SIST EN ISO 8536-8:2015
(Main)Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure
infusion apparatus up to a maximum of 200 kPa (2 bar).
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 8: Infusionsgeräte zur einmaligen Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015)
Dieser Teil von ISO 8536 liefert den Anwendern Angaben über sterilisierte Infusionsgeräte zur einmaligen Verwendung mit Druckinfusionsapparaten bis zu einem Maximaldruck von 200 kPa (2 bar).
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 8: Appareils de perfusion non réutilisables avec des appareils de perfusion sous pression (ISO 8536-8:2015)
L'ISO 8536-8:2015 donne aux utilisateurs des informations sur les appareils de perfusion stérilisés non réutilisables avec des appareils de perfusion sous pression jusqu'à 200 kPa (2 bar) maximum.
Infuzijska oprema za uporabo v medicini - 8. del: Infuzijski seti za enkratno uporabo s tlačno črpalko (ISO 8536-8:2015)
Ta del standarda ISO 8536 uporabnikom zagotavlja informacije o steriliziranih infuzijskih setih za enkratno uporabo s tlačno
črpalko do največ 200 kPa (2 bara).
V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 8536.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 8536-8:2015
01-september-2015
1DGRPHãþD
SIST EN ISO 8536-8:2005
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO ,QIX]LMVNLVHWL]DHQNUDWQR
XSRUDERVWODþQRþUSDONR ,62
Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure
infusion apparatus (ISO 8536-8:2015)
Infusionsgeräte zur medizinischen Verwendung - Teil 8: Infusionsgeräte zur einmaligen
Verwendung mit Druckinfusionsapparaten (ISO 8536-8:2015)
Matériel de perfusion à usage médical - Partie 8: Appareils de perfusion non réutilisables
avec des appareils de perfusion sous pression (ISO 8536-8:2015)
Ta slovenski standard je istoveten z: EN ISO 8536-8:2015
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 8536-8:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 8536-8:2015
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SIST EN ISO 8536-8:2015
EUROPEAN STANDARD
EN ISO 8536-8
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2015
ICS 11.040.20 Supersedes EN ISO 8536-8:2004
English Version
Infusion equipment for medical use - Part 8: Infusion sets for
single use with pressure infusion apparatus (ISO 8536-8:2015)
Matériel de perfusion à usage médical - Partie 8: Appareils Infusionsgeräte zur medizinischen Verwendung - Teil 8:
de perfusion non réutilisables avec des appareils de Infusionsgeräte zur einmaligen Verwendung mit
perfusion sous pression (ISO 8536-8:2015) Druckinfusionsapparaten (ISO 8536-8:2015)
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 8536-8:2015 E
worldwide for CEN national Members.
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SIST EN ISO 8536-8:2015
EN ISO 8536-8:2015 (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 8536-8:2015
EN ISO 8536-8:2015 (E)
European foreword
This document (EN ISO 8536-8:2015) 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 8536-8:2004.
In this edition the following changes have been made:
— the part title has been changed from 'Infusion equipment …' to 'Infusion sets …';
— the former Clause 4 on designation has been deleted;
— 6.14 has been amended and an appropriate Annex B 'Storage volume' added;
— Clause 10 on labelling was amended by a note regarding the usage of the symbol “XXX” according
ISO 7000-2725;
— Clause 11 on disposal has been added;
— A.3 'Tests for leakage' has been amended;
— the former A.4 specifying a test of male conical fitting for leakage 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.
