SIST EN ISO 1135-3:2017

SLOVENSKI STANDARD
01-maj-2017
Transfuzijska oprema za uporabo v medicini - 3. del: Seti za odvzem krvi za
enkratno uporabo (ISO 1135-3:2016)
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO
1135-3:2016)
Transfusionsgeräte zur medizinischen Verwendung - Teil 3: Blutentnahmegeräte zur
einmaligen Verwendung (ISO 1135-3:2016)
Matériel de transfusion à usage médical - Partie 3: Appareils non réutilisables pour
prélèvement de sang (ISO 1135-3:2016)
Ta slovenski standard je istoveten z: EN ISO 1135-3:2017
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 1135-3
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2017
EUROPÄISCHE NORM
ICS 11.040.20
English Version
Transfusion equipment for medical use - Part 3: Blood-
taking sets for single use (ISO 1135-3:2016)
Matériel de transfusion à usage médical - Partie 3: Transfusionsgeräte zur medizinischen Verwendung -
Appareils non réutilisables pour prélèvement sanguin Teil 3: Blutentnahmegeräte zur einmaligen
(ISO 1135-3:2016) Verwendung (ISO 1135-3:2016)
This European Standard was approved by CEN on 24 August 2016.

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, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-3:2017 E
worldwide for CEN national Members.

Contents
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered. 5
European foreword
This document (EN ISO 1135-3:2017) 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 August 2017, and conflicting national standards shall
be withdrawn at the latest by August 2017.
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 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(s), 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard "within the
meaning of Annex ZA", the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1— Correlations between undated normative references and dated EN and ISO standards
Normative Equivalent dated standard
references as listed
EN ISO or IEC
in Clause 2 of the
ISO standard
ISO 3696 EN ISO 3696:1995 ISO 3696:1987
ISO 7864 EN ISO 7864:2016 ISO 7864:2016
ISO 11607-1 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006
plus ISO 11607-1 Amd 1:2014
ISO 14644-1:2015 EN ISO 14644-1:2015 ISO 14644-1:2015
ISO 15223-1 EN ISO 15223-1:2012 ISO 15223-1:2012
Endorsement notice
The text of ISO 1135-3:2016 has been approved by CEN as EN ISO 1135-3:2017 without any
modification.
Annex ZA
(informative)
Relationship between this European standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission's standardization request ‘M/295
concerning the development of European standards related to medical devices’ to provide a voluntary
means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993
concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced "as far as possible", "to a minimum", "to the lowest possible level",
"minimized" or "removed", according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to Table 1 of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/subclause(s) Remarks/Notes
Directive 93/42/EEC of this EN
7.2 3.3, 5.1, 5.2, 5.3, Clause 6, The part of ER 7.2 relating to
Clause 7, A.1, A.2 packaging is not addressed
(for packaging see Clause 9 of
this standard).
7.3 (first part only) Clause 4, 5.1, 5.2, 5.3, Clause 6,
Clause 7, A.1, A.2
7.5 5.2, 5.3, Clause 7, A.2 Only the first paragraph 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
standards.
7.6 5.1, 5.2, 5.3, A.1, A.2
8.1 3.4, 3.5, Clause 5 The part of ER 8.1 relating to
handling is not addressed.
Manufacturing processes are
not covered.
The reduction of the risk of
infection is not fully covered.
8.3 3.3, 3.4, 5.9, Clause 9
8.4 7.2 Only the sterilization method
is covered.
8.5 5.1, A.1
8.7 8.2, 8.3
9.1 5.4, 5.5 The second sentence of ER 9.1
is not addressed.
Coverage of this ER is partly
provided by normative
reference to EN ISO 7864.
9.2 (first indent) Clause 5, 7.1 Covered in respect of the
following:
- Particulate contamination;
- Leakage;
- Tensile strength;
- Dimensions;
- Physical characteristics of
tube and needle.
9.2 (second indent) 5.2 Covered in respect of the
following:
- Variations in pressure.
9.2 (fourth indent) Clause 4 Covered in respect of the
following:
- Undesirable effects on blood
or fluid used.
12.7.1 5.3 Only tensile strength is
addressed.
13.1 Clause 8 Only requirements for
labelling are covered.
13.2 8.1, 8.2, 8.3 The final sentence is not
addressed.
13.3 b) 8.2 b), 8.3 b)
13.3 c) 8.2 c), 8.3 c)
13.3 d) 8.2 d), 8.3 d) Only covered if the batch
number is preceded by the
word "LOT".
13.3 e) 8.2 e), 8.3 e)
13.3 f) 8.2, 8.3 Requirement "indication of
single use must be consistent
across the Community" is not
addressed in the standard.
13.4 8.2, 8.3 13.4 is addressed regarding to
the label.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 1135-3
Second edition
2016-11-01
Transfusion equipment for medical
use —
Part 3:
Blood-taking sets for single use
Matériel de transfusion à usage médical —
Partie 3: Appareils non réutilisables pour prélèvement sanguin
Reference number
ISO 1135-3:2016(E)
©
ISO 2016
ISO 1135-3:2016(E)
© ISO 2016, 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 2016 – All rights reserved

ISO 1135-3:2016(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 General requirements . 1
3.1 Types of sets . 1
3.2 Blood taking assembly. 2
3.3 Air-outlet assembly . 2
3.4 Sterilization . 3
3.5 Maintenance of sterility. 3
4 Materials . 3
5 Physical requirements . 3
5.1 Particulate contamination . 3
5.2 Leakage . 3
5.3 Tensile strength . 3
5.4 Bottle needle . 3
5.5 Air-outlet needle . 3
5.6 Blood-taking needle . . 3
5.7 Tubing . 4
5.8 Flow regulator . 4
5.9 Protective caps . 4
6 Chemical requirements . 4
6.1 Reducing (oxidizable) matter . 4
6.2 Metal ions . 4
6.3 Titration acidity or alkalinity. 4
6.4 Residue on evaporation . 4
6.5 UV absorption of extract solution . 5
7 Biological requirements . 5
7.1 General . 5
7.2 Sterility . 5
7.3 Pyrogenicity . 5
7.4 Haemolysis . 5
7.5 Toxicity . 5
8 Labelling . 5
8.1 General . 5
8.2 Unit container . 5
8.3 Shelf or multi-unit container . 6
9 Packaging . 6
10 Disposal . 6
Annex A (normative) Physical tests . 7
Annex B (normative) Chemical tests . 9
Annex C (normative) Biological tests .11
Bibliography .12
ISO 1135-3:2016(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 e
...