Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO 1135-4:2012)

ISO 1135-4:2011 specifies requirements for single-use transfusion sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.
Secondary aims of ISO 1135-4:2011 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets and to present designations for transfusion set components.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-4:2011.

Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-4:2012)

Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non réutilisables (ISO 1135-4:2012)

L'ISO 1135-4:2012 spécifie les exigences applicables aux appareils de transfusion à usage médical, non réutilisables, afin d'assurer leur compatibilité avec les conteneurs renfermant du sang et des composants du sang, ainsi qu'avec les appareils intraveineux.
Les objectifs secondaires de l'ISO 1135-4:2012 sont de donner des lignes directrices sur les spécifications relatives à la qualité et aux performances des matériaux utilisés dans les appareils de transfusion, et de proposer une terminologie relative aux composants de ces derniers.
Dans certains pays, la pharmacopée nationale ou d'autres réglementations nationales sont légalement contraignantes et priment sur l'ISO 1135-4:2012.

Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za enkratno uporabo (ISO 1135-4:2012)

Ta del standarda ISO 1135 določa zahteve za transfuzijske garniture za enkratno uporabo v medicini, da se zagotovi njihova združljivost z vsebniki za kri in krvne sestavine ter z intravenozno opremo. Druga cilja tega dela standarda ISO 1135 sta zagotoviti navodila za specifikacije v zvezi s kakovostjo in učinkovitostjo materialov, uporabljenih za transfuzijske garniture, ter predstaviti oznake za sestavne dele transfuzijskih garnitur. V nekaterih državah je nacionalna farmakopeja ali druga nacionalna zakonodaja pravno zavezujoča in ima prednost pred tem delom standarda ISO 1135.

General Information

Status
Withdrawn
Publication Date
29-Feb-2012
Withdrawal Date
22-Dec-2015
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
23-Dec-2015

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SLOVENSKI STANDARD
SIST EN ISO 1135-4:2012
01-maj-2012
1DGRPHãþD
SIST EN ISO 1135-4:2012
Transfuzijska oprema za uporabo v medicini - 4. del: Transfuzijske garniture za
enkratno uporabo (ISO 1135-4:2012)

Transfusion equipment for medical use - Part 4: Transfusion sets for single use (ISO

1135-4:2012)
Transfusionsgeräte zur medizinischen Verwendung - Teil 4: Transfusionsgeräte zur
einmaligen Verwendung (ISO 1135-4:2012)
Matériel de transfusion à usage médical - Partie 4: Appareils de transfusion non
réutilisables (ISO 1135-4:2012)
Ta slovenski standard je istoveten z: EN ISO 1135-4:2012
ICS:
11.040.20 Transfuzijska, infuzijska in Transfusion, infusion and
injekcijska oprema injection equipment
SIST EN ISO 1135-4:2012 en

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

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SIST EN ISO 1135-4:2012
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SIST EN ISO 1135-4:2012
EUROPEAN STANDARD
EN ISO 1135-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2012
ICS 11.040.20 Supersedes EN ISO 1135-4:2011
English Version
Transfusion equipment for medical use - Part 4: Transfusion
sets for single use (ISO 1135-4:2012)

Matériel de transfusion à usage médical - Partie 4: Transfusionsgeräte zur medizinischen Verwendung - Teil 4:

Appareils de transfusion non réutilisables (ISO 1135- Transfusionsgeräte zur einmaligen Verwendung (ISO 1135-

4:2012) 4:2012)
This European Standard was approved by CEN on 29 February 2012.

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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1135-4:2012: E

worldwide for CEN national Members.
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2012 (E)
Contents Page

Foreword ..............................................................................................................................................................3

Annex ZA (informative) Relationship between this European Standard and the Essential

Requirements of EU Directive 93/42/EEC on medical devices ........................................................4

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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2012 (E)
Foreword

This document (EN ISO 1135-4:2012) 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 September 2012, and conflicting national standards shall be

withdrawn at the latest by September 2012.

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 1135-4:2010.