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 8536-8:2015
EN ISO 8536-8:2015 (E)
Endorsement notice
The text of ISO 8536-8:2015 has been approved by CEN as EN ISO 8536-8:2015 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 8536-4 EN ISO 8536-4:2013 and ISO 8536-4:2010 and
EN ISO 8536-4:2013/A1:2013 Amd.1:2013
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
4
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SIST EN ISO 8536-8:2015
EN ISO 8536-8:2015 (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
3.2, Clause 4 7.2 The part of ER 7.2 relating to
packaging is not addressed. For
packaging see Clause 8 of this
standard
Clause 4 7.3 ER covered by biological
evaluation
5.3, 5.5, A.3 7.5 Presumption of conformity with
the Essential Requirements
relating to the biological
evaluation can only be provided
if the manufacturer chooses to
apply the ISO 10993- series of
standards
5.2 7.6 Section 5.1 of this EN refers to
ISO 8536-4, sections 6.1
3.2, Clause 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
8.4
8.5
9.2, 9.3 8.7
Clause 4, 9.2 i) 9.1 The second sentence of ER 9.1
is not addressed
3.2 9.2
5
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SIST EN ISO 8536-8:2015
EN ISO 8536-8:2015 (E)
Clause(s)/subclause(s) Essential Requirements (ERs) Qualifying remarks/Notes
of this EN of Directive 93/42/EEC
5.2, A.2 12.7.1 Only tensile strength is
addressed
Clause 9 13.1
9.2 d), e), f), g), 9.3 c) and d) 13.2
9.2, 9.3 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
9.2, 9.3 13.4 13.4 is addressed regarding to
the label
9.2, 9.3 13.5 13.5 is not addressed regarding
to the detachable components
9.2, 9.3 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 8536-8:2015
INTERNATIONAL ISO
STANDARD 8536-8
Second edition
2015-06-15
Infusion equipment for medical use —
Part 8:
Infusion sets for single use with
pressure infusion apparatus
Matériel de perfusion à usage médical —
Partie 8: Appareils de perfusion non réutilisables avec des appareils
de perfusion sous pression
Reference number
ISO 8536-8:2015(E)
©
ISO 2015
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SIST EN ISO 8536-8:2015
ISO 8536-8:2015(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. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 8536-8:2015
ISO 8536-8:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
5 Materials . 5
6 Physical requirements . 5
6.1 Particulate contamination . 5
6.2 Tensile strength . 5
6.3 Leakage . 5
6.4 Male conical fitting . 6
6.5 Injection site . 6
6.6 Fluid filter . 6
6.7 Flow rate of infusion fluid . 6
6.8 Closure-piercing device . 6
6.9 Air-inlet device . 6
6.10 Drip chamber and drip tube . 6
6.11 Tubing . 6
6.12 Flow regulator . 6
6.13 Protective caps . 6
6.14 Storage volume . 6
7 Chemical requirements . 6
8 Biological requirements . 6
9 Packaging . 7
10 Labelling . 7
10.1 General . 7
10.2 Label on unit container . 7
10.3 Label on shelf or multi-unit container . 7
11 Disposal . 8
Annex A (normative) Physical tests . 9
Annex B (normative) Storage volume.10
Bibliography .13
© ISO 2015 – All rights reserved iii
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SIST EN ISO 8536-8:2015
ISO 8536-8:2015(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 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
...
SLOVENSKI STANDARD
oSIST prEN ISO 8536-8:2013
01-december-2013
,QIX]LMVNDRSUHPD]DXSRUDERYPHGLFLQLGHO ,QIX]LMVNDRSUHPD]DHQNUDWQR
XSRUDERVWODþQRþUSDONR ,62',6
Infusion equipment for medical use - Part 8: Infusion equipment for single use with
pressure infusion apparatus (ISO/DIS 8536-8:2013)
Infusionsgeräte zur medizinischen Verwendung - Teil 8: Infusionsgeräte zur einmaligen
Verwendung mit Druckinfusionsapparaten (ISO/DIS 8536-8:2013)
Matériel de perfusion à usage médical - Partie 8: Matériel de perfusion non-réutilisables
avec des appareils de perfusion sous pression (ISO/DIS 8536-8:2013)
Ta slovenski standard je istoveten z: prEN ISO 8536-8
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
oSIST prEN ISO 8536-8:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 8536-8:2013
---------------------- Page: 2 ----------------------
oSIST prEN ISO 8536-8:2013
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ISO/DIS 8536-8
ISO/TC 76 Secretariat: DIN
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2013-09-26 2014-02-26
Infusion equipment for medical use —
Part 8:
Infusion equipment for single use with pressure infusion
apparatus
Matériel de perfusion à usage médical —
Partie 8: Matériel de perfusion non-réutilisables avec avec des appareils de perfusion sous pression
[Revision of first edition (ISO 8536-8:2004)]
