ISO 17351:2013 包装—医薬品の包装に関する点字 | 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.

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 17351 was prepared by Technical Committee ISO/TC 122, Packaging.

Introduction

This International Standard has been developed to meet various national and regional requirements for Braille on packaging for medicinal products, and technical constraints and user requirements, to harmonize technical standardization and specifications. The knowledge and experience that has been gained in EN 15823:2010 was used for the development of this International Standard.

The background for the creation of an European Standard for Braille on packaging for medicinal products (EN 15823) was a European Directive issued in 2004 by the European Commission (Council Directive 2004/27/EC). This Directive requires Braille labelling on outer packaging for medicinal products within the European Union. In practice it means that basically the name of the medicinal product and ここで, required, the form and strength has to be in Braille as an aid to identification for blind and partially sighted people.

Braille will continue to be an essential means of communication for blind and visually impaired people around the world. Once other accessible packaging technologies emerge additional standards may be created to complement this International Standard.

1 Scope

This International Standard specifies requirements and provides guidance for the application of Braille to the labelling of medicinal products.

2 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

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