YY/T 1740.2-2021Clinical mass spectrometer - Part 2: Matrix-assisted laser desorption ionization-time of flight mass spectrometer (English PDF)

Foreword

YY/T 1740 "Medical Mass Spectrometer" is divided into 4 parts.

--- Part 1: Liquid chromatography-mass spectrometry;

--- Part 2: Matrix-assisted laser desorption ionization time-of-flight mass spectrometer;

--- Part 3: Gas chromatography-mass spectrometry;

--- Part 4: Inorganic mass spectrometers. This part is Part 2 of YY/T 1740.

This section is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This part of YY/T 1740 specifies the requirements, test methods, identification, Labels and instructions, packaging, transportation and storage.

This section applies to medical mass spectrometry using matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOFMS for short).

It is mainly used for the identification of microbial protein fingerprints of clinical samples, nucleic acid detection of biological samples, etc.

2 Normative references

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

GB/T 191 Graphical signs of packaging, storage and transportation

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: Laboratory use for analysis and other purposes Particular requirements for automatic and semi-automatic equipment

GB 7247.1 Safety of Laser Products Part 1: Equipment Classification and Requirements

GB/T 14710 Medical Electrical Environment Requirements and Test Methods

GB/T 18268.1 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 1: General Requirements

GB/T 18268.26 Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use Part 26: Special Requirements In vitro diagnostic (IVD) medical devices

GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) - 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.In Vitro Diagnostic (IVD) Medical Equipment specific requirements

3 Terms and Definitions, Abbreviations