What are Class 1 Medical Devices?
Class I devices are the lowest risk classification. The Class is determined by a set of rules and for example are intended for: • External use • May rely on an energy source other than the body or gravity, if not used for diagnosis or therapy, • Does not deliver energy to the body, • Does not deal with material introduced into the body or that comes in contact with injured skin; or • Continuous use less than 60 minutes in a body orifice or stoma; or • Continuous use less than 30 days in the oral cavity, ear canal or nasal cavity, or are: • Reusable surgical instruments; or • Medical devices for export only.
