Electrical Safety Testing Medical Devices

It is important to test equipment for any electrical internal breakdowns and leakage currents as well as damage to power cords ac main feeds fuses and power bars.

Electrical safety testing medical devices. Iec60601 aami nfpa 99 the primary standard for medical devices is iec 60601. The introduction of iec 62353 medical electrical equipment recurrent test and test after repair of medical electrical equipment seeks to streamline this situation and harmonise all standards that specify measures to ensure the safety of electromedical devices used in the diagnosis and treatment of patients. Esa612 electrical safety analyzer. Ground wire or protective earth resistance.

Basic electrical safety testing with the esa609. Recognized by medical device regulators in most markets worldwide the standard s current version is iec 60601 3rd edition am. General connections to an electrical safety analyzer. Basic electrical safety e g component modeling such as batteries study long term electrical conductivity characteristics of thin film or polymeric materials used in implantable medical devices.

There are general and specific standards for medical device electrical safety. Ground wire earth leakage. At first this test was mandatory for medical devices only. It includes two electrical safety test load selections for global use and is compatible with the ansur software.

Please note that although hei 95 and db9801 are no longer current they are referred to in the text since many medical electronics departments have used them as a basis for local acceptance testing and even routine testing protocols. The following paragraphs and diagrams describe the electrical safety tests commonly available on medical equipment safety testers. Medical electrical equipment general safety requirements this standard applies to the safety of medical electrical equipment as defined in sub clause 2 2 15. Iec 60601 is a harmonized standard for evaluating the electrical safety and effectiveness of medical devices and equipment.

These include standards for electro medical equipment. The maximum acceptable limit of a leakage current is generally 210 micro amperes. The esa612 electrical safety analyzer for medical devices combines the power of a ecg simulator electrical safety tester in a single rugged portable device. General requirements for protection against electric shock hazards are covered in iec 60601 1 section 3.

The main purpose of performing an electrical safety test on medical equipment is to ensure patient safety.