ISO 1135-4:1987
(Main)Transfusion equipment for medical use — Part 4: Transfusion sets for single use
Transfusion equipment for medical use — Part 4: Transfusion sets for single use
Matériel de transfusion à usage médical — Partie 4: Appareils pour transfusion non réutilisables
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Standards Content (Sample)
IS0
INTERNATIONAL STANDARD 1135-4
First edition
1987-12-01
____
Fmy
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~ INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
ORGANISATION INTERNATIONALE DE NORMALISATION
MEXAYHAPOAHAR OPTAHMBAUMR il0 CTAHflAPTM3AUMM
Transfusion equipment for medical use -
Part 4:
Transfusion sets for single use
Matériel de transfusion à usage médical -
Partie 4: Appareils pour transfusion non réutilisables
Reference number
IS0 1135-4 : 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 1135-4 was prepared by Technical Committee ISO/TC 76,
Transfusion, infusion and injection equipment for medical use.
IS0 1135-4 is a revision, in part, of IS0 1135: 1977; this first edition of IS0 1135-4
together with the other parts of IS0 1135 and IS0 8536 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 far Standardization, 1987
Printed in Switzerland
ii
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IS0 1135-4 : 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 filter . 6
C Testing of the injection site . 7
D Chemical test on the extract . 7
E Biological tests . 9
...
III
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INTERNATIONAL STANDARD
IS0 1135-4 : 1987 (E)
Transfusion equipment for medical use -
Part 4:
- Transfusion sets for single use
1 Scope and field of application 2 References
This part of IS0 1135 specifies requirements for types of single-
IS O 594- 1 , Conical fittings with a 6 % (L uer) taper for syringes,
use transfusion sets for medical use in order to ensure com-
needles and certain other medical equipment - Part I: General
patibility of use with containers for blood and blood com-
requirements.
ponents and intravenous catheters and cannulas.
IS0 594-2, Conical fittings with a 6 % (Luer) taper for syringes,
The materials and components of the sets are validated by
needles and certain other medical equipment - Part 2: Lock
various test methods (type tests) and, in addition, tests are per-
fittings. 1)
formed for the release of lots of finished sets (lot tests).
IS0 3696, Water for analytical laboratory use - Specifications
The manufacturer shall select appropriate test methods to com-
'L
and test methods.
ply with the requirements laid down in this part of IS0 1135.
Secondary aims of this part of IS0 1135 are to provide
a) specifications relating to the quality and performance of
3 General requirements
in transfusion sets;
materials used
b) a unified presentation of terms and designations for
3.1 Components for use with blood containers
transfusion sets.
In some countries, the national pharmacopoeia or other The transfusion set shall consist of the components as il-
lustrated in figure l. An air-inlet device as illustrated in figure 2
national regulations are legally binding and take precedence
is required for use with rigid containers.
over this part of IS0 1135.
This part of IS0 1135 specifies requirements applicable to
NOTE - Figures 1 and 2 illustrate examples of configurations of typical
sterilized transfusion sets intended for single use and for a
transfusion sets but they do not form part of the requirements for
single patient only. transfusion sets for single use as laid down in this part of IS0 1135.
1) At present at the stage of draft.
1
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IS0 1135-4 : 1987 (E)
@ Protective cap
Protective cap of the closure-piercing device
@
@ Closure-piercing device or needle
@ Closure-piercing device
@ Tubing
@ Fluid channel
@ Ciampli
Filter for blood and blood components’)
@
@ Air filter
@ Drip tube (counter)
@ Drip chamber
@ Tubing
@ FIOW regulator
@ injection site21
@ Male fitting
Protective cap of the male fitting
@
Figure 2 - Example of a typical air-inlet device
Figure 1 - Example of a typical transfusion set
11 Other designs are acceptable if the same safety aspects are guaranteed.
21 Optional
2
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IS0 1135-4 : 1987 (E)
Dimensions in millimetres
3.2 Sterilization
The set shall be sterile in its unit container. Evidence of the ef-
-
fectiveness of the sterilization process used shall be provided.
:-r -37- '1
8 -I
3.3 Maintenance of sterility
I
22
4- --
I
The set shall be provided with protective caps designed to
I 28.1 -
maintain sterility of the internal parts of the set until the set is
used.
Figure 3 - Dimensions for the closure-piercing device
5.4 Air-inlet device
3.4 Designation examples
5.4.1 The air-inlet device shall be provided with a filter
3.4.1 Transfusion set
designed to prevent the ingress of micro-organisms into the
container into which the device is to be inserted.
Designation example of a transfusion set (TS) complying with
the requirements laid down in this part of IS0 1135:
5.4.2 The air-inlet device shall be separate from the closure-
U
piercing device.
Transfusion set IS0 1135-4 TS
3.4.2 Air-inlet device 5.4.3 When an air-inlet device is inserted into a rigid trans-
fusion container, the air admitted into the container shall not
become entrained in the liquid outflow.
Designation example of an air-inlet device (AD) complying with
the requirements laid down in this part of IS0 1135:
5.4.4 If the end of the air-inlet device is connected to an air
Air-inlet IS0 1135-4 AD
filter by means of flexible tubing, the tubing shall have an inter-
nal diameter not less than 2,7 mm and shall be not less than
250 mm in length.
4 Materials
5.4.5 If the air-inlet device incorporates a length of flexible
The materials from which the transfusion set is made shall not tubing, means for fixing the filter above the level of the fluid
have undesirable effects on the blood passing through the set shall be provided.
under ordinary conditions of use, or on the fluids used in con-
nection with the blood. They shall not produce any general
5.5 Air filter
toxic effects or any local reaction on the recipient of the blood.
