INTERNATIONAL ISO

STANDARD 7886-2
First edition
1996-05-15

Sterile hypodermic syringes for single use —

Part 2:
Syringes for use with power-driven syringe
pumps

Seringues hypodermiques steriles, non reutilisables

Partie 2: Seringues pour pousse-seringues mOs par un moteur

Copyright International Organization for standardization ISO, Geneva, Switzerland. All

rights reserved. This copy has been made by Book Supply Bureau with the permission
from ISO. No resale of this document is permitted. No part of this document may be
copied or reproduced in any form by any means (graphic, electronic or mechanical,
including photocopying, recording, retrieval system), nor made available on
the intemet or any public network without the prior written consent of ISO.

ISO Reference number

ISO 7886-2:1996(E)
!SU 7886-2:11396(E)

Contents
Page

1 Scope 1
2 Normative references 1
3 Definitions 1
4 Nomencicture 1

5 Cleanliness 1

6 Limits for acidity or alkalinity

7 Limits for extractable metals 2

8 Lubricant 2
9 Tolerance on graduated capacity 2

10 Graduated scale 2

11 Syringe design 2
12 Piston/plunger assembly 2

13 Nozzle 3

14 Performance 3

15 Packaging 3
16 Labelling 4

Annexes

A Determination of flow characteristics 5

B Determination of compliance of syringe 10

C Determination of forces required to move the piston 11

D Rationale for flowrate characteristics 13

E Bibliography 14

© ISO 1996
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 the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Geneve 20 • Switzerland
Printed in Switzerland
© ISO ISO 7866-2:1996(E)

Foreword
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 rep-
resented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, aisc take part in the work. ISO
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electiotechnical standardization.

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

ON 01/02/2010
a vote.

International Standard ISO 7886-2 was prepared by Technical Committee

ISOfTC 84, Medical devices for injections, Subcommittee SC 1, Syringes,

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needles and intravascular catheters for single use.

ISO 7886 consists of the following parts, under the general title Sterile
hypodermic syringes for single use:
— Part 1: Syringes for manual use

— Part 2: Syringes for use with power-driven syringe pumps

Annexes A, B and C form an integral part cf this part of ISO 7886. Annexes
D and E are for information only.

ISO 7886 was first published in 1984. It was subsequently decided to

divide it into two parts, ISO 7886-1 retaining essentially the scope of
ISO 7886:1984, and ISO 7886-2 being applicable to sterile, single-use
syringes for use with power-driven pumps.

iii
ISO 7836-2:1996(E) © ISO

fritroduction

1 General

In the preparation of this part of ISO 7886, it was recognized at an early

stage that the absolute criterion of performance is achieved by the combi-
nation of the power-driven syringe pump and the syringe working as a
complete system. The dependence of one element of the system on the
performance of the other is a key factor. It is essential for the manufac-
turer of one of these components to liaise with the manufacturer of the
other when considering changes in design, in order to ensure satisfactory
operation of the system. In particular, when requested by a pump manu-
facturer, a syringe manufacturer should give information on tolerances and
relationships between the syringe dimensions specified in this part cf
ISO 7886 and on performance characteristics, such as force to move the
plunger, and the variations which might be expected.

2 Design criteria

The use of syringes which were initially designed and used as manually-
operated devices in syringe pumps now makes it desirable to achieve
much tighter tolerances on syringe dimensions than normally required for
manual use.

It is understood that the degree of investment worldwide by all syringe

manufacturers in moulding and manufacturing equipment is such that a
change such as modifying diameters of push-buttons or the barrel inside
diameter is largely out of reach of the syringe industry.

Typically the hard height of a syringe has never been regarded as a particu-
larly critical dimension. Its tolerances are ordinarily relatively loose. The
hard-height dimension is a function of not only the total length of plunger
red and the barrel, but also the thickness of the piston and finger grips. The
piston thickness, by virtue of its relatively unsophisticated manufacturing
process, can vary considerably. Because all these components are manu-
factured in multicavity moulds from many moulds around the world, the
cumulative extreme tolerance buildup from cavity to cavity and mould to
mould and location to location is such that these previously noncritical
dimensions cannot be instantly tightened.