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This draft has been developed within the International Organization for
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---------------------- Page: 3 ----------------------
oSIST prEN ISO 8536-8:2013
ISO/DIS 8536-8:2013(E)
Copyright notice
��is������������t�is����r�ft���t�r��ti������t����r������is�����ri��t-�r�t��t����������������t��s�
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
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---------------------- Page: 4 ----------------------
oSIST prEN ISO 8536-8:2013
ISO/DIS 8536-8
Contents Page
Foreword . iv
1 Scope . 1
2 Normative references . 1
3 General requirements . 1
4 Designation . 4
4.1 Infusion set . 4
4.2 Air-inlet device . 4
5 Materials . 4
6 Physical requirements . 5
6.1 Particulate contamination. 5
6.2 Tensile strength . 5
6.3 Leakage . 5
6.4 Male conical fitting . 5
6.5 Injection site . 5
6.6 Fluid filter . 5
6.7 Flow rate of infusion fluid . 5
6.8 Closure-piercing device . 5
6.9 Air-inlet device . 5
6.10 Drip chamber and drip tube. 5
6.11 Tubing . 5
6.12 Flow regulator . 5
6.13 Protective caps . 6
6.14 Storage volume . 6
7 Chemical requirements . 6
8 Biological requirements . 6
9 Packaging . 6
10 Labelling . 6
10.1 General . 6
10.2 Label on unit container . 6
10.3 Label on shelf or multi-unit container . 7
Annex A (normative) Physical tests . 8
Bibliography . 9
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices . 10
© ISO 2013 – All rights reserved iii
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oSIST prEN ISO 8536-8:2013
ISO/DIS 8536-8
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8536-8 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood
processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 8536-8:2004, of which A.3 Tests for leakage
has been amended and A.4 specifying a test of male conical fitting for leakage has been deleted. In addition
6.14 has been slightly amended. Clause 10 on labelling was amended by a note regarding the usage of the
symbol "XXX" according ISO 7000-2725. Finally some minor editorial changes were introduced in the whole
document.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
Part 1: Infusion glass bottles
Part 2: Closures for infusion bottles
Part 3: Aluminium caps for infusion bottles
Part 4: Infusion sets for single use, gravity feed
Part 5: Burette infusion sets for single use, gravity feed
Part 6: Freeze drying closures for infusion bottles
Part 7: Caps made of aluminium-plastics combinations for infusion bottles
Part 8: Infusion equipment for single use with pressure infusion apparatus
Part 9: Fluid lines for single use with pressure infusion equipment
Part 10: Accessories for fluid lines for single use with pressure infusion equipment
Part 11: Infusion filters for single use with pressure infusion equipment
Part 12: Check valves
The following parts are under preparation:
iv © ISO 2013 – All rights reserved
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oSIST prEN ISO 8536-8:2013
ISO/DIS 8536-8
Part 13: Graduated flow regulators for single use with infusion sets
© ISO 2013 – All rights reserved v
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oSIST prEN ISO 8536-8:2013
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oSIST prEN ISO 8536-8:2013
DRAFT INTERNATIONAL STANDARD ISO/DIS 8536-8
Infusion equiment for medical use — Part 8: Infusion equipment
for single use with pressure infusion apparatus
1 Scope
This part of ISO 8536 gives users information on sterilized infusion sets for single use with pressure infusion
equipment up to a maximum of 200 kPa (2 bar).
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment —
Part 2: Lock fittings
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
3 General requirements
3.1 The nomenclature to be used for components of infusion sets and of a separate air-inlet device is given
in Figures 1, 2 and 3. These figures illustrate examples of the configuration of infusion sets and air-inlet
devices; other configurations may be used provided they lead to the same results. Infusion sets as illustrated
in Figure 2 should only be used for collapsible plastics containers. Infusion sets as illustrated in Figure 2 used
with separate air-inlet devices as illustrated in Figure 3, or infusion sets as illustrated in Figure 1 shall be used
for rigid containers.
© ISO 2013 – All rights reserved
1
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oSIST prEN ISO 8536-8:2013
ISO/DIS 8536-8
Key
1 protective cap of closure-piercing device 8 tubing
2 closure-piercing device 9 flow regulator
3 air-inlet with air filter and closure 10 injection site
4 fluid channel 11 m
...
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