Medical DeviceS Labelling to EN ISO 15223-1:2016
ISO 15223-1:2016 has been published. There are no differences in the symbol-set (compared to 2012) to be used, so you can safely purchase our 2012 version for your use. The main difference is the implementation of the added EiOF (electronic instructions for use) to the "Consult Instructions for Use 5.4.3" (just URL) and added explanations for the applications of symbols for IVD. Unfortunately the standard does not encourage the use of Q-codes.., although they are not explicitly forbidden.
If your company manufactures medicines, medical devices, or medical related equipment, you will definitely need the symbols below for marking your medical devices.
Medical devices labelling (True Type Font) according to EN ISO 15223-1:2012 and EN ISO 15223-1:2016
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EN ISO 15223-1 has become the successor of the successful EN 980 standard for medical device labelling.
Compared to EN980 many of the symbols have been slightly modified to become part of this standard, and even between the previous version of ISO 15223-1 many subtle changes have been made. We know, as we had to manually redraw the full collection for the 2012 version.
Most symbols/ markings 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 yesterday. This is where this font comes to help. In literally five minutes from now you may have ordered, paid, downloaded and installed this font and will all these symbols be available in all your favorite Windows / Apple software in the same easy way as ordinary fonts such as Arial and Times Roman may be selected.
Our medical symbol font was created using a professional drawing editor in vector format, using real scalable elements. True Type Fonts 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 400 points or more if your software allows for!
Our advanced symbols even let you add numbers/text to the appropriate symbols WITHOUT having to use a graphics program...yes, you can do it all in Word, or whatever your favorite software is... We have sold this font to over a 1000 international medical manufacturers and laboratories, and our symbols have become number one on the market.
Customized marking symbols
We have made use of the advanced features available in font files to allow you to create the full possibilities you need for product marking. You can easily insert the required numbers next to the temperature symbols by using subscript and superscript. You even can insert any numbers INSIDE the DROPS PER MILLILITRE symbol, by making use of the reverse spacing possibilities of the font.
From the standards Introduction:
" This document addresses the presentation of certain items of information that are considered by regulatory authorities to be essential for the safe and proper use of medical devices. As such, the items are required to appear with the medical device in most regulatory domains. The information can be required to appear on the medical device itself, as part of the label, or provided with the medical device.
Many countries require that their own language be used to display textual information with medical devices. At the same time, manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This can cause problems in relation to translation, design and logistics when multiple languages are included on a single label or piece of documentation. For example, users of medical devices labelled in a number of different languages can experience confusion and delay in locating the appropriate language.
This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined descriptions.
While compiling symbols to be included in this document, ISO/TC 210 recognized the need for systematic methodology for the selection, development and validation of symbols proposed for adoption. This is the subject of ISO 15223-2.
This document is primarily intended to be used by manufacturers of medical devices 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, and
— consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities."
(Source: ISO 15223-1:2016)
We created a sample PDF file for you to judge the possibilities yourself..
All symbols are easy to include by typing a suitable alphanumeric symbol, and changing the font type to the required "iso-15223-1" font (just as you would choose between "Arial" and "Times New Roman") The symbols can be changed to any size without degradation as far as your software allows for, just as if you change font size with ordinary characters.
This font is easy to order using our secure server, operated by a US founded intermediary (SWREG). Drawing these symbols yourself takes days of work and will definitely cost you more.
This True Type/Open Type Font is easy to install under Windows 95/98/2000/XP/VISTA/Windows7-10 and Apple Computers. Just copy the file into your system root (c:\) directory and use windows font utility (configuration menu : add fonts ) and you are ready to use it. For Apple users, note that you need to install the OTF version of the font by placing it in your font directory.
EN 15223-1:2016 free update !
No modifications to the 2012-version of the symbol set have been published.
By clicking on one of the order buttons above you are lead to a secure server were you can use any payment method to pay the required amount to be able to use our Font / Symbols in your company. Your order will be processed immediately and within minutes you will receive a download link by e-mail.
After your payment has been received (immediately if CC payment) you will be provided a download URL by Email. Installation is easy and instructions are enclosed in the download kit.
Please note that order confirmation mails are often treated as spam by your spam filter. Your download link should arrive very fast, 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 order details).
For an overview of our other certification related products click here
Medical devices symbols (True Type Font) according to ISO15223-1:2016