EN ISO 8536-4:2010

SLOVENSKI STANDARD
01-december-2010
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SIST EN ISO 8536-4:2007
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Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2010)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2010)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2010)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2010
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 8536-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2010
ICS 11.040.20 Supersedes EN ISO 8536-4:2007
English Version
Infusion equipment for medical use - Part 4: Infusion sets for
single use, gravity feed (ISO 8536-4:2010)
Matériel de perfusion à usage médical - Partie 4: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 4:
de perfusion non réutilisables, à alimentation par gravité Infusionsgeräte für Schwerkraftinfusionen zur einmaligen
(ISO 8536-4:2010) Verwendung (ISO 8536-4:2010)
This European Standard was approved by CEN on 14 September 2010.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2010: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA .4

Foreword
The text of ISO 8536-4:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion
and injection equipment for medical and pharmaceutical use” of the International Organization for
Standardization (ISO) and has been taken over as EN ISO 8536-4:2010 by Technical Committee CEN/TC 205
“Non-active medical devices” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by April 2011, and conflicting national standards shall be withdrawn at the
latest by April 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8536-4:2007.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 8536-4:2010 has been approved by CEN as a EN ISO 8536-4:2010 without any modification.
Annex ZA
(informative)
Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical devices
This International Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC, Medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC, Medical
devices
Clause(s)/subclause(s) of this Essential Requirements (ERs) of
Qualifying remarks/Notes
International Standard Directive 93/42/EEC
3.2 8.1
4 13.3
5 1, 2, 3
6.1 7.2
6.2 7.6
6.3 9.1, 12.7.1
6.4 7.6
6.5 7.6
6.6 12.8
6.7 7.2
6.8 12.8
6.9 10, 12.8
6.10 10, 12.8
6.11 8
6.12 9.1
6.13 8
7 7
8.1 7, 7.5 Presumption of conformity with the
Essential Requirements relating to
the biological evaluation can only
be provided if the manufacturer
chooses to apply the ISO 10993
series of standards.
8.2 8.4
8.3 7.1, 7.2
8.4 7.1, 7.2
8.5 7.1, 7.2
9 13 The part of ER 13.3 a) relating to
the authorized representative is
not addressed.
ERs 13.3 f) and 13.6 h) relating to
single-use are not fully addressed.
ER 13.6 q) is not addressed.
10 5, 8.3
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 8536-4
Fifth edition
2010-10-01
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 8536-4:2010(E)
©
ISO 2010
ISO 8536-4:2010(E)
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ii © ISO 2010 – All rights reserved

ISO 8536-4:2010(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

ISO 8536-4:2010(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 fifth edition cancels and replaces the fourth edition (ISO 8536-4:2007), of which it constitutes a minor
revision. In detail, 7.1 was more clarified in alignment with B.2, and A.2.2 was changed in order to go back
with the leakage test pressure to 20 kPa and to restrict the leakage test for (40 ± 1) °C.
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
⎯ Part 12: Check valves
iv © ISO 2010 – All rights reserved

INTERNATIONAL STANDARD ISO 8536-4:2010(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, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical
equipment — Part 1: General requirements
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
1)
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
2)
be supplied — Part 1: General requirements
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 plastic containers. Infusion sets as illustrated in Figure 2 used

1) Under preparation. (Revision of ISO 14644-1:1999)
2) To be published. (Revision of ISO 15223-1:2007)
ISO 8536-4:2010(E)
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1, shall be used
for rigid containers.
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.
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

2 © ISO 2010 – All rights reserved

ISO 8536-4:2010(E)
Key
1 protective cap of 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

ISO 8536-4:2010(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
4 Designation
4.1 Infusion set
Infusion sets complying with the requirements specified in this part of ISO 8536 shall be designated by th
...