Derived Test Requirements - describes a specific portion of the certification criterion which will be addressed in the test procedure. To provide traceability, each is denoted using the following form: DTR [FR certification criterion number] – [Sequence number] Required Vendor Information - describes the information needed from the Vendor in order to perform the test procedure. To provide traceability, each is denoted using the following form: VE [FR certification criterion number] – [Sequence number] Required Test Procedure – describes the test activities required to be performed by the Tester. To provide traceability, each is denoted using the following form: TE [FR certification criterion number] – [Sequence number] Inspection Guide – provides additional guidance to the Tester on how to evaluate conformance to the certification criterion. To provide traceability, each is denoted using the following form: IN [FR certification criterion number] – [Sequence number] Test Story – an English language description of a clinical situation that gives context to the test data. It can describe the patient-physician interactions or the physician-lab interactions, for instance. They may be very simple and short or long and complex. |