SIST EN ISO 22413:2011
(Main)Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren (ISO 22413:2010)
Diese Internationale Norm gilt für sterilisierte, zur einmaligen Verwendung bestimmte Überleitgeräte für pharmazeutische Zubereitungen.
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes d'essai (ISO 22413:2010)
L'ISO 22413:2010 s'applique aux ensembles de transfert st�rilis�s, non r�utilisables, utilis�s pour les pr�parations pharmaceutiques.
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO 22413:2010)
Ta mednarodni standard velja za steriliziran pribor za enkratno uporabo, ki se uporablja za prenos farmacevtskih pripravkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22413:2011
01-september-2011
Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO
22413:2010)
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO
22413:2010)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren
(ISO 22413:2010)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes
d'essai (ISO 22413:2010)
Ta slovenski standard je istoveten z: EN ISO 22413:2011
ICS:
11.120.99 Drugi standardi v zvezi s Other standards related to
farmacijo pharmaceutics
SIST EN ISO 22413:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22413:2011
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SIST EN ISO 22413:2011
EUROPEAN STANDARD
EN ISO 22413
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2011
ICS 11.040.20
English Version
Transfer sets for pharmaceutical preparations - Requirements
and test methods (ISO 22413:2010)
Ensemble de transfert pour préparations pharmaceutiques Überleitgeräte für pharmazeutische Zubereitungen -
- Exigences et méthodes d'essai (ISO 22413:2010) Anforderungen und Prüfverfahren (ISO 22413:2010)
This European Standard was approved by CEN on 5 May 2011.
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 and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22413:2011: E
worldwide for CEN national Members.
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SIST EN ISO 22413:2011
EN ISO 22413:2011 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EC Directive 93/42/EEC on medical devices .4
2
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SIST EN ISO 22413:2011
EN ISO 22413:2011 (E)
Foreword
The text of ISO 22413:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and
injection, and blood processing equipment for medical and pharmaceutical use” of the International
Organization for Standardization (ISO) and has been taken over as EN ISO 22413:2011 by 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 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 22413:2010 has been approved by CEN as a EN ISO 22413:2011 without any modification.
3
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SIST EN ISO 22413:2011
EN ISO 22413:2011 (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 Union 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)/sub-clause(s) of this Essential Requirements (ERs) Qualifying remarks/Notes
EN of Directive 93/42/EEC
3.3 13.3 (b)
4 1, 2, 3
5.1 7.2
5.2 9.1, 12.7.1
5.3 7.6
5.4 12.8.1
5.5 7.6
5.6 9.1, 12.7.1
5.7 7.6
5.8 8.1
5.9 8.3
5.10.2 9.2
5.11 9.1
5.12 7.2
6 7.1, 7.2, 7.3
7 7.3, 7.5, 8.1, 8.4
Presumption of conformity with
the Essential Requirements
relating to biological evaluation
can only be provided if the
manufacturer chooses to apply
the EN ISO 10993 series
standard, as proposed in the
normative reference EN ISO
8536-4.
4
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SIST EN ISO 22413:2011
EN ISO 22413:2011 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of this Essential Requirements (ERs)
Qualifying remarks/Notes
EN of Directive 93/42/EEC
11 5, 8.3
12 5, 8.3
13 13.3
The part of 13.3.a) relating to the
authorized representatives is not
addressed.
ERs 13.3.c) relating to the
symbol STERILE and 13.3.f)
relating to single use are not fully
addressed.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
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SIST EN ISO 22413:2011
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SIST EN ISO 22413:2011
INTERNATIONAL ISO
STANDARD 22413
Second edition
2010-06-15
Transfer sets for pharmaceutical
preparations — Requirements and test
methods
Ensemble de transfert pour préparations pharmaceutiques —
Exigences et méthodes d'essai
Reference number
ISO 22413:2010(E)
©
ISO 2010
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SIST EN ISO 22413:2011
ISO 22413:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2010
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 2010 – All rights reserved
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SIST EN ISO 22413:2011
ISO 22413:2010(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Normative references.1
3 Design and designation.1
3.1 Design.1
3.2 Design for a transfer set with housing.4
3.3 Designation .4
4 Material .4
5 Physical requirements .5
5.1 Particulate contamination.5
5.2 Tensile strength.5
5.3 Tightness.5
5.4 Free flow.5
5.5 Piercing device .5
5.6 Penetration force .5
5.7 Fragmentation.6
5.8 Air inlet and air outlet.6
5.9 Protective caps .6
5.10 Transfer sets with a housing.6
5.11 Luer connector .6
5.12 Filter for particles .6
6 Chemical requirements.6
7 Biological requirements.6
8 Testing of physical requirements .6
8.1 Particulate contamination.6
8.2 Tensile strength.7
8.3 Tightness of transfer set.7
8.4 Free flow.7
8.5 Piercing device .7
8.6 Penetration force .7
8.7 Testing on fragmentation .7
8.8 Effectiveness of air inlet and air outlet with air filter.7
8.9 Efficiency of protective caps.7
8.10 Luer connector .7
8.11 Filter for particles .7
9 Testing of chemical requirements .8
10 Testing of biological requirements.8
11 Packaging.8
12 Storage .8
13 Labelling.8
13.1 Unit container .8
13.2 Shelf or multi-unit container .8
Annex A (normative) Testing of fragmentation of transfer sets with plastic piercing devices .9
© ISO 2010 – All rights reserved iii
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SIST EN ISO 22413:2011
ISO 22413:2010(E)
Annex B (normative) Testing of fragmentation of transfer sets with metal piercing devices .11
Bibliography .13
iv © ISO 2010 – All rights reserved
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SIST EN ISO 22413:2011
ISO 22413:2010(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 22413 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 22413:2007), of which the scope was
enhanced by introducing further product groups like transfer sets with integrated Luer connectors and particle
filters. In that framework the following major changes were introduced:
⎯ the Introduction was amended by h) and j);
⎯ the Normative references were updated;
⎯ the Figures in 3.1 were updated;
⎯ 5.11 and 8.10 on the physical requirements and testing for Luer connector were added;
⎯ 5.12 and 8.11 on the physical requirements and testing for filter for particles were added.
© ISO 2010 – All rights reserved v
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SIST EN ISO 22413:2011
ISO 22413:2010(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 Luer
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 can
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Pribor za prenos farmacevtskih pripravkov - Zahteve in preskusne metode (ISO 22413:2010)Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren (ISO 22413:2010)Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes d'essai (ISO 22413:2010)Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)11.120.99Drugi standardi v zvezi s farmacijoOther standards related to pharmaceuticsICS:Ta slovenski standard je istoveten z:FprEN ISO 22413kSIST FprEN ISO 22413:2011en01-februar-2011kSIST FprEN ISO 22413:2011SLOVENSKI
STANDARD
kSIST FprEN ISO 22413:2011
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
FINAL DRAFT
FprEN ISO 22413
November 2010 ICS 11.040.20 English Version
Transfer sets for pharmaceutical preparations - Requirements and test methods (ISO 22413:2010)
Ensemble de transfert pour préparations pharmaceutiques - Exigences et méthodes d'essai (ISO 22413:2010)
Überleitgeräte für pharmazeutische Zubereitungen - Anforderungen und Prüfverfahren (ISO 22413:2010) This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee CEN/TC 205.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 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 and United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. FprEN ISO 22413:2010: EkSIST FprEN ISO 22413:2011
FprEN ISO 22413:2010 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EC Directive 93/42/EEC on medical devices .4 kSIST FprEN ISO 22413:2011
FprEN ISO 22413:2010 (E) 3 Foreword The text of ISO 22413:2010 has been prepared by Technical Committee ISO/TC 76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use” of the International Organization for Standardization (ISO) and has been taken over as FprEN ISO 22413:2010 by Technical Committee CEN/TC 205 “Non-active medical devices” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. 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.
