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What defines a significant risk device?

  1. Intended as an implant and represents serious risk

  2. Used in support/sustaining life and important in treating diseases

  3. Non-invasive with minimal health impact

  4. Both A and B

The correct answer is: Both A and B

Intended as an implant and representing a serious risk and used in support/sustaining life and important in treating diseases are both defining characteristics of a significant risk device. A non-invasive device with minimal health impact would not fall under this category. Therefore, options A, B, and C cannot be the sole defining factors.