ISO/TR 19727:2017

Medical devices — Pump tube spallation test — General procedure

ISO/TR 19727:2017 provides a method of measuring, analysing and assessing the particle shedding from an infusion pump set during pumping.

Dispositifs médicaux — Essai de spallation des tubes de pompes — Mode opératoire général

General Information

• Status: Published
• Publication Date: 16-Aug-2017
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
• Current Stage: 6060 - International Standard published
• Completion Date: 17-Aug-2017

Relations

• Consolidated By: ISO 17700:2019 - Footwear — Test methods for upper components and insocks — Colour fastness to rubbing and bleeding
• Effective Date: 06-Jun-2022

Standards Content (Sample)

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/TR 19727:2017(E)
©
ISO 2017

---------------------- Page: 1 ----------------------
ISO/TR 19727:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2017 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TR 19727:2017(E)

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
© ISO 2017 – All rights reserved iii

---------------------- Page: 3 ----------------------
ISO/TR 19727:2017(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
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

---------------------- Page: 4 ----------------------
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:
...