YY/T 1789.3-2022 English Version, YY/T 1789.3-2022 In vitro diagnestic test systems—Performance evaluation method一Part 3: Limit of detection and limit of quantitation (English Version)

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YY/T 1789.3-2022 In vitro diagnestic test systems—Performance evaluation method一Part 3: Limit of detection and limit of quantitation (English Version)
Standard No.:	YY/T 1789.3-2022	Status:	valid remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	18500 words	Translation Price(USD):	555.0 remind me the price change Email:
Implemented on:	2024-1-1	Delivery:	via email in 1~5 business day

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Standard No.:	YY/T 1789.3-2022
English Name:	In vitro diagnestic test systems—Performance evaluation method一Part 3: Limit of detection and limit of quantitation
Chinese Name:	体外诊断检验系统性能评价方法第3部分：检出限与定量限
Chinese Classification:	C30 Medical apparatus and devices in general
Professional Classification:	YY Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2022-07-01
Implemented on:	2024-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	18500 words
Translation Price(USD):	555.0
Delivery:	via email in 1~5 business day

Standard

YY/T 1789.3-2022 In vitro diagnestic test systems—Performance evaluation method一Part 3: Limit of detection and limit of quantitation (English Version)
Standard No.	YY/T 1789.3-2022
Status	valid
Language	English
File Format	PDF
Word Count	18500 words
Price(USD)	555.0
Implemented on	2024-1-1
Delivery	via email in 1~5 business day

Detail of YY/T 1789.3-2022

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Introduction of YY/T 1789.3-2022

本文件规定了体外诊断检验系统的检出限与定量限性能评价方法。本文件适用于制造商对定量测定的体外诊断检验系统进行性能评价。
本文件不适用于结果报告为名义标度和序数标度的体外诊断检验系统的性能评价，例如用于血细胞鉴定、微生物分型、核酸序列鉴定、尿液颗粒鉴定，结果报告为阴性、阳性或1+、2+、3+的体外诊断检验系统。

Contents of YY/T 1789.3-2022

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