3 Syringe identification

It is important that when a syringe is fitted to a syringe pump, the pump is

correctly programmed to perform satisfactorily with the particular syringe
installed.

In view of the consequences of incorrect syringe identification by the

pump, the need lor an automatic system is recognized. Methods already in

iv
© ISO ISO 7886-2:1996(E)

use, such as mechanical sensing of the syringe outside diameter, are not
deemed feasible in the long term. This is due to overlapping ranges of
diameter of syringes produced by different manufacturers, and the lack of
relationship between the outside and inside diameters of a syringe. It is
also recognized that standardization of syringe barrel diameters across the
industry is not a realistic option.

A means by which the pump could automatically identify the syringe model
and use this to programme such information as barrel inside diameter,
plunger force and occlusion alarm settings is seen as the next stage of this
part of ISO 7886. A possible method of recognition is to identify the syr-
inge and nominal capacity by means of a marking code on the barrel,
printed at the same time as the syringe scale, and to use this to pro-
gramme the pump automatically. It is recommended that development of
such a system be worked on as soon as possible.

010
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INTERNATIONAL STANDARD © ISO ISO 7886-2:1996(E)
-•■■
•=a1m110••■

Sterile hypodermic syringes for singie use

Part 2:
Syringes for use with power-driven syringe pumps

1 Scope ISO 3696:1987, Water for analytical laboratory use —

Specification and test methods.
This part of ISO 7886 specifies requirements for
sterile single-use hypodermic syringes of nominal ISO 7864:1993, Sterile hypodermic needles for single
capacity 5 ml and above, made of plastics materials use.

LIMITED - VADODARAON 01/02/20 10

and intended for use with power-driven syringe
ISO 7886-1:1993, Sterile hypodermic syringes for
pumps. single use — Part 1: Syringes for manual use.
This part of ISO 7886 does not apply to syringes for
use with insulin (specified in ISO 8537), single-use ISO 8601:1988, Data elements and interchange
syrinaes made of glass (specified in ISO 595), syr- formats — Information interchange — Representation
inges prefilled with the injection by the manufacturer of dates and times.
and syringes supplied with the injection as a kit for
filling by a pharmacist. It does not address compati- IEC 601-2-24:-11, Medical electrical equipment —
Part 2: Particular requirements for safety of infusion
bility with injection fluids.
pumps and controllers.

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2 Normative references 3 Definitions
The following standards contain provisions which,
through reference in this text, constitute provisions of For the purposes of this part of ISO 7886, the defi-
this part of ISO 7886. At the time of publication, the nitions given in ISO 7886-1 apply.
editions indicated were valid. All standards are subject
to revision, and parties to agreements based on this
part of ISO 7886 are encouraged to investigate the 4 Nomenclature
possibility of applying the most recent editions of the
standards indicated below. Members of IEC and ISO Clause 4 of ISO 7886-1:1993 shall apply.
maintain registers of currently valid International
Standards.
5 Cleanliness
ISO 594-1:1986, Conical fittings with a 6 % (Luer)
taper for syringes, needles and certain other medical Clause 5 of ISO 7886-1:1993 shall apply.
equipment — Part 1: General requirements.

ISO 594-2:1990, Conical fittings with a 6 % (Luer) 6 Limits for acidity or alkalinity
taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings. Clause 6 of ISO 7883-1:1993 shall apply.

1) To be published .

1
 © ISO
!SO 7586-2:1996(E)

Dimensions in millimetres
/ Limits for extractable mPtals 1:

Clause 7 of ISO 7886-1: i 993 shall apply. S

T
ti
8 Lubricant t(

Clause 8 of ISO 7886-1:1993 shall apply.

