YY/T 1441-2016 English Version, YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices (English Version)

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YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices (English Version)
Standard No.:	YY/T 1441-2016	Status:	valid remind me the status change Email:
Target Language:	English	File Format:	PDF
Word Count:	5500 words	Translation Price(USD):	130.0 remind me the price change Email:
Implemented on:	2017-1-1	Delivery:	via email in 1~3 business day

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Standard No.:	YY/T 1441-2016
English Name:	General requirements of performance evaluation of in vitro diagnostic medical devices
Chinese Name:	体外诊断医疗器械性能评估通用要求
Chinese Classification:	C30 Medical apparatus and devices in general
Professional Classification:	YY Professional Standard - Pharmaceutics
Source Content Issued by:	China Food and Drug Adminstration
Issued on:	2016-01-26
Implemented on:	2017-1-1
Status:	valid
Target Language:	English
File Format:	PDF
Word Count:	5500 words
Translation Price(USD):	130.0
Delivery:	via email in 1~3 business day

YY/T 1441-2016 is referred in:

Standard

YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices (English Version)
Standard No.	YY/T 1441-2016
Status	valid
Language	English
File Format	PDF
Word Count	5500 words
Price(USD)	130.0
Implemented on	2017-1-1
Delivery	via email in 1~3 business day

Detail of YY/T 1441-2016

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Introduction of YY/T 1441-2016

本标准规定了制造商在体外诊断医疗器械性能评估研究中对研究计划、实施、评估和制定文件的职责和总体要求。
本标准适用于对体外诊断医疗器械的性能评估。本标准不适用于对某一特定体外诊断医疗器械或某一具体用途的评估方案。

Contents of YY/T 1441-2016

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