ISO 11418-5:2015 医薬品用の容器および付属品—パート5：ドロッパーアセンブリ | ページ 2

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.

The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives ).

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The committee responsible for this document is 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 which has been revised in order to update the references.

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

1 Scope

This part of ISO 11418 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations.

This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1.

Dropper assemblies are applicable to primary packs used in direct contact with the drug.

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

Bibliography