Signal Words
Signal words are normatively defined terms used in safety and warning notices to indicate the severity of a hazard. According to ISO 3864 and the harmonised standard ANSI Z535, four levels are distinguished: DANGER (immediate hazard that will result in death or serious injury), WARNING (potentially hazardous situation that could result in death or serious injury), CAUTION (potentially hazardous situation that could result in minor or moderate injury), and NOTICE (important information without a direct safety reference, e.g. for product protection). In medical device instructions for use, signal words are essential as they enable users to make an immediate risk assessment.
In IFU translation, signal words are particularly critical because incorrect translation or assignment can impair usability and in serious cases lead to misuse. The EU MDR requires that safety information must be clearly understandable for the user – this includes the standards-compliant use of signal words in every language version.
Frequently Asked Questions
How must signal words be handled in IFU translations?+
Signal words must not be freely translated but must correspond to the respective national versions of ISO 3864 and harmonised standards. For each target language, normatively defined equivalents exist: e.g. "DANGER" → "GEFAHR" (German), "DANGER" (French), "PERICOLO" (Italian). The assignment of hazard levels must remain consistent. CAT tools and terminology databases should be configured so that signal words are treated as locked terms and cannot be accidentally modified.