1、Medical devices Pump tube spallation test General procedure PD ISO/TR 19727:2017 BSI Standards Publication WB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06National foreword This Published Document is the UK implementation of ISO/TR 19727:2017. The UK participation in its preparation was entr
2、usted to Technical Committee CH/212, IVDs. A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standa
3、rds Institution 2017 Published by BSI Standards Limited 2017 ISBN 978 0 580 87006 4 ICS 11.040.20 Compliance with a British Standard cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 30 September
4、 2017. Amendments/corrigenda issued since publication Date Text affected PUBLISHED DOCUMENT PD ISO/TR 19727:2017 ISO 2017 Medical devices Pump tube spallation test General procedure Dispositifs mdicaux Essai de spallation des tubes de pompes Mode opratoire gnral TECHNICAL REPORT ISO/TR 19727 Referen
5、ce number ISO/TR 19727:2017(E) First edition 2017-08-10 PD ISO/TR 19727:2017 ISO/TR 19727:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized
6、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 ISOs member body in the country of the requester. ISO copyright of
7、fice Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.org PD ISO/TR 19727:2017 ISO/TR 19727:2017(E)Foreword iv 1 Scope . 1 2 Normative references 1 3 T erms and definitions . 1 4 Materials and equipment 1 5 Identifica
8、tion 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 Contents Page PD ISO/TR 19727:2017 ISO/TR 19727:2017(E) Foreword ISO (the
9、 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 committe
10、e 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 electrotechni
11、cal 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 i
12、n 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.
13、 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
14、 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 ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the
15、following URL: www.iso.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 PD ISO/TR 19727:2017 Medical devices Pump tube spallation
16、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 T erms a nd definiti ons No terms and definitions are list
17、ed 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:/ /www.electropedia.org/ 4 Materials and equipment The following materials
18、and equipment are needed for the test set-up. IV-fluid container, container or bag with IV-fluid. A container with high volume is preferable. Maybe several containers or bags are needed depending on volume, flow rate and test time. If a glass or rigid container is used, the container should be suffi
19、ciently vented. No air born particles enters the container. Recommendation for the IV-fluid is a 0,9 % NaCl solution. IV-filter with 0,2 m pore size or less which is vented. Several IV-filters may be need depending on the number of IV-fluid container. Distributor 1, e.g. electronically driven manifo
20、ld or a manually driven stopcock manifold. Pump set to be tested. Infusion pump to be tested. Distributor 2, e.g. electronically driven manifold or a manually driven stopcock manifold. The number of output of distributor 2 is N = N r+ N s+ 1, where N ris the number of reference containers, N sis the
21、 number of sample containers and “+1” for the waste container. Reference containers, container or bag to collect reference sample IV-fluid. Several containers or bags can be used to collect several reference samples. A container with a volume between 50 ml to 500 ml is preferable. If a glass or rigi
22、d container is used then the container should be sufficiently vented. No air born particles enter the container. Sample containers, container or bag to collect sample IV-fluid. Several containers or bags are needed depending on volume, flow rate and test time. A container with a volume between 50 ml
23、 to 500 ml is preferable. If a glass or rigid container is used then the container should be sufficiently vented. No air born particles enter the container. TECHNICAL REPORT ISO/TR 19727:2017(E) ISO 2017 All rights reserved 1 PD ISO/TR 19727:2017 ISO/TR 19727:2017(E) Waste container, container or ba
24、g with high volume, depending on volume of the IV-fluid used. A container with high volume is preferable. If a glass or rigid container then the container should be sufficiently vented. Timer, if manually driven distributors are used. Sample containers and reference containers are identical and from
25、 the same production batch. 5 Identifi cation Remove pump set from package and mark each pump set with the date, the initials of tester, the Lab Test Request (LT) number and a reference number. Also note the reference number on a blank area of the set label. 6 Preparation 6.1 General The test should
26、 be conducted at a temperature between (23 2) C. All IV-fluids, the test set-up, the pump set and the infusion pump should be stored at a temperature between (23 2) C for at least 24 h. 6.2 Pump set to be tested Remove (e.g. cut off) the drip chamber of the pump set and replace it by a connector, e.
