Electrical Safety Testing Medical Devices

Esa612 electrical safety analyzer.

Electrical safety testing medical devices.

Ground wire or protective earth resistance. 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. 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.

At first this test was mandatory for medical devices only. Although this standard is primarily concerned with safety it contains some requirements regarding reliable operation where this is connected with safety. The following paragraphs and diagrams describe the electrical safety tests commonly available on medical equipment safety testers. The esa612 electrical safety analyzer for medical devices combines the power of a ecg simulator electrical safety tester in a single rugged portable device.

Basic electrical safety testing with the esa609. Medical electrical equipment general safety requirements this standard applies to the safety of medical electrical equipment as defined in sub clause 2 2 15. Ground wire earth leakage. Please note that although hei 95 and db9801 are no longer current they are referred to in the text since many medical electronics departments have used them as a basis for local acceptance testing and even routine testing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.

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. Iec60601 aami nfpa 99 the primary standard for medical devices is iec 60601. The esa609 integrates all functions needed to test medical devices when patