ISO 22413:2007
(Main)Transfer sets for pharmaceutical preparations — Requirements and test methods
Transfer sets for pharmaceutical preparations — Requirements and test methods
ISO 22413:2006 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
Ensemble de transfert pour préparations pharmaceutiques — Exigences et méthodes d'essai
General Information
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 22413
First edition
2007-03-01
Transfer sets for pharmaceutical
preparations — Requirements and test
methods
Ensemble de transfert pour préparations pharmaceutiques —
Exigences et méthodes d'essai
Reference number
ISO 22413:2007(E)
©
ISO 2007
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ISO 22413:2007(E)
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ii © ISO 2007 – All rights reserved
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ISO 22413:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Design and designation . 2
3.1 Design . 2
3.2 Designation 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
6 Chemical requirements . 6
7 Biological requirements. 6
8 Testing of physical requirements . 6
8.1 Particulate contamination. 6
8.2 Tensile strength . 6
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
9 Testing of chemical requirements . 7
10 Testing of biological requirements . 7
11 Packaging . 7
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
Annex B (normative) Testing of fragmentation of transfer sets with metal piercing devices . 11
Bibliography . 13
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ISO 22413:2007(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.
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ISO 22413:2007(E)
Introduction
Transfer sets for pharmaceutical preparations transmit fluids from one container to another by using gravity,
vacuum or overpressure. The transfer sets shall mix fluids or dissolve dry substances and are used in
combination with infusion and injection containers.
The transfer sets consist of at least two piercing devices, 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 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.
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INTERNATIONAL STANDARD ISO 22413:2007(E)
Transfer sets for pharmaceutical preparations — Requirements
and test methods
1 Scope
This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical
preparations.
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 7864:1993, Sterile hypodermic needles for single use
ISO 8362 (all parts), Injection containers and accessories
ISO 8536 (all parts), Infusion equipment for medical use
ISO 15223, Medical devices — Symbols to be used with medical device labels, labelling and information to be
supplied
ISO 15747, Plastics containers for intravenous injection
ISO 15759, Medical infusion equipment — Plastics caps with inserted elastomeric liner for containers
manufactured by the blow-fill-seal (BFS) process
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ISO 22413:2007(E)
3 Design and designation
3.1 Design
The designs of the individual components are given in Figures 1, 2 a), 2 b), 3 a) and 3 b). The drawings serve
as an illustration of possible transfer sets. Other designs are acceptable.
Key for Figures 1 to 3
1 piercing device
2 channel
3 channel with air filter for ventilation, optionally lockable
4 protective cap
5 connection of piercing devices by hub, grip plate or tube
Figure 1 — Transfer set with one channel
Figure 2 a) — Transfer set with two channels Figure 2 b) — Alternative transfer set
with two channels
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ISO 22413:2007(E)
Figure 3 a) — Transfer set with an air inlet/air Figure 3 b) — Alternative transfer set with an
outlet air inlet/air outlet
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ISO 22413:2007(E)
3.2 Designation for a transfer set with housing
The designation of a transfer set with housing is given in Figure 4. The drawing serves as an illustration of a
possible transfer set. Other designs are acceptable.
Key
1 piercing device
2 channel
3 housing
Figure 4 — Transfer set with housing
3.3 Designation
Example 1:
A transfer set without housing (NH) is designated by the term "Transfer set", the number of this International
Standard and the initials NH.
Transfer set ISO 22413 – NH
Example 2:
A transfer set with housing (WH) is designated by the term "Transfer set", the number of this International
Standard and the initials WH.
Transfer set ISO 22413 – WH
4 Material
The materials for the transfer sets and their individual components shall comply with the requirements in
accordance with Clause 5. If the components come into contact with the liquid to be transferred, the chemical
and biological requirements in accordance with ISO 8536-4 shall be met.
Piercing devices are manufactured from appropriate materials, e.g. metal and/or plastic.
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