Classification According to Contact Time

It should be classified as follows according to the contact time foreseen in the medical devices.

a) Limited exposure (A) - Devices with a cumulative single, multiple or repeated use or contact time of up to 24 hours.

b) Long term exposure (B) - Devices with a cumulative duration of single, multiple or repeated prolonged use or contact possibly exceeding 24 hours but not exceeding 30 days.

c) Permanent contact (C) - Devices with a cumulative single, multiple or repeated long-term use or contact time exceeding 30 days.