FDAnews Device Daily Bulletin

New International Standard for Labels Replaces Earlier Version

Aug. 10, 2012
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European medical devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and reduces potential confusion and delays for selecting the appropriate language when using a device.
“Countries require their local languages to be used to display information associated with medical devices and this can cause problems relating to translation, design and labeling of products and documentation,” said Andy Vaughan, committee member of the British Standards Institution (BSI), which published the new standard. This standard provides a set of internationally recognized symbols with precise descriptors, he added.
International Medical Device Regulatory Monitor