Share

Standard in Focus: DIN EN ISO 15223-1:2020-04 – Draft

Introduction of 25 new symbols

The standard DIN EN ISO 15223-1 contains a large number of symbols that we as manufacturers use on our medical devices and the accompanying instructions for use. Uniform symbols are intended to ensure safe and effective use. This draft standard introduces 25 new symbols, some of which replace older ones or appear for the first time. These symbols result from the new requirements of the EU regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostic medical devices, respectively.

The following symbols are proving to be very relevant in our everyday life:

  • Symbol MD (Medical Device)
  • Symbol UDI (Unique Device Identification)
  • Only one symbol for manufacturer and date of manufacture (information can apparently be combined in future)
  • Symbol for importer
  • Symbol for distributor
  • Symbol for “country of manufacture” with country code according to ISO 3166-1, can also be combined with date of manufacture
  •  Symbol for “product contains biological material of animal origin”.
  • Symbol for “product contains biological material of human origin”.
  • Symbol for “product for reuse on a single patient”.

Additional Changes

In addition to the new symbols, the informative annexes have also been changed, which are very helpful in practice. Here you will find examples of the application of the requirements that are suitable for everyday use. This is still a draft document, but as the transition period from MDD (Medical Device Directive) to MDR (Medical Device Regulation) is now over, we hope that the final version will be published soon.

 

1 Stern2 Sterne3 Sterne4 Sterne5 Sterne (3 Bewertung(en), durchschnittlich: 5.00 aus 5)
Loading...

More News & Events

Menu