The air filter shall be so made that all air entering the bottle
Appropriate type tests for assessing biological compatibility are
passes through it and that the flow of fluid is not significantly
L given in annex E.
reduced.
5.6 Tubing
5 Physical requirements
5.6.1 The tubing, made of suitable material, shall be
5.1 Integrity
transparent or sufficiently translucent for the passage of
bubbles of air to be readily detected.
The transfusion set, when tested in accordance with annex A,
shall show no signs of air leakage.
5.6.2 The tubing shall have an internal diameter of not less
than 2,7 mm. The tubing length distal to the drip chamber shall
5.2 Connection between the male fitting,
be not less than 1 500 mm in length. The tubing shall be flexible
injection site and tubing
and shall not have any kinks.
The connection between the male fitting, injection site and the
5.7 Filter for blood and blood derivates
tubing shall withstand a static tensile force of 15 N for 15 s.
The transfusion set shall be provided with a filter. The filter
5.3 Closure-piercing device
shall have uniform apertures covering a total area of not less
than 10 cm2. When tested in accordance with annex B, the dry
The dimensions of the closure-piercing device shall conform
residue retained on the filter shall be not less than 80 % (rn/rn)
with the dimensions shown in figure 3. of the residue retained on the reference filter.
3
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IS0 1135-4 : 1987 (E)
5.8 Drip chamber and drip tube 6 Chemical requirements
The drip chamber shall assist the procedure of priming and per-
6.1 Reducing (oxidizable) matter
mit continuous observation of the fall of drops. The liquid shall
enter the drip chamber through a tube which projects into the
When tested in accordance with clause D.2, the total amount of
chamber. There shall be a distance of not less than 40 mm be-
potassium permanganate solution, c(KMn04) = 0,002 mol/l,
tween the end of the drip tube and the outlet of the chamber or
used shall not exceed 2,0 ml.
a distance of not less than 20 mm between the drip tube and
filter. The wall of the drip chamber shall not be closer than
5 mm to the end of the drip tube. The drip tube shall be such
6.2 Metal ions
OC and at a flow rate of
that 20 drops of distilled water at 20
50 f 5 drops/min deliver 1 + 0,l ml (1 f 0,l 9).
The extract shall not contain in total more than 1 pg/ml(l ppm)
of barium, chromium, copper, lead and tin, and not more than
0,l pg/l (0,l ppm) of cadmium, when determined by atomic
5.9 Flow regulator
absorption spectroscopy (AAS) or equivalent method.
5'9'1
The flow regulator shall adjust the flow Of the trans-
When tested in accordance with clause D.3, the colour produced
fusion fluid between zero and the maximum.
in the test solution shall not exceed that of the standard
matciiing solution containing e(Pb2+) = 1 pg/ml.
5.9.2 The flow regulator shall be capable of continuous use
d
throughout a transfusion without damaging the tubing. There
6.3 Titration acidity Or alkalinity
shall be no deleterious reaction between the flow regulator and
the tubing when stored in contact.
When tested in accordance with clause D.4, not more than 1 ml
of either standard volumetric solution shall be required for the
5.10 Flow rate of blood
indicator to change to the colour grey.
The complete transfusion set shall deliver not less than 1 O00 ml
6m4 Residue On evaporation
of whole blood in 30 min under a static head of 1 m. The blood
shall have been collected into a suitable anticoagulant solution,
When tested in accordance with clause D.5, the total amount
be stored for not less than 2 weeks and be free of large clots.
of dry residue shall not exceed 5 mg.
The set shall also deliver 500 ml of blood in 2 min under a
pressure of 100 kPa (1 bar) above the atmospheric pressure.
6.5 Absorbance
When tested in accordance with clause D.6, the extract solution
5.11 Injection site
S, shall not show absorbance greater than 0,l (optical density).
There shall be a self-sealing injection port or other equivalent
means near the distal end. Self-sealing injection ports shall
reseal under normal working pressure after being perforated by 7 Biological requirements
a needle 0.6 mm in diameter.
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The transfusion set shall not release any substances which may
adversely affect the therapeutic effectiveness of the blood or
NOTE - The injection site should be located near the male fitting.
the blood components, including those substances which may
exhibit toxic, pyrogenic, bacteriostatic, bactericidal or haemo-
When tested in accordance with annex C, there shall be no
lytic reactions.
signs of air leakage.
5.12 Male fitting 7.1 Requirements for type test
The type test shall be established and assessed by an expert (or
The distal end of the tubing shall terminate in a male fitting
experts) in the transfusion field and on toxicology of plastics
having a cone with a 6 % taper conforming with IS0 594-1 or
material. It shall cover the following elements:
IS0 594-2.
a) General biocompatibility of the plastics material of the
When tested in accordance with IS0 594-1 or IS0 594-2 using a
set.
female reference fitting, there shall be no signs of air leakage.
Materials shall be assessed for biocompatibility by carrying out
suitable tests for those properties detailed in clause E.2 and
5.13 Protective caps
the results of the tests shall indicate freedom from toxicity.
The protective caps at the end of the transfusion set shall main-
NOTE - In many countries there are national pharmacopoeias,
tain the sterility of the closure-piercing device, the male fitting
governmental regulations or standards detailing suitable tests for
and the interior of the transfusion set. They shall be secure but assessing biocompatibility. However, if no such
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