ISO 8536-4:2004

Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed

ISO 8536-4:2004 specifies requirements for single-use, gravity feed infusion sets for medical use in order to ensure their compatibility with containers for infusion solutions and intravenous equipment. Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and performance of materials used in infusion sets and to present designations for infusion set components. In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.

Matériel de perfusion à usage médical — Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité

General Information

• Status: Withdrawn
• Publication Date: 11-Aug-2004
• Withdrawal Date: 11-Aug-2004
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 16-Mar-2007

Relations

• Revised: ISO 8536-4:2007 - Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
• Effective Date: 15-Apr-2008
• Consolidates: ISO 3837:1993 - Liquid petroleum products — Determination of hydrocarbon types — Fluorescent indicator adsorption method
• Effective Date: 06-Jun-2022
• Revises: ISO 8536-4:1998 - Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
• Effective Date: 15-Apr-2008
• Consolidated By: ISO 12402-3:2020 - Personal flotation devices — Part 3: Lifejackets, performance level 150 — Safety requirements
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 8536-4
Third edition
2004-08-15


Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
Matériel de perfusion à usage médical —
Partie 4: Appareils de perfusion non réutilisables, à alimentation par
gravité





Reference number
ISO 8536-4:2004(E)
©
ISO 2004

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ISO 8536-4:2004(E)
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©  ISO 2004
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ii © ISO 2004 – All rights reserved

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ISO 8536-4:2004(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 General requirements. 1
4 Designation. 4
4.1 Infusion set. 4
4.2 Air-inlet device. 4
5 Materials. 4
6 Physical requirements. 5
6.1 Particulate contamination. 5
6.2 Leakage. 5
6.3 Tensile strength. 5
6.4 Closure-piercing device. 5
6.5 Air-inlet device. 5
6.6 Tubing. 6
6.7 Fluid filter. 6
6.8 Drip chamber and drip tube . 6
6.9 Flow regulator. 6
6.10 Flow rate of infusion fluid . 6
6.11 Injection site. 6
6.12 Male conical fitting. 6
6.13 Protective caps. 6
7 Chemical requirements. 7
7.1 Reducing (oxidizable) matter. 7
7.2 Metal ions. 7
7.3 Titration acidity or alkalinity . 7
7.4 Residue on evaporation. 7
7.5 UV absorption of extract solution . 7
8 Biological requirements. 7
8.1 General. 7
8.2 Sterility. 7
8.3 Pyrogenicity. 7
8.4 Haemolysis. 7
8.5 Toxicity. 8
9 Labelling. 8
9.1 Unit container. 8
9.2 Shelf or multi-unit container . 8
10 Packaging. 9
Annex A (normative) Physical tests . 10
Annex B (normative) Chemical tests. 14
Annex C (normative) Biological tests. 16
Bibliography . 17

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ISO 8536-4:2004(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 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 8536-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 8536-4:1998) which has been technically
revised.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
 Part 1: Infusion glass bottles
 Part 2: Closures for infusion bottles
 Part 3: Aluminium caps for infusion bottles
 Part 4: Infusion sets for single use, gravity feed
 Part 5: Burette infusion sets for single use, gravity feed
 Part 6: Freeze drying closures for infusion bottles
 Part 7: Caps made of aluminium-plastics combinations for infusion bottles
 Part 8: Infusion equipment for use with pressure infusion apparatus
 Part 9: Fluid lines for use with pressure infusion equipment
 Part 10: Accessories for fluid lines for use with pressure infusion equipment
 Part 11: Infusion filters for use with pressure infusion equipment

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INTERNATIONAL STANDARD ISO 8536-4:2004(E)

Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
1 Scope
This part of ISO 8536 specifies requirements for single-use, gravity feed infusion sets for medical use in order
to ensure their compatibility with containers for infusion solutions and intravenous equipment.
Secondary aims of this part of ISO 8536 are to provide guidance on specifications relating to the quality and
performance of materials used in infusion sets and to present designations for infusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take
precedence over this part of ISO 8536.
2 Normative references
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 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 2: Lock fittings
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7864:1993, Sterile hypodermic needles for single use
ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air
cleanliness
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given
in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet
devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated
in Figure 2 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used
for rigid containers.
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ISO 8536-4:2004(E)

Key
1 protective cap of closure-piercing device 7 fluid filter
2 closure-piercing device 8 tubing
3 air inlet with air filter and closure 9 flow regulator
4 fluid channel 10 injection site
5 drip tube 11 male conical fitting
6 drip chamber 12 protective cap of male conical fitting

a
Closure of the air inlet is optional.

