BH GSO ISO 3826-2:2016
ISO 3826-2:2008
Bahraini Standard
Current Edition
·
Approved on
08 February 2016
Plastics collapsible containers for human blood and blood components - Part 2: Graphical symbols for use on labels and instruction leaflets
BH GSO ISO 3826-2:2016 Files
English
11 Pages
Current Edition
Reference Language
BHD
30.34
BH GSO ISO 3826-2:2016 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.
medical technology.
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