ISO/TR 19727:2017

TECHNICAL ISO/TR
REPORT 19727
First edition
2017-08
Medical devices — Pump tube
spallation test — General procedure
Dispositifs médicaux — Essai de spallation des tubes de pompes —
Mode opératoire général
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Materials and equipment . 1
5 Identification . 2
6 Preparation . 2
6.1 General . 2
6.2 Pump set to be tested . 2
7 Test setup . 2
8 Test method . 3
8.1 Sampling . 3
8.2 Analysing . 4
9 Test conditions and acceptance criteria . 4
Bibliography . 5
Foreword
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electrotechnical standardization.
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This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
iv © ISO 2017 – All rights reserved

TECHNICAL REPORT ISO/TR 19727:2017(E)
Medical devices — Pump tube spallation test — General
procedure
1 Scope
This document provides a method of measuring, analysing and assessing the particle shedding from an
infusion pump set during pumping.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:
...