BRITISH STANDARD BS ISO

28620:2010

Medical devices — Non-

electrically driven
portable infusion
devices

ICS 1 1. 040. 20

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW

BS ISO 28620:2010

National foreword

This British Standard is the UK implementation of ISO 28620:2010.

The UK participation in its preparation was entrusted 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.
Compliance with a British Standard cannot confer immunity
from legal obligations.

This British Standard Amendments/corrigenda issued since publication

was published under the
authority of the Standards
Policy and Strategy Date Comments
Committee on 28 February
2010
© BSI 2010

ISBN 978 0 580 60002 9

 BS ISO 28620:2010
INTERNATIONAL I SO

STANDARD 2 862 0

First edition
201 0-02-1 5

M ed i cal d e vi ces — N on -el e ctri cal l y d ri ve n

portabl e i n fu s i on d e vi ces

Dispositifs médicaux — Diffuseurs portables de médicaments, non mus

électriquement

Reference number
ISO 28620:201 0(E)

© ISO 201 0
BS ISO 28620:2010
I S O 2 8 62 0 : 2 0 1 0(E )

P D F d i s cl ai m er

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C O PYRI G H T PRO TE C TED D O C U M E N T

© ISO 201 0
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
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Published in Switzerland

ii © ISO 201 0 – All rights reserved

 BS ISO 28620:2010
I S O 2 8 62 0 : 2 0 1 0(E )

C on ten ts Page

F oreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i v

1 S cope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

2 N orm ati ve referen ces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

3 Term s an d d efi n i ti on s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

4 G en eral req u i rem en ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4. 1 C om pon en ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4. 2 M ateri al s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

4. 3 D es i g n an d ch aracte ri s ti cs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

4. 4 S teri l i ty an d n on -p yrog en i ci ty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

5 O p erati n g req u i rem en ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

5. 1 Accu racy of th e d evi ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

6 Tes t m eth od s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

6. 1 G en eral tes t con d i ti on s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

6. 2 D eterm i n ati on of th e fl ow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

6. 3 Res i s tan ce to pres s u re . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

6. 4 D rop tes t m eth od . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

6. 5 Water-ti g h tn es s of th e co m p on en ts of th e d evi ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

6. 6 Res i s tan ce to tracti on of th e en ti re d evi ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6. 7 B ol u s vol u m e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6. 8 Refi l l ti m e. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

7 I n form ati on to be l i s ted o n packag i n g an d /or p rod u ct . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

8 Accom pan yi n g d ocu m en ts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

B i bl i og raph y . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1

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BS ISO 28620:2010
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F oreword

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.

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 prepare 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 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.

ISO 28620 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment

for medical and pharmaceutical use .

iv © ISO 201 0 – All rights reserved

 BS ISO 28620:2010
I N TE RN ATI O N AL S TAN D ARD I S O 2 8 62 0 : 2 0 1 0(E )

M ed i cal d e vi ces — N on -el e ctri cal l y d ri ve n p ortabl e i n fu s i on

d e vi ces

1 S cope

This International Standard specifies essential requirements and related test methods for non-electrically
driven portable infusion devices 1 ). It 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 the 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 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 N orm ati ve referen ces

The following referenced documents are indispensable for the application of this document. For dated
references, 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 fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —

Part 2: Lock fittings

ISO 1 0993 (all parts), Biological evaluation of medical devices

ISO 1 5223-1 , Medical devices — Symbols to be used with medical device labels, labelling and information to

be supplied — Part 1 : General requirements

1) Thereafter called “device”.

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3 Term s an d d efi n i ti on s

For the purposes of this document, the following terms and definitions apply.

3. 1

b ol u s

discrete volume of solution which is delivered in a short time

3. 2

bol u s refi l l ti m e

time required to refill the emptied bolus device to the bolus volume

3. 3

n om i n al bol u s refi l l ti m e

bolus refill time indicated by marking on the device or its packaging

3. 4

fi l l i n g vol u m e

nominal volume plus residual volume

3. 5

res i d u a l vol u m e

volume remaining in the device and applicable components, after completion of infusion

3. 6

i n s tan tan eou s fl ow rate

ratio, in millilitres per hour (ml/h), between a volume administered and the time necessary to administer it

3. 7

m ean fl ow rate

ratio, in millilitres per hour (ml/h), between the nominal volume and the actual time for administration