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, 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.
Endorsement notice

The text of ISO 1135-4:2012 has been approved by CEN as a EN ISO 1135-4:2012 without any modification.

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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2012 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU 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
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
3.2 7.2, 8.1
3.3 13.3 b)
4 1, 2, 3
5.1 7.2
5.2 7.6
5.3 9.1, 12.7.1
5.4 7.6
5.5 12.8
5.6 7.2
5.7 12.8
5.8 10, 12.8
5.9 10, 12.8
5.10 8
5.11 9.1
5.12 8
6 7
7.1 7, 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 EN ISO 10993
series standards
7.2 8.4
7.3 7.1, 7.2
7.4 7.1, 7.2
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SIST EN ISO 1135-4:2012
EN ISO 1135-4:2012 (E)
Table ZA.1 (continued)
Essential Requirements (ERs) of
Clause(s)/sub-clause(s) of this EN Qualifying remarks/Notes
Directive 93/42/EEC
7.5 7.1, 7.2
8 13 The part of 13.3.a) relating to the
authorized representative is not
addressed. 13.3.f) and 13.6.h)
relating to single use are not fully
addressed. 13.6.q) is not addressed.
9 5, 8.3
10 13.6 n)

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling

within the scope of this standard.
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SIST EN ISO 1135-4:2012
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SIST EN ISO 1135-4:2012
INTERNATIONAL ISO
STANDARD 1135-4
Fifth edition
2012-03-01
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
Matériel de transfusion à usage médical —
Partie 4: Appareils de transfusion non réutilisables
Reference number
ISO 1135-4:2012(E)
ISO 2012
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SIST EN ISO 1135-4:2012
ISO 1135-4:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or

ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
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SIST EN ISO 1135-4:2012
ISO 1135-4:2012(E)
Contents Page

Foreword ............................................................................................................................................................ iv

1  Scope ...................................................................................................................................................... 1

2  Normative references ............................................................................................................................ 1

3  General requirements ........................................................................................................................... 2

3.1  Nomenclature for components of the transfusion set ...................................................................... 2

3.2  Maintenance of sterility ......................................................................................................................... 2

3.3  Designation ............................................................................................................................................ 3

4  Materials ................................................................................................................................................. 3

5  Physical requirements .......................................................................................................................... 3

5.1  Particulate contamination..................................................................................................................... 3

5.2  Leakage .................................................................................................................................................. 3

5.3  Tensile strength ..................................................................................................................................... 3

5.4  Closure-piercing device ........................................................................................................................ 3

5.5  Tubing ..................................................................................................................................................... 4

5.6  Filter for blood and blood components .............................................................................................. 4

5.7  Drip chamber and drip tube.................................................................................................................. 4

5.8  Flow regulator ........................................................................................................................................ 4

5.9  Flow rate of blood and blood components ......................................................................................... 4

5.10  Injection site ........................................................................................................................................... 5

5.11  Male conical fitting ................................................................................................................................ 5

5.12  Protective caps ...................................................................................................................................... 5

6  Chemical requirements ......................................................................................................................... 5

6.1  Reducing (oxidizable) matter ............................................................................................................... 5

6.2  Metal ions ............................................................................................................................................... 5

6.3  Titration acidity or alkalinity ................................................................................................................. 5

6.4  Residue on evaporation ........................................................................................................................ 5

6.5  UV absorption of extract solution ........................................................................................................ 5

7  Biological requirements ........................................................................................................................ 6

7.1  General ................................................................................................................................................... 6

7.2  Sterility.................................................................................................................................................... 6

7.3  Pyrogenicity ........................................................................................................................................... 6

7.4  Haemolysis ............................................................................................................................................. 6

7.5  Toxicity ................................................................................................................................................... 6

8  Labelling ................................................................................................................................................. 6

8.1  Unit container ........................................................................................................................................ 6

8.2  Shelf or multi-unit container ................................................................................................................ 7

9  Packaging ............................................................................................................................................... 7

10  Disposal .................................................................................................................................................. 7

Annex A (normative) Physical tests .................................................................................................................. 8

Annex B (normative) Chemical tests .............................................................................................................. 12

Annex C (normative) Biological tests ............................................................................................................. 14

Bibliography ...................................................................................................................................................... 15

© ISO 2012 – All rights reserved iii
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SIST EN ISO 1135-4:2012
ISO 1135-4:2012(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.

