ISO 15223-2:2010
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 2: Symbol development, selection and validation
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- Language: English
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About This Item
ISO 15223-2:2010 is the second part of the ISO 15223 series on symbols used with medical device labels, labelling, and the information supplied with devices. In general technical terms, it addresses the development, selection, and validation of symbols so that medical-device graphics can communicate clearly across languages and markets. The standard is therefore about the design logic behind symbols, not merely about their appearance.
Why medical-device symbols matter
Medical-device labels and accompanying documents often need to convey critical information in limited space. Symbols help reduce text, support multilingual use, and create consistent visual cues for users, operators, and support personnel. From a broader documentation perspective, a symbol only works well when its meaning is stable, recognizable, and appropriately matched to the context in which it is used.
Development, selection, and validation in practice
This part should be understood as a methodological framework for symbol lifecycle management. Symbol selection typically depends on the intended use environment, the target audience, available label space, and the need to align with other communication channels. Validation, in general technical context, is concerned with whether the symbol is understandable and fit for purpose for the intended users. That makes the document relevant to organizations that create or manage medical-device symbol systems, not just to end users reading labels.
- Language-independent communication on labels and packaging
- Consistent interpretation across user groups and regions
- Efficient communication when label space is limited
- Structured support for symbol development and review
- Publication Date:
- Standard Status: U (Yürürlükteki Standard/Standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 01.080.20 Özel Ekipmanlarda Kullanılan Grafik Semboller ; 11.040.01 Tıbbi Ekipman (Genel)
- Pages: 0
- Source Standard:
- International Equivalents:
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