Medical DEVICE Symbols

Symbols for marking and labeling of medical devices and medical products

EN-980:2008 Symbols for medical device labeling (standard is withdrawn per 2/2013).

EN ISO15223-1:2012 Symbols to be used with medical device labels, labeling and information to be supplied.

Medical Symbols to EN 15223-1:2012

Medical Symbols to EN 15223-1:2012

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 15223-1:2012 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 15223-1:2012 is essentially the same standard as ISO 15223-1:2012, which in its turn is identical to ANSI/AAMI 15223-1. These symbols may also be applied for In Vitro Diagnostic devices.

Labelling without textual explanation (US)

The FDA has finally ruled (june 2016) that these symbols are allowed to be used without further explanatory text. In the past ISO 15223-1 symbols were allowed only if accompanied with textual explanations.

 

From Global Harmonization Task Force

(Citation 2011)

The primary purpose of labelling is to identify the medical device and its manufacturer, and communicate safety and performance related information to the user, professional or lay, or other person, as appropriate. Such information may appear on the device itself, on packaging or as instructions for use. The medium, format, content, legibility, and location of the label and instructions for use should be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use should be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams. The information required on the label, should be provided on the device itself. If this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, and/or on the packaging of multiple devices. The use of internationally recognized symbols should be encouraged provided that device safety is not compromised by a lack of understanding on the part of the user. Where the meaning of the symbol is not obvious to the device user, e.g. for a newly introduced symbol, an explanation should be provided within the instructions for use.

 

Symbol Quality

Now you have purchased the EN 15223-1:2012 standard just to discover that the symbols in the standard are of such bad quality that you cannot decently reproduce them for use on your product. The symbols need to match the quality of your product. Of course, most symbols are simple and relatively easy to draw; but drawing is not your primary job, and you have a schedule to meet.

Manuals, safety recommendations and type plates need to be completed today, not yesterday !

Now your next challenge is to find a resource for good quality symbols. That's how you came to us and this is exactly where our symbols comes to help. Our symbols allow you to quickly and easily reproduce all EN 15223-1:2012 symbols in Word and any other Windows software you have at any size you want to.

You know that -when editing texts in Word-, the size of your characters is expressed  in points. By changing the point size, you can literally blow up each character to the size you need ! That is what you can do with our TTF/OTF - symbols too ! The font file contains all required medical symbols as a vector drawing, meaning that the quality is not reduced by enlarging.

Or alternately if your application really need bitmaps, we also provide a bitmap set of GIF symbols in 6 different sizes.

TTF / OTF Font

A True Type or Open Type symbol font are used the same easy way as ordinary fonts such as Arial and Times Roman. Our font contains all symbols from the standard, so in the place where you normally would type a 'C', now the 'ce mark' is printed, and instead of a 'G' a 'sterile' symbol is printed.

Our medical symbols were created using a professional drawing editor in vector format, using real scalable elements. The font can be used in drawing programs, text editors and presentation programs. You may select symbols in any available color, and even use them as a background in your  presentations. You can select sizes from 6 to 4000 points or more if your software allows for!

Bitmap set

We provide high quality high resolution symbols in 6 different sizes, from 30 pixels high to a full blown 800 pixels high!

Start right today

In literally five (5!) minutes from now you may have ordered, paid, downloaded and installed these symbols and will all these symbols be available in all your favorite Windows/Apple software.

 

Available symbols

All symbols from the EN 15223-1:2012 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)
  • Sufficient for ... appliances symbol
  • 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

Applications

You may use our font to create lay-outs for :

  • Type designation plates,
  • User manuals,
  • Customs documentation,
  • Packing material and shipping boxes,
  • Safety manuals, Installation manual or Service manuals,
  • Advertisements,
  • Power Point Presentations,
  • in virtually every Windows or Apple application !

All symbols are easy to include in your documents by typing a suitable alphabetic symbol (for instance "C" = CE mark), and changing the font type to the required "MDDISO15223" font  (just as you would choose between "Arial" and "Times new Roman")

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.

Installation

This True Type Fonts is easy to install under Windows 95/98/2000/XP/VISTA and Windows 7/8 as well on every Mac.

Just copy the file into your system root (ce:\) directory and use windows font utility (configuration menu : add fonts ) and  you are ready to use it. Please note that MAC users may need to install the OTF version of this font instead of the True Type.

Order now !

This font is easy to order using our secure server, operated by SWREG . Your order will be processed immediately and within minutes you will receive a download link by e-mail. Installation is easy and instructions are enclosed in the download kit.

Please note that order confirmation mails are sometimes treated as spam by your spam filter. Your download link should arrive very fast, and if not, look in your spam filter and/or notify your IT department. No worry however, if your confirmation mail got lost: "We will provide unlimited support based on your order number (or other pertinent order details).

Note that the standard EN 980:2008 has been superseded by EN 15223-1. The EN980 version is still available, but not recommended for new purchase.

EN 15223-1:2012 pixel images

Order as GIF file set in standard heights of 30-50-100-200-400 and 800 pixels, ready to use in every graphics application, a total of 234 graphs. The GIF files are B/W only.

EN 15223-1:2012 True Type Font (TTF)

Suitable for all Windows
Operating Systems.

Medical Devices TrueType Symbols Font

EN 15223-1:2012 Open Type Font (OTF)

for Apple OS X
Operating Systems.
Medical Devices OpenType Symbols Font

Order Medical Devices symbols as GIF fileset Order Medical Symbol Font for PC Order Medical Symbols for Apple

 

Other products

We have several other product marking related fonts available, such as ce mark , symbols from EN 15223-1, EN 50419 and EN 15986, as well as samples of a commercial DoC etc. All our fonts are Windows/Apple compatible.

For an overview of our certification related products click here