Safety and Analysis

At Hamel Medical we provide comprehensive safety analisys solutions packages. The FDA/CLIA has adopted ANSI/AAMI/IEC 60601-1-2:2001 which is the U.S. Version of IEC 60601-1-2:2001 with identical requirements for medical electrical equipment. Regardless of the governing body, equipment tests are necessary.

UL 60601-1 differentiates between patient-care equipment (6 ft around and 7.5 ft above the patient) and non-patient-care equipment for leakage current tests. The typical leakage current values for a Class I device are 300 µA in a patient-care area and 500 µA outside the Patient Care Area. For a Class II device, the values are 150 µA in a patient-care area and 250 µA outside the Patient Care Area.

We test to this criteria as a minimal requirement. Governing bodies of organizations and standards vary. We can accommodate the needs of almost any facility. Custom forms and reports based on the requirements of your facility are generated and submitted to you upon completion of testing.