ISO/TR 19727:2017
(Main)Medical devices — Pump tube spallation test — General procedure
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
- Current Stage
- 6060 - International Standard published
- Start Date
- 17-Aug-2017
- Completion Date
- 14-Feb-2026
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
Overview
ISO/TR 19727:2017 - Medical devices - Pump tube spallation test - General procedure is a technical report developed by the International Organization for Standardization (ISO). This standard provides a systematic method for measuring, analyzing, and assessing particle shedding-referred to as "spallation"-from infusion pump sets during operation. Reducing and monitoring particle contamination is crucial for the safety and effectiveness of medical infusion devices, making this standard highly relevant to manufacturers, laboratories, and regulatory agencies involved in medical device quality control.
Key Topics
- Objective: Establishes a general procedure to evaluate particle shedding from pump tubes in infusion pump sets.
- Components and Materials: Details the necessary test materials, such as IV-fluid containers, filters, distributors, reference and sample containers, and pumps.
- Test Conditions: Specifies preparation procedures, equipment setup, environmental conditions, and step-by-step testing instructions.
- Data Collection and Analysis: Outlines sampling techniques, calculation formulas for fluid volumes, and requirements for laboratory analysis of collected samples.
- Acceptance Criteria and Risk Assessment: Provides guidance on selecting appropriate flow rates and run times, and emphasizes integrating test results into product risk analysis as per regulatory requirements.
Applications
ISO/TR 19727:2017 is highly applicable across the medical technology and healthcare sectors:
- Medical Device Manufacturers: Enables consistent test protocols for infusion pump set quality assurance, supporting product validation and regulatory compliance.
- Testing Laboratories: Assists laboratories in executing standardized particle spallation tests to ensure data repeatability and comparability.
- Regulatory Affairs: Offers supporting evidence for market approval submissions by documenting the control of particulate contamination in line with quality and safety codes.
- Risk Management: Facilitates inclusion of spallation data in overall product risk evaluation, aligning with best practices in pre-market and post-market surveillance.
- Research and Development: Supports engineering and development teams in designing safer pump sets, reducing the risk of adverse patient reactions caused by particulate contamination.
The methodology focuses on quality control for infusion systems and helps minimize potential health risks associated with particulate matter entering a patient’s bloodstream.
Related Standards
For comprehensive compliance and best practices in medical device safety and performance, the following related standards should be considered:
- USP 788: Particulate matter in injections - referenced for microscopic and light obscuration particle count testing.
- ISO 8536 Series: Infusion equipment for medical use.
- ISO 13485: Quality management systems for medical devices.
- ISO 14971: Application of risk management to medical devices.
- IEC Standards: For electromechanical safety in infusion devices.
Summary
ISO/TR 19727:2017 provides essential guidelines for the evaluation of particle shedding from infusion pump tubing, ensuring high standards for patient safety and device reliability. Its practical procedure supports manufacturers, laboratories, and regulators in the consistent assessment, documentation, and mitigation of contamination risks in medical infusion devices. Implementing this standard in quality control and risk management processes contributes significantly to the delivery of safer healthcare solutions.
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Frequently Asked Questions
ISO/TR 19727:2017 is a technical report published by the International Organization for Standardization (ISO). Its full title is "Medical devices — Pump tube spallation test — General procedure". This standard covers: ISO/TR 19727:2017 provides a method of measuring, analysing and assessing the particle shedding from an infusion pump set during pumping.
ISO/TR 19727:2017 provides a method of measuring, analysing and assessing the particle shedding from an infusion pump set during pumping.
ISO/TR 19727:2017 is classified under the following ICS (International Classification for Standards) categories: 11.040.20 - Transfusion, infusion and injection equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/TR 19727:2017 has the following relationships with other standards: It is inter standard links to ISO 17700:2019. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO/TR 19727:2017 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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 2017
© 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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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
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
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:
...
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
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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
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
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
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:
...
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