YY/T 1740.3-2024 in English

VALID

Clinical mass spectrometer-Part 3 : Inductively coupled plasma mass spectrometry

Issued on:2024-02-07
Implemented on:2025-03-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $250.00
$243.00

Standard No:	YY/T 1740.3-2024
Document status:	VALID
Title in English:	Clinical mass spectrometer-Part 3 : Inductively coupled plasma mass spectrometry
Title in Chinese:	医用质谱仪第3部分：电感耦合等离子体质谱仪
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2024-02-07
Implemented on:	2025-03-01
Professional Classification:	YY-Pharmaceutics
Related Keywords:	clinical mass inductively coupled plasma mass spectrometer test methods clinical significance mass resolution plasma mass spectrometry introduction analysis mass spectrum
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本文件规定了医用电感耦合等离子体质谱仪的要求、标签、使用说明、包装、运输和贮存，描述了相应的试验方法。
本文件适用于医用电感耦合等离子体质谱仪（ICP-MS），该仪器主要用于分析人源样本中的无机元素，如钾、钙、锌、碘等。

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 K_i=(A_i4-A_i6)/(A_i3-A_i6)×100%, and the requirement is ≤0.05%. This indicator directly affects the accuracy of continuous detection of clinical samples.

Key points for standard implementation

The laboratory environment must meet the requirements of constant temperature and humidity of 15-25℃ and humidity ≤75%
The software system must contain a library of standard analysis methods for more than 12 elements (including Li, Hg, Pb, etc.)
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)

More samples: JC/T 2453-2018 JJG 21-2008 NB/T 47013.2-2015

Sample only — not a preview of YY/T 1740.3-2024

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