Plastics Collapsible Containers for Human Blood and Blood Components — Part 2: Graphical Symbols for Use on Labels and Instruction Leaflets
1 Scope
This part of GB 14232 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 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 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 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 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 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.
ISO 15223-1 Medical Devices — Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied — Part 1: General Requirements
3 Terms and Definitions
For the purposes of this document, the following terms and definitions apply.
3.1
basic symbol
graphical representation of a particular object or feature
3.2
compound symbol
graphical representation of a concept formed by the combination of two or more basic symbols
Foreword II
Introduction III
1 Scope
2 Normative References
3 Terms and Definitions
4 Requirements for Graphical Symbols and Their Use
Annex A (Informative) Illustrative Examples of Symbols Used in the Labelling of Medical Devices Used for Blood Treatment and Transfusion
Annex B (Informative) Symbols as Applied to Properties of Blood or Blood Components Containers
Bibliography
