חומר רקע

FDA Class I devices are devices that are subject to "General Controls". General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices.Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Examples of Class I device: elastic bandages, non-sterile examination gloves, and hand-held dental surgical. EU (from the guideline rather than the Directive itself) Class I devices are those that pose a low risk to the patient and, except for sterile products or measuring devices. Generally speaking, these devices do not enter into contact or interact with the body.