EN ISO 8537:1994

SLOVENSKI STANDARD
01-januar-2000
Sterilne injekcijske brizge za insulin za enkratno uporabo, z iglo ali brez nje (ISO
8537:1991)
Sterile single-use syringes, with or without needle, for insulin (ISO 8537:1991)
Sterile Insulin-Einmalspritzen mit oder ohne Kanüle (ISO 8537:1991)
Seringues a insuline stériles non réutilisables avec ou sans aiguille (ISO 8537:1991)
Ta slovenski standard je istoveten z: EN ISO 8537:1994
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

INTERNATIONAL
STANDARD
First edition
1991-05-01
Sterile single-use syringes, with or without
needle, for insulin
Seringues 5 insuline sf&-iles non r&.dilisables avec ou sans aiguille
Reference number
IS0 8537:1991(E)
IS0 8537:1991(E)
Contents
Page
1 Scope . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .~. 1
2 Normative references . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
3 Definitions and nomenclature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
. . .*.
4 Types of syringe 2
5 Freedom from extraneous matter . . . . . . .I. 3
6 Limits for extractable matter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
7 Lubrication of syringes and needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
8 Range of sizes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
9 Graduated scale . . . . . . . .*. 4
10 Barrel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
11 Piston/plunger assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
12 Nozzle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
13 Needles . . . . .r. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
14 Performance of assembled syringe . 5
...................................................................................... 6
15 Packaging
16 Marking .
Annexes
A Fluid for determination of acidity/alkalinity and extractable
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
metals
B Test method for air leakage past syringe piston during
. . . . . . . . . . . . . . . .*. 9
aspiration
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
B.1 Procedure
8.2 Test report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*.*. 9
. . . . . . . . . . . . . .f. 11
C Test method for force required to operate plunger
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Cl Procedure
0 IS0 1991
All rights reserved. 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 l CH-1211 Geneve 20 l Switzerland
Printed in Switzerland
ii
IS0 8537:1991(E)
C.2 Test report *.
D Properties of needles with external diameter less than 0,45 mm 12
. . . . . . . . . . . . . . . . . . . . . . . . . . 13
E Test method for determination of dead space
E.l Preparation of samples . .-.-. 13
E.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .“. 13
E.3 Calculation of results . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
E.4 Test report
F Test method for liquid leakage at syringe piston and syringe
. . . . . . . . 14
nozzle/hub or needle/barrel unions during compression
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .*. 14
F.l Preparation of samples for testing
F.2 Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F.3 Test report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
G Test method for air leakage past nozz I e/hub or needle/barrel
................................................. ............ 16
unions during aspiration
............................................................ 16
GA Preparation of samples
................................ .................................................. 16
G.2 Procedure
............................................................ ..................... 16
G.3 Test report
H Preparation of extract for test for pyrogenicity and toxicity . 17
J Symbol for “do not re-use” . .
......................... ..................... 18
J-1 General . .
............................................................... 18
J.2 Original design .
....................... 18
J.3 Reduction and enlargement of original design
. . .
Ill
IS0 8537:1991(E)
Foreword
IS0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
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, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. IS0 collaborates closely with the International Electrotechnical
Commission (IEC) on all matters of electrotechnical standardization.
Draft International Standards adopted by the technical committees are
circulated to the member bodies for voting. Publication as an lnter-
national Standard requires approval by at least 75 % of the member
bodies casting a vote.
International Standard IS0 8537 was prepared by Technical Committee
ISO/TC 84, Syringes for medical use and needles for injections.
Annexes A, B, C, D, E, F and G form an integral part of this International
Standard. Annexes H and J are for information only.
iv
IS0 8537:1991(E)
Introduction
This International Standard deals with products primarily intended for
use with humans and provides performance requirements, but permits
some variations of design and of the methods of packaging and
sterilization by individual manufacturers.
Materials to be used for the construction and lubrication of sterile
syringes and needles for single use are not specified as their selection
will depend to some extent upon the design, process of manufacture and
sterilization method employed by individual manufacturers.
