prEN ISO 3826-2 rev

Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets

General information

10.99 New project approved   Jan 11, 2024

CEN

CEN/TC 205 Non-active medical devices

European Norm

Scope

ISO 3826-2:2008 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 ISO 3826-2:2008 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. ISO 3826-2:2008 proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings.
ISO 3826-2:2008 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.
ISO 3826-2:2008 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.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

PREVIOUSLY

PUBLISHED
EN ISO 3826-2:2008

NOW

IN_DEVELOPMENT
prEN ISO 3826-2 rev
10.99 New project approved
Jan 11, 2024