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YY/T 0663.1-2014 Cardiovascular implant—Endovascular devices—Part 1:Endovascular prostheses
Standard No.:
YY/T 0663.1-2014
Status:
VALID
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Email:
OK
Target Language:
English
File Format:
PDF
Word Count:
38000 words
Translation Price:
1140 (USD)
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Email:
OK
Implemented on:
2015-07-01
Delivery:
via email in 1-8 business day
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Detail
Introduction
Contents
Standard No.:
YY/T 0663.1-2014
Chinese Name:
心血管植入物 血管内装置 第1部分:血管内假体
English Name:
Cardiovascular implant—Endovascular devices—Part 1:Endovascular prostheses
Professional Classification:
YY Professional Standard - Pharmaceutics
ICS Classification:
11.040.40
Issued by:
Issued on:
2014-06-17
Implemented on:
2015-07-01
Status:
VALID
Target Language:
English
File Format:
PDF
Word Count:
38000 words
Translation Price:
1140 (USD)
Delivery:
via email in 1-8 business day
前言 Ⅰ
1 范围 1
2 规范性引用文件 1
3 术语和定义 2
4 预期性能 3
5 设计属性 3
6 材料 4
7 设计评价 4
8 制造 20
9 灭菌 20
10 包装 21
附录A (资料性附录) 血管内器械的属性———技术和临床需考虑的事项 23
附录B(资料性附录) 试验室分析测试 30
附录C (资料性附录) 应报告临床事件的定义 33
附录D (资料性附录) 测试方法 35
附录E (资料性附录) D.5.3.19疲劳耐久性测试(脉动的)分析方法的补充 68
参考文献 70
YY/T 0663.1-2014 The following standards are cited:
YY/T 0663.1-2014 Cited by the following standards:
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