YY/T 1740.1-2021Clinical mass spectrometer - Part 1: Liquid chromatography-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 spectrometer. This part is part 1 of YY/T 1740.

This section was 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, labels, instructions for use, packaging, Transportation and storage.

This part is applicable to single quadrupole and triple quadrupole liquid chromatography-mass spectrometer (hereinafter referred to as liquid chromatography-mass spectrometer), which mainly It is used to analyze molecular substances in human samples such as blood and urine, such as proteins, small metabolic molecules, drugs, etc.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 191 Packaging, storage and transportation pictorial signs

GB 4793.1 Safety requirements for electrical equipment for measurement, control and laboratory use Part 1: General requirements

GB 4793.6 Safety requirements for electrical equipment for measurement, control and laboratory use Part 6: Characteristics of material heating equipment for laboratory use Special requirements

GB 4793.9 Safety requirements for electrical equipment for measurement, control and laboratory use-Part 9: Laboratory use for analysis and other purposes Special requirements for mobile and semi-automatic equipment

GB/T 14710 Environmental requirements and test methods for medical electrical appliances

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 External diagnostic (IVD) medical equipment

GB/T 29791.3 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 3: In vitro diagnostic devices 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 Dedicated requirements

3 Terms and definitions

The following terms and definitions apply to this document.