Electrical Safety Testing Medical Devices

Medical electrical equipment general safety requirements this standard applies to the safety of medical electrical equipment as defined in sub clause 2 2 15.

Electrical safety testing medical devices.

General requirements for protection against electric shock hazards are covered in iec 60601 1 section 3. Iec 60601 is a harmonized standard for evaluating the electrical safety and effectiveness of medical devices and equipment. 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.

Ground wire or protective earth resistance. The maximum acceptable limit of a leakage current is generally 210 micro amperes. Esa612 electrical safety analyzer. Ground wire earth leakage.

The esa612 electrical safety analyzer for medical devices combines the power of a ecg simulator electrical safety tester in a single rugged portable device. Although this standard is primarily concerned with safety it contains some requirements regarding reliable operation where this is connected with safety. Basic electrical safety testing with the esa609. The main purpose of performing an electrical safety test on medical equipment is to ensure patient safety.

At first this test was mandatory for medical devices only. There are general and specific standards for medical device electrical safety. The esa609 integrates all functions needed to test medical devices when patient lead testing is not required including. 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.

These include standards for electro medical equipment. 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. It includes two electrical safety test load selections for global use and is compatible with the ansur software. 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.

The following paragraphs and diagrams describe the electrical safety tests commonly available on medical equipment safety testers.