental requirement and test methods for medical electrical equipment
- YY/T 0466.1Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
- YY 0648Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
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Related Standards
GB 4793.1-2007 — Safety requirements for electrical equipment for measurement,control,andlaboratory use-Part 1:General requirements
GB/T 14710-2009 — The environmental requirement and test methods for medical electrical equipment
GB/T 191-2025 — Graphical symbols marking for handling and storage of packages
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YY/T 1245-2014
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