BS EN ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets
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.
BS EN ISO 3826-2:2008 Referenced Document
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
BS EN ISO 3826-2:2008 history
2008BS EN ISO 3826-2:2008 Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets