Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed (ISO 8536-4:2019)

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.

Infusionsgeräte zur medizinischen Verwendung - Teil 4: Infusionsgeräte für Schwerkraftinfusionen zur einmaligen Verwendung (ISO 8536-4:2019)

Dieses Dokument legt Anforderungen an zur einmaligen Verwendung bestimmte medizinische Infusionsgeräte für Schwerkraftinfusionen fest, um sicherzustellen, dass sie zur Verwendung mit Behältern für Infusionslösungen und Geräten zur intravenösen Punktion geeignet sind.
Sekundäres Ziel dieses Dokuments ist eine Anleitung zu Festlegungen bezüglich Qualität und Leistungsfähigkeit der Werkstoffe, die für Infusionsgeräte verwendet werden. Außerdem werden Benennun¬gen für die Einzelteile von Infusionsgeräten angegeben.

Matériel de perfusion à usage médical - Partie 4: Appareils de perfusion non réutilisables, à alimentation par gravité (ISO 8536-4:2019)

Le présent document spécifie les exigences applicables aux appareils de perfusion à usage médical, non réutilisables, à alimentation par gravité, afin d'assurer leur compatibilité avec les récipients contenant des solutions de perfusion et avec les appareils intraveineux.
Le deuxième objectif du présent document est de donner des recommandations sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de perfusion et de proposer une terminologie concernant les composants de ces derniers.

Infuzijska oprema za uporabo v medicini - 4. del: Infuzijski seti za enkratno uporabo, delujoči na osnovi gravitacije (ISO 8536-4:2019)

Ta dokument določa zahteve za infuzijske sete za enkratno uporabo, delujoče na osnovi gravitacije, za uporabo v medicini za zagotavljanje združljivosti z vsebniki za infuzijske raztopine in intravenozno opremo. Druga cilja tega dokumenta sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za infuzijske sete, ter predstaviti oznake za sestavne dele transfuzijskih setov.

General Information

Status
Published
Publication Date
28-Jan-2020
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
29-Jan-2020
Completion Date
29-Jan-2020

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SLOVENSKI STANDARD
SIST EN ISO 8536-4:2020
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
SIST EN ISO 8536-4:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 8536-4:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 8536-4:2020
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 8536-4:2020
EN ISO 8536-4:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 8536-4:2020
EN ISO 8536-4:2020 (E)
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.
---------------------- Page: 5 ----------------------
SIST EN ISO 8536-4:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 8536-4:2020
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
---------------------- Page: 7 ----------------------
SIST EN ISO 8536-4:2020
ISO 8536-4:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
---------------------- Page: 8 ----------------------
SIST EN ISO 8536-4:2020
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 2019 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 8536-4:2020
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
---------------------- Page: 10 ----------------------
SIST EN ISO 8536-4:2020
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 2019 – All rights reserved 1
---------------------- Page: 11 ----------------------
SIST EN ISO 8536-4:2020
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
Closure of the air-inlet is optional.
The fluid filter may be positioned at other sites,
preferably near the patient access.
The injection site is optional.
Figure 1 — Example of a vented infusion set
2 © ISO 2019 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 8536-4:2020
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
The fluid filter may be positioned at other sites,
preferably near the patient access.
The injection site is optional.
Figure 2 — Example of a non-vented infusion set
© ISO 2019 – All rights reserved 3
---------------------- Page: 13 ----------------------
SIST EN ISO 8536-4:2020
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
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
---------------------- Page: 14 ----------------------
SIST EN ISO 8536-4:2020
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 filter to prevent the ingress of microorganisms into

the container into which the device is to be inserted.

When the air-inlet device is in use the air admitted into the container shall not become entrained in the

liquid-entry of the closure-piercing device.

The air filter and the design of the air-inlet device shall be such that all air entering the rigid container

passes through it, and such 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.5.2 and A.5.3.

The closure-piercing device or needle of the stand-alone device shall be capable of piercing and

penetrating the closure of a fluid container without pre-piercing. No coring should occur during this

procedure.
7.6 Tubing

The tubing, made of flexible material, shall be transparent or sufficiently translucent 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.
7.7 Fluid filter
The infusion set shall be provided with a fluid filter.

When tested in accordance with A.6, the retention of latex particles on the filter shall be not less

than 80 %.
© ISO 2019 – All rights reserved 5
---------------------- Page: 15 ----------------------
SIST EN ISO 8536-4:2020
ISO 8536-4:2019(E)
7.8 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 that 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 and 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. Depending on the design, the drip tube shall be such that 20 drops or 60 drops

of distilled water at (23 ± 2) °C at a flow rate of (50 ± 10) drops/min deliver a volume of (1 ± 0,1) ml or a

mass of (1 ± 0,1) g. The drip chamber should permit and facilitate the priming procedure.

7.9 Flow regulator
The flow regulator shall be in accordance with ISO 8536-13 or ISO 8536-14.
7.10 Flow rate of infusion set

The infusion set without the use of an air-inlet device shall deliver not less than 1 000 ml of a sodium

chloride solution [concentration of NaCl = 9 g/l] in 10 min for a drip tube that delivers 1 ml with

20 drops. Testing shall be done in accordance with A.5.1.
7.11 Injection site

When provided, the self-sealing injection site shall reseal when tested in accordance with A.7, and there

shall be no leakage of water. The injection site should be located near the male conical fitting.

7.12 Male conical fitting

The distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 80369-7.

7.13 Protective caps

The protective caps shall cover the respective surfaces of the infusion equipment to prevent

contamination from surrounding environment, to avoid stick injuries and packaging damages.