9 Tolerance on graduated capacity

Clause 9 of ISO 7886-1 .1993 shall apply. 1

10 Graduated scale

Clause 10 of ISO 7886-1:1993 shall apply.

11 Syringe design G 1
0
itical dimensions for the fit of the syringe in a syr-
inge bump shall be designated as shown in figure 1
and shall be as given in table 1.
cz)
All other dimensional and design requirements shall
be as specified in ISO 7886-1.

The push-button should be of such a design as to

inhibit neither the fit in a syringe pump driver mech- 0J
anism designed to accept a flat push-button nor de-
tection by a built-in detection device. A Mean inside diameter of the barrel over the swept
volume.

12 Piston/plunger assembly B Distance of the projection of the finger grips from the
outside surface of the barrel.

12.1 Design C Thickness of the finger grips.

NOTE — The finger grips should not be tapered.
The components of the syringe should be designed in
such a manner that it is not possible easily to with- D Distance from the surface of the finger grips nearer to
draw the plunger completely from the barrel. the push-button to the surface of the push-button
further from the finger grips when the fiducial line of
the piston coincides with the zero line of the scale.
Table 1
E Projection of the push-button beyond the outer dimen-
Syringe dimensions sion of the plunger ribs.

Toler- F Overall thickness of the push-button (including ribs,

ance on etc., if present).
Nominal
capacity A B C D E F
G Outside diameter of the barrel measured at a distance
min. max. min. min. max. of 10 mm from the underside of the finger grips.
ml ± `)/0 mm mm mm mm mm
H Hard height (C + D).
.--- 5 and < 10 1 4 3 10 2 3
1 4 3 10 2 3 J Diameter of push-button.
_.-- 10 and < 20
?.-. 20 and < 30 1 4 3 10 2 4 Luer lock fitting.
..- 30 and < 50 0,5 4 3,5 10 2 4
.--- 50 0,5 4 3,5 10 2 4 Figure 1 — Designation of dimensions

2
 IS0
c ISO ISO 7883-2:1996(E)

netres
12.2 Fit of the piston in the barrel Table 2

Subclause 12.2 of ISO 7886-1:1993 shall apply. Maximum variation In I

Observation lime window
flowrate
The fit of the piston on the plunger should be such min %
that relative axial movement between the two is kept
2 r5
to a minimum in order to reduce the possibility of
siphoning. 5 ±2

Table 3
13 Nozzle
Maximum displacement of fluid
ml
13.1 Conical fitting
Syringe
Test pressure
nominal
The male conical fitting of the syringe nozzle shall be capacity kPall
in accordance with ISO 594-i and shall have a iocking
fitting in accordance with ISO 594-2. ml 7 40 70 90 133
..- 5 and < 10 0,03 0,1 0,15 0,2 0,25
13.2 Nozzle lumen -••• 10 and < 20 0,1 0,2 0,3 0,35 0,4
..-- 20 and <30 0,1 0,4 0,6 0,8 0,9
The nozzle lumen shall have a diameter of not less ..-. 30 and < 50 0,1 0,4 0,6 0,8 0,9
than 1,2 mm. ---- 50 0,4 1,2 1,5 1,8 2,1
1) 1 kPa = 7,5 mmH,0 (approx.) = 0,145 lbfiin2 (p.s.i.) (approx.).

14 Performance

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14.5 Plunger movement forces
14.1 Dead space
When tested as described in annex C, the maximum
Subclause 14.1 of ISO 7886-1:1993 shall apply. force (inclusive of any variation) required to initiate
movement of the piston, the maximum sustaining
force and the maximum allowable variation of the
14.2 Freedom from air and liquid leakage past sustaining force shall be as given in table 4.
the piston
Table 4
Subclause 14.2 of ISO 7886-1:1993 shall apply.
Piston movement forces

14.3 Flow characteristics Force to Total

Flowrate Sustaining variation in
initiate
movement force, max. sustaining
14.3.1 When tested as described in annex A at a
force, max.
flowrate of 1 ml/h, the maximum time lag from initiat- ml/h N1l N %
ing plunger push-button movement to achieving a
steady flowrate of at least 95 % of the set flowrate 1 30 20 20
shall not exceed 10 min. 5 30 15 15

14.3.2 When tested as described in annex A, the 99,9 30 15 10

overall percentage error of the flow/set delivery rate 1) 1 N = 0,224 lbf lapprox I
shall not exceed ± 2 % at both the flowrates given in
A.4.