27、g. female Luer lock, in order to connect the pump set with the distributor 1. The part with the new connector is called the input of the test pump set and the part with the original male Luer connector of the pump set is called the output of the test pump set. 7 Test setup 7.1 Close the distributor
28、1, no flow allowed. 7.2 Connect the following parts of the test setup according to Figure 1: IV-fluid filters to distributor 1; IV-fluid filter to IV-fluid container; distributor 1 to pump set input (former place of drip chamber); do not install pump set into pump; pump set output to distributor 2;
29、distributor 2 to reference, sample and waste containers. 7.3 Hang up the IV-fluid containers with a height of (1 0,1) m between IV-fluid containers output and pump input. 7.4 The height difference between pump output and sample container input is less than 30 cm. 7.5 Fill each line of the test set-u
30、p with IV-fluid by allowing flow from IV-fluid container to the waste container. No air bubble is in the fluid line.2 ISO 2017 All rights reserved PD ISO/TR 19727:2017 ISO/TR 19727:2017(E) 7.6 Flush under gravity conditions (do not use pump) the test set-up from distributor 1 onward to the waste con
31、tainer with minimum 500 ml IV-fluid. Please consider the internal volume of the test set-up for the amount of flushing volume. Figure 1 Flow diagram of test setup 8 Test method 8.1 Sampling 8.1.1 Take reference sample by filling one or more reference sample containers under gravity conditions (do no
32、t use pump). 8.1.2 Install pump set into pump. 8.1.3 Set distributor 2 to sample container 1. 8.1.4 Start pump with desired flow rate. 8.1.5 Fill sample container 1, filling time t s(min) = filling volume (l)/flow rate (l/min). 8.1.6 After sample container 1 is filled set distributor 2 to waste. 8.1
33、.7 Fill waste container, filling time t w(min). 8.1.8 Repeat steps 8.1.5 to 8.1.7 to fill the sample containers 2 to N s . ISO 2017 All rights reserved 3 PD ISO/TR 19727:2017 ISO/TR 19727:2017(E) 8.1.9 After all sample containers are filled, shut off infusion pump, disconnect the sample container fr
34、om distributor 2 and close the sample container. The minimum volume of the IV-fluid (V i, min ) needed for this method is calculated using Formula (1):V i, min= flow rate N s (t s+ t w ) + N r V r(1) where flow rate is given in l/min; N s is the number of sample containers; t s is the filling time o
35、f the sample container in min; t r is the filling time of the reference container in min; N r is the number of reference containers; V r is the volume of the reference container in l. This is considered for the selection of the IV-fluid and waste container volume as well as for the layout of the dis
36、tributor 1. 8.2 Analysing After 7.1, a number of sample containers (N s ) and reference containers (N r ) have been prepared. The particle concentration as well as the particle distribution of each container should be analysed using a method described in the USP or other corresponding national pharm
37、acopoeia. 9 Test conditions and acceptance criteria The flow rate to be tested is at least the maximum flow rate of the pump and a typical flow rate of the desired application. The running time of the pump t p= N s (t s+ t w ). The running time is selected as follows: a) maximum time for the desired
38、 application at maximum flow rate; b) maximum time for the desired application at the typical flow rate. The recommended number of samples (N s ) is 10 pieces for each running time. The reference sample is understood as the blank value for the determination of the particle concentration and distribu
39、tion. The impact of the measured particle concentration and distribution is a subject within the framework of the product risk analysis. Risk evaluation can be supported by literature, e.g. pharmacopoeias.4 ISO 2017 All rights reserved PD ISO/TR 19727:2017 ISO/TR 19727:2017(E) Bibliography 1 USP 788
40、, Microscopical Particle Count Test or Light Obscuration Particle Count Test ISO 2017 All rights reserved 5 PD ISO/TR 19727:2017This page deliberately left blankThis page deliberately left blankBSI is the national body responsible for preparing British Standards and other standards-related publicati
41、ons, information and services. BSI is incorporated by Royal Charter. British Standards and other standardization products are published by BSI Standards Limited. British Standards Institution (BSI) About us We bring together business, industry, government, consumers, innovators and others to shape t
42、heir combined experience and expertise into standards -based solutions. The knowledge embodied in our standards has been carefully assembled in a dependable format and refined through our open consultation process. Organizations of all sizes and across all sectors choose standards to help them achie
43、ve their goals. Information on standards We can provide you with the knowledge that your organization needs to succeed. Find out more about British Standards by visiting our website at or contacting our Customer Services team or Knowledge Centre. Buying standards You can buy and download PDF versio
44、ns of BSI publications, including British and adopted European and international standards, through our website at where hard copies can also be purchased. If you need international and foreign standards from other Standards Development Organizations, hard copies can be ordered from our Customer Se
45、rvices team. Copyright in BSI publications All the content in BSI publications, including British Standards, is the property of and copyrighted by BSI or some person or entity that owns copyright in the information used (such as the international standardization bodies) and has formally licensed suc
46、h information to BSI for commercial publication and use. Save for the provisions below, you may not transfer, share or disseminate any portion of the standard to any other person. You may not adapt, distribute, commercially exploit, or publicly display the standard or any portion thereof in any mann
47、er whatsoever without BSIs prior written consent. Storing and using standards Standards purchased in soft copy format: A British Standard purchased in soft copy format is licensed to a sole named user for personal or internal company use only. The standard may be stored on more than 1 device provide
48、d that it is accessible by the sole named user only and that only 1 copy is accessed at any one time. A single paper copy may be printed for personal or internal company use only. Standards purchased in hard copy format: A British Standard purchased in hard copy format is for personal or internal co
49、mpany use only. It may not be further reproduced in any format to create an additional copy. This includes scanning of the document. If you need more than 1 copy of the document, or if you wish to share the document on an internal network, you can save money by choosing a subscription product (see Subscriptions). Reproducing extracts For permission to reproduce content from BSI publications contact the BSI Copyright & Licensi
