AI and safety · Question 51 of 60
A medical device manufacturer wants to use an AI module as a safety component and rely solely on a mature functional safety standard. Which problems are there?
2 answers are correct. Hard
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Answer
- B AI is currently not included in mature functional safety standards, and some even prohibit it
- D The EU AI Act classifies such safety components as high-risk with strict requirements for development and testing
Explanation
The rules for AI in safety-related systems keep changing. Established functional safety standards do not yet provide for AI, and some even rule it out. The EU AI Act classifies AI as a safety component, for example in aircraft, medical devices or cars, as high risk and demands correspondingly strict development and testing.