LABELLING AS PER EN ISO 15223-1

LABELLING AS PER EN ISO 15223-1

Posted By: | June 19, 2019 | 0

Medical Device Regulations place great importance on information supplied by a manufacturer to the user so as to ensure the safe and effective use of a medical device. This can be seen being cascaded down into ISO 13485:2016 whereby labelling comprises of the label, the instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device.

In order to be in compliance, the usage of standards such EN ISO 15223-1 in conjunction with other recognized harmonized standards (both horizontal & vertical) need to be considered together with emerging requirement on unique device identification (UDI). These requirements vary in different regulated jurisdictions. Mistakes in labeling strategy may result in rejection during market authorization or even prosecution and/or penalties.

If your company manufactures medical devices, medicines or medical related equipment, you will definitely need the EN ISO 15223-1 medical symbols for labelling your products Worldwide.

By applying these harmonized symbols you need no further textual explanation on the packaging of your product.

EN 15223-1 has been listed as a harmonized standard in Europe under the Medical Devices Directive.

The Medical Devices Directive has designated EN 15223-1:2016 as the standard providing labeling symbols for all medical devices, and is currently the only labeling standard for medical devices listed in the EU official journal.

Note that EN 15223-1:2016 is essentially the same standard as ISO 15223-1:2016, which in its turn is identical to ANSI/AAMI 15223-1. These symbols may also be applied for In Vitro Diagnostic devices.

Available symbols

All symbols from the EN 15223-1:2016 standard have been included (see also image above):

  • CE-mark  ( used in most EC directives including MDD),
  • suitable numbers 0-9 (right size to use with temperature),
  • Do not reuse symbol (This symbol is used for disposable one-time-use products)
  • Use by symbol (This symbol is accompanied by a date to indicate that the device should not be used after the end of the year, month or day shown)
  • Batch code symbol (The symbol is accompanied by the manufacturer's batch code)
  • Serial number
  • Date of manufacture
  • Sterile, including the method of sterilization
  • Sterile using aseptic processing techniques
  • Read the manual symbol
  • Caution
  • Manufacturer
  • Authorized representative in the European Community (mandatory symbol for imported to the EU)
  • For IVD performance evaluation only
  • IN VITRO diagnostic medical device
  • Temperature limits, including indication of limits of temperature
  • Consult instructions for use
  • Biological risks 
  • Keep away from sunlight
  • Keep dry
  • Do not re-sterilize
  • Non-sterile
  • Latex (Symbol for an item that contains or has a presence of natural rubber latex. This symbol is used when natural rubber latex is used to make the device or packaging )
  • Control (This symbol is used to indicate a device that controls the intended performance of another device)
  • Negative control
  • Positive control

The symbols can be changed to any print size without degradation as far as your software allows for, just the way you change font size with ordinary characters. Drawing these symbols yourself takes hours of work and will definitely cost you more.