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YY/T 1295-2015 Biological evaluation of medical devices—Nanomaterial:Endotoxin test
Standard No.:
YY/T 1295-2015
Status:
VALID
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Email:
OK
Target Language:
English
File Format:
PDF
Word Count:
12000 words
Translation Price:
360 (USD)
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Email:
OK
Implemented on:
2016-01-01
Delivery:
via email in 1-3 business day
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Detail
Introduction
Contents
Standard No.:
YY/T 1295-2015
Chinese Name:
医疗器械生物学评价 纳米材料:细菌内毒素试验
English Name:
Biological evaluation of medical devices—Nanomaterial:Endotoxin test
Professional Classification:
C30 Medical apparatus and devices in general
Professional Classification:
YY Professional Standard - Pharmaceutics
ICS Classification:
11.040.30 Surgical instruments and materials
Issued by:
Issued on:
2015-03-02
Implemented on:
2016-01-01
Status:
VALID
Target Language:
English
File Format:
PDF
Word Count:
12000 words
Translation Price:
360 (USD)
Delivery:
via email in 1-3 business day
前言 Ⅰ
1 范围 1
2 规范性引用文件 1
3 术语和定义 1
4 缩略语 2
5 试验前准备 2
6 供试品 3
7 供试品制备 3
8 试验方法 4
9 结果评价 5
10 试验报告 6
附录A (资料性附录) 鲎试验潜在干扰的举例 7
附录B(资料性附录) 凝胶法 8
附录C (资料性附录) 终点光度法 11
附录D (资料性附录) 动态法 14
附录E (资料性附录) 本标准与国际标准章条编号对照一览表和技术性差异及原因一览表 16
参考文献 18
YY/T 1295-2015 The following standards are cited:
YY/T 1295-2015 Cited by the following standards:
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