Syringes and needles should be manufactured and sterilized in accord-
ance with recognized national or international codes of good manufac-
turing practice for medical devices, and should be free from defects
affecting appearance, safety and serviceability for their intended use.
Certain grades of polypropylene, polystyrene and styrene/acryIonitrile
copolymer have been extensively used for the barrels of sterile syringes
for single use. A high quality natural rubber composition is frequently
used for the piston, although other materials such as silicone rubber are
also used, the surface of the piston being lubricated with
polydimethylsiloxane. For 2 ml syringes, high density polyethylene is
frequently used for the seal of the two-component design of syringe in
combination with a polypropylene barrel containing a fatty acid amide
slip additive.
When selecting materials the following should be considered:
- Clarity of barrel: Materials used in the construction of the wall of the
syringe barrel should be of sufficient clarity to enable dosages to be
read without difficulty and for air bubbles to be seen.
- Compatibility with insulin preparations: The materials of syringes and
needles (including lubricant) and packaging should not, in their final
form after sterilization and under conditions of normal use, detri-
mentally affect the efficacy, safety and acceptability of insulin prep-
arations: neither should the construction materials be themselves
affected physically or chemically by insulin preparations.
- Biocompatibility: The materials should not cause the syringes and
needles to yield, under conditions of normal use, significant amounts
of toxic substances and should permit them to satisfy the appropriate
national requirements or regulations for freedom from pyrogenic
materials and abnormal toxicity. For testing these properties, an ex-
tract as specified in annex H may be used.
It is strongly recommended that regulatory authorities, pharmacopoeiae
and relevant trade associations should recognize the need for further
testing, especially for incompatibility between the insulins and syringes
when they are in contact for prolonged periods.

IS0 8537:1991(E)
countries nation al reg U lations
In some are legally binding and the ir re-
quireme nts may ta ke pre ceden C e over this Interna
tional St andard.
This International Standard describes syringes with or without needles
for use with 40 units of insulin/ml (U-40) and 100 units of insulin/ml
(U-100). It is recommended that syringes graduated for only one strength
of insulin be used in each country to avoid accidents. For those coun-
tries using more than one strength of insulin, the importance of having
individual syringes appropriately graduated for only one strength of
insulin as specified in this International Standard is emphasized. Seri-
ous problems may result if a syringe is used with a strength of insulin
for which it is not designed. If the syringe is used for mixing different
types of insulin, it is strongly recommended that the procedure is per-
formed in the same order each time.
Vi
~~~
IS0 8537:1991 (E)
INTERNATIONAL STANDARD
Sterile single-use syringes, with or without needle, for insulin
IS0 7864:X388, Sterile hypodermic needles for single
1 scope
use.
This International Standard specifies requirements
and test methods for sterile syringes with or without
needles intended for single use solely for the in-
jection of insulin and primarily in humans. It covers 3 Definitions and nomenclature
syringes for use with 40 units of insulin/ml (U-40)
and 100 units of insulin/ml (U-100).
For the purposes of this International Standard, the
following definitions apply. The nomenclature of
Sterile syringes specified in this International Stan-
some components of syringes for single use is given
dard are intended for use soon after filling as they
in figure 1.
are not suitable for containing insulin over extended
periods of time.
3.4 gratuated capacity: Volume of water at 20 OC
+ 3 *C or 27 *C + 3 *C expelled from the syringe
-
2 Normative references
when the fiducial line on the piston traverses a given
scale interval or intervals.
