ISO 11418-7:2016

DRAFT INTERNATIONAL STANDARD
ISO/DIS 11418-7
ISO/TC 76 Secretariat: DIN
Voting begins on: Voting terminates on:
2015-01-12 2015-04-12
Containers and accessories for pharmaceutical
preparations —
Part 7:
Screw-neck vials made of glass tubing for liquid dosage forms
Récipients et accessoires pour préparations pharmaceutiques —
Partie 7: Flacons avec bague à vis en verre étiré pour diagnostics forme liquide
ICS: 11.120.99; 11.040.20
THIS DOCUMENT IS A DRAFT CIRCULATED
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THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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Reference number
NATIONAL REGULATIONS.
ISO/DIS 11418-7:2014(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 2014

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ISO/DIS 11418-7:2014(E)

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© ISO 2014
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ii © ISO 2014 – All rights reserved

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ISO/DIS 11418-7:2014(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Dimensions and designation . 1
3.1 Dimensions . 1
3.2 Designation . 1
4 Material . 3
5 Characteristics . 3
6 Requirements . 3
6.1 Hydrolytic resistance . 3
6.2 Annealing quality . 3
6.3 Light resistance . 3
7 Marking . 3
8 Packaging . 3
© ISO 2014 – All rights reserved iii

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ISO/DIS 11418-7:2014(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 11418-7 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection, and
blood processing equipment for medical and pharmaceutical use.
This second edition cancels and replaces the first edition (ISO 114118-7:1998) that has been
technically revised by
— amending the mass of screw-neck vials in Table 1, and
— editorially revising this standard.
ISO 11418 consists of the following parts, under the general title Containers and accessories for
pharmaceutical preparations:
— Part 1: Drop-dispensing glass bottles
— Part 2: Screw-neck glass bottles for syrups
— Part 3: Screw-neck glass bottles (veral) for solid and liquid dosage forms
— Part 4: Tablet glass bottles
— Part 5: Dropper assemblies
— Part 7: Screw-neck vials made of glass tubing for liquid dosage forms
iv © ISO 2014 – All rights reserved

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ISO/DIS 11418-7:2014(E)

Introduction
The purpose of this part of ISO 11418 is to specify the dimensions, capacities, form and requirements
of screw-neck vials made from tubular glass intended for medical use. Vials made from glass tubing
are considered to be suitable for the packaging and storage of pharmaceutical preparations until they
are administered for medicinal purposes. Such vials may be made of different types of glass which can
affect chemical resistance properties. For example, those made from borosilicate glass will have a very
high level of chemical resistance where others made from soda-lime-silica glass will have a lower
...