Standard Swedish standard · SS-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 (ISO 3826-2:2008)

Status: Valid

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.

Subjects

For specific equipment (01.080.20) Transfusion, infusion and injection equipment (11.040.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-66988

Edition: 1

Approved: 8/18/2008

No of pages: 28