3. 8

n om i n al ti m e

operating time for administering the nominal volume

3. 9

n om i n al fl ow rate

ratio, in millilitres per hour (ml/h), between the nominal volume and nominal time

3. 1 0

n om i n al vol u m e

volume indicated by marking on the device or its packaging

3. 1 1

n om i n al b ol u s vol u m e

bolus volume indicated by marking on the device or its packaging

3. 1 2

p ortabl e i n fu s i on d evi ce

equipment intended for the controlled infusion of liquids into the patient and intended to be carried or worn by
the patient

3. 1 3

p rotecti ve p ackag i n g

configuration of materials designed to prevent damage to the sterile barrier system and its contents from the
time of their assembly until the point of use

[ISO 1 1 607-1 :2006, definition 3.1 3]

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3. 1 4

s teri l e b arri e r s ys tem

minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at
the point of use

[ISO 1 1 607-1 :2006, definition 3.22]

4 G en eral req u i rem en ts

4. 1 C om pon en ts

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 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 connector 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 element 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;

⎯ an air-eliminating feature.

4. 2 M ateri al s

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 1 0993.

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4. 3 D es i g n an d ch aracteri sti cs

4. 3. 1 G en eral

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 available, minimizing the risk of leakage of the
solution from the reservoir.

4. 3. 2 F i tti n g s

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 to be connected to other medical devices or to accessories shall comply with
ISO 594-1 and ISO 594-2.

4. 3. 3 F i l ter

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 1 5 µm.

4. 3. 4 Tu bi n g

If the device is designed with tubing 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 1 5 N for 1 5 s.

4. 3. 5 Res e rvoi r

The reservoir of the device shall be designed so as to allow visual inspection of the solution.

4. 4 S teri l i ty an d n on -p yrog en i ci ty

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 Operati n g req u i rem en ts

5. 1 Accu racy of th e d evi ce

5. 1 . 1 F l ow 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) and g)].

The mean flow rate shall have a tolerance of ±1 5 % 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 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.

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5. 1 . 2 B ol u s , i f ap p l i cab l e

The bolus volume shall be not more than 1 1 5 % 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
1 1 5 % of the nominal bolus volume.

Activating the bolus device one or more times prior to the nominal refill time shall not result in an accumulated
bolus volume of more than 1 50 % of the nominal bolus volume, applying the test method described in 6.8.

6 Tes t m eth od s

6. 1 G en eral tes t con d i ti on s

NOTE Except for particular indications, the following provisions are common and applicable before each test.

6. 1 . 1 Ap p a ratu s an d re ag en ts

N eed l e s , with sizes recommended by the manufacturer, or in the absence thereof, needles with
6. 1 . 1 . 1

minimum inner diameter of 1 ,2 mm.

6. 1 . 1 . 2 C on trol sol u ti on s , recommended by the manufacturer and listed in the accompanying

documents [see 8 c)].

6. 1 . 2 Op erati n g con d i ti on s

Prepare the 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 temperature of
(23 ± 2) °C at (50 ± 5) % relative humidity, with ambient pressure between 86 kPa and 1 06 kPa with the
reservoir and the distal outlet at the same head height.

6. 1 . 3 E xp res s i on of res u l ts

6. 1 . 3 . 1 M ean fl ow rate

The mean flow rate, Qm , is determined by measuring the time, T, necessary for the 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′ = 0,75⋅ VN (2)

6. 1 . 3 . 2 I n s tan tan eou s fl ow rates

The instantaneous flow rates, Qi , are determined by the volume of the solution, Vn , delivered by the device
during regular time intervals, Tn , with Tn being 1 % of the nominal time.

Qi = Vn /Tn (3)

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6. 1 . 3 . 3 Proces s i n g of th e re s u l ts

Plot the curves Qm and Qi = f( t) allowing the respective fluctuations of the 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 D eterm i n ati on of th e fl ow rate

6. 2 . 1 Pri n ci p l e

The purpose of this test is to confirm that the difference between the mean flow rate, the instantaneous flow
rates and the nominal flow rate remains within the tolerances defined in 5.1 during the entire administration
time of the solution.

6. 2 . 2 Ap p a ratu s

Apparatus consisting of the elements shown in Figure 1 . A and B shall be positioned at the same level unless
otherwise specified by the manufacturer.

