BS EN ISO 15223-1:2016 PDF Download

What is this standard about?

Many countries want information displayed on medical devices to be in their own language, but this can be problematic: multiple languages can cause confusion and delays as well as problems with translation, design and logistics. More variables can add costs for manufacturers. To help, this standard provides internationally recognized symbols with precisely defined descriptions that can appear on the device itself, as part of the label, or can be provided with the device.

Who is this standard for?

This standard is targeted at medical devices manufacturers and in vitro diagnostic product manufacturers. It is particularly relevant to manufacturers who market identical products in countries where there are different language requirements for medical device labelling.

It can also be of assistance to:

• Distributors of medical devices or other representatives of manufacturers
• Healthcare providers responsible for training, as well as those being trained
• Those responsible for post-market vigilance
• Healthcare regulatory authorities, testing organizations, certification bodies and other organizations which are responsible for implementing regulations affecting medical devices and which have responsibility for post-market surveillance
• Consumers or end-users of medical devices who draw their supplies from a number of sources and can have varied language capabilities

Why should you use this standard? 

It lists symbols to be used with medical device labels, labelling and information to be supplied. The standard also identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

The symbols are used in a broad spectrum of medical devices which are marketed globally and therefore need to meet different regulatory requirements.

The standard is relevant to all medical device markets. It is also provides symbols for the in vitro diagnostic market.

Note: It is intended for this standard to be harmonized to the medical device directives.

What’s changed since the last update?

The 2012 standard was systematically reviewed by technical experts to ensure its continued market relevance. In this 2016 version, none of the symbols have been changed but some of the requirements have been updated.