YY/T 1740.3-2024
Medical mass spectrometers Part 3: Inductively coupled plasma mass spectrometers (English Version)

Standard No.
YY/T 1740.3-2024
Language
Chinese, Available in English version
Release Date
2024
Published By
Professional Standard - Medicine
Latest
YY/T 1740.3-2024
 
Introduction

Analysis of the core technical requirements of the standard

Technical indicators Required values Test methods Clinical significance
Mass resolution <0.8u（Li/In/Tl） 10% peak width method Ensure the mass spectrum peak separation between elements
Detection sensitivity Hg≥1×106cps/(mg/L) Signal-to-noise ratio method Ensure the detection capability of trace elements
Oxide Interference <3.0%（CeO+/Ce+） Standard Solution Method Control Polyatomic Ion Interference

Key Performance Test Methods

Take the carryover contamination rate test of Inductively Coupled Plasma Mass Spectrometer as an example: high/low concentration alternating injection mode is required, calculated by the formula Ki=(Ai4-Ai6)/(Ai3-Ai6)×100%, and the requirement is ≤0.05%. This indicator directly affects the accuracy of continuous detection of clinical samples.

Key points for standard implementation

  1. The laboratory environment must meet the requirements of constant temperature and humidity of 15-25℃ and humidity ≤75%
  2. The software system must contain a library of standard analysis methods for more than 12 elements (including Li, Hg, Pb, etc.)
  3. Regularly verify quality stability (8h drift < ±0.05u) and measurement stability (4h range < 10%)

Technology evolution analysis

Compared with the GB/T 34826-2017 general ICP-MS standard, this document adds:
1. Specific requirements for whole blood matrix samples (component proportion > 85%)
2. Supporting detection methods for clinical element groups (12 items including K/Ca/Fe/Se)
3. EMC/safety requirements specific to medical devices (referenced to standards such as YY0648)

YY/T 1740.3-2024 history

  • 2024 YY/T 1740.3-2024 Medical mass spectrometers Part 3: Inductively coupled plasma mass spectrometers

Topics on standards and specifications

National monitoring of plasma mass spectrometer mass spectrometer and icp mass spectrometer Ion Trap Mass Spectrometers and Mass Spectrometers APIMS mass spectrometer Ion trap mass spectrometer Inductively Coupled Charge Plasma Mass Spectrometer Plasma sheet spectrometer Inductive high frequency plasma instrument ion mass spectrometer mass spectrometer ion ratio mass spectrometer Plasma mass spectrometer X7 Quadruple Ion Mass Spectrometer

Standard and Specification

JJF 1159-2006 Calibration Specification for Quadrupole Inductively Coupled Plasma Mass Spectrometers JJF 1508-2015 Primary Method of Isotopic Abundance Measurement ISO 5724:2023 Jewellery and precious metals — Determination of very high purity gold — Difference method using ICP-MS DS/EN 61010-2-061:2005 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-061: Particular requirements for laboratory atomic UL 61010-2-061-2015 UL Standard for Safety Requirements for Electrical Equipment for Measurement@ Control and Laboratory Use – Part 2-061: Particular Requirements for Laboratory UL 61010-2-061-2019 UL Standard for Safety Requirements for Electrical Equipment for Measurement@ Control@ and Laboratory Use – Part 2-061: Particular Requirements for Laboratory CAN/CSA-C22.2 No.1010.2.061-1996(C2000 Safety rules for electrical measuring, regulating and laboratory devices - Part 2-061: Particular requirements for laboratory spectrometers with thermal CAN/CSA-C22.2 No.1010.2.061-1996(R2000 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-061: Particular requirements for laboratory atomic IEC 61010-2-061:2003 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-061: Particular requirements for laboratory atomic BS EN 61010-2-061:2003 Safety requirements for electrical equipment for measurement, control and laboratory use. Particular requirements for laboratory atomic spectrometers


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