Labeling and Symbols
ISO 15223-1: Symbols for Medical Device Labeling
ISO 15223-1 specifies symbols that can be used on medical device labels, packaging and accompanying information, each with a defined meaning. It lets manufacturers convey common information, such as the manufacturer, use-by date, lot, sterilization method or single use, without depending on one language.
At a Glance
- Standard
- ISO 15223-1
- Subject
- Symbols for Medical Device Labeling
- Group
- Labeling and Symbols
- Industries
- 5 industry guides reference it
A plain-language summary of scope, not the standard itself. Buy the current edition from the publisher and check which edition your auditor or market expects.
What It Covers
Each symbol in the standard has a title, a description and requirements for its use. Familiar examples include the symbols for manufacturer, use-by date, batch code, catalog number, serial number, sterilization method, do not reuse, consult instructions for use, caution, and storage conditions. Using a symbol means using it as the standard defines it, not adapting it.
Symbols save label space and translation, but only work if users understand them. Manufacturers typically explain the symbols used in the instructions or other accompanying information, and decide where a symbol alone is enough and where text is needed, depending on the market and the user.
Labeling is a QMS process, not just artwork. Under the QMSR, FDA-specific labeling and packaging controls apply alongside ISO 13485, so symbol selection, review and approval of label content, and inspection of labels before use all need records.
Who It Applies To
- Manufacturers designing labels for devices sold in several markets
- Labeling and regulatory teams maintaining a symbol glossary
- Firms updating labels after a standard or regulation changes
- Contract manufacturers that print or apply labels for device makers
What Auditors Check
Correct Symbol Use
Symbols used in their defined form and meaning, with no homemade variants presented as standard symbols.
Symbol Explanation
An explanation of the symbols used in the accompanying information wherever users may need it.
Label Review and Approval
Documented review and approval of label content, symbols included, before release.
Label Control in Production
Label inspection, issuance and reconciliation records, and controls that prevent mix-ups.
Label Change Management
A process for updating labels when the standard, the device or market requirements change.
Related Services
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
QMSR Transition
Bringing a QSR-era or ISO 13485 quality system in line with FDA's QMSR, which is now in effect.
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
Industry Guides That Reference ISO 15223-1
ISO 15223-1
Check Your Quality System Against ISO 15223-1
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