14.3.3 When tested as described in annex A, the 15 Packaging

maximum variation in flowrate when measured at
two observation-time windows shall be as shown in
table 2 at both the flowrates given in A.4. 15.1 Primary container

Eauh syringe shall be sealed in a primary container.

14.4 Compliance of syringe
The materials of the container should not have detri-
When tested as described in annex B, the maximum mental effects on the contents, and the material and
displacement of fluid shall be as given in table 3. design of the container should be such es to ensure:

3
ISO 7886-2:1996(E) © ISO

a) the maintenance of sterility of the contents under b) the model identification, if a manufacturer offers
dry, clean and adequately ventilated storage con- mare than one product of the same nominal ca-
ditions; pacity.

b) the minimum risk of contamination of the con-

tents during opening of the container and removal
16.2 Secondary container
of the contents;

c) adequate protection of the contents during normal The secondary container shall be marked in accord-
handling, transit and storage; ance with ISO 7886-1 and with the information listed
in 16.1 a) and b).
d) that once opened, the container cannot be easily
resealed, and it should be obvious that the con-
tainer has been opened.
16.3 Storage container

15.2 Secondary container if a storage container is used, subclause 16.3 of

ISO 7886-1:1993 sha!! apply.
One or more primary containers shall be packaged in
a secondary container. The storage container shall be marked with the
statement "Suitable for use with power-driven syringe
The secondary container should be sufficiently robust pumps" or equivalent
to protect the contents during normal handling, transit
and storage.
16.4 Transport wrapping
NOTE — One or more secondary containers may be pack-
aged in a storage and/or transit container.
Subclause 16.4 of ISO 7886-1:1993 shall apply.

16 Labelling
16.5 Syringe barrel

16.1 Primary container The syringe barrel shall be marked with:

The primary container shall be marked in accordance a) the manufacturer's name or logo;
with ISO 7886-1 and with the following information:
b) the model identification, if a manufacturer offers
a) the statement "Suitable for use with power-driven more than one product of the same nominal Ca-
syringe pumps" or equivalent; nacity.

4
© ISO ISO 7886-2:19961E)

Annex A
(normative)

Determination of flow characteristics

A.1 Principle c) capable of accepting syringes of the nominal

capacities specified in this part of ISO 7886 and
Flow characteristics of the syringe (i.e. the time taken providing appropriate clamping of barrel and push-
to achieve a steady flowrate, the overall percentage button (both sides) in accordance with the dimen-
sions of these components specified in this part
error of the flow/set delivery rate and the maximum
variation in flowrate) are determined by measuring the of ISO 7886.
flowrate produced by the use of a reference syringe
driver. A.3.2 Distilled water, complying with grade 3 of
ISO 3696.

A.2 General requirements

A.3.3 Test rig, as shown in figure A.1.
A.2.1 Perform tests as described in subclause 50.4
of IEC 601-2-24.

