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ISO 15223-1 is the international standard that specifies the symbols used to express information supplied with a medical device. Its full title is “Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements”. The current edition is ISO 15223-1:2021 with Amendment 1, published in its European form (BS EN ISO 15223-1:2021+A1:2025) on 30 November 2025. It standardises the symbols; it does not decide which information a label must carry.
Definition and scope
The catalogue entry for the standard at BSI states that it “specifies symbols used to express information supplied for a medical device.” That wording matters for how you read a label. The standard is a symbol vocabulary: each symbol has a reference number, a title and a description of what it means. Whether a particular device must show a manufacturer, a lot or batch code, a storage limit or an expiry date is set elsewhere, by the regulation that applies in the market where the device is sold.
Searches for “ISO 15223” usually mean this same standard. The “-1” marks Part 1, the general requirements. “ISO 15223” without the part number is a common shorthand for the same standard. Check the edition year on whatever document you are reading before relying on it.
How it is used in practice
A manufacturer picks symbols from the standard and prints them on the device, its packaging or its accompanying information instead of, or alongside, text. The reason is practical: one symbol can replace a sentence in several languages. One entry is worth knowing by item number: item 5.1.2 in Table 1 is the authorised representative symbol.
Because the symbols come from a standard, anyone reading a label can look up the meaning in a single place rather than relying on a manufacturer’s own convention. In the United States, though, using a symbol without explanatory text is governed by federal rules, covered below.
Editions and the 2025 amendment
The amendment published in 2025 (A1:2025) changed two things according to BSI’s description:
- It added a defined term, “authorized representative”, at clause 3.20.
- It revised the authorised representative symbol (item 5.1.2 in Table 1, and A.4 in Annex A) so that it is no longer country- or region-specific.
BSI lists the European text as identical to EN ISO 15223-1:2021/Amd 1 and to ISO 15223-1:2021/Amd 1. For a reader checking documents, that means a label or glossary that still shows the earlier region-specific representative symbol may be following an earlier text.
Using symbols on US labeling (21 CFR 801.15)
For devices labeled in the United States, 21 CFR 801.15(c)(1) sets the conditions for showing a symbol without adjacent explanatory text. Under the regulation text, a symbol can qualify when it is contained in a standard that FDA recognizes under section 514(c) of the Federal Food, Drug, and Cosmetic Act and is used according to FDA’s recognition specifications. A second route covers a symbol established in a standards development organization’s standard and determined by the manufacturer to be likely to be read and understood by the ordinary individual.
In either case the regulation also requires that the symbol be explained in a paper or electronic symbols glossary included in the device labeling, and that the packaging carry a prominent and conspicuous statement saying where the glossary is. The regulation states that using symbols that do not meet these requirements renders a device misbranded under section 502(c) of the Act.
Whether a given edition or symbol of ISO 15223-1 is FDA-recognized is a separate question that is answered in FDA’s database of recognized consensus standards, not by the existence of the ISO standard itself.
Where it matters for labs, clinics and supply decisions
For staff who receive, store or use medical devices, the standard is a reading aid for labels and instructions. A short checklist:
| What to look at | Why it matters |
|---|---|
| Edition cited on the label or glossary (2021, Amendment 1, A1:2025) | The 2025 amendment revised the authorised representative symbol and added the defined term. |
| A symbols glossary in the labeling (US) | 21 CFR 801.15(c)(1) requires symbols used without text to be explained in a glossary in the labeling. |
| A statement on the package saying where the glossary is (US) | The same regulation requires a prominent and conspicuous statement identifying its location. |
| Whether the symbol means what the glossary says | The standard defines the symbol; the glossary is where the manufacturer explains it for that device. |
For related label elements, see the CASRAI guides on the lot number, UDI labeling and GUDID submission and structured product labeling, and the overview what is a medical device. Packaging questions are covered in shelf life and packaging validation for medical devices.
Common misunderstandings
A symbol on a label is not proof that the information is required
The standard specifies how information is expressed. The requirement to supply that information comes from the applicable regulation.
“ISO 15223” and “ISO 15223-1” do not by themselves name an edition
The number alone does not tell you the edition. The year and any amendment (2021, A1:2025) do.
An ISO standard is not automatically a US-recognised one
US use of symbols without text depends on the conditions in 21 CFR 801.15, including FDA recognition or the manufacturer determination, and the glossary.
FAQ
What is ISO 15223?
It is the common name for ISO 15223-1, the standard that specifies symbols used to express information supplied for a medical device, for example the authorised representative symbol.
What is ISO 15223-1 used for?
It gives manufacturers a standard set of symbols to print on devices, packaging and accompanying information so that the meaning is the same wherever the label is read.
What is the current edition?
BSI lists BS EN ISO 15223-1:2021+A1:2025, published 30 November 2025, with status Current (checked 29 October 2026).
Does a US device label need a glossary?
Under 21 CFR 801.15(c)(1), a symbol used without adjacent text must be explained in a symbols glossary in the labeling, with a statement on the package identifying where the glossary is.
Sources
- BSI Knowledge, BS EN ISO 15223-1:2021+A1:2025 catalogue entry: knowledge.bsigroup.com (checked 29 October 2026).
- 21 CFR 801.15, Medical devices; prominence of required label statements, via Cornell LII: law.cornell.edu/cfr/text/21/801.15 (checked 29 October 2026).