Protective caps should be secure but easily removable.
8 Chemical requirements
8.1 Reducing (oxidizable) matter

When tested in accordance with B.2, the difference of volume of Na S O solution [concentration of

2 2 3

Na S O = 0,005 mol/l] for the extract solution S and of volume of Na S O solution for blank solution

2 2 3 1 2 2 3
S shall not exceed 2,0 ml.
8.2 Metal ions

The extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead and tin, and

not more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an

equivalent method.

When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not

exceed that of the standard matching solution with a concentration of Pb = 1 µg/ml.

8.3 Titration acidity or alkalinity

When tested in accordance with B.4, not more than 1 ml of either standard volumetric solution shall be

required for the indicator to change to the colour grey.
6 © ISO 2019 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 8536-4:2020
ISO 8536-4:2019(E)
8.4 Residue on evaporation

When tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.

8.5 UV absorption of extract solution

When tested in accordance with B.6, the extract solution S shall be S(λ) < 0,1 with λ in the range from

250 nm to 320 nm.
9 Biological requirements
9.1 General
The infusion set and the stand-alone air-inlet device shall be assessed
...

SLOVENSKI STANDARD
SIST EN ISO 8536-4:2020
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
SIST EN ISO 8536-4:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 8536-4:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 8536-4:2020
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.

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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 8536-4:2020
EN ISO 8536-4:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 8536-4:2020
EN ISO 8536-4:2020 (E)
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 January 2023.

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.
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SIST EN ISO 8536-4:2020
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SIST EN ISO 8536-4:2020
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
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SIST EN ISO 8536-4:2020
ISO 8536-4:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© 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.
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Phone: +41 22 749 01 11
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
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SIST EN ISO 8536-4:2020
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 2019 – All rights reserved iii
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SIST EN ISO 8536-4:2020
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
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SIST EN ISO 8536-4:2020
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

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SIST EN ISO 8536-4:2020
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
Closure of the air-inlet is optional.
The fluid filter may be positioned at other sites,
preferably near the patient access.
The injection site is optional.
Figure 1 — Example of a vented infusion set
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SIST EN ISO 8536-4:2020
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
The fluid filter may be positioned at other sites,
preferably near the patient access.
The injection site is optional.
Figure 2 — Example of a non-vented infusion set
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SIST EN ISO 8536-4:2020
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
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.
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SIST EN ISO 8536-4:2020
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 filter to prevent the ingress of microorganisms into

the container into which the device is to be inserted.

When the air-inlet device is in use the air admitted into the container shall not become entrained in the

liquid-entry of the closure-piercing device.

The air filter and the design of the air-inlet device shall be such that all air entering the rigid container

passes through it, and such 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.5.2 and A.5.3.

The closure-piercing device or needle of the stand-alone device shall be capable of piercing and

penetrating the closure of a fluid container without pre-piercing. No coring should occur during this

procedure.
7.6 Tubing

The tubing, made of flexible material, shall be transparent or sufficiently translucent 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.
7.7 Fluid filter
The infusion set shall be provided with a fluid filter.

When tested in accordance with A.6, the retention of latex particles on the filter shall be not less

than 80 %.
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SIST EN ISO 8536-4:2020
ISO 8536-4:2019(E)
7.8 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 that 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 and 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. Depending on the design, the drip tube shall be such that 20 drops or 60 drops

of distilled water at (23 ± 2) °C at a flow rate of (50 ± 10) drops/min deliver a volume of (1 ± 0,1) ml or a

mass of (1 ± 0,1) g. The drip chamber should permit and facilitate the priming procedure.

7.9 Flow regulator
The flow regulator shall be in accordance with ISO 8536-13 or ISO 8536-14.
7.10 Flow rate of infusion set

The infusion set without the use of an air-inlet device shall deliver not less than 1 000 ml of a sodium

chloride solution [concentration of NaCl = 9 g/l] in 10 min for a drip tube that delivers 1 ml with

20 drops. Testing shall be done in accordance with A.5.1.
7.11 Injection site

When provided, the self-sealing injection site shall reseal when tested in accordance with A.7, and there

shall be no leakage of water. The injection site should be located near the male conical fitting.

7.12 Male conical fitting

The distal end of the tubing shall terminate in a male conical fitting in accordance with ISO 80369-7.

7.13 Protective caps

The protective caps shall cover the respective surfaces of the infusion equipment to prevent

contamination from surrounding environment, to avoid stick injuries and packaging damages.

Protective caps should be secure but easily removable.
8 Chemical requirements
8.1 Reducing (oxidizable) matter

When tested in accordance with B.2, the difference of volume of Na S O solution [concentration of

2 2 3

Na S O = 0,005 mol/l] for the extract solution S and of volume of Na S O solution for blank solution

2 2 3 1 2 2 3
S shall not exceed 2,0 ml.
8.2 Metal ions

The extract shall not contain in total more than 1 µg/ml of barium, chromium, copper, lead and tin, and

not more than 0,1 µg/ml of cadmium, when determined by atomic absorption spectroscopy (AAS) or an

equivalent method.

When tested in accordance with B.3, the intensity of the colour produced in the test solution shall not

exceed that of the standard matching solution with a concentration of Pb = 1 µg/ml.

8.3 Titration acidity or alkalinity

When tested in accordance with B.4, not more than 1 ml of either standard volumetric solution shall be

required for the indicator to change to the colour grey.
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SIST EN ISO 8536-4:2020
ISO 8536-4:2019(E)
8.4 Residue on evaporation

When tested in accordance with B.5, the total amount of dry residue shall not exceed 5 mg.

8.5 UV absorption of extract solution

When tested in accordance with B.6, the extract solution S shall be S(λ) < 0,1 with λ in the range from

250 nm to 320 nm.
9 Biological requirements
9.1 General

The infusion set and the stand-alone air-inlet device shall be assessed for biological compatibility

according to the guidelines given in C.2.
9.2 Sterility
The infusion set and the stand-alo
...

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