EN ISO 15223-1
EN ISO 15223-1:2021 (Medical devices - Symbols to be used with information to be supplied by the manufacturer) is the fundamental symbol standard for medical devices. It defines graphical symbols that may be used in place of text on product labelling.
Use of symbols:
- Symbols enable language-independent, internationally understood product information
- They replace text entries in national languages, which is particularly beneficial for export products
- Symbols must be explained in accompanying documents (instructions for use) where they cannot be assumed to be generally known
Key symbol groups in EN ISO 15223-1:
- Manufacturer information: manufacturer symbol, date of manufacture, expiry date
- Batch information: LOT (batch number), SN (serial number), REF (product reference)
- Sterility status: STERILE, STERILE EO, STERILE R, NON STERILE
- Handling instructions: keep dry, protect from light, do not reuse, fragile
- Food contact, latex-free, recycling
MDR (EU) 2017/745 requires the use of harmonised symbols per EN ISO 15223-1 on product labelling.
Frequently asked questions
Why are symbols used on medical devices instead of text?
Symbols per EN ISO 15223-1 are internationally understood and language-independent. They enable consistent labelling for global export without translating every text element. The MDR requires harmonised symbols.
Must every symbol on packaging be explained?
Not necessarily for commonly known symbols. Lesser-known symbols must be explained in the instructions for use. EN ISO 15223-1 and the MDR specify which symbols can be assumed to be generally known.
Does EN ISO 15223-1 apply to PPE products?
EN ISO 15223-1 is specific to medical devices. PPE uses its own symbols per EN ISO 7000 and product-specific standards (e.g. EN 388 pictogram for mechanical protection). For products complying with both frameworks, both symbol sets may appear alongside each other.