ISO 15223-1:2021
ISO 15223-1 labelling duties for medical devices: when to use the standard symbols for essential information, how to size them and write dates, and what must sit beside each symbol for manufacturer and operator identity, dates and identifiers, sterility and barriers, storage limits, hazards, IVD and infusion values, patient data, translation, repackaging and UDI.
ISO 15223-1:2021 is a compliance framework from International with 2 domains and 18 controls. The largest domains are Clause 5 and Table 1: Symbols and their requirements of use – ISO 15223-1:2021 (14 controls), Clause 4: General requirements for symbol use – ISO 15223-1:2021 (4 controls). Every control below carries what it requires and what an assessor expects to see.
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Framework Domains (2)
Clause 4: General requirements for symbol use – ISO 15223-1:2021
| Code | Title |
|---|---|
| iso-15223-1-2021::4.1 | Validate any symbol proposed for inclusion and show it applies across devices and regions |
| iso-15223-1-2021::4.2a | Convey information essential for proper use with the matching Table 1 symbol |
| iso-15223-1-2021::4.2b | Size each symbol so it stays legible for its purpose |
| iso-15223-1-2021::4.2c | Write every date and time next to a symbol in the ISO 8601 form |
Clause 5 and Table 1: Symbols and their requirements of use – ISO 15223-1:2021
| Code | Title |
|---|---|
| iso-15223-1-2021::5.1a | Manufacturer and authorised representative: place the name and address beside the symbol |
| iso-15223-1-2021::5.1b | Date of manufacture and use-by date: place the date beside the symbol in ISO 8601 form |
| iso-15223-1-2021::5.1c | Batch code, catalogue number, serial number and model number: place the value beside the symbol |
| iso-15223-1-2021::5.1d | Importer and distributor: place the name and address beside the symbol |
| iso-15223-1-2021::5.1e | Country of manufacture: replace the placeholder with the ISO 3166-1 code |
| iso-15223-1-2021::5.2a | Sterility: use the symbol for the actual sterilisation method and identify what is sterile |
| iso-15223-1-2021::5.2b | Sterile barrier system symbols: place them with the sterility symbol |
| iso-15223-1-2021::5.3 | Storage conditions: write the limit values beside the limit lines |
| iso-15223-1-2021::5.4 | Safe use: mark hazards and contents with the matching symbols |
| iso-15223-1-2021::5.5 | IVD devices: use the IVD symbols and state the number of tests and the evaluation restriction |
| iso-15223-1-2021::5.6 | Transfusion and infusion devices: replace example values with the device's own |
| iso-15223-1-2021::5.7a | Patient and health care information: place the data beside the symbol when used |
| iso-15223-1-2021::5.7b | Translation and repackaging: name the responsible entity and use the symbols only when another party acted |
| iso-15223-1-2021::5.7c | Unique device identifier: place the UDI symbol beside the UDI carrier if used |
What is ISO 15223-1:2021 and who does it apply to?
ISO 15223-1:2021 is a compliance framework from International with 2 domains and 18 controls. ISO 15223-1 labelling duties for medical devices: when to use the standard symbols for essential information, how to size them and write dates, and what must sit beside each symbol for manufacturer and operator identity, dates and identifiers, sterility and barriers, storage limits, hazards, IVD and infusion values, patient data, translation, repackaging and UDI. It is used by organisations to establish and maintain compliance with industry standards and regulatory requirements.
What does ISO 15223-1:2021 actually require?
ISO 15223-1:2021 has 18 controls organised across 2 domains. The largest domains are Clause 5 and Table 1: Symbols and their requirements of use – ISO 15223-1:2021 (14 controls), Clause 4: General requirements for symbol use – ISO 15223-1:2021 (4 controls). Each control defines specific requirements that organisations must implement to achieve compliance.
If I already comply with another framework, how much of ISO 15223-1:2021 do I already cover?
ISO 15223-1:2021 does not currently have cross-framework mappings in our system. Check back as we continuously expand our mapping database.
How do I implement ISO 15223-1:2021?
Start your ISO 15223-1:2021 compliance journey by running a self-assessment on our platform to identify your current compliance posture. Our AI advisory can answer specific questions about ISO 15223-1:2021 requirements, and cross-framework mapping helps you leverage existing controls from other frameworks you may already comply with. Create a free account to access all 18 controls and track your progress.
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