The following standards contain provisions which,
through reference in this text, constitute provisions
3.2 needle cap: Protective end cap intended to
of this International Standard. At the time of publi-
maintain the sterility of the needle tube and to pro-
cation, the editions indicated were valid. All stan-
tect physically the needle tube and needle hub, if
dards are subject to revision, and parties to
present.
agreements based on this International Standard
are encouraged to investigate the possibility of ap-
3.3 needle sheath: Cover intended to provide
plying the most recent editions of the standards in-
physical protection to the needle tube.
dicated below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
3.4 protective end caps: Covers intended to en-
IS0 594-q :I 986, Conical fittings with a 6 o//o (her) ta- close the projecting portion of the plunger and
push-button at one end and the nozzle and/or the
per for syringes, needles and certain other medical
Part I: General requirements. needle at the other end.
equipment -
IS0 8537:1991(E)
4----- Needle cap
Protective end cap
fl-
A------- No;zi;men
Zero line
Barrel
Graduation lines
Nominal capacity
Seals
Finger grips
k
Plunger
I
- Push-button
Protective end cap
NOTE - The drawing is intended to be illustrative of components of
a syringe only. It does not show a detachable needle or a perma-
nently attached needle tube, and does not form part of the specifi-
cation. The piston/plunger assembly may or may not be of integral
construction and may incorporate more than one seal.
Figure 1 - Schematic representation of insulin syringe for single use
Type 2: Syringe having a 6 % (Luer) male conical
4 Types of syringe
fitting, and supplied without a needle and
fitted with protective end caps.
The types of syringe shall be designated as follows
Syringe having a 6 % (Luer) male conical
Type 3:
in relation to their packaging and combinations with
fitting, and supplied with a detached or
needles:
detachable needle and packaged in a
unit container.
Type 1: Syringe having a 6 % (Luer) male conical
fitting, supplied without a needle and
packaged in a unit container.
IS0 8537:1991 (E)
Type 4: Syringe having a 6 % (Luer) male conical
6 Limits for extractable matter
fitting, and supplied with a detachable
needle and fitted with protective end
6.1 Limits for acidity or alkalinity
caps.
The pH value of the extract prepared as described
Type 5: Syringe having a fitting other than a 6 %
in annex A shall be determined with a laboratory
(Luer) taper, supplied with a needle not
potentiometric pH meter using a general purpose
intended to be detached and packaged in
electrode, and shall be within one pH unit of that of
a unit container.
the control fluid.
Type 6: Syringe having a fitting other than a 6 %
(Luer) taper, supplied with a needle not
6.2 Limits for extractable metals
intended to be detached and fitted with
protective end caps.
An extract prepared as described in annex A shall
contain not more than a combined total of 5 mg/kg
Type 7: Syringe with fixed needle tube and pack-
of lead, tin, zinc and iron when tested by a recog-
aged in a unit container.
nized micro-analytical method, for example by an
atomic absorption method. The cadmium content of
Type 8: Syringe with fixed needle tube and fitted
the extract shall be less than 0,l mg/kg.
with protective end caps.
NOTE 1 Eight types are designated to encompass dif-
7 Lubrication of syringes and needles
feren t present ations, but it is likely that the number of
n use in a particular country will be less than eight.
tY Pes If the interior surface of the syringe, including the
piston, and the exterior surface of the needle tube
are lubricated, the lubricant shall not form pools of
fluid on the interior surface of the syringe nor drops
on the exterior surface of the needle tube or in the
bore.
8 Range of sizes
The range of sizes of syringes and graduations shall
5 Freedom from extraneous matter
be as given in table 1.
The surfaces of the syringe and needle which come
NOTE 2 Syringes having different nominat capacities
in contact with insulin shall be clean and free from
and scale intervals are designated to encompass different
extraneous matter when viewed by normal or cor-
presentations, but the number of types in use in a par-
rected vision without magnification. ticular country could be less than those given in table 1.

