YY/T 0456.1-2003
Replaced
YY/T 1817-2022
Active
Industry standards-Medicine
YY/T 1817-2022 Thyroglobulin testing kit (chemiluminescent immunoassay)
YY/T 1817-2022 Thyroglobulin testing kit (chemiluminescent immunoassay)
Basic Information
Standard Code:
YY/T 1817-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2022-05-18
Implement Date:
2023-12-01
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
本文件规定了甲状腺球蛋白测定试剂盒的要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。
本文件适用于以化学发光免疫分析为原理的定量检测人血液中的甲状腺球蛋白的测定试剂盒，包括以微孔板、管、磁颗粒、微珠和塑料珠等为载体的酶促、非酶促化学发光免疫分析测定试剂盒，包括手工操作法和仪器自动操作法。
Development Information
Drafting Units:
北京市医疗器械检验所、首都医科大学附属北京同仁医院、深圳市新产业生物医学工程股份有限公司、雅培贸易(上海)有限公司
Drafting Persons:
刘艳春、孙雪晴、刘向祎、袁锦云、吴晓军
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