A.2.2 Perform tests at a temperature constant to A.4 Procedure

± 1 °C, preferably (20 ± 1) °C. If tests are performed at

ON 01/02/2 010
a different constant temperature, correct the results
to 20 °C. A.4.1 Time lag to achieve steady fiowrate

A.2.3 Equilibrate the syringe, distilled water and

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apparatus at the chosen test temperature for 4 h A.4.1.1 Fill the syringe with distilled water (A.3.2) to
before testing. beyond its nominal capacity. Invert the syringe so that
the nozzle lumen is uppermost and depress the
plunger to eject any air bubbles in the syringe. Attach
the extension set shown in figure A.1 and the 1,2 mm
A.3 Apparatus
(18G) needle.
A.3.1 Reference syringe driver, having the follow-
ing characteristics: A.4.1.2 Mount the syringe in the test driver (A.3.1)
as shown in figure A.1.
a) constant long-term linear drive accuracy equal to
or better than ± 0,1 % of set drive rate, measured
over a period of 60 min at drive rates essentially A.4.1.3 Prime the line by running the test driver at a
equivalent to flowrates of 1 ml/h, 5 ml/h and fairly high rate until drops of water appear steadily at
100 ml/h; the end of the needle and the fiducial line of the
plunger is at the nominal capacity mark of the syringe.
NOTE — Actual linear drive rates should be determined Turn off the drive.
for all relevant syringe nominal capacities and brands to
achieve flowrates closely approximating those speci-
fied. A.4.1.4 Fill the beaker on the balance pan with a
small volume of distilled water and pour in approxi-
b) short-term variation in drive accuracy as follows: mately 10 ml of colourless heavy liquid paraffin to
form a layer preventing evaporative loss.
1) any 1-min period: equal to or better than
± 0,5 % of mean drive
rate. Suspend the needle over the beaker (without mech-
anical contact with the balance) and position the tip of
2) any 2-min period: equal to or better than the needle so that it is below the paraffin layer but
± 0,25 % of mean just inside the water layer without touching any part
drive rate. of the beaker.

3) any period of > 5 min: equal to or better than

± 0,1 % of mean drive A.4.1.5 Allow the balance to stabilize for 5 min and
rate. when it has stabilized, tare it.

5
ISO 7886-2:1996(E) © ISO

NOTES A.4.1.7 Switch on the drive and begin the test period
at this instant. Allow the test to continue for a period
1 The balance should be tared just prior to starting the
of 2 h.
equipment, because the tare cycle takes a finite time and
the balance has to settle prior to starting the test.
A.4.1.8 Compute the flowrate at 0,5-min successive
2 The electronic balance shown in figure A.1 should be intervals and plot the tlowrate in ml/h against time, in
placed on an antivibretion mount and be protected from minutes, with a solid line on the graph (see A.4.4.1).
shock, vibration and draughts. The temperature should be Mark the 1 ml/h set flowrate on the graph using a
controlled during the tests as specified in A.2.2. dotted line (see figure A.2).

A.4.1.6 Set the test driver to a rate equivalent to a A.4.1.9 Determine the time taken from the instant of
flowrate of 1 mlih in the syringe under test. Set the start-up to achieve a steady flowrate by recording the
sampling interval of the computer to 0,5 min. time to reach 95 % of the set flowrate (see 14.3.1).

1 3 7 4 6

1 Syringe under test

2 Reference syringe driver (see A.3.1)
3 Administration set (1,2 mm i.d. x 1 m polyethylene tubing)
4 Needle [1,2 mm (18G) x approximately 10 cm length)
5 Electronic balance, accurate to four decimal places
6 Digital computer
7 Constant liquid level

Figure A.1 — Test apparatus for determination of flowrate characteristics

Flowra te, 0, (m l /h )

1.5

"-- Set delivery flowrate (qv)

0,5

- 0,5
120
Test period, t (min)

Figure A.2 — Example of data gathered during first two hours of test

6
© ISO ISO 7886-2:1996(E)

A.4.2 Overa!! percentage flovvrate error where

is the 1, 2, .., tits;