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 1135-4 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and blood

processing equipment for medical and pharmaceutical use.

This fifth edition cancels and replaces the fourth edition (ISO 1135-4:2010), which has been revised at

Figure 2 (dimensions of the closure-piercing device), at 6.1, at 8.2 (Note), and at B.2 (last sentence).

ISO 1135 consists of the following parts, under the general title Transfusion equipment for medical use:

 Part 3: Blood-taking set
 Part 4: Transfusion sets for single use
iv © ISO 2012 – All rights reserved
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SIST EN ISO 1135-4:2012
INTERNATIONAL STANDARD ISO 1135-4:2012(E)
Transfusion equipment for medical use —
Part 4:
Transfusion sets for single use
1 Scope

This part of ISO 1135 specifies requirements for single-use transfusion sets for medical use in order to ensure

their compatibility with containers for blood and blood components as well as with intravenous equipment.

Secondary aims of this part of ISO 1135 are to provide guidance on specifications relating to the quality and

performance of materials used in transfusion sets and to present designations for transfusion set components.

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 referenced documents are indispensable for the application 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 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 1: General requirements

ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical

equipment — Part 2: Lock fittings

ISO 3696:1987, Water for analytical laboratory use — Specification and test methods

ISO 3826-1:2003, Plastics collapsible containers for human blood and blood components — Part 1:

Conventional containers
ISO 7864:1993, Sterile hypodermic needles for single use

ISO 14644-1:1999, Cleanrooms and associated controlled environments — Part 1: Classification of air

cleanliness
1 )

ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements
1) To be published. (Revision of ISO 15223-1:2007)
© ISO 2012 – All rights reserved 1
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SIST EN ISO 1135-4:2012
ISO 1135-4:2012(E)
3 General requirements
3.1 Nomenclature for components of the transfusion set
The nomenclature for components of transfusion sets is given in Figure 1.
Key
1 protective cap of the 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 filter for blood and blood components

Indicates alternative locations of the filter for blood and blood components. Other designs are acceptable if the same

safety aspects are ensured.
Injection site is optional.
Figure 1 — Example of a transfusion set
3.2 Maintenance of sterility

The transfusion set shall be provided with protective caps to maintain sterility of the internal parts of the set

until the set is used.
2 © ISO 2012 – All rights reserved
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SIST EN ISO 1135-4:2012
ISO 1135-4:2012(E)
3.3 Designation

A transfusion set complying with the requirements of this part of ISO 1135 is designated as follows.

Transfusion set ISO 1135-4
4 Materials

The materials from which the transfusion sets given in Clause 3 are manufactured shall comply with the

requirements specified in Clause 5. If components of the transfusion set come into contact with blood and

blood components, they shall additionally comply with the requirements specified in Clauses 6 and 7.

5 Physical requirements
5.1 Particulate contamination

The transfusion 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 transfusion 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 transfusion set, excluding protective caps, shall withstand a

static tensile force of not less than 15 N for 15 s.
5.4 Closure-piercing device

5.4.1 The dimensions of the closure-piercing device shall conform to the dimensions shown in Figure 2.

NOTE The dimension of 15 mm in Figure 2 is a reference measurement. The cross-section of the piercing device at

this site is a circle.
Dimensions in millimetres
Figure 2 — Dimensions of the closure-piercing device

5.4.2 The closure-piercing device shall be capable of piercing and penetrating the closure of a container for

blood and blood components without prepiercing. No coring should occur during this procedure.

NOTE 1 A carefully controlled surface treatment of the closure-piercing device (e.g. siliconization) is recommended to

facilitate its insertion into the blood bag port. The same effect may b
...

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