Containers and accessories for pharmaceutical preparations

ISO 11418-1:2005 specifies the design, dimensions, material and requirements of drop-dispensing glass bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug. ISO 11418-1:2005 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not intended for parenteral use.

Récipients et accessoires pour préparations pharmaceutiques

General Information

Status
Replaced
Publication Date
06-Feb-2005
Withdrawal Date
06-Feb-2005
Current Stage
6060 - International Standard published
Start Date
09-Dec-2004
Completion Date
07-Feb-2005
Ref Project

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ISO 11418-1:2005 - Containers and accessories for pharmaceutical preparations
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INTERNATIONAL ISO
STANDARD 11418-1
Second edition
2005-02-01
Containers and accessories for
pharmaceutical preparations —
Part 1:
Drop-dispensing glass bottles
Récipients et accessoires pour préparations pharmaceutiques —
Partie 1: Flacons compte-gouttes en verre
Reference number
ISO 11418-1:2005(E)
ISO 2005
---------------------- Page: 1 ----------------------
ISO 11418-1:2005(E)
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© ISO 2005

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ii © ISO 2005 – All rights reserved
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ISO 11418-1:2005(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 11418-1 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 11418-1:1996), which has been technically

revised.

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
© ISO 2005 – All rights reserved iii
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INTERNATIONAL STANDARD ISO 11418-1:2005(E)
Containers and accessories for pharmaceutical preparations —
Part 1:
Drop-dispensing glass bottles
1 Scope

This part of ISO 11418 specifies the design, dimensions, material and requirements of drop-dispensing glass

bottles. Drop-dispensing glass bottles are applicable to primary packs used in direct contact with a drug.

This part of ISO 11418 is applicable to drop-dispensing glass bottles used in pharmacy. Together with the

corresponding closure systems, they serve for packaging of pharmaceutical preparations which are not

intended for parenteral use.

NOTE The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected

by the nature and performance of the primary pack.
2 Normative references
The follow
...

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