Endorsement notice The text of ISO 22413:2010 has been approved by CEN as a FprEN ISO 22413:2010 without any modification.
kSIST FprEN ISO 22413:2011
FprEN ISO 22413:2010 (E) 4 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 Union 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)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 3.3 13.3 (b)
4 1, 2, 3
5.1 7.2
5.2 9.1, 12.7.1
5.3 7.6
5.4 12.8.1
5.5 7.6
5.6 9.1, 12.7.1
5.7 7.6
5.8 8.1
5.9 8.3
5.10.2 9.2
5.11 9.1
5.12 7.2
6 7.1, 7.2, 7.3
7 7.3, 7.5, 8.1, 8.4 Presumption of conformity with the Essential Requirements relating to biological evaluation can only be provided if the manufacturer chooses to apply the EN ISO 10993 series standard, as proposed in the normative reference EN ISO 8536-4. 11 5, 8.3
kSIST FprEN ISO 22413:2011
FprEN ISO 22413:2010 (E) 5 12 5, 8.3
13 13.3 The part of 13.3.a) relating to the authorized representatives is not addressed. ERs 13.3.c) relating to the symbol STERILE and 13.3.f) relating to single use are not fully addressed.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.
kSIST FprEN ISO 22413:2011
kSIST FprEN ISO 22413:2011
Reference numberISO 22413:2010(E)© ISO 2010
INTERNATIONAL STANDARD ISO22413Second edition2010-06-15Transfer sets for pharmaceutical preparations — Requirements and test methods Ensemble de transfert pour préparations pharmaceutiques — Exigences et méthodes d'essai
kSIST FprEN ISO 22413:2011
ISO 22413:2010(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
©
ISO 2010 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 2010 – All rights reserved
kSIST FprEN ISO 22413:2011
ISO 22413:2010(E) © ISO 2010 – All rights reserved iii Contents Page Foreword.v Introduction.vi 1 Scope.1 2 Normative references.1 3 Design and designation.1 3.1 Design.1 3.2 Design for a transfer set with housing.4 3.3 Designation.4 4 Material.4 5 Physical requirements.5 5.1 Particulate contamination.5 5.2 Tensile strength.5 5.3 Tightness.5 5.4 Free flow.5 5.5 Piercing device.5 5.6 Penetration force.5 5.7 Fragmentation.6 5.8 Air inlet and air outlet.6 5.9 Protective caps.6 5.10 Transfer sets with a housing.6 5.11 Luer connector.6 5.12 Filter for particles.6 6 Chemical requirements.6 7 Biological requirements.6 8 Testing of physical requirements.6 8.1 Particulate contamination.6 8.2 Tensile strength.7 8.3 Tightness of transfer set.7 8.4 Free flow.7 8.5 Piercing device.7 8.6 Penetration force.7 8.7 Testing on fragmentation.7 8.8 Effectiveness of air inlet and air outlet with air filter.7 8.9 Efficiency of protective caps.7 8.10 Luer connector.7 8.11 Filter for particles.7 9 Testing of chemical requirements.8 10 Testing of biological requirements.8 11 Packaging.8 12 Storage.8 13 Labelling.8 13.1 Unit container.8 13.2 Shelf or multi-unit container.8 Annex A (normative)
Testing of fragmentation of transfer sets with plastic piercing devices.9 kSIST FprEN ISO 22413:2011
ISO 22413:2010(E) iv © ISO 2010 – All rights reserved Annex B (normative)
Testing of fragmentation of transfer sets with metal piercing devices.11 Bibliography.13
kSIST FprEN ISO 22413:2011
ISO 22413:2010(E) © ISO 2010 – All rights reserved v 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 22413 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use. This second edition cancels and replaces the first edition (ISO 22413:2007), of which the scope was enhanced by introducing further product groups like transfer sets with integrated Luer connectors and particle filters. In that framework the following major changes were introduced: ⎯ the Introduction was amended by h) and j); ⎯ the Normative references were updated; ⎯ the Figures in 3.1 were updated; ⎯ 5.11 and 8.10 on the physical requirements and testing for Luer connector were added; ⎯ 5.12 and 8.11 on the physical requirements and testing for filter for particles were added. kSIST FprEN ISO 22413:2011
ISO 22413:2010(E) vi © ISO 2010 – All rights reserved 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 Luer 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;
...
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