Application of the Rules - Flow Diagram Part 1

Special Rules

Rules 6 and 9

A Near Patient IVDD listed in Rule 9 is a Class II IVDD.

Otherwise, a Near Patient IVDD is Class III unless:

• it detects HIV, HTLV, HBV, HCV or HDV where it is a Class IV.

Rule 7

When one IVDD is intended to work with another, each IVDD will be classified, but the higher risk classification will apply to both.