Compliance · Nº 06 · International
ISO 15223-1
ISO 15223 medical-device label symbols
Applies to — Medical-device labels
ISO 15223-1 defines the graphical symbols used on medical-device labels — use-by, sterile state, storage temperature, manufacture date, lot, single-use — so meaning carries across languages and markets without text. It is a harmonised standard under the EU MDR (2017/745) and is accepted by the US FDA when paired with explanatory text or a symbols glossary. It mandates no specific label material, but overall durability must meet the applicable regulation.
What it covers
The standardised symbols that let a medical-device label communicate use-by date, sterile state, storage temperature, manufacture date, lot number and single-use status through pictograms rather than translated text — so one label works across markets. It also includes a UDI reference symbol pointing at the device identifier.
Where it applies
It is a harmonised standard under the EU MDR (2017/745) and is accepted by the US FDA when paired with explanatory text or a symbols glossary. It mandates no specific label material — but the label’s durability must still meet the applicable regulation (for example FDA 21 CFR Part 801), so the symbols staying legible for the device’s life is the material requirement it implies.
How to comply
Use the correct ISO 15223-1 symbols for your device, pair them with a symbols glossary where the market requires it, and choose a label construction durable enough to keep them legible through sterilisation and the device’s service life. Confirm the exact requirements by device class and market.
Common questions
Answered
straight.
What is ISO 15223 used for?
It defines the graphical symbols on medical-device labels (use-by, sterile, storage temperature, lot, single-use) so the label carries meaning across languages. It is harmonised under the EU MDR and accepted by the US FDA when paired with explanatory text.
Does ISO 15223 specify a label material?
No — it standardises symbols, not materials. But the label must stay legible for the device life under the applicable regulation, so a durable construction (often PET with a resin ribbon for sterilised devices) is implied.
General guidance — not legal advice
This is a plain-English overview to help you ask the right questions — not a legal opinion or a compliance certification. Requirements change and depend on your specific product, market, and packaging. Always confirm with your supplier’s compliance documents and, where it matters, a qualified regulatory advisor.
Official source · ISO — 15223-1:2021 ↗
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