Standard EN ISO 15223-1:2012 (“The New Standard”) was revised as a part of the new European standard on symbols.

Background

Standard EN ISO 15223-1:2012, which replaced standard EN 980, was published on 31 January 2013 . At the time standard EN ISO 15223-1:2012 was published, its predecessor, standard EN 980 was accidently delisted from the Official Journal of the European Union. The delisting was temporary, and the standard was than reinstated as a harmonized standard.

The New Standard has the same scope as the standard that it replaces. It is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

The New Standard was intended to be harmonised in early 2014 in response to revision of European Union (“EU”) standards. European Committee for Standardization (“CEN”) and European Committee for Electrotehnical Standardisation (“CENELEC”), responsible for the harmonisation of standards within the EU, were delayed in revision due to International Standards Organisation (“ISO”) conducting an international revision of symbols.

Once ISO completed its revision of standards, CEN and CENELEC submitted a revision of The New Standard to the European Commission.

EN ISO 15223-1:2012

The New Standard refers to symbols to be used with medical device labels, labelling and information to be supplied with medical devices. The Standard’s provisions are applicable to all medical devices falling within the scope of EU directives on medical devices. This means that they apply to medical devices, in vitro diagnostic and active implantable medical devices.

Compliance with the standard is voluntary. However, use of symbols enables manufacturer to avoid potential confusion and delays when placing a medical device on the market. Moreover, it avoids the need and cost related to translation into 24 official European languages of at least some elements of device labels, labelling and information.

The New Standard was harmonised with the existing EU medical devices directives. This means that it will need to be revised when the forthcoming medical device regulations are adopted.

The New Standard is expected to be submitted to CEN and CENELEC for a formal vote 5 May 2016 , with the vote closing on 5 July 2016. CEN and CENELEC predict the New Standard could be available from 5 October 2016, however this date may be subject to change.