SIST EN ISO 22413:2021
(Main)Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2021)
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren (ISO 22413:2021)
Dieses Dokument gilt für sterilisierte, zur einmaligen Verwendung bestimmte Überleitgeräte für pharmazeutische Zubereitungen.
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes d'essai (ISO 22413:2021)
Le présent document spécifie les exigences et les méthodes d’essai relatives aux ensembles de transfert stérilisés, non réutilisables, utilisés pour les préparations pharmaceutiques.
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO 22413:2021)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22413:2021
01-september-2021
Nadomešča:
SIST EN ISO 22413:2013
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO
22413:2021)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO
22413:2021)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren
(ISO 22413:2021)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes
d'essai (ISO 22413:2021)
Ta slovenski standard je istoveten z: EN ISO 22413:2021
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 22413:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22413:2021
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SIST EN ISO 22413:2021
EN ISO 22413
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2021
EUROPÄISCHE NORM
ICS 11.040.20 Supersedes EN ISO 22413:2013
English Version
Transfer sets for pharmaceutical preparations -
Requirements and test methods (ISO 22413:2021)
Ensemble de transfert pour préparations Überleitgeräte für pharmazeutische Zubereitungen -
pharmaceutiques - Exigences et méthodes d'essai (ISO Anforderungen und Prüfverfahren (ISO 22413:2021)
22413:2021)
This European Standard was approved by CEN on 23 April 2021.
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, Republic of North Macedonia, 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: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22413:2021 E
worldwide for CEN national Members.
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SIST EN ISO 22413:2021
EN ISO 22413:2021 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 22413:2021
EN ISO 22413:2021 (E)
European foreword
This document (EN ISO 22413:2021) 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 2021, and conflicting national standards
shall be withdrawn at the latest by December 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 22413:2013.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 22413:2021 has been approved by CEN as EN ISO 22413:2021 without any modification.
3
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SIST EN ISO 22413:2021
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SIST EN ISO 22413:2021
INTERNATIONAL ISO
STANDARD 22413
Third edition
2021-06
Transfer sets for pharmaceutical
preparations — Requirements and
test methods
Ensemble de transfert pour préparations pharmaceutiques —
Exigences et méthodes d'essai
Reference number
ISO 22413:2021(E)
©
ISO 2021
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SIST EN ISO 22413:2021
ISO 22413:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 22413:2021
ISO 22413:2021(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design and designation . 2
4.1 Design for transfer sets without housing . 2
4.2 Design for a transfer set with housing . 5
4.3 Designation . 5
5 Materials . 5
6 Physical requirements . 5
6.1 Particulate contamination . 5
6.2 Tensile strength . 5
6.3 Leakage . 6
6.4 Free flow . 6
6.5 Piercing device . 6
6.6 Penetration force . 6
6.7 Fragmentation . 6
6.8 Air inlet and air outlet. 7
6.9 Protective caps . 7
6.10 Transfer sets with housing . 7
6.11 Small-bore connectors. 7
6.12 Fluid filter . 7
7 Chemical requirements . 7
8 Biological requirements . 7
9 Packaging . 7
10 Labelling . 8
10.1 General . 8
10.2 Unit container . 8
10.3 Shelf or multi-unit container . 8
11 Disposal . 9
Annex A (normative) Physical tests .10
Bibliography .14
© ISO 2021 – All rights reserved iii
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SIST EN ISO 22413:2021
ISO 22413:2021(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 of the voluntary nature of standards, 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection,
and blood processing equipment for medical and pharmaceutical use, in collaboration with the European
Committee for Standardization (CEN) Technical Committee CEN/TC 205, Non-active medical devices, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 22413:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the structure (moving all tests to the new Annex A) and partly the content were aligned with
ISO 8536-4;
— Table 1 on penetration force was amended by a new entry;
— 6.7 (formerly 5.7) on fragmentation was clarified;
— former Clause 12 on storage was deleted;
— Clause 10 (formerly Clause 13) on labelling was updated;
— Clause 11 on the disposal has been added due to the single-use character of the product;
— former Annexes A and B on testing of fragmentation of transfer sets were moved to a new Annex A
on physical tests;
— most of the tests in Annex A were, as far as necessary, aligned with the appropriate tests in
ISO 8536-4;
— a new Clause A.9 on a test for stress cracking of small-bore connectors was added;
— Clause 2 and the Bibliography were updated.
iv © ISO 2021 – All rights reserved
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SIST EN ISO 22413:2021
ISO 22413:2021(E)
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2021 – All rights reserved v
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SIST EN ISO 22413:2021
ISO 22413:2021(E)
Introduction
Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The
transfer sets mix fluids or dissolve dry substances and are used in combination with infusion and
injection containers.
The transfer sets consist either of two piercing devices or of a piercing device in combination with a
small-bore connector, which can be connected with each other in different ways. Transfer sets can have
a housing.
Examples of different designs:
a) two piercing devices connected to each other (similar to piercing devices of infusion containers);
b) a metal cannula, bevelled on both sides or a combination of a) and b);
c) metal cannulae, mostly having a hub or a grip plate in the middle, fixed to the plastic part;
d) plastic piercing devices directly connected to a grip plate, or held by a tube at a distance to allow a
higher hydrostatic pressure;
e) piercing devices with an additional ventilation channel that can end in the other tip or outside;
f) piercing devices with an air filter;
g) piercing device in combination with a small-bore connector;
h) piercing device in combination with a small-bore connector and a particle filter;
i) piercing devices with housings serving, among other things, as a guide and a fixation on the
connected containers for a secure, injury-free and contactless application.
vi © ISO 2021 – All rights reserved
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SIST EN ISO 22413:2021
INTERNATIONAL STANDARD ISO 22413:2021(E)
Transfer sets for pharmaceutical preparations —
Requirements and test methods
1 Scope
This document specifies requirements and test methods for sterilized single-use transfer sets that are
used for pharmaceutical preparations.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods
ISO 8362 (all parts), — Injection containers and accessories
ISO 8536 (all parts), — Infusion equipment for medical use
ISO 8871-5, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional
requirements and testing
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15747, Plastic containers for intravenous injections
ISO 15759, Medical infusion equipment — Plastics caps with inserted elastomeric liner for containe
...