A.4.2.1 Repeat the test in A.4.1 at drive rates
equivalent to a flowrate of 2.5 ml/h for syringes of
m is the total mass, expressed in grams
nominal capacity of 5 ml, and to 5 ml/h for all ether
nominal capacities. (corrected for evaporative loss);

mi is the ith sample mass, expressed in

A.4.2.2 Determine the overall percentage flowrate
error during the second hour of the test (see A.4.4 for grams, from the analysis period t
calculations). (corrected for evaporative loss);

is the analysis period, expressed in min-

A.4.3 Maximum variation in flow utes (60 min);
Determine the maximum percentage variation in
t, is the sampling interval, expressed in min-
flowrate during the second hour of the test computed
utes (0,5 min);
from the data obtained in the test of A.4.2.1 (see
A.4.4 for calculations). Plot the percentage variation in
flowrate against observation-time window as illus- is the). density of water (0,998 g/m1 at
2
trated in figure A.3. 0 °C

A.4.4 Calculation of results A.4.4.2 Calculate Ep(max) and Eomin) for the 2-min
and 5-min observation-time windows using equations
A.4.4.1 Calculate the actual flowrate Qi , in millilitres
(2) and (3) respectively, over the analysis period t1
per hour, for each sampling interval for the first
(minutes) of the second hour of the test period.
120 min of the test period using equation (1).

Calculate Eomax) and Eomin) using the trumpet algor-

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6G (m, – mi _ 1 )
(1) ithm as follows:
rp

Set delivery flowrate (qv)

Overall error. A (V
-5

E p Irntr,)
- 10
[tilt
1 2 3 L 5 32

Observation window, t w (min)

Figure A.3 — Example of plot of data gathered during second hour of test

7
ISO 7866-2:1996(E)

For observation windows of duration t,= 2 min and where

5 min, within the analysis period t, there are a maxi-
mum of a observation windows, such that: qv is the set flowrate, expressed in millilitres
per hour;
11- tw)
n= +1
is is the total mass (corrected for evaporative
loss), expressed in grams;
whei e
m is the sample mass, expressed in grams, at
is the maximum number of observation the end of analysis period t1 (where
windows; j = 240);
tw is the observation window duration, ex- mk is the sample mass, expressed in grams, at
pressed in minutes;
the start of analysis period t1 (where
is is the sampling interval, expressed in min- k = 120);
utes (0,5 min).
p is the density of water (0,998 g/ml at
The maximum Ep(max) and minimum Eplmin) percent- 20 °C).
aoe variations within an observation window of dur-
A.4.4.4 Plot the following graphs using a linear scale
ation period tw minutes are given by:
with scale ratios as follows:
j+ where
E p(max) = MAX [—L
t — qv (100) ... (2)
j=1 tw j qv qv is the set flowrate.

For the.start-up graph, the flowrate axis shall show.

tw/ts -,
ts maximum = 2qv
E p( mi n ) = MIN — qv (100) ... (3)
=1 L tw . . qv
minimum = —0,2qv

60 (mi— m, _ 1) scale increment = 0,2qv

=
ts p time = 0 min — 120 min (10-min in-
tervals)
where
For the trumpet graph, the flowrate axis shall show:
m1 is the ith sample mass, expressed in
grams, from the analysis period t (cor- maximum = 15 %
rected for evaporative loss); minimum = —15 %

qv is the set flowrate, expressed in millilitres; scale increment = 5 %

is is the sampling interval, expressed in min- time = 0 min — 31 min (1-min inter-
utes; vals)
tw is the observation window duration, ex- Plot flowrate Q, (ml/h) against time t (minutes) for the
pressed in minutes; first two hours of the test period (see example in
figure A.2). Indicate the set flowrate by means of a
p is the density of water (0,998 g/ml at broken line. Indicate flowrate Qi by means of a solid
20 °C). line.

A.4.4.3 Calculate the overall mean percentage Plot percentage variation Ep(maxl and Ep(min) against
flowrate error A using the following expression where observation window duration t, (minutes) and the
A is measured over the analysis period t, (the second overall mean percentage error A [derived from
hour of the test period): equation (4)1 measured over the analysis period ti
(minutes) of the second hour of the test period (see
100(Q— qv) example in figure A.3).
A=
qv
Indicate Ep(m„) and Ep(min) and the overall mean
60 (m — mk percentage flowrate error A by means of a solid line.
Q= i (nl/h)
tip Indicate the zero error by means of a dotted line.

