Medicaldevices-Non- electricallydriven portableinfusion devices
Nationalforeword
This British Standardwas published under the authority of tbe StandardsCommittee on 28 February Policy and Strategy2010
BSI 2010
ISBN 978 0 580 60002 9
This British Standard is the UK implementation of ISO 28620:2010.
The UK participation in its preparation was entrusted to TechnicalCommittee CH/212 IVDs.
request to its secretary. A list of organizations represented on this mittee can be obtained on
This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.
from legal obligations. Compliance with a British Standard cannot confer immunity
Amendments/corrigenda issued since publication
CommentsDate
INTERNATIONAL STANDARD
First edition2010-02-15
portableinfusiondevices Medicaldevices-Non-electricallydriven
Dispositifs medicaux -Diffuseurs portables de medicaments non mus6lectriquement
PDF disclaimer
pq paman Jo pogud aq Aew ogy sug fayod Sursuaol spcopy um souepuosse ul sosejadk poppaqwo ujeuco feu aly dOd su shall not be edited unless the typefaces which are embedded are licensed to and installed on the puter performing the editing. Indownloading this fle parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liabity in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Detalls of the sofware products used to create this PDF fle can be found in the General Info relative to thefle; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the fle is suitable for use by ISO member bodies. Inthe unlikely event that a problem relating to it is found please inform the Central Secretariat at the address given below.
COPYRIGHTPROTECTEDDOCUMENT
ISO 2010
su ue Aq so woy Aue u pzn ao pnpdau aq Ae uogend s jo ued ou paods asmo sseun paas suu electronic or mechanical including photocopying end microfim without pemission in writing from either ISO at the address below orISO's member body in the country of the requester.
ISO copyright officeCase postale 56 ● CH-1211 Geneva 20 Tel. 41 22 749 01 11Fax 41 22 749 09 47 E-mail copyright@iso.orgPublished in Switzerland Web
Contents
Foreword Iv1 Scope....2 Normative references..3 4 Terms and definitions ...... Generalrequsrerment.... .3 24.1 Components..4.2 4.3 Materials... Design and characteristics. 34.4 Sterility and non-pyrogenicity. .45 5.1 Operating requirements. Accuracy of the device ... 4 46 Testmethods. .56.1 6.2 General test conditions Determination of the flowrate.. 5 66.3 6.4 Resistance to pressure.... Drop test method... .7 .76.5 Water-tightness of the ponents of the device...6.7 6.6 Bolus volume... Resistance to traction of the entire device. .8 86.8 Refill time... Information to be listed on packaging and/or product.7 8 Acpanying document..Bibliography... 11 .9