SLOVENSKI STANDARD
oSIST prEN ISO 22413:2020
01-julij-2020
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode
(ISO/DIS 22413:2020)
Transfer sets for pharmaceutical preparations - Requirements and test methods
(ISO/DIS 22413:2020)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren
(ISO/DIS 22413:2020)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes
d'essai (ISO/DIS 22413:2020)
Ta slovenski standard je istoveten z: prEN ISO 22413
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
oSIST prEN ISO 22413:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 22413:2020
---------------------- Page: 2 ----------------------
oSIST prEN ISO 22413:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 22413
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-05-27 2020-08-19
Transfer sets for pharmaceutical preparations —
Requirements and test methods
Ensemble de transfert pour préparations pharmaceutiques — Exigences et méthodes d'essai
ICS: 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 22413:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 22413:2020
ISO/DIS 22413:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 22413:2020
ISO/DIS 22413:2020(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Design and designation . 2
4.1 Design for transfer sets without housing . 2
4.2 Design for a transfers set with housing . 5
4.3 Designation . 5
5 Materials . 5
6 Physical requirements . 5
6.1 Particulate contamination . 5
6.2 Tensile strength . 6
6.3 Leakage . 6
6.4 Free flow . 6
6.5 Piercing device . 6
6.6 Penetration force . 6
6.7 Fragmentation . 6
6.8 Air inlet and air outlet. 6
6.9 Protective caps . 7
6.10 Small bore connectors . 7
6.11 Fluid filter . 7
7 Chemical requirements . 7
8 Biological requirements . 7
9 Packaging . 7
10 Labelling . 7
10.1 General . 7
10.2 Unit container . 7
10.3 Shelf or multi-unit container . 8
11 Disposal . 8
Annex A (normative) Physical tests . 9
Bibliography .13
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 22413:2020
ISO/DIS 22413:2020(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 of the voluntary nature of standards, 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection,
and blood processing equipment for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 22413:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the structure (moving all tests to the new Annex A) and partly the content were aligned with
ISO 8536-4;
— for formal reasons Clause 3 on normative references was inserted;
— in sub-clause 6.6 (formerly 5.6) the Table 1 on penetration force was amended by a new entry for a
counterpart according ISO 15747;
— 6.7 (formerly 5.7) on fragmentation was more clarified;
— the former sub-clause 5.10 on transfer sets with housing was deleted;
— the former Clause 12 on the storage was deleted;
— Clause 10 (formerly Clause 13) on the labelling was completely updated according the current
requirements;
— Clause 11 on the disposal has been inserted due to the single-use character of the product;
— the former Annexes A and B on testing of fragmentation of transfer sets were moved to a new Annex
A on physical tests with appropriate sub-clauses;
— most of the tests in Annex A were, as far as necessary, aligned with the appropriate tests in
ISO 8536-4;
— a new Clause A.8 on a test for stress cracking of small bore connectors was inserted;
iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 22413:2020
ISO/DIS 22413:2020(E)
— the normative references and the bibliography were updated.
A list of all parts in the ISO 22413 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 22413:2020
ISO/DIS 22413:2020(E)
Introduction
Transfer sets for pharmaceutical preparations transmit fluids from one container to another. The
transfer sets mix fluids or dissolve dry substances and are used in combination with infusion and
injection containers.
The transfer sets consist either of two piercing devices or of a piercing device in combination with a
small bore connector, which may be connected with each other in different ways. Transfer sets may
have a housing.
Examples of different designs:
a) two piercing devices connected to each other (similar to piercing devices of infusion containers);
b) a metal cannula, bevelled on both sides or a combination of a) and b);
c) metal cannulae mostly having a hub or a grip plate in the middle to be fixed to the plastic part;
d) plastic piercing devices directly connected to a grip plate, or held by a tube at a distance to allow a
higher hydrostatic pressure;
e) piercing devices with an additional ventilation channel that may end in the other tip or outside;
f) piercing devices also with an air filter;
g) piercing device in combination with a small bore connector;
h) piercing device in combination with a small bore connector and a particle filter.
vi © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 22413:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 22413:2020(E)
Transfer sets for pharmaceutical preparations —
Requirements and test methods
1 Scope
This document applies to sterilized single use transfer sets that are used for pharmaceutical
preparations.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3826-2, Plastics collapsible containers for human blood and blood components — Part 2: Graphical
symbols for use on labels and instruction leaflets
ISO 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods
ISO 8362-2, Injection containers and accessories — Part 2: Closures for injection vials
ISO 8536-2, Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 8536-4, Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15747, Plastic containers for intravenous injections
ISO 80369-1, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20:
Common test methods
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
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oSIST prEN ISO 22413:2020
ISO/DIS 22413:2020(E)
4 Design and designation
4.1 Design for transfer sets without housing
The designs of the individual components are given in Figures 1 to 8. The drawings serve as an
illustration of possible transfer sets. Other designs are acceptable.
The key for Figures 1 to 7 is to be found on page 3.
2 © ISO 2020 – All rights reserved
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