Ke y

1 device to be tested
2 additional components (administration tubing, needle etc.) required by the manufacturer
3 anti-evaporation fluid container
4 electronic scale with appropriate accuracy
5 data processing system

F i g u re 1 — D i ag ram m ati c represen tati on of th e app aratu s u sed for th e d eterm i n ati on of th e fl ow rate

The temperature conditions for the test shall be controlled by placing the entire device or the flow restrictor
within the controlled temperature environment or as specified by the manufacturer.

The distal end of the needle shall be at the same level of the reservoir unless specified otherwise by the
manufacturer.

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6. 2 . 3 P roced u re

Perform the test with zero counter-pressure or with the counter-pressure indicated by the manufacturer.

At time t = 0, start the flow.

NOTE Before starting flow, stabilization might be required following recommendation by the manufacturer.

Take measurements in accordance with 6.1 .3.2 until the solution initially present in the device is totally
delivered.

6. 3 Res i s tan ce to pres s u re

Apply perpendicularly to the device reservoir along its longest axis, a force of 1 50 N, for 5 s, using an adapted
assembly that has two hard parallel plates capable of covering the entire device reservoir.

At the end of the test after the pressure is removed, the device shall comply with the flow rate test in 6.2 and
with the leak-proof test described in 6.5.

6. 4 D rop test m eth od

Let the device filled with a dyed solution to nominal volume, fall twice from a height of one meter, unless
otherwise specified by the manufacturer, over a thick hardwood board (for example > 600 kg/m 3 ), positioning
the device once on its axis, then once perpendicular to its axis.

NOTE A suitable solution is one containing Patent Blue V2) 2 mg/1 00 ml.

At the end of this test the device shall comply with the leak-proof test described in 6.5.

6. 5 Water-ti g h tn es s of th e com pon en ts of th e d evi ce

Other methods equivalent to that described below can be used.

Fill the device with dyed solution to nominal volume and after the drop test, immerse the device for 5 min in a
container of water.

NOTE A suitable solution is one containing Patent Blue V2) 2 mgl/1 00 ml.

If applicable, an air filter should be sealed or kept out of the water.

Under the test conditions described above, the device shall remain watertight, and the solution in the
container shall not become coloured.

2) See Commission Directive 2008/1 28/EC [1 5] .

E 1 31 PATENT BLUE V Definition Patent Blue V consists essentially of the calcium or sodium compound of
[4-( α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1 -ylidene] diethylammonium
hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulfate and/or calcium
sulfate as the principal uncoloured components. The potassium salt is also permitted.
Class Triarylmethane
Colour Index No 42051
Einecs 222-573-8

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6. 6 Res i stan ce to tracti on of th e en ti re d evi ce

Apply a force of 1 5 N for 1 5 s between each of the ends of the device.

At the end of this test, the device shall not show deterioration liable to affect the performance as specified in
5.1 and shall pass the leak-proof test described in 6.5.
6. 7 B ol u s vol u m e

6. 7 . 1 Prepare the device according to 6.1 .2.

6. 7 . 2 Allow sufficient time to fill the reservoir by doubling the nominal refill time. For example, if the device
refill time is 60 min, allow a minimum of 1 20 min to fill the bolus reservoir.
6. 7 . 3Activate the bolus device according to the manufacturer's instructions and measure the volume
delivered.
Repeat readings two additional times with the same device. Calculate the average of the three volume
6. 7 . 4

measurements.
6. 8 Refi l l ti m e

6. 8 . 1 Prepare the device in accordance with 6.1 .2.

6. 8 . 2 Activate the bolus device and allow the bolus device to empty completely.
6. 8 . 3Test 1 : after the nominal bolus refill time, activate the bolus device again. Measure the volume
delivered.
Test 2: after 50 % of the nominal bolus refill time, activate the bolus device again. Measure the
6. 8 . 4

volume delivered.
6. 8 . 5 Repeat readings for both tests two additional times with the same device.
6. 8 . 6 Calculate the average of the three volume measures for both tests.
6. 8 . 7 The average bolus volumes shall be in the range of 50 % to 1 1 5 % of the nominal bolus volume for
the first test, and less than 75 % of the nominal bolus volume for the second test.
EXAMPLE If the nominal bolus volume is 5 ml the result of the second test should be no more than 3,75 ml.

