1、BS ISO28620:2010ICS 11.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDMedical devices Non-electrically drivenportable infusiondevicesThis British Standardwas published under theauthority of the StandardsPolicy and StrategyCommittee on 28 February2010 BSI
2、2010ISBN 978 0 580 60002 9Amendments/corrigenda issued since publicationDate CommentsBS ISO 28620:2010National forewordThis British Standard is the UK implementation of ISO 28620:2010.The UK participation in its preparation was entrusted to TechnicalCommittee CH/212, IVDs.A list of organizations rep
3、resented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.BS ISO 28620
4、:2010Reference numberISO 28620:2010(E)ISO 2010INTERNATIONAL STANDARD ISO28620First edition2010-02-15Medical devices Non-electrically driven portable infusion devices Dispositifs mdicaux Diffuseurs portables de mdicaments, non mus lectriquement BS ISO 28620:2010ISO 28620:2010(E) PDF disclaimer This P
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8、T ISO 2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISOs member body in
9、 the country of the requester. ISO copyright office Case postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2010 All rights reservedBS ISO 28620:2010ISO 28620:2010(E) ISO 2010 All rights reserved iiiConten
10、ts Page Foreword iv 1 Scope1 2 Normative references1 3 Terms and definitions .2 4 General requirements .3 4.1 Components.3 4.2 Materials .3 4.3 Design and characteristics.4 4.4 Sterility and non-pyrogenicity4 5 Operating requirements4 5.1 Accuracy of the device .4 6 Test methods .5 6.1 General test
11、conditions.5 6.2 Determination of the flow rate6 6.3 Resistance to pressure.7 6.4 Drop test method.7 6.5 Water-tightness of the components of the device.7 6.6 Resistance to traction of the entire device.8 6.7 Bolus volume .8 6.8 Refill time8 7 Information to be listed on packaging and/or product8 8
12、Accompanying documents.9 Bibliography11 BS ISO 28620:2010ISO 28620:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is nor
13、mally 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
14、the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepar
15、e International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that som
16、e 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. ISO 28620 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. BS ISO 2
17、8620:2010INTERNATIONAL STANDARD ISO 28620:2010(E) ISO 2010 All rights reserved 1Medical devices Non-electrically driven portable infusion devices 1 Scope This International Standard specifies essential requirements and related test methods for non-electrically driven portable infusion devices1). It
18、applies to devices designed for continuous (fixed or adjustable) flow and/or for bolus application. These devices can be used in health care and non-health care settings. They can be applied or administered by health care professionals or by the intended patient. These devices can be pre-filled by t
19、he manufacturer or filled before use by a health care professional or the intended patient. This International Standard does not apply to electrically driven or electrically controlled infusion pumps that are covered by IEC 60601-2-24; implantable devices; enteral feeding pumps; transdermal delivery
20、 devices; devices where the energy for infusion is not provided by the device or through active intervention by the patient (e.g. devices only powered by gravity). 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references,
21、only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 594-1, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements ISO 594-2, Conical fitt
22、ings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings ISO 10993 (all parts), Biological evaluation of medical devices ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: Gene
23、ral requirements 1) Thereafter called “device”. BS ISO 28620:2010ISO 28620:2010(E) 2 ISO 2010 All rights reserved3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 bolus discrete volume of solution which is delivered in a short time 3.2 bolus re
24、fill time time required to refill the emptied bolus device to the bolus volume 3.3 nominal bolus refill time bolus refill time indicated by marking on the device or its packaging 3.4 filling volume nominal volume plus residual volume 3.5 residual volume volume remaining in the device and applicable
25、components, after completion of infusion 3.6 instantaneous flow rate ratio, in millilitres per hour (ml/h), between a volume administered and the time necessary to administer it 3.7 mean flow rate ratio, in millilitres per hour (ml/h), between the nominal volume and the actual time for administratio
26、n 3.8 nominal time operating time for administering the nominal volume 3.9 nominal flow rate ratio, in millilitres per hour (ml/h), between the nominal volume and nominal time 3.10 nominal volume volume indicated by marking on the device or its packaging 3.11 nominal bolus volume bolus volume indica
27、ted by marking on the device or its packaging 3.12 portable infusion device equipment intended for the controlled infusion of liquids into the patient and intended to be carried or worn by the patient 3.13 protective packaging configuration of materials designed to prevent damage to the sterile barr
28、ier system and its contents from the time of their assembly until the point of use ISO 11607-1:2006, definition 3.13 BS ISO 28620:2010ISO 28620:2010(E) ISO 2010 All rights reserved 33.14 sterile barrier system minimum package that prevents ingress of microorganisms and allows aseptic presentation of
29、 the product at the point of use ISO 11607-1:2006, definition 3.22 4 General requirements 4.1 Components The device shall contain the following components: an energy source (other than battery); a flow restrictor; a reservoir designed to contain the solution to be administered; a particulate matter
30、filter in the fluid path. NOTE 1 These components can be integrated or separately delivered. The device may also contain one or more of the following components (not an exhaustive list): a system to adjust the flow rate; a filling port preferably with check valve; a 6 % (Luer) conical locking connec
