YY/T 1915-2023 English Version, YY/T 1915-2023 General requirments for laboratory testing of immunochromatographic kits (English Version)

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YY/T 1915-2023 General requirments for laboratory testing of immunochromatographic kits (English Version)
Standard No.:	YY/T 1915-2023	Status:	valid remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	5500 words	Translation Price(USD):	150.0 remind me the price change Email:
Implemented on:	2024-3-15	Delivery:	via email in 1~3 business day

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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
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2023-09-05
Implemented on:	2024-3-15
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	150.0
Delivery:	via email in 1~3 business day

Standard

YY/T 1915-2023 General requirments for laboratory testing of immunochromatographic kits (English Version)
Standard No.	YY/T 1915-2023
Status	valid
Language	English
File Format	PDF
Word Count	5500 words
Price(USD)	150.0
Implemented on	2024-3-15
Delivery	via email in 1~3 business day

Detail of YY/T 1915-2023

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Introduction of YY/T 1915-2023

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。

Contents of YY/T 1915-2023

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