YY/T 0654-2017Automatic chemistry analyzer (English PDF)

Foreword

This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This Standard was revised based on YY/T 0654-2008. Compared with YY/T 0654-2008, in addition to the editorial modifications, the main technical changes are as follows.

- modified the applicable scope as automatic biochemical analyzer for quantitative analysis of various samples by ultraviolet-visible spectrophotometry;

- in normative references, modified GB/T 14710 "The environmental requirements and test methods for medical electrical equipment" to GB/T 14710 "Medical electrical environment requirements and test methods.' - deleted GB/T 2829 "Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability)" from normative references;

- deleted YY 0466 "Medical devices - Symbols to be used with medical device labels labelling and information to be supplied" (ISO 15233:2000, IDT) from normative references;

- modified the sample carryover rate as not exceeding 0.1% and modified its test methods (see 5.8, 6.7);

- adjusted the UREA (urea) test range in the intra-assay precision of clinical projects to 7.0 mmol/L ~ 11.0 mmol/L (see 5.10);

- added the requirements and test methods for applicable provisions of GB 4793.9 and YY 0648 in safety requirements (see 5.13, 6.12);

- added GB/T 18268.1, GB/T 18268.26 electromagnetic compatibility requirements and test methods (see 5.14, 6.13);

- in the absorbance stability test method, the potassium dichromate solution used at a wavelength of 340 nm was changed to a yellow orange G solution (see 6.4);

- in the absorbance repeatability test method, the potassium dichromate solution used at a wavelength of 340 nm was changed to a yellow orange G solution (see 6.5);

- the accuracy and repeatability of the test method is modified by the manufacturer to choose one of two methods (see 6.8);

- the mark and instructions for use shall be changed to meet the requirements of GB/T 29791.3 (see 7);

- Annex B was replaced by the 1990 International Temperature Standard Pure Water Density Table.

1 Scope

This Standard specifies the terms and definitions, classification, requirements, test methods, marks and instructions for use, packaging, transport and storage of automatic chemistry analyzer (hereinafter referred to as the analyzer).

This Standard is applicable to automatic biochemical analyzer for quantitative analysis of various samples by UV-visible spectrophotometry.

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 and storage marks

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

3 Terms and definitions

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

4 Classification

5 Requirements

6 Test methods

7 Marks and instructions for use

Meet the requirements of GB/T 29791.3.

8 Packaging, transport and storage