YY/T 0456.1-2003
Replaced
YY/T 1216-2020
Active
Industry standards-Medicine
YY/T 1216-2020 Alpha-fetoprotein testing kit
YY/T 1216-2020 Alpha-fetoprotein testing kit
Basic Information
Standard Code:
YY/T 1216-2020
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2020-06-30
Implement Date:
2021-06-01
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
Pages:
12 pages
Scope
本标准规定了甲胎蛋白标记免疫测定试剂产品的分类、要求、检验方法、标示、标签、使用说明书、包装、运输和贮存等。
本标准适用于以标记免疫测定为原理检测人血液基质或其他体液成分中的甲胎蛋白(AFP) 定量测定试剂，包括以酶、化学发光、荧光物等方法标记捕获抗体，以微孔板、管、磁颗粒、微珠和塑料珠、微流控芯片、纳米材料等为载体包被抗体定量测定AFP的免疫测定试剂盒。
本标准不适用于：
a)胶体金标记AFP试纸条；
b)用125I等放射性同位素标记的各类放射免疫。
Development Information
Drafting Units:
中国食品药品检定研究院、北京市医疗器械检验所、北京华大吉比爱生物技术有限公司、博奥生物集团有限公司、厦门万泰凯瑞生物技术有限公司、广州市达瑞生物技术股份有限公司
Drafting Persons:
王玉梅、王瑞霞、刘利成、郭健夫、孙旭东、吴英松
Replace the following standards
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 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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 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