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Position: Chinese Standard in English/YY/T 1512-2017
YY/T 1512-2017   Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process (English Version)
Standard No.: YY/T 1512-2017 Status:valid remind me the status change

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Target Language:English File Format:PDF
Word Count: 7500 words Translation Price(USD):140.0 remind me the price change

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Implemented on:2018-7-1 Delivery: via email in 1~3 business day

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,,2018-7-1,7F069BEE8C3B42DB1512019527916
Standard No.: YY/T 1512-2017
English Name: Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
Chinese Name: 医疗器械生物学评价风险管理过程中生物学评价的实施指南
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by: China Food and Drug Administration
Issued on: 2017-07-17
Implemented on: 2018-7-1
Status: valid
Target Language: English
File Format: PDF
Word Count: 7500 words
Translation Price(USD): 140.0
Delivery: via email in 1~3 business day
本标准规定了依据ISO10993-1的要求,实施医疗器械的生物学评价的要求。
本标准适用于包括有源、无源、植入和非植入医疗器械在内的各种类型医疗器械的所有生物学评价。
Code of China
Standard
YY/T 1512-2017  Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process (English Version)
Standard No.YY/T 1512-2017
Statusvalid
LanguageEnglish
File FormatPDF
Word Count7500 words
Price(USD)140.0
Implemented on2018-7-1
Deliveryvia email in 1~3 business day
Detail of YY/T 1512-2017
Standard No.
YY/T 1512-2017
English Name
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process
Chinese Name
医疗器械生物学评价风险管理过程中生物学评价的实施指南
Chinese Classification
C30
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Administration
Issued on
2017-07-17
Implemented on
2018-7-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
7500 words
Price(USD)
140.0
Keywords
YY/T 1512-2017, YY 1512-2017, YYT 1512-2017, YY/T1512-2017, YY/T 1512, YY/T1512, YY1512-2017, YY 1512, YY1512, YYT1512-2017, YYT 1512, YYT1512
Introduction of YY/T 1512-2017
本标准规定了依据ISO10993-1的要求,实施医疗器械的生物学评价的要求。
本标准适用于包括有源、无源、植入和非植入医疗器械在内的各种类型医疗器械的所有生物学评价。
Contents of YY/T 1512-2017
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