Grafiska symboler

Kommittébeteckning: SIS/TK 355 (Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik)
Källa: CEN
Svarsdatum: den 5 maj 2020
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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.

This document is applicable to symbols used in a broad spectrum of medical devices, which are marketed globally and therefore need to meet different regulatory requirements.

These symbols are marked on the medical device itself, placed on its packaging or placed in the associated accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards.