DZ/T 0101.12-1994
Active
YY/T 1870-2023
Active
Industry standards-Medicine
YY/T 1870-2023 General requirements of liquid chromatography-mass spectrometry testing kit
YY/T 1870-2023 General requirements of liquid chromatography-mass spectrometry testing kit
Basic Information
Standard Code:
YY/T 1870-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2023-01-13
Implement Date:
2024-01-15
Publisher:
国家药品监督管理局
Technical Committee:
全国医用临床检验实验室和体外诊断系统标准化技术委员会(SAC/TC 136)
Pages:
12 pages
Scope
本文件规定了液相色谱-质谱法检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。
本文件适用于以液相色谱-质谱法对人体样本（全血、血清、血浆、尿液等）进行定量检测的试剂盒（以下简称试剂盒）。
注：试剂盒一般包括前处理液、内标液、校准品、质控品及其他相关组分。
Development Information
Drafting Units:
北京市医疗器械检验研究院、上海市徐汇区中心医院、山东省食品药品审评查验中心、上海市临床检验中心、美康生物科技股份有限公司、深圳华大基因股份有限公司
Drafting Persons:
孙雪晴、李水军、郭金双、居漪、沈敏、章申燕
Referenced Standards
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
YY/T 1789.5-2023 In vitro diagnostic test systems—Performance evaluation method—Part 5:Analytical specificity
GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples
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