DZ/T 0101.12-1994
Active
YY/T 1199-2023
Active
Industry standards-Medicine
YY/T 1199-2023 Triglycerides assay kit(Oxidase method)
YY/T 1199-2023 Triglycerides assay kit(Oxidase method)
Basic Information
Standard Code:
YY/T 1199-2023
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:
2023-07-15
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
本文件规定了甘油三酯测定试剂盒（酶法)的要求、试验方法、标识、标签和使用说明书、包装、运输和贮存等内容。
本文件适用于基于分光光度法原理的甘油三酯测定试剂盒（酶法)的质量控制，该产品用于体外定量测定人体血清或血浆中甘油三酯（TG)的量。
Development Information
Drafting Units:
中国食品药品检定研究院、吉林省医疗器械检验研究院、重庆医疗器械质量检验中心、中生北控生物科技股份有限公司、北京利德曼生化股份有限公司、迈克生物股份有限公司、罗氏诊断产品(上海)有限公司、西门子医学诊断产品(上海)有限公司、深圳迈瑞生物医疗电子股份有限公司
Drafting Persons:
高飞、陈丽娟、兰华林、金玲、任轶昆、史丽娟、赖留恋、韩慧、万仙子、黄杰
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 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements
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
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