ISO 8536-7:2009

INTERNATIONAL ISO
STANDARD 8536-7
Third edition
2009-01-15
Infusion equipment for medical use —
Part 7:
Caps made of aluminium-plastics
combinations for infusion bottles
Matériel de perfusion à usage médical —
Partie 7: Capsules en combinaison aluminium-plastique pour flacons de
perfusion
Reference number
©
ISO 2009
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ii © ISO 2009 – All rights reserved

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
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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 8536-7 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment
for medical and phamaceutical use.
This third edition cancels and replaces the second edition (ISO 8536-7:1999), Clause 2 of which has been
updated.
ISO 8536 consists of the following parts, under the general title Infusion equipment for medical use:
⎯ Part 1: Infusion glass bottles
⎯ Part 2: Closures for infusion bottles
⎯ Part 3: Aluminium caps for infusion bottles
⎯ Part 4: Infusion sets for single use, gravity feed
⎯ Part 5: Burette infusion sets for single use, gravity feed
⎯ Part 6: Freeze drying closures for infusion bottles
⎯ Part 7: Caps made of aluminium-plastics combinations for infusion bottles
⎯ Part 8: Infusion equipment for use with pressure infusion apparatus
⎯ Part 9: Fluid lines for use with pressure infusion equipment
⎯ Part 10: Accessories for fluid lines for use with pressure infusion equipment
⎯ Part 11: Infusion filters for use with pressure infusion equipment
⎯ Part 12: Check valves
Introduction
The materials from which infusion glass bottles (including elastomeric closures) are made are suitable primary
packaging materials for storing infusion solutions until they are administered. However, in this part of
ISO 8536, caps of aluminium-plastics combinations are not considered as primary packaging materials in
direct contact with the infusion solution.

iv © ISO 2009 – All rights reserved

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