SIST EN ISO 8536-9:2015

Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)

This part of ISO 8536 applies to sterilized fluid lines for single use for use with pressure infusion
equipment up to a maximum of 200 kPa (2 bar).
The following items are covered by this part of ISO 8536:
a) syringe pump lines (SPL);
b) connecting lines (CL);
c) lines with integrated injection cannula (LIC).
In some countries, the national pharmacopoeia or other national regulations are legally binding and
take precedence over this part of ISO 8536.

Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015)

Dieser Teil von ISO 8536 gilt für sterilisierte, zur einmaligen Verwendung bestimmte Übertragungsleitungen für Infusionen unter Druckeinwirkung zur Verwendung mit Druckinfusionsapparaten bis maximal 200 kPa (2 bar).
Dieser Teil von ISO 8536 erfasst:
a)   Spritzenpumpenleitungen (SPL);
b)   Verbindungsleitungen (CL);
c)   Leitungen mit integrierter Injektionskanüle (LIC).
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 8536.

Matériel de perfusion à usage médical - Partie 9: Tubulures non réutilisables avec des appareils de perfusion sous pression (ISO 8536-9:2015)

L'ISO 8536-9:2015 s'applique aux tubulures stériles à usage unique, destinées à être utilisées avec un matériel de perfusion sous une pression maximale de 200 kPa (2 bar).
L'ISO 8536-9:2015 traite des éléments suivants:
a)   les tubulures pour pousse-seringue (SPL);
b)   les prolongateurs (CL);
c)   les tubulures à canule à injection intégrée (LIC).

Infuzijska oprema za uporabo v medicini - 9. del: »Fluidne« cevke za enkratno uporabo z infuzijsko opremo, delujočo na osnovi tlaka (ISO 8536-9:2015)

Ta del standarda ISO 8536 se uporablja za sterilizirane »fluidne« cevke za enkratno uporabo z infuzijsko opremo, delujočo na osnovi tlaka, do največ 200 kPa (2 bara).
Naslednji elementi so vključeni v ta del standarda ISO 8536:
a) cevke s črpalko za brizgo (SPL);
b) priključne cevke (CL);
c) cevke z vgrajenim kanilom za injiciranje (LIC).
V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.

General Information

• Status: Published
• Public Enquiry End Date: 14-Jan-2014
• Publication Date: 04-Aug-2015
• ICS: 11.040.20 - Transfusion, infusion and injection equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 08-Jul-2015
• Due Date: 12-Sep-2015
• Completion Date: 05-Aug-2015
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 8536-9:2015 - Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)

Relations

• Replaces: SIST EN ISO 8536-9:2005 - Infusion equipment for medical use - Part 9: Fluid lines for use with pressure infusion equipment (ISO 8536-9:2004)
• Effective Date: 01-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8536-9:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 8536-9:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHOª)OXLGQH©FHYNH]DHQNUDWQR
XSRUDER]LQIX]LMVNRRSUHPRGHOXMRþRQDRVQRYLWODND,62
Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure
infusion equipment (ISO 8536-9:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 9: Übertragungsleitungen zur
einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-9:2015)
Matériel de perfusion à usage médical - Partie 9: Tubulures non réutilisables avec des
appareils de perfusion sous pression (ISO 8536-9:2015)
Ta slovenski standard je istoveten z: EN ISO 8536-9:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-9:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8536-9:2015

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SIST EN ISO 8536-9:2015

EUROPEAN STANDARD
EN ISO 8536-9

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2015
ICS 11.040.20 Supersedes EN ISO 8536-9:2004
English Version
Infusion equipment for medical use - Part 9: Fluid lines for single
use with pressure infusion equipment (ISO 8536-9:2015)
Matériel de perfusion à usage médical - Partie 9: Tubulures Infusionsgeräte zur medizinischen Verwendung - Teil 9:
non réutilisables avec des appareils de perfusion sous Übertragungsleitungen zur einmaligen Verwendung mit
pression (ISO 8536-9:2015) Druckinfusionsapparaten (ISO 8536-9:2015)
This European Standard was approved by CEN on 16 April 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 8536-9:2015 E
worldwide for CEN national Members.

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SIST EN ISO 8536-9:2015
EN ISO 8536-9:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .5

2

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SIST EN ISO 8536-9:2015
EN ISO 8536-9:2015 (E)
European foreword
This document (EN ISO 8536-9:2015) 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 December 2015, and conflicting national standards shall be withdrawn
at the latest by December 2015.
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 8536-9:2004.
In this edition, the following changes have been made:
— the former Clause 3 on designation has been deleted;
— 5.8 has been amended and an appropriate Annex C added;
— Clause 9 on labelling was amended by addition of information regarding the usage of the symbol “XXX”
according ISO 7000, Symbol 2725;
— Clause 10 on disposal has been added;
— A.4 has been amended;
— the former A.5 specifying a test for leakage of adapters with female and/or male conical fittings has been
deleted;
— normative references and the Bibliography have been updated;
— document has been editorially revised.
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(s).
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
3

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SIST EN ISO 8536-9:2015
EN ISO 8536-9:2015 (E)
Endorsement notice
The text of ISO 8536-9:2015 has been approved by CEN as EN ISO 8536-9:2015 without any modification.
Table — Correlations between undated normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2
EN ISO
ISO 594-2 –- ISO 594-2:1998
ISO 7000 –- ISO 7000:2014
ISO 7864 EN ISO 7864:1995 ISO 7864:1993
ISO 8536-10 EN ISO 8536-10:2015 ISO 8536-10:2015
ISO 8536-11 EN ISO 8536-11:2015 ISO 8536-11:2015
ISO 10993-4 EN ISO 10993-4:2009 ISO 10993-4:2002 plus
Amd.1:2006
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
4

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SIST EN ISO 8536-9:2015
EN ISO 8536-9:2015 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices
This European 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 on medical devices
Once this standard is cited in the Official Journal of the European Communities 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 European Standard
and Directive 93/42/EEC on medical devices
Clause(s)/subclause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
Clause 3, 4.1, 4.2, 4.3, 4.4, 4.5, 7.2 The part of ER 7.2 relating to
4.8, 4.9, Clause 6 packaging is not addressed. For
packaging see Clause 7 of this
standard.
4.1, 4.2, 4.3, 4.4, 4.5, 4.8, 4.9, 7.3 ER covered by biological
Clause 6 evaluation.
4.3, 4.4, A.3, A.4 7.5 Only the first sentence is
covered. 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.
4.2, 4.3 7.6
4.2, 4.3, 4.4 8.1 The part of ER 8.1 relating to
handling is not addressed.
Manufacturing processes are not
covered. Only sterility of product
is covered.
 8.3
6.1 8.4 Only the sterilization method is
covered.
4.2 8.5
8.2, 8.3 8.7
4.5, 4.8, 8.2 g) 9.1 The second sentence of ER 9.1
is not addressed.
5

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SIST EN ISO 8536-9:2015
EN ISO 8536-9:2015 (E)
Clause(s)/subclause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
Clause 3, 4.1, 4.2, 4.3, 4.4, 4.5, 9.2
4.8, 4.9
4.8 10.1 to 10.3
4.3, A.3 12.7.1 Only tensile strength is
addressed.
8 13.1
8.2 d), e), f), g), 8.3 c) 13.2
8.2, 8.3 13.3 The part of 13.3 a) relating to the
authorized representative is not
addressed. Presumption of
conformity to the rest of 13.3 a)
is only provided if the name and
address of the manufacturer are
given.
13.3 d) is only covered if the
batch number is preceded by the
word 'LOT'.
13.3 f) Requirement „indication
of single use must be consistent
across the Community“ is not
addressed in the standard.
13.3 g), h) is not addressed in
the standard.
8.2, 8.3 13.4 13.4 is addressed regarding to
the label.
8.2, 8.3 13.5 13.5 is not addressed regarding
to the detachable components.
8.2, 8.3 13.6 13.6 e), f), h), i), j), l), m), o) are
not applicable for devices
according to this standard
13.6 q) is not addressed.
WARNING — Other requirements and other EC Directives may be applicable to the product(s) falling within
the scope of this standard

6

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SIST EN ISO 8536-9:2015
INTERNATIONAL ISO
STANDARD 8536-9
Second edition
2015-06-15
Infusion equipment for medical use —
Part 9:
Fluid lines for single use with pressure
infusion equipment
Matériel de perfusion à usage médical —
Partie 9: Tubulures non réutilisables avec des appareils de perfusion
sous pression
Reference number
ISO 8536-9:2015(E)
©
ISO 2015

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SIST EN ISO 8536-9:2015
ISO 8536-9:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2015 – All rights reserved

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SIST EN ISO 8536-9:2015
ISO 8536-9:2015(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Termes and definitions . 1
4 Materials . 2
5 Physical requirements . 3
5.1 Transparency . 3
5.2 Particulate contamination . 3
5.3 Tensile strength . 3
5.4 Leakage . 3
5.5 Adapters with female and/or male conical fittings . 3
5.6 Accessories . 3
5.7 Filters . 3
5.8 Storage volume . 3
5.9 Injection needles . 3
5.10 Protective caps . 3
6 Chemical requirements . 4
7 Biological requirements . 4
7.1 Sterility . 4
7.2 Pyrogens . 4
7.3 Haemolysis . 4
8 Packaging . 4
9 Labelling . 4
9.1 General . 4
9.2 Label on unit container . 4
9.3 Label on shelf or multi-unit container . 5
10 Disposal . 5
Annex A (normative) Physical tests . 6
Annex B (normative) Chemical tests . 7
Annex C (normative) Storage volume . 8
Bibliography .11
© ISO 2015 – All rights reserved iii

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SIST EN ISO 8536-9:2015
ISO 8536-9:2015(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
...