YY/T 0456.1-2003
Replaced
YY/T 1916-2023
Active
Industry standards-Medicine
YY/T 1916-2023 Interleukin-6(IL-6) testing kit(labelling immunoassay)
YY/T 1916-2023 Interleukin-6(IL-6) testing kit(labelling immunoassay)
Basic Information
Standard Code:
YY/T 1916-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2023-09-05
Implement Date:
2024-09-15
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
本文件规定了白介素6（以下简称“IL-6”)测定试剂盒（标记免疫分析法)的要求、试验方法及标识、标签和使用说明、包装、运输和贮存等要求。
本文件适用于以标记免疫为反应原理定量测定人血清、血浆或全血中IL-6含量的试剂盒，方法学包含荧光标记免疫层析法、化学发光法等。
本文件不适用于对IL-6校准品和质控品的评价。
Development Information
Drafting Units:
北京利德曼生化股份有限公司、重庆医疗器械质量检验中心、北京市医疗器械检验研究院、深圳市新产业生物医学工程股份有限公司、郑州安图生物工程股份有限公司、南京诺唯赞医疗科技有限公司、罗氏诊断产品(上海)有限公司、中翰盛泰生物技术股份有限公司
Drafting Persons:
李冉、罗春媚、刘艳春、王文峰、陈静、王慧颖、苏建臣、王忠
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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
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
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
Related Standards
YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active