8
c ISO ISO 7886-2:1996(E)

A.5 Test report b) the time, in minutes, taken to achieve a steady

flowrate;
The test report shall include at least the following
c) the overall percentage flowrate error;
information:
d) the maximum variation in flowrate at 2-min and
al the identity of the syringe; 5-min observation windows.

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9
ISO 7886-2:1996(E) © ISO

Annex B
(normative)

Determination of compliance of syringe

B.1 Principle B.3.3 By means of the three-way valve, isolate the

syringe under test from the pressurizing syringe and
The compliance of the syringe (i.e. the amount by the pressure gauge.
which the nominal capacity of the syringe changes
when an internal hydraulic pressure is applied) is B.3.4 Use the pressurizing syringe to exert in turn
measured by recording the volume of liquid intro- the test pressures in the fluid system given in table 3.
duced into a full syringe in order to generate specified
hydraulic pressures within the syringe. B.3.5 Note the maximum volume displaced in the
pressurizing syringe to achieve each of the test press-
B_2 Apparatus ures.

B.2.1 Test apparatus, as shown in figure B.1. For B.3.6 By means of the three-way valve, connect the
syringes under test of nominal capacity less than syringe under test to the pressurizing syringe and the
50 ml, use a 1-ml pressurizing syringe. For syringes pressure gauge.
under test of nominal capacity 50 ml and above, use a
5-ml pressurizing syringe. B.3.7 Repeat B.3.4 and B.3.5. Calculate the differ-
ence between the volumes recorded in B.3.5 and
B.2.2 Distilled water, complying with grade 3 of B.3 7 for each test pressure and record it as the
ISO 3696. compliance of the syringe under test at that pressure.

B.3 Procedure B.4 Test report

B.3.1 Purge the syringe under test and fill it to its
The test report shall include at least the following
nominal capacity with distilled water (B.2.2). Ensure
information:
that all air is excluded from the system.
a) the identity of the syringe;
B.3.2 Connect the syringe under test to the test
apparatus (B.2.1) and rigidly clamp the plunger so that b) the volumes recorded in B.3.7 for each test press-
it cannot be moved within the barrel. ure.

0%11 ///,

1 4- 3 5
1 Pressurizing syringe with fine graduations
2 Pressure gauge
3 Syringe under test
4 Three-way valve
5 Nominal capacity mark
6 Securing clamp
Figure B.1 — Apparatus for determination of compliance

10
© ISO ISO 7886-2:1996(E)

Annex C
(normative)

Determination of forces required to move the piston

C.1 Principle C.3.11 Ploi the forces required tc move the piston
during the second half of the test period.
A mechanical testing machine is used to expel water
while the force to move the piston is being recorded. C.3.12 For large syringes (i.e. greater than 30 ml
nominal capacity) and at low flowrates (i.e. less than
5 ml/h), repeat C.3.2 to C.3.11 three times, with the
fiducial line of the piston set at three different points
C.2 Apparatus along the syringe barrel, once for each setting.

C.2.1 Mechanical testing machine, as shown in

figure C.1, capable of attachment to the syringe under
test and of depressing the syringe piston at a con-
C.4 Calculation of results
stant linear rate, while at the same time continuously
measuring and recording the force with an accuracy For each flowrate, determine
of 1 % of full-scale reading.
a) the force required to initiate movement of the
piston;
C.2.2 Distilled water, complying with grade 3 of
ISO 3696. h) the maximum force (Froax ) required to sustain

LIM ITED - VADODARAON01/02/20 10

movement of the piston. Disregard that portion of
the trace that relates to the passage of the piston
C.3 Procedure through the parking position;

Record the position of the piston seal in the c) the minimum force (Fmi n) required to sustain
C.3.1
movement of the piston. Disregard that portion of
barrel.
the trace that relates to the passage of the piston
through the parking position;
C.3.2 Fill the syringe with water (C.2.2) to beyond
the nominal capacity. d) the range of forces (F,x — Fmi n);

C.3.3 Attach the administration set and needle as e) the maximum total variation. expressed as a

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.
shown in figure Cl. percentage, using the expression:

C.3.4 Expel water until the fiducial line of the piston (Fmax — Fmin) 100
is at the nominal capacity mark of the syringe.
Fmax
C.3.5 Mount the syringe in the test fixture and
clamp the push-button to the driving head of the
mechanical testing machine (C.2.1). C.5 Test report

C.3.6 Set the translation speed of the piston to be The test report shall include at least the following
equivalent to the desired volumetric flowrate. information:

C.3.7 Wait 30 s. a) the identity of the syringe;

b) the force required to initiate movement of the

C.3.8 Start the testing machine.
piston;

C.3.9 Measure and note the force required to initiate c) the minimum and maximum forces required to
movement of the piston. sustain movement of the piston;

C.3.10 Expel water for a period of 2 h, or until the d) the maximum total percentage variation of the
syringe is empty, whichever is shorter. sustaining force.

11
ISO /886-2:1990(E)
© ISO

Ii

oll

1 Water level adjusted graduation mark at 50 % of nominal capacity of syringe

2 Needle [1,2 mm (18G) x approximately 10 cm length;
3 Administration set (1,2 mm i.d. x 1 m polyethylene tubing)

Figure C.1 — Apparatus for determination of force to move piston

12
© ISO ISO 7886-2:1996(E)

Annex D
(informative)

Rationale for flowrate characteristics

D.1 Long-term accuracy measurements, it is reasonable to assume that the

maximum allowable for a 1-min observation window
In order to comply with this part of ISO 7886, the would have been ± 10 %, although measurements
overall percentage error of the flow/set delivery rate will only be taken for the 2-min and 5-min windows.
of the syringe tested is not to exceed ± 2 % when
measured over a period of 1 h (see 14.3.2). Using the same philosophy as for long-term accuracy,
the short-term accuracy required is as specified
The test instrumentation is required to have an in- above. Note that accuracy has also been specified for
herent accuracy at least one order of magnitude observation windows greater than 5 min to ensure
better than this, in order to keep measurement errors that there are no long cycles giving rise to excessive
to a minimum. The accuracy required is therefore one- measurement errors.
tenth of ± 2 % divided by a factor of 2, giving a speci-
fication of ± 0,1 %.
D.3 Feasibility of design

D.2 Short-term accuracy It is assumed that the reference syringe driver will be
calibrated periodically and a certificate of accuracy
In order to comply with this part of ISO 7886, the provided. Design of such a device is regarded as

VADODARAON 01/0 2/2010

maximum variation in flowrate is ± 5 % for a 2-min being realistic. and the device could be calibrated
observation window and ± 2 % for a 5-min obser- using a remote (no-contact) linear measurement
vation window (see 14.3.3). With experience of these transducer of sufficient resolution.

SUPPL IEDBYBSBUN DERLI CENCEFROMI SOF ORSU NPHAR MACEUTICALI N DUST RIES LI MITED -

13
ISO 7886.-2:1396(E) © 'so

Annex E
(informative)

Bib!iography

(11 ISO 595-1:1986, Reusable all-glass or metal-and-glass syringes for medical use — Part 1: Dimensions.

121 iSO 595-2:1987, Reusable all-glass or metal-and-glass syringes for medical use — Part 2: Design, perform-
ance requirements and tests.

(31 ISO 8537:1991, Sterile single-use syringes, with or without needle, for insulin.

14
 Auelq -01 Ancuopap ;Bed sNi

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ISO 7836-2:1996(E) ©

ICS 11.040.20
Descriptors: medical equipment, sterile equipment, disposable equipment, syringes, specifications, performance, dimensions, tests,
packaging, labelling.

Price based on 14 pages