7 I n form ati on to be l i s ted on packag i n g an d /or prod u ct

The information given in Table 1 shall be on the sterile barrier system, the protective packaging and/or the
device, as indicated.

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Tab l e 1 — I n form ati on to b e l i s ted on th e d evi ce, th e steri l e b a rri er s yste m

an d /or th e prote cti ve p ackag i n g

I n form ati on D evi ce S teri l e b arri er P rotecti ve

s ys tem packag i n g

Nominal flow rate in millilitres per hour (ml/h) X X

Nominal filling volume in millilitres (ml) X X
Legible warning or symbol concerning compliance X
with use instructions
If bolus is provided, bolus volume X
Commercial reference (model number) X X
Name and address of manufacturer X X
Designation “Sterile” a X X
Sterilization method X X
Lot number X X
Expiration date (year – month) b X X
Designation “Disposable device”, if appropriate, or X X
corresponding symbol b
Special storage and/or handling conditions if X
appropriate (e.g. temperature, humidity, pressure)
a See regional or national requirements, e.g. EN 556-1 or ANSI/AAMI ST67.
b In accordance with ISO 1 5223-1 .

8 Accom pan yi n g d ocu m en ts

The accompanying documents shall give information on at least the following points:

a) description of the device, its operating principle and tubing length;

b) instructions for use of the device;

c) control solutions used to calibrate nominal flow rate, temperature (see 5.1 ), as well as possible counter-
pressure used at the distal end of the device;

d) flow rate, tolerances and residual volume;

e) drugs with which the device is known to the device manufacturer/producer to be incompatible;

f) if bolus is provided, bolus volume and time to refill the bolus device;

g) all other information needed for correct use of the device (e.g. parallel infusion, flow rate variation due to
temperature variation, flow rate variation due to partial fill or overfill of the reservoir);

h) counter-indications;

i) if appropriate:

⎯ modalities of disinfection;

⎯ a warning about the fact that the performance of the device is reached only with disposable device(s)
recommended by the manufacturer.

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In addition, the results of device specific drug compatibility/stability studies should include at least:

⎯ origin of the data and the studied device;

⎯ concentrations tested for each drug;

⎯ diluents used;

⎯ temperature conditions;

⎯ stability time.

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B i bl i og raph y

[1 ] ISO 554, Standard atmospheres for conditioning and/or testing — Specifications

[2] ISO 1 0555-1 , Sterile, single-use intravascular catheters — Part 1 : General requirements

[3] ISO 1 1 1 35-1 , Sterilization of health care products — Ethylene oxide — Part 1 : Requirements for

development, validation and routine control of a sterilization process for medical devices

[4] ISO 1 1 1 37 (all parts), Sterilization of health care products — Radiation

[5] ISO 1 1 607-1 , Packaging for terminally sterilized medical devices — Part 1 : Requirements for materials,

sterile barrier systems and packaging systems

[6] ISO 1 4937, Sterilization of health care products — General requirements for characterization of a

sterilizing agent and the development, validation and routine control of a sterilization process for

medical devices

[7] ISO 1 7665-1 , Sterilization of health care products — Moist heat — Part 1 : Requirements for the

development, validation and routine control of a sterilization process for medical devices

[8] ISO 80369-1 , Small bore connectors for liquids and gases in healthcare applications — Part 1 :

General requirements

[9] IEC 60601 -2-24, Medical electrical equipment — Part 2-24: Particular requirements for the safety of

infusion pumps and controllers

[1 0] EN 556-1 , Sterilization of medical devices — Requirements for medical devices to be designated

“STERILE” — Part 1 : Requirements for terminally sterilized medical devices

[1 1 ] EN 1 041 , Information supplied by the manufacturer of medical devices

[1 2] EN 1 3868, Catheters — Test methods for kinking of single lumen catheters and medical tubing

[1 3] ANSI/AAMI ST67:2003, Sterilization of health care products — Requirements for products labeled

“STERILE”

[1 4] C APES , D.F. and ASIIMWE , D., Performance of selected flow-restricting infusion devices , Am J Health —
Syst Pharm., 55, pp. 351 -359, 1 998

[1 5] Commission Directive 2008/1 28/EC of 22 December 2008 laying down specific purity criteria
concerning colours for use in foodstuffs

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I CS 1 1 . 0 40 . 2 0

Price based on 1 1 pages

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BS ISO
28620:2010
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