Medical device symbols standard gets an update

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Medical device manufacturers and others in the supply chain must provide certain information about a medical device, such as its use or safety instructions.

This information can appear on the device itself, on its packaging, or in the accompanying instructions. To make it simpler and avoid the need for translation, standardised symbols with specific meanings are used instead. 

ISO 15223-1 is used by manufacturers of medical devices who market products in countries where there are specific language requirements. These symbols allow for a consistent portrayal of information. It can also be used by consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities. 

It does not specify the information that needs to be provided, but specifies internationally recognised symbols for presenting this information.

The latest amendment introduces:

• addition of defined term for authorised representative,
• modified EC REP symbol to not be country or region specific. 

More medical device standards can be found from our e-shop.