IS0 8537:1991 (E)
- insulin syringes, range of sizes, graduated scale and tolerance on graduated capacity
Table 1
T
Minimum length
Tolerance on graduated capacity
Unit scale Nominal capacity Scale interval
of scale
Volumes equal to
Volumes less
or greater than
than half the
half the nominal
nominal capacity
capacity
units
ml mm
03 41 1
Ov5 43 1
u-1 00
190 57 1
190 57 2
-& (1 l/2 % of the
095 43 075 nominal capacity + 5 % of the
expelled volume
+ 2 O/o of the
- expelled volume)
095 43 1
u-40 170 50 1
zo 60 1
270 60 2
9.2 Numbering of scale
9 Graduated scale
The graduation lines shall be numbered at every five
units for the 0,3 ml and 0,5 ml syringes and at every
IO units for the I,0 ml and 2,0 ml syringes.
9.1 Scale
The minimum height of the figures should be at least
The scale shall be graduated in units of insulin and
3 mm.
shall refer to one strength of insulin only. The nomi-
nal capacity shall be designated in millilitres (ml).
When the syringe is held vertically with the zero line
uppermost and with the scale to the front, the num-
The tolerances on the graduated capacity shall be
bers shall appear upright on the scale and in a
in accordance with table 1.
position such that they would be bisected by a
prolongation of the graduation lines to which they
NOTE 3 The graduated capacity can be conveniently
relate. The numbers shall be close to, but shall not
determined by weighing the expelled fluid. See 3.1.
touch, the ends of the graduation lines to which they
relate.
The graduation lines shall be of a uniform thickness
between 0,2 mm and 0,4 mm. They shall lie in
planes at right angles to the axis of the barrel. 9.3 Overall length of scale
The graduation lines shall be evenly spaced along
The overall length of the scale shall be in accord-
the longitudinal axis between the zero line and the
ance with table 1.
line for the total graduated capacity.
When the syringe is held vertically, the ends of all
10 Barrel
graduation lines of similar length shall be vertically
beneath each other.
10.1 Dimensions
The length of the short graduation lines shall be ap-
The barrel length shall be such that the syringe has
proximately half the length of the long lines.
a usable capacity of at least 10 % more than the
nominal capacity or 5 mm of plunger travel beyond
The scale and scale numbers should be legible and
the scale marking, whichever is less.
of a colour that contrasts clearly with the syringe.
IS0 8537:1991 (E)
10.2 Finger grips
12 Nozzle
The open end of the barrel shall be provided with
12.1 Conical fitting
finger grips which shall ensure that the syringe will
not roll when it is placed with the scale uppermost
The male conical fitting of the syringe nozzle on
on a flat surface inclined at an angle of IO0 to the
syringe types 1, 2, 3 and 4 shall comply with the re-
horizontal.
quirements of IS0 594-l.
The finger grips shall be free from flash and sharp
edges.
12.2 Position of nozzle on end of barrel
Finger grips should be of adequate size, shape and
The syringe nozzle shall be situated centrally, i.e.
strength for the intended purpose and should enable
shall be co-axial with the barrel.
the syringe to be held securely during use.
13 Needles
11 Piston/plunger assembly
Needles of syringes of types 3, 4, 5, 6, 7 and 8 shall
be of length not less than 12 mm and of external di-
ameter not greater than 0,45 mm. Needles of ex-
11 .l General
ternal diameter 0,45 mm shall be in accordance with
IS0 7864. Needles of external diameter less than
The design of the plunger and push-button of the
0,45 mm shall have the properties given in
syringe shall be such that when the barrel is held in
annex D, as determined by the methods given in
one hand the plunger can be depressed by the
IS0 7864.
thumb of that hand. The piston shall not become
detached from the plunger during the test described
in annex B.
14 Performance of assembled syringe
The projection of the plunger and the configuration
of the push-button should be such as to enable the
14.1 Dead space
plunger, when in the fully inserted position, to be
grasped and drawn back without difficulty.
When tested in accordance with annex E, the dead
space shall not exceed the limits given in table 2.
11.2 Fiducial line
Table 2 - Maximum dead space
There shall be a visible and defined edge serving
Type of syringe Maximum dead space
as the fiducial line at the end of the piston for de-
ml
termining the graduated capacity corresponding to
any syringe scale reading. The fiducial line shall be
in contact with the inn
...