31、tor at the distal end of the tubing; a clamp to stop the flow if necessary; a sterility protector, e.g. Luer cap, at the distal end of the tubing and of the filling site; a system to administer a bolus with a means for controlling the maximum amount of solution infused over time; a protective elemen
32、t of the reservoir, preventing the drug solution from flowing out should the reservoir break or leak (that may be necessary to fulfill the leakage test in 6.4 and 6.5); a means of indicating the end of infusion; NOTE 2 This can be achieved by visual, sound or other indication. administration tubing;
33、 an air-eliminating feature. 4.2 Materials The materials used in the manufacture of the parts that come in contact with the drug solution shall have undergone a biological evaluation according to the pertinent parts of ISO 10993. BS ISO 28620:2010ISO 28620:2010(E) 4 ISO 2010 All rights reserved4.3 D
34、esign and characteristics 4.3.1 General All elements of the device designed to receive the drug shall constitute a closed, water-tight system. This requirement shall be verified by the tests in accordance with 6.3, 6.4, 6.5 and 6.6. If necessary, a redundant mechanism of the reservoir shall be avail
35、able, minimizing the risk of leakage of the solution from the reservoir. 4.3.2 Fittings If fittings at the distal end of the tubing are used they shall be interlocking male fittings. If applicable, the fitting at the filling port shall be an interlocking female fitting. All device fittings designed
36、to be connected to other medical devices or to accessories shall comply with ISO 594-1 and ISO 594-2. 4.3.3 Filter The system shall include a particulate matter filter on the fluid path of the solution. Its pore size shall be less than or equal to 15 m. 4.3.4 Tubing If the device is designed with tu
37、bing it may be fixed or removable. If the tubing is removable, the connection system to the device shall use an interlocking fitting. The junction between the reservoir and the tubing shall resist a static traction of 15 N for 15 s. 4.3.5 Reservoir The reservoir of the device shall be designed so as
38、 to allow visual inspection of the solution. 4.4 Sterility and non-pyrogenicity All parts of the device in contact with the drug solution shall have been subjected to a validated sterilization process and be delivered sterile and non-pyrogenic, and be for single use only. 5 Operating requirements 5.
39、1 Accuracy of the device 5.1.1 Flow rate Each nominal flow rate of the device shall be calibrated using control solutions at a given temperature. The nominal flow rate as well as the control solutions and the temperatures shall be specified in the instructions for use accompanying the device see 8 c
40、) and g). The mean flow rate shall have a tolerance of 15 % compared to the nominal flow rate. The adjustable flow rate shall have a tolerance of 20 %. At least 80 % of the nominal volume shall be delivered at an instantaneous flow rate within 50 % of the nominal flow rate. These requirements shall
41、be verified using the test methods described in Clause 6. NOTE The instantaneous flow rate can deviate by more than 50 % of the nominal flow rate if the device is exposed to external pressure. BS ISO 28620:2010ISO 28620:2010(E) ISO 2010 All rights reserved 55.1.2 Bolus, if applicable The bolus volum
42、e shall be not more than 115 % of the nominal bolus volume (see 6.7). Activating the bolus device after the nominal bolus refill time, the bolus volume shall be in the range of 50 % to 115 % of the nominal bolus volume. Activating the bolus device one or more times prior to the nominal refill time s
43、hall not result in an accumulated bolus volume of more than 150 % of the nominal bolus volume, applying the test method described in 6.8. 6 Test methods 6.1 General test conditions NOTE Except for particular indications, the following provisions are common and applicable before each test. 6.1.1 Appa
44、ratus and reagents 6.1.1.1 Needles, with sizes recommended by the manufacturer, or in the absence thereof, needles with minimum inner diameter of 1,2 mm. 6.1.1.2 Control solutions, recommended by the manufacturer and listed in the accompanying documents see 8 c). 6.1.2 Operating conditions Prepare t
45、he device according to the instructions for use and accompanying documents see 8 c) so that the solution can be administered. Fill the reservoir to the filling volume or as specified by the manufacturer. Perform the tests at the conditions as specified by the manufacturer or, if not specified, at a
46、temperature of (23 2) C at (50 5) % relative humidity, with ambient pressure between 86 kPa and 106 kPa with the reservoir and the distal outlet at the same head height. 6.1.3 Expression of results 6.1.3.1 Mean flow rate The mean flow rate, Qm, is determined by measuring the time, T, necessary for t
47、he device to deliver the majority of the nominal volume, VN, of solution. This volume can be determined by the weight of the solution delivered divided by its density. Qm= V/T (1) where V = 0,75VN (2) 6.1.3.2 Instantaneous flow rates The instantaneous flow rates, Qi, are determined by the volume of
48、the solution, Vn, delivered by the device during regular time intervals, Tn, with Tnbeing 1 % of the nominal time. Qi= Vn/Tn (3) BS ISO 28620:2010ISO 28620:2010(E) 6 ISO 2010 All rights reserved6.1.3.3 Processing of the results Plot the curves Qmand Qi= f(t) allowing the respective fluctuations of t
49、he mean flow rate to be calculated, as well as the instantaneous flow rates on both sides of the characteristic straight line of the nominal flow rate, QN, provided by the manufacturer. Thus, determine the correlation between the differences between the measured value of the mean flow rate of the nominal flow rate, and the various measured values of the instantaneous flow rates of the nominal flow rate based on the requirements in 5.1. 6.2 Determination of the flow rate
