ISO 10985:2009
(Main)Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods
Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods
ISO 10985:2009 specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4. The purpose of ISO 10985:2009 is to specify caps that provide: guarantee of originality of the closure up to the point of administration; compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles; protection of the sealing element against soiling and mechanical damage; simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.
Capsules en combinaison aluminium-plastique pour flacons de perfusion et d'injection — Spécifications et méthodes d'essai
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 10985
Third edition
2009-02-15
Caps made of aluminium-plastics
combinations for infusion bottles and
injection vials — Requirements and test
methods
Capsules en combinaison aluminium-plastique pour flacons de
perfusion et d'injection — Spécifications et méthodes d'essai
Reference number
ISO 10985:2009(E)
©
ISO 2009
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ISO 10985:2009(E)
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ii © ISO 2009 – All rights reserved
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ISO 10985:2009(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 10985 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and pharmaceutical use.
This third edition cancels and replaces the second edition (ISO 10985:1999) Clause 2 of which has been
updated.
© ISO 2009 – All rights reserved iii
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ISO 10985:2009(E)
Introduction
The materials from which injection and infusion containers (including elastomeric closures) are made are
suitable primary packaging materials for storing injectable products and infusion solutions until they are
administered. However, in this International Standard, caps are not considered as primary packaging
materials in direct contact with pharmaceutical preparations.
iv © ISO 2009 – All rights reserved
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INTERNATIONAL STANDARD ISO 10985:2009(E)
Caps made of aluminium-plastics combinations for infusion
bottles and injection vials — Requirements and test methods
1 Scope
This International Standard specifies general requirements and test methods for caps made of aluminium-
plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion
bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4.
The purpose of this International Standard is to specify caps that provide:
a) guarantee of originality of the closure up to the point of administration;
b) compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or
injection bottles;
c) protection of the sealing element against soiling and mechanical damage;
d) simple and injury-free opening of the closure in order
...
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