Standard No.:	YY/T 1915-2023
English Name:	General requirments for laboratory testing of immunochromatographic kits
Chinese Name:	免疫层析试剂盒实验室检测通则
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.100.10 11.100.10    In vitro diagnostic test systems 11.100.10
Issued by:	National Medical Products Adminstration
Issued on:	2023-09-05
Implemented on:	2024-3-15
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	150.00
Delivery:	via email in 1~3 business day

本文件规定了实验室在对免疫层析试剂盒进行性能验证过程中的检测质量要求，包括人员、环境、仪器以及检测过程控制和检测结果分析等环节的要求。
本文件适用于对体外诊断用免疫层析试剂盒性能验证的检测实验室，包括生产企业实验室。