YY/T 0659-2017Blood coagulation analyzer (English PDF)

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009. This Standard integrates YY/T 0658-2008, Semi-automated coagulation analyzer, and YY/T 0659-2008, Automated coagulation analyzer. Compared with YY/T 0658-2008 and YY/T 0659-2008, in addition to editorial changes, the major technical changes are as follows: -- it changes the standard name, from "Semi-automated coagulation analyzer" and "Automated coagulation analyzer" into "Blood coagulation analyzer"; -- it changes the scope, adds the specification that this Standard does not apply to the instruments for platelet aggregation function testing, hemorheological function testing and point-of-care testing, and add the specification that it only applies to the instruments for coagulation method (see Clause 1); -- the text description in the normative references is drafted as specified in GB/T 1.1-2009; -- all the normative reference documents are not dated, i.e. their latest editions apply to this Standard; -- the terms and definitions of accuracy, precision, linearity and carry-over rate are the references to the commonly-used terms and definitions listed in GB/T 29791.1 (see Clause 3); -- it changes the sample requirements in the precision items, adds the requirements for normal samples and deletes the requirements for abnormal samples (higher than 2 times of normal samples) (see 5.7); -- it changes the requirements for the linearity index r, r >= 0.980 (see 5.9); -- it adds the requirements for the linearity deviation (see 5.9); -- it changes the requirements for continuous working hours, changes the continuous working hours from 24 h into 8 h and changes the requirements (see 5.10); -- it adds the safety requirements of GB 4793.9 and YY 0648 (see 5.13); -- it adds the electromagnetic compatibility requirements of GB/T 18268.1 and GB/T 18268.26 (see 5.14); -- it changes the test method of carry-over rate (see 6.6); Blood coagulation analyzer

1 Scope

YY/T 0659 is the Chinese standard for coagulation analyzers, the instruments that measure prothrombin time, APTT, fibrinogen and the specialised assays behind anticoagulant management and bleeding investigation. It sets the requirements such an analyzer has to meet and the test methods that verify them, covering the accuracy and repeatability of the clotting time measurement, carryover between samples, the temperature control that the reaction depends on, and the software that converts a detected clot into a reported result and an INR. The INR in particular drives warfarin dosing directly, so a systematic bias in the instrument becomes a systematic error in anticoagulation across every patient it tests. The standard carries Amendment 1 of 2022. For a manufacturer, this is the text a Chinese registration is assessed against.

This Standard specifies the terms and definitions, product classification, technical requirements, testing methods, labelling, marking, instructions for use, packaging, transportation and storage for blood coagulation analyzers. This Standard applies to blood coagulation analyzers which are used clinically for the analysis of coagulation-anticoagulation and fibrinolysis-antifibrinolysis of patients' blood. This Standard does not apply to the instruments for platelet aggregation function testing, hemorheological function testing and point-of-care testing.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition dated applies to this document. For undated references, the latest edition of the referenced documents (including all amendments) applies to this document.

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

4 Product classification

4.1 Automation degree classification Semi-automated and full-automated.

4.2 Channel type classification (semi-automated) Single-channel, double-channel and multiple-channel.

5 Technical requirements

5.1 Preheating time Preheating time shall be less than 30 min.

6 Test methods...