YY/T 0653-2017 in English

Hematology analyzer

1 Scope

This standard specifies the terms and definitions, product classification, technical requirements, test methods, labeling, marking and instructions as well as packaging, transportation and storage of hematology analyzers.

This standard is applicable to hematology analyzers (hereinafter referred to as analyzer) used for analyzing visible components in human blood and providing relevant information.

This standard is not applicable to reticulocyte detection.

2 Normative references

The following referenced 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 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 9: Particular requirements for automatic and semi-automatic laboratory equipment for analysis and other purposes
GB/T 14710 Environmental requirement and test methods for medical electrical equipment
GB/T 18268.1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
GB/T 18268.26 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 26: Particular requirements - In vitro diagnostic (IVD) medical equipment
GB/T 29791.1 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
GB/T 29791.3 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
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 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1
hematology analyzer
instrument used to detect human blood samples, being able to quantitatively analyze the visible components in blood and provide relevant information

3.2
semi-automatic
device for blood cell analysis that requires off-machine dilution function.
It means that some analysis steps of an instrument or test system are mechanized, while other steps still require operator involvement

3.3
automatic
device for blood cell analysis with in-machine dilution function.
It means that all analysis steps of an instrument or test system are mechanized, including sample and reagent addition, sample/reagent interaction, chemical/biological analysis, result calculation and result readout

Foreword i
1 Scope
2 Normative references
3 Terms and definitions
4 Product classification
5 Technical requirements
6 Test method
7 Labeling, marking and instructions
8 Packaging, transportation and storage
Annex A (Normative) Test method for five-part analyzer
Bibliography