b
The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has
a nominal pore size of 15 µm.

c
The injection site is optional.
Figure 1 — Example of a vented infusion set
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ISO 8536-4:2004(E)

Key
1 protective cap of the closure-piercing device 7 tubing
2 closure-piercing device 8 flow regulator
3 fluid channel 9 injection site
4 drip tube 10 male conical fitting
5 drip chamber 11 protective cap of the male conical fitting
6 fluid filter
a
The fluid filter may be positioned at other sites, preferably near the patient access. Generally, the fluid filter used has
a nominal pore size of 15 µm.
b
The injection site is optional.
Figure 2 — Example of a non-vented infusion set

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ISO 8536-4:2004(E)

Key
1 protective cap 4 clamp
2 closure-piercing device or needle 5 air-inlet with air filter
3 tubing
a
Other designs are acceptable if the same safety aspects are ensured.
Figure 3 — Example of an air-inlet device
3.2 The infusion set shall be provided with protective caps to maintain sterility of the internal parts of the set
until the set is used. The air-inlet device shall be provided with a protective cap over the closure-piercing
device or needle.
4 Designation
4.1 Infusion set
Infusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by the
descriptor words, followed by a reference to this part of ISO 8536, followed by the letters IS, followed by the
letter G:
Infusion set ISO 8536-4 — IS — G
4.2 Air-inlet device
Air-inlet devices complying with the requirements specified in this part of ISO 8536 shall be designated by the
descriptor words, followed by a reference to this part of ISO 8536, followed by the letters AD:
Air-inlet device ISO 8536-4 — IS — AD
5 Materials
The materials from which the infusion set and its components as given in Clause 3 are manufactured shall
comply with the requirements as specified in Clause 6. Where components of the infusion set come into
contact with solutions, the materials additionally shall comply with the requirements as specified in Clauses 7
and 8.
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ISO 8536-4:2004(E)
6 Physical requirements
6.1 Particulate contamination
The infusion sets shall be manufactured under conditions that minimize particulate contamination. All parts
shall be smooth and clean at the fluid pathway surfaces. When tested as specified in A.1, the number of
particles shall not exceed the contamination index.
6.2 Leakage
The infusion set, when tested in accordance with A.2, shall show no signs of air leakage.
6.3 Tensile strength
When tested as specified in A.3, the infusion set, excluding protective caps, shall withstand a static tensile
force of not less than 15 N for 15 s.
6.4 Closure-piercing device
The dimensions of the closure-piercing device shall conform with the dimensions shown in Figure 4.
NOTE The dimension of 15 mm in Figure 4 is a reference measurement. The cross section of the piercing device at
this site is a circle.
The closure-piercing device shall be capable of piercing and penetrating the closure of a fluid container
without pre-piercing. No coring should occur during this procedure.
Dimensions in millimetres

Figure 4 — Dimensions of the closure-piercing device
6.5 Air-inlet device
The air-inlet device shall conform with 3.2 and 8.2.
The air-inlet device shall be provided with an air filter to prevent the ingress of microorganisms into the
container into which the device is to be inserted.
The air-inlet device shall be separate from, or integral with, the closure-piercing device.
When the air-inlet device is inserted into a rigid infusion container, the air admitted into the container shall not
become entrained in the liquid outflow.
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ISO 8536-4:2004(E)
The air filter shall be fitted so that all air entering the rigid container passes through it and that the flow of fluid
is not reduced by more than 20 % of that from a freely ventilated container when tested in accordance with
A.4.
6.6 Tubing
The tubing, made of flexible material, shall be transparent or sufficiently translucent so that the interface of air
and water during the passage of air bubbles can be observed with normal or corrected vision.
The tubing from the distal end to the drip chamber shall be not less than 1 500 mm in length, including the
injection site, when provided, and the male conical fitting.
6.7 Fluid filter
The infusion set shall be provided with a fluid filter.
When tested in accordance with A.5, the retention of latex particles on the filter shall be not less than 80 %.
6.8 Drip chamber and drip tube
The drip chamber shall permit continuous observation of the fall of drops. The liquid shall enter the drip
chamber through a tube which projects into the chamber. There shall be a distance of not less than 40 mm
between the end of the drip tube and the outlet of the chamber, or a distance of not less than 20 mm between
the drip tube and the fluid 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 that 20 drops of distilled water or 60 drops of distilled water at
(23 ± 2)
...