TS EN ISO 15223-1
Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
This document identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices. It also lists symbols that satisfy the requirements of this document.
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About This Item
TS EN ISO 15223-1 addresses the symbols used on medical device labels, labelling, and information supplied with the device. It defines general requirements for symbols that help convey information needed for the safe and effective use of medical devices, and it also provides a list of symbols that meet those requirements. In practice, symbol-based labelling supports concise communication across languages and markets.
Why symbols matter in medical device information
In the medical device field, symbols are used to express essential information such as instructions for use, storage conditions, traceability data, sterilization status, or single-use designation in a compact form. Their value depends not only on visual design but also on standardized meaning and consistent interpretation. As general technical context, a well-defined symbol system reduces repeated text on labels and helps users identify critical information more quickly, especially in multilingual environments.
What this part provides
- General requirements for symbols used in medical device labelling and accompanying information
- A list of symbols that satisfy the requirements of this document
- A framework for consistent, widely understood communication of safety- and use-related information
This record represents a withdrawn edition of the standard, so it should be understood as a reference for the period in which it was current. When working with symbols, the key distinction is that the graphic mark is only part of the meaning; its standardized definition and intended use give it technical significance. For that reason, the document functions as more than a symbol catalogue: it supports a common language for medical device communication.
- Publication Date: 9.12.2016
- Standard Status: H (İptal Edilmiş Standard/Withdrawn standard)
- Publisher: TSE
- Document Language: en
- ICS Classification: 01.080.20 Özel Ekipmanlarda Kullanılan Grafik Semboller ; 11.040.01 Tıbbi Ekipman (Genel)
- Pages: 45
- Source Standard: EN ISO 15223-1:2016
- International Equivalents: EN ISO 15223-1:2016-EQV; ISO 15223-1-EQV
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