| URS ID | URS Statement | Risk (H/M/L) | DQ Test Ref | IQ Test Ref | OQ Test Ref | PQ Test Ref | Evidence/Record | Result |
|---|---|---|---|---|---|---|---|---|
| [URS_ID_1] | The Ultrasonicator must achieve the specified power amplitude for effective size reduction. | [H/M/L] | [DQ_Test_Ref_1] | [IQ_Test_Ref_1] | [OQ_Test_Ref_1] | [PQ_Test_Ref_1] | [Evidence_Record_1] | [Result_1] |
| [URS_ID_2] | The Ultrasonicator must maintain the set temperature during operation to ensure product integrity. | [H/M/L] | [DQ_Test_Ref_2] | [IQ_Test_Ref_2] | [OQ_Test_Ref_2] | [PQ_Test_Ref_2] | [Evidence_Record_2] | [Result_2] |
| [URS_ID_3] | The Ultrasonicator must operate within the defined time limits for optimal dispersion. | [H/M/L] | [DQ_Test_Ref_3] | [IQ_Test_Ref_3] | [OQ_Test_Ref_3] | [PQ_Test_Ref_3] | [Evidence_Record_3] | [Result_3] |