SIST EN ISO 1135-3:2017
(Main)Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)
This part of EN ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
The materials and the components of the sets are validated by various test methods.
The manufacturer shall select appropriate test methods to comply with the requirements laid down in this part of EN ISO 1135.
Secondary aims of this part of EN ISO 1135 are to provide
a) specifications relating to the quality and performance of materials used in transfusion equipment;
b) a unified presentation of terms and designations for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of EN ISO 1135.
Transfusionsgeräte zur medizinischen Verwendung - Teil 3: Blutentnahmegeräte zur einmaligen Verwendung (ISO 1135-3:2016)
Dieser Teil von ISO 1135 legt Anforderungen an Blutentnahmegeräte für die medizinische Verwendung fest, um die funktionelle Austauschbarkeit von Transfusionsgeräten sicherzustellen. Sie ist auf sterilisierte Blutentnahmegeräte zur einmaligen Verwendung anzuwenden.
Dieser Teil von ISO 1135 stellt auch zur Verfügung:
a) Qualitätsanforderungen für die in Blutentnahmegeräten verwendeten Werkstoffe, und
b) eine einheitliche Darstellung von Benennungen für Blutentnahmegeräte
festzulegen.
In einigen Ländern sind das nationale Arzneibuch oder andere nationale Bestimmungen rechtlich bindend und haben Vorrang vor diesem Teil von ISO 1135.
Matériel de transfusion à usage médical - Partie 3: Appareils non réutilisables pour prélèvement de sang (ISO 1135-3:2016)
ISO 1135-3:2016 fixe les spécifications des divers types d'appareils pour prélèvement sanguin à usage médical afin d'assurer I'interchangeabilité fonctionnelle du matériel de transfusion. Elle s'applique aux appareils stériles non réutilisables pour prélèvement sanguin.
ISO 1135-3:2016 a également pour but de fournir
a) des spécifications relatives à la qualité et aux performances des matériaux utilisés pour le matériel de transfusion; et
b) une terminologie uniforme concernant ce type de matériel.
Dans certains pays, la pharmacopée nationale ou d'autres règlements nationaux sont juridiquement contraignants et prévalent sur les dispositions de l'ISO 1135-3:2016.
Transfuzijska oprema za uporabo v medicini - 3. del: Seti za odvzem krvi za enkratno uporabo (ISO 1135-3:2016)
Ta del standarda EN ISO 1135 določa zahteve za vrste setov za odvzem krvi za uporabo v medicini, da se zagotovi funkcijska zamenljivost opreme za transfuzijo. Uporablja se samo za sterilizirane sete za odvzem krvi za enkratno uporabo. Materiali in sestavni deli setov so validirani na podlagi različnih preskusnih metod. Proizvajalec izbere ustrezne preskusne metode za uskladitev z zahtevami, določenimi v tem delu standarda EN ISO 1135. Druga cilja tega dela standarda EN ISO 1135 sta zagotoviti a) specifikacije glede kakovosti in učinkovitosti materialov, ki se uporabljajo v opremi za transfuzijo; b) enotno predstavitev pogojev in označb za takšno opremo. V nekaterih državah so nacionalne farmakopeje ali drugi nacionalni predpisi pravno zavezujoči in imajo prednost pred tem delom standarda EN ISO 1135.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 1135-3:2017
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
SIST EN ISO 1135-3:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 1135-3:2017
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SIST EN ISO 1135-3:2017
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.
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
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
2
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
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
3
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
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.
4
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
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.
5
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
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)
6
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SIST EN ISO 1135-3:2017
EN ISO 1135-3:2017 (E)
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.
7
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SIST EN ISO 1135-3:2017
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SIST EN ISO 1135-3:2017
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
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SIST EN ISO 1135-3:2017
ISO 1135-3:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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SIST EN ISO 1135-3:2017
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 2016 – All rights reserved iii
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SIST EN ISO 1135-3:2017
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 endorsement.
For an explanation on 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 the following URL: www.iso.org/iso/foreword.html.
The committee responsible for this document is 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 1135-3:1986), which has been technically
revised with the following changes:
— part title has been amended by “for single use” in alignment with the other parts of ISO 1135;
— figures have been updated;
— subclause 3.6, “Designation examples” has been deleted;
— physical, chemical and biological requirements have been aligned with ISO 1135-4;
— Clause 10, “Disposal” has been added;
— Annexes A, B and C have been aligned with ISO 1135-4;
— all references have been updated.
ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use:
— Part 3: Blood-taking sets for single use
— Part 4: Transfusion sets for single use, gravity feed
— Part 5: Transfusion sets for single use with pressure infusion apparatus
iv © ISO 2016 – All rights reserved
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SIST EN ISO 1135-3:2017
INTERNATIONAL STANDARD ISO 1135-3:2016(E)
Transfusion equipment for medical use —
Part 3:
Blood-taking sets for single use
1 Scope
This part of ISO 1135 specifies requirements for types of blood-taking sets for medical use in order
to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-
taking sets intended for single use only.
This part of ISO 1135 also aims to provide
a) specifications relating to the quality and performance of materials used in transfusion
equipment, and
b) a unified presentation of terms for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and
take precedence over this part of ISO 1135.
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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7864, Sterile hypodermic needles for single use
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14644-1:2015, 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
3 General requirements
3.1 Types of sets
The blood-taking set shall consist of the blood-taking assembly and the air-outlet assembly, which may
be separate or combined.
A diagram of a typical blood-taking set is illustrated in Figure 1.
© ISO 2016 – All rights reserved 1
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SIST EN ISO 1135-3:2017
ISO 1135-3:2016(E)
a) Blood-taking assembly b) Air outlet assembly
Key
1 protective cap 5 blood-taking needle
2 bottle needle 6 air filter
3 tubing 7 air filter housing
4 flow regulator (optional) 8 air-outlet needle
Figure 1 — Examples of typical blood-taking sets
3.2 Blood taking assembly
The blood-taking assembly shall consist of a blood-taking needle for vein puncture and of a bottle
needle to be inserted through one of the specified areas provided on the bottle closure. Each needle is
connected to one end of a length of tubing.
3.3 Air-outlet assembly
The air-outlet assembly shall consist of an air filter housing with air filter combined with an air-outlet
needle for piercing the specified area provided on the bottle closure.
The filter shall be capable of preventing microbial ingress.
2 © ISO 2016 – All rights reserved
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SIST EN ISO 1135-3:2017
ISO 1135-3:2016(E)
3.4 Sterilization
The blood-taking set shall be sterile in its unit container. Evidence of the effectiveness of the sterilization
process used shall be provided.
3.5 Maintenance of sterility
The blood-taking set shall be provided with protective caps designed to maintain sterility of the
internal surface of the set and the internal and external surfaces of the needles until the set is used.
4 Materials
The materials from which the blood-taking set is made shall not have undesirable effects on the blood
passing through the set under ordinary conditions of use, or on the fluids used in connection with the
blood. They shall not produce any general toxic effects or any local reaction on the recipient of the blood.
Appropriate type tests for assessing biological compatibility are given in Annex C.
5 Physical requirements
5.1 Particulate contamination
The blood-taking sets 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.1, the
number of particles detected shall not exceed the contamination index limit.
5.2 Leakage
The blood-taking set, when tested in accordance with A.2, shall show no signs of air leakage.
5.3 Tensile strength
Any connections between the components of the blood-taking set, excluding protective caps, shall
withstand a static tensile force of not less than 15 N for 15 s.
5.4 Bottle needle
5.4.1 The bottle needle shall not be less than 35 mm in length. The external diameter shall not be less
than 1,8 mm and the internal diameter shall not be less than 70 % of the external diameter.
5.4.2 The internal and external surfaces of the needle tube shall be clean and smooth.
5.4.3 The bottle needle shall be designed in accordance with ISO 7864 in order to minimize the number
of rubber particles when the closure is pierced.
5.5 Air-outlet needle
The air-outlet needle shall have an internal diameter not less than 0,7 mm, an external diameter not
greater than 1,9 mm and a needle not exceeding 25 mm in length.
5.6 Blood-taking needle
5.6.1 The blood taking needle shall not be less than 35 mm in length. The external diameter shall not
be greater than 2 mm and the internal diameter shall not be less than 70 % of the external diameter.
© ISO 2016 – All rights reserved 3
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SIST EN ISO
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