YY/T 1291-2016: Translated English of Chinese Standard. (YYT 1291-2016, YY/T1291-2016, YYT1291-2016): Single use subcutaneous infusion sets for use with insulin pump

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https://www.chinesestandard.net, 2018 M04 23 - 23 pages
This Standard specifies the requirements for the subcutaneous infusion set for use with insulin pump that consists of interface, piping, piercing assembly. This product is a single use sterile product. This Standard does not include the requirements for insulin-filled devices (e.g., drug reservoirs, pre-filled cassette bottles) in insulin pumps.
 

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Contents

Foreword
3
Introduction
4
Scope
5
Terms and definitions
6
Structure and composition
7
Materials
8
Chemical properties
12
Biological requirements
13
Type inspection
14
Packaging
17
Annex A Normative Physical test
18
Annex B Informative Design guide for subcutaneous infusion set
21
Bibliography
23

Common terms and phrases

About the author (2018)

www.ChineseStandard.net specializes in providing translation services of all Chinese Standards.

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