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
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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
