YY/T 0456.1-2003
Replaced
YY/T 1181-2021
Active
Industry standards-Medicine
YY/T 1181-2021 Immunohistochemistry kit
YY/T 1181-2021 Immunohistochemistry kit
Basic Information
Standard Code:
YY/T 1181-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2021-09-06
Implement Date:
2023-03-01
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
本标准规定了免疫组织化学试剂盒通用的产品分类、要求、试验方法及标识、标签、使用说明书、包装、运输和贮存等内容。本标准适用于基于抗原抗体反应，用于检测人体组织及细胞样本等的组织化学/细胞化学定性试剂或试剂盒。
Development Information
Drafting Units:
北京市医疗器械检验所、福州迈新生物技术开发有限公司、安捷伦科技(中国)有限公司、罗氏诊断产品(上海)有限公司、厦门通灵生物医药科技有限公司、基因(科技)上海股份有限公司、中国食品药品检定研究院
Drafting Persons:
毕春雷、杨清海、刘佳、袁钧、郭金灿、王东、孙楠
Replace the following standards
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 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