EN ISO 8536-4:2020

SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 8536-4:2013
SIST EN ISO 8536-4:2013/A1:2013
Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno
uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2019)
Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
(ISO 8536-4:2019)
Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für
Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2019)
Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non
réutilisables, à alimentation par gravité (ISO 8536-4:2019)
Ta slovenski standard je istoveten z: EN ISO 8536-4:2020
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.

EN ISO 8536-4
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 8536-4:2013
English Version
Infusion equipment for medical use - Part 4: Infusion sets
for single use, gravity feed (ISO 8536-4:2019)
Matériel de perfusion à usage médical - Partie 4: Infusionsgeräte zur medizinischen Verwendung - Teil
Appareils de perfusion non réutilisables, à 4: Infusionsgeräte für Schwerkraftinfusionen zur
alimentation par gravité (ISO 8536-4:2019) einmaligen Verwendung (ISO 8536-4:2019)
This European Standard was approved by CEN on 17 October 2019.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 04 March 2020.

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-CENELEC 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-CENELEC 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-4:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 8536-4:2020) has been prepared by Technical Committee ISO/TC 76
"Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical
use" in collaboration with 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 July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 8536-4:2013.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 8536-4:2019 has been approved by CEN as EN ISO 8536-4:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 8536-4
Sixth edition
2019-09
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 8536-4:2019(E)
©
ISO 2019
ISO 8536-4:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 8536-4:2019(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Designation . 4
6 Materials . 4
7 Physical requirements . 4
7.1 Particulate contamination . 4
7.2 Leakage . 4
7.3 Tensile strength . 4
7.4 Closure-piercing device . 5
7.5 Air-inlet device . 5
7.6 Tubing . 5
7.7 Fluid filter . 5
7.8 Drip chamber and drip tube . 6
7.9 Flow regulator . 6
7.10 Flow rate of infusion set . 6
7.11 Injection site . 6
7.12 Male conical fitting . 6
7.13 Protective caps . 6
8 Chemical requirements . 6
8.1 Reducing (oxidizable) matter . 6
8.2 Metal ions . 6
8.3 Titration acidity or alkalinity. 6
8.4 Residue on evaporation . 7
8.5 UV absorption of extract solution . 7
9 Biological requirements . 7
9.1 General . 7
9.2 Sterility . 7
9.3 Pyrogenicity . 7
9.4 Haemolysis . 7
9.5 Toxicity . 7
10 Labelling . 7
10.1 General . 7
10.2 Unit container . 7
10.3 Shelf or multi-unit container . 8
11 Packaging . 8
12 Disposal . 9
Annex A (normative) Physical tests .10
Annex B (normative) Chemical tests .15
Annex C (normative) Biological tests .17
Bibliography .18
ISO 8536-4:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso
.org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This sixth edition cancels and replaces the fifth edition (ISO 8536-4:2010), which has been technically
revised. It also incorporates the Amendment ISO 8536-4:2010/Amd.1:2013.
The main changes compared to the previous edition are as follows:
— Clause 5 'Designation' now refers to Clause 10 'Labelling';
— the physical requirements – especially regarding stand-alone air-inlet devices – have been further
clarified;
— Clause 10 'Labelling' has been updated;
— test for leakage in A.3 has been updated;
— determination of flow rate in A.5 has been totally reviewed;
— normative references in Clause 2 and the Bibliography have been updated.
A list of all parts in the ISO 8536 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
iv © ISO 2019 – All rights reserved

INTERNATIONAL STANDARD ISO 8536-4:2019(E)
Infusion equipment for medical use —
Part 4:
Infusion sets for single use, gravity feed
1 Scope
This document 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 document 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3696, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use — Requirements and test methods
ISO 8536-13, Infusion equipment for medical use — Part 13: Graduated flow regulators for single use with
fluid contact
ISO 8536-14, Infusion equipment for medical use — Part 14: Clamps and flow regulators for transfusion
and infusion equipment without fluid contact
ISO 14644-1, Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness
by particle concentration
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors
for intravascular or hypodermic applications
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
4 General requirements
4.1 The nomenclature to be used for components of infusion sets and of a stand-alone 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
ISO 8536-4:2019(E)
as illustrated in Figure 2 should only be used for collapsible plastic containers. Infusion sets as illustrated
in Figure 2 used with stand-alone air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated
in Figure 1, shall be used for rigid containers.
4.2 The infusion set shall be provided with protective caps. The air-inlet device shall be provided with
a protective cap over the closure-piercing device or needle (see Figure 3).
Key
1 protective cap of closure-piercing device 7 fluid filter
2 closure-piercing device 8 tubing
3 integral 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.
c
The injection site is optional.
Figure 1 — Example of a vented infusion set
2 © ISO 2019 – All rights reserved

ISO 8536-4:2019(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.
b
The injection site is optional.
Figure 2 — Example of a non-vented infusion set
ISO 8536-4:2019(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 a stand-alone air-inlet device
5 Designation
Designation shall follow label requirements according to Clause 10.
6 Materials
The materials from which the infusion set, its components and the stand-alone air-inlet device are
manufactured (as described in Clause 4) shall comply with the requirements specified in Clause 7.
Where components of the infusion set come into contact with solutions, the materials shall also comply
with the requirements specified in Clauses 8 and 9.
7 Physical requirements
7.1 Particulate contamination
The infusion set and stand-alone air-inlet device 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.2, the number of particles shall not exceed the contamination index limit.
7.2 Leakage
The infusion set, when tested in accordance with A.3, shall show no signs of air leakage.
7.3 Tensile strength
When tested as specified in A.4, the infusion set, excluding protective caps, shall withstand a static
tensile force of not less than 15 N for 15 s.
4 © ISO 2019 – All rights reserved

ISO 8536-4:2019(E)
7.4 Closure-piercing device
The dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 4. The
cross-section of the closure-piercing device over the length of 15 mm shall be a circle.
NOTE The dimension of 15 mm in Figure 4 is a reference measurement.
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
7.5 Air-inlet device
The air-inlet device can be an integral part of the infusion set (Figure 1) or a stand-alone device
(Figure 3).
The air-inlet device shall be provided with an air f
...