ISO 8536-4:1987
(Main)Infusion equipment for medical use — Part 4: Infusion sets for single use
Infusion equipment for medical use — Part 4: Infusion sets for single use
Matériel de perfusion à usage médical — Partie 4: Appareils de perfusion non réutilisables
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Standards Content (Sample)
IS0
INTERNATIONAL STANDARD 8536-4
First edition
1987- 1 1-01
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ORGANISATION INTERNATIONALE DE NORMALISATION
MEXAYHAPOAHAR OPrAHM3AL&'lR il0 CTAHAAPTMSAUMM
Infusion equipment for medical use -
Part 4:
Infusion sets for single use
Matériel de perfusion à usage médical -
Partie 4: Appareils pour perfusion non réutilisables
leference number
SO 8536-4: 1987 (E)
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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.
Draft International Standards adopted by the technical committees are circulated to
the member bodies for approval before their acceptance as International Standards by
the IS0 Council. They are approved in accordance with IS0 procedures requiring at
least 75 % approval by the member bodies voting.
International Standard IS0 8536-4 was prepared by Technical Committee ISO/TC 76,
Transfusion, infusion and injection equipment for medical use.
IS0 8536-4 is a revision, in part, of IS0 1135: 197ï'; this first edition of IS0 8536-4
together with the other parts of IS0 8536 and IS0 1135 will cancel and replace
IS0 1135: 1977.
Users should note that all International Standards undergo revision from time to time
and that any reference made herein to any other International Standard implies its
latest edition, unless otherwise stated.
O International Organization for Standardization, 1987
Printed in Switzerland
ii
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IS0 8536-4 : 1987 (E)
Contents
Page
1 Scope and field of application . 1
2 References .
1
3 General requirements .
1
4 Materials .
3
5 Physical requirements .
3
6 Chemical requirements .
4
7 Biological requirements .
4
8 Marking and labelling .
5
9 Packaging .
5
Annexes
A Test for integrity .
6
B Test for efficiency of the fluid filter . 6
C
Testing of the injection site . 8
D Chemical tests on the extract .
8
E Biological tests .
10
iii
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IS0 8536-4 : 1987 (E)
INTERNATIONAL STANDARD
Infusion equipment for medical use -
O ~art4:
Infusion sets for single use
1 Scope and field of application
2 References
IS0 594-1, Conical fittings with a 6 % (Lueri taper for syringes,
This part of IS0 8536 specifies requirements for types of single-
needles and certain other medical equipment - Part 1: General
use infusion sets for medical use in order to ensure compati-
requirements.
bility of use with containers for infusion solutions and intra-
venous equipment.
IS0 594-2, Conical fittings with a 6 % (Luer) taper for syringes,
needles and certain other medical equipment - Part 2: Lock
The materials and components of the sets are validated by
fittings. 1 )
various test methods (type tests) and, in addition, tests are per-
formed for the release of lots of finished sets (lot tests).
IS0 3696, Water for analytical laboratory use - Specifications
and test methods.
i. The manufacturer shall select appropriate test methods to
comply with the requirements laid down in this part of
IS0 8536.
3 General requirements
Secondary aims of this part of IS0 8536 are to provide
3.1 Components for use with infusion containers
specifications relating to the quality and performance of
a)
3.1.1 The infusion set shall consist of the components as
materials used in infusion sets;
illustrated in figures 1 and 2.
b) a unified presentation of terms and designations for
3.1.2 Infusion sets as illustrated in figure 2 shall be used for
infusion sets.
collapsible plastics containers.
In some countries, the national pharmacopoeia or other
3.1.3 Infusion sets with separate air-inlet device or a device as
national regulations are legally binding and take precedence
illustrated in figure 1 shall be used for rigid bottles.
IS0 8536.
over this part of
NOTE - Figures 1 and 2 illustrate examples of configurations of typical
IS0 8536 specifies requirements applicable to
This part of
infusion sets but they do not form part of the requirements for infusion
sterilized infusion sets intended for single use.
sets for single use as laid down in this part of IS0 8536.
1) At present at the stage of draft.
1
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IS0 8536-4 : 1987 (E)
Protective cap of the closure-piercing device
Protective cap of the closure-piercing device
@
@
@ Closure-piercing device
@ Closure-piercing device
Air inlet with air filter and closurell
@ Fluid channel
@
@ Fluid channel
@ Drip tube
@ Drip tube
@ Drip chamber
@ Drip chamber
@ Fluid filter
@ Fluid filter2)
@ Tubing
@ Tubing
@ FIOW regulator
@ FIOW regulator
@ injectioa site
@ Injection site
@ Male fitting
@ Male fitting
Protective cap of the male fitting
@
Protective cap of the male fitting
@
Figure 1 - Example of a typical vented infusion set Figure 2 - Example of a typical non-vented infusion set
1) Closure of air inlet is optional.
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IS0 8536-4 : 1987 (E)
5.4 Air-inlet device
3.2 Sterilization
The set shall be sterile in its unit container. Evidence of the ef-
5.4.1 The air-inlet device shall be provided with a filter
fectiveness of the sterilization process used shall be provided.
designed to prevent the ingress of micro-organisms into the
container into which the device is to be inserted.
3.3 Maintenance of sterility
5.4.2 The air-inlet device may be separate from or integral
The set shall be provided with protective caps designed to main-
with the clcsure-piercing device.
tain sterility of the internal parts of the set until the set is used.
5.4.3 When an air-inlet device is inserted into a rigid infusion
3.4 Designation example
container, the air admitted into the container shall not become
entrained in the liquid outflow.
3.4.1 Designation example of an infusion set (IS) with an
integral air-inlet device complying with the requirements laid
down in this part of IS0 8536: 5.5 Air filter
Infusion set IS0 8536-4 IS-V
The air filter shall be so made that all air entering the rigid con-
tainer passes through it and that the flow of fluid is not
significantly reduced.
3.4.2 Designation example of an infusion set (IS) with
separate air-inlet device (NV) complying with the requirements
a
laid down in this part of IS0 8536:
5.6 Tubing
Infusion set IS0 8536-4 IS-NV
5.6.1 The tubing, made of suitable material, shall be
transparent or sufficiently translucent for the passage of
4 Materials bubbles of air to be readily detected.
The materials from which the infusion set is made shall not
5.6.2 The tubing shall have an internal diameter of not less
have undesirable effects on the infusion solution passing
than 2,7 mm. The tubing length distal to the drip chamber shall
through the set under ordinary conditions of use. They shall not
be not less than 1 500 mm in length. The tubing shall be flexible
produce any general toxic effects or any local reaction on the
and shall not have any kinks.
recipient of the infusion solution.
Appropriate type tests for assessing biological compatibility are
5.7 Fluid filter
given in annex E.
The infusion set shall be provided with a fluid filter which can
be visibly observed.
5 Physical requirements
When tested in accordance with annex B, the amount of latex
particles retained on the filter shall be not less than 80 %.
5.1 Integrity
NOTES
The infusion set, when tested in accordance with annex A,
0
shall show no signs of air leakage.
1 The filter should preferably be positioned between the male fitting
and the injection site near the patient access.
5.2 Connection between the male fitting,
2 A fluid filter in general use has an aperture size of 15 pm.
injection site and tubing
5.8 Drip chamber and drip tube
The connection between the male fitting, the injection site and
the tubing shall withstand a static tensile force of 15 N for 15 s.
The drip chamber shall assist the procedure of priming and per-
mit continuous observation of the fall of drops. The liquid shall
5.3 Closure-piercing device
enter the drip chamber through a tube which projects into the
chamber. There shall be a distance of not less than 40 mm be-
The dimensions of the closure-piercing device shall conform
tween the end of the drip tube and the outlet of the chamber or
3.
with the dimensions shown in figure
a distance of not less than 20 mm between the drip tube and
Dimensions in millimetres
filter. The wall of the drip chamber shall not be closer than
c; 0'
5 mm to the end of the drip tube. The drip tube shall be such
+I
Ln
that 20 drops of distilled water at 20 OC and at a flow rate of
-. 8
r----h
O +I
50 f 5 drops/min deliver 1 I 0,l ml (1 f 0,l g).
:-I
v
8
5.9 Flow regulator
22
4
28 '1
c - 5.9.1 The flow regulator shall adjust the flow of the infusion
Figure 3 - Dimensions for the closure-piercing device solution between zero and the maximum.
3
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IS0 8536-4 : 1987 (E)
5.9.2 The flow regulator shall be capable of continuous use 6.4 Residue on evaporation
throughout an infusion without damaging the tubing. There
When tested in accordance with clause D.5, the total amount
shall be no deleterious reaction between the flow regulator and
of dry residue shall not exceed 5 mg.
the tubing when stored in contact.
6.5 Absorbance
5.10 Flow rate of infusion fluid
When tested in accordance with clause D.6, the extract solution
The complete infusion set shall deliver not less than 1 O00 ml of
SI shall not show absorbance greater than 0,l (optical density).
a sodium chloride solution [@(NaCl) = 9 g/ll in 10 min under a
static head of 1 m.
7 Biological requirements
5.11 Injection site
The infusion set shall not release any substances which may
There shall be a self-sealing injection port or other equivalent
adversely affect the therapeutic effectiveness of the infusion,
means near the distal end. Self-sealing injection ports shall
including those substances which may exhibit toxic, pyrogenic,
reseal under normal working pressure after being perforated by
bacteriostatic, bactericidal or haemolytic reactions.
a needle 0,6 mm in diameter.
NOTE - The injection site should be located near the male fitting. 7.1 Requirements for type test
When tested in accordance with annex C, there shall be no The type test shall be established and assessed by an expert (or
signs of air leakage. experts) in the infusion field and on toxicology of plastics
material. It shall cover the following elements:
5.12 Male fitting
a) General biocompatibility of the plastics material of the
set.
The distal end of the tubing shall terminate in a male fitting
having a cone with a 6 % taper conforming with IS0 594-1 or Materials shall be assessed for biocompatibility by cartying out
E.2 and
IS0 594-2. suitable tests for those properties detailed in clause
the results of the tests shall indicate freedom from toxicity.
When tested in accordance with IS0 594-1 or IS0 594-2 using a
NOTE - In many countries there are national pharmacopoeias,
female reference fitting, there shall be no signs of air leakage.
governmental regulations or standards detailing suitable tests for
assessing biocompatibility. However, if no such regulations are
provided, the test methods specified in the table should be used.
5.13 Protective caps
b) Compatibility of the infusion set with the process of
The protective caps at the end of the infusion set shall be main-
manufacture and sterilization.
tain the sterility of the closure-piercing device, the male fitting
and the interior of the infusion set. They shall be secure but The process of manufacture and sterilization, and the pro-
easily removable.
longed contact with the infusion fluid shall not alter proper-
ties of the plastics material and of the set itself.
c) Compatibility of the plastics material of the set with the
6 Chemical requirements
infusion fluid.
Absence of migration after sterilization and prolonged con-
6.1 Reducing (oxidizable) matter
tact of the constituents of the plastics material shall not alter
the properties of the infusion fluid or cause any toxicological
When tested in accordance with clause D.2, the total amount of
risk for the patient.
= 0,002 mol/l,
potassium permanganate solution, c(KMn04)
used sha
...
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