ISO 3826-2:2008 人間の血液および血液成分用のプラスチック製の折りたたみ式容器—パート2：ラベルおよび取扱説明書で使用するためのグラフィックシンボル | 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, 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 3826-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.

ISO 3826 consists of the following parts, under the general title Plastics collapsible containers for human blood and blood components:

• Part 1: Conventional containers
• Part 2: Graphical symbols for use on labels and instruction leaflets
• Part 3: Blood bag systems with integrated features

Introduction

This part of ISO 3826 has been prepared to:

• reduce the need for multiple translations of words into national languages;
• simplify and rationalize the labelling of blood treatment and transfusion devices which are medical devices used in critical situations, thereby reducing risk of misidentification, promoting safety for the patient and reducing the amount of training required by healthcare personnel;
• promote the movement of blood treatment and transfusion devices across national boundaries;
• support the essential requirements of relevant EU Directives.

The meaning of many of these graphical symbols should be self-evident. The meaning of others will become clear with use or when viewed in the context of the device itself. If appropriate, the meaning of symbols should be explained in accompanying literature when provided. Annex A provides examples of how the symbols specified in this part of ISO 3826 can be used. These are illustrative only and do not represent the only ways in which requirements of this part of ISO 3826 can be met.

1 Scope

This part of ISO 3826 addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users.

The symbols specified in this part of ISO 3826 do not replace current national regulatory requirements.

Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation. As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This part of ISO 3826 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings.

This part of ISO 3826 is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling.

This part of ISO 3826 may also be of assistance to different stages of the blood supply chain, e.g.:

• distributors of blood collection devices (manual or automated) or other representatives of manufacturers;
• blood centres and distribution centres to simplify and secure the operating procedures.

The use of these symbols is primarily intended for the medical device rather than the therapeutic product.

This part of ISO 3826 does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing.

Several of the symbols specified in this part of ISO 3826 may be suitable for application in other areas of medical technology.

2 Normative references

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

3 Terms and definitions

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

Bibliography