ISO 15223-1 regulates the symbols that manufacturers can (or must) use to label medical devices.

In January 2022, the EU Commission harmonized EN ISO 15223-1 as one of the relatively few standards under the MDR and added it to the list of harmonized standards. This alone makes it clear how relevant labeling has become.

Read in this article what the ISO 15223-1:2021 standard actually describes and requires and where you can get the symbols.

Update: The revised 2024 version is available as a draft (see below).

Regulatory context

The MDR requires manufacturers to provide information on the label (see Annex I, Section 23.2). These include:

• Lot or serial number
• Validity period and/or production date
• Storage conditions
• The fact that the product is a medical device
• Contains medicines
• Contains tissues or derivatives of human or animal origin
• Contains carcinogenic, mutagenic, reproductive toxicant or endocrine disrupting substances
• He has been sterilized
• It can be reused or not
• If necessary, the EU representative

Typically, manufacturers use symbols to communicate this information clearly and in minimal space. These symbols, in turn, are defined by standards such as ISO 15223-1. There are also further product or process specific standards such as IEC 60601-1 with requirements for the symbols to be used, which are currently not (yet?) harmonised.

Due to EU Member States’ national requirements for accompanying information, it is necessary to provide all information required for regulatory purposes in accordance with the MDR in a recognized language (usually the official language or languages). This means that the information must be translated into text form – fortunately the use of recognized symbols saves manufacturers this effort, at least for labelling. The operating instructions may need to be translated further.

Information on ISO 15223-1

Structure of the standard

ISO 15223-1:2021 or its German counterpart, DIN EN ISO 15223-1:2022, is not a short 74-page standard, but it is quite clear thanks to numerous tables:

• 22 pages of it serve the purpose Attachments ZA and ZBwhich create the mapping between the requirements of the EU medical device regulations (MDR and IVDR).
• That’s in the next 10 pages Prefacedie Introduction, Definitions and few regulatory needs how to obtain the size of the symbols based on the intended function. Also in this case, ISO 15223-1 requires the use of symbols on the medical device, on the packaging or in the documents provided (e.g. instructions for use).
• There are 25 pages of tables that introduce the symbols and their meaning.
• Another 9 pages explain possible uses using examples.
• The rest of the scope consists of covers and indexes.

New 2021 version

The current harmonized version EN ISO 15223-1:2021 features some innovations and a total of 25 new symbols.

Compared to the DIN EN ISO 15223-1:2017-04 standard, the following changes have been made:

1. Addition of 25 new symbols
2. Update of definitions taking into account the standards DIN EN ISO 20417, DIN EN ISO 14971 and DIN EN ISO 13485
3. Revision of the requirements for the use of symbols (4.2) (among other things, the first paragraph has been completely reworded with a similar meaning. Furthermore, the manufacturer now “shall” determine the appropriate size of the symbol instead of simply “shall” “).
4. Expand on the examples in Information Appendix A to provide suggestions and examples of using symbols, including using multiple symbols together
5. Addition of informative annexes on the relationship between this European Standard and the essential safety and performance requirements of the covered Regulation (EU) 2017/745 on medical devices and the relationship between this European Standard and the essential safety and performance requirements of the covered Regulation (EU) ) 2017/746 on in vitro diagnostics
6. Title changed to “Symbols for use in the context of information provided by the manufacturer”
7. Editorial review

According to Annex I, article 23.1 h) of the MDR Medical Device Regulation (2017/745), the corresponding new symbols must be used. Due to the harmonization of the EN ISO 15223-1:2021 standard, it is not always necessary to explain the symbols listed in the standard in the instructions for use. However, this only applies if the product does not pose any increased risks. Manufacturers should determine whether this is the case in usability studies.

However, if the product is intended for non-expert users, the symbols must always be explained. Manufacturers cannot assume that laypeople will understand symbols without explanation. It remains to be seen whether the numerous new and very detailed symbols can be used in practice without a laser printer, especially when one considers that the facility card, for which some symbols were probably specially created, would have to be the size of a credit card.

Additional symbols are as follows:

Change 2024

At the request of the European Commission, the ISO 15223-1 standard will have to be modified. To avoid confusion with Ecuador (ISO 3166 ALPHA-2 EC country code), the EU representative symbol should be changed from EC- to EU-REP.

Although there is no obligation for Ecuador to indicate the local representative on the label, it is obviously commendable to counteract this possible error. The change is currently 10 pages (in draft) very short and at just over €40 it is not extremely expensive.

But: per relevant letter (U instead of C), this is probably the most expensive standard of all time. This adjustment is not relevant to safety, so it is unclear why an immediate change is explicitly required and why manufacturers should pay for it. The abbreviation EC for Ecuador dates back to the last millennium. Especially since many manufacturers are hoping for symbols for placing systems on the market according to Article 22 of the MDR or to indicate that rapid tests are not intended for self-use (Article 20.2 r) in Annex I of the IVDR) , to avoid text on the label.

We therefore advise against purchasing the modification for now. You can read where to find the symbol below. Just remember to update your technical documentation accordingly.

Example of symbol setting

ISO 15223-1:2021 specifies the requirements for the representation and use of symbols in a table. Tables contain columns

• Reference number and graphics
• Title symbol
• Description of the symbols
• Requirements
• Notes
• Restriction of use
• ISO/IEC symbol number and registration date

Using the “Manufacturer” symbol as an example, it looks like this:

Reference number and graphics	title	Description	Requirements	Notes	Restriction of use		ISO/IEC symbol number and registration date
5.1.1	Producer	Show manufacturer of the medical device A	Name and address of the manufacturer it must be very close to this specified symbol become.	NOTE 1 This symbol is used to display information required in Europe and other relevant authorities can be requested. […]	–		ISO7000-3082 2011-10-02082 2011-10-02

The DIN ISO 7000 standard is entitled “Graphic symbols on equipment”. The symbols defined there are by no means limited to the medical device sector.

The ISO website lists all the symbols:

The ISO offers them for purchase. A free publication from MedTechEurope contains most of the symbols.

Change the history

• 08-22-2024: Added Amendment 2024 section, removed references to ISO 980, added reference to national specifications, text adapted to ISO 15223-1:2021
• 2022-08-17: Added 2021 release notes
• 11-30-2021: MedTechEurope publication added
• 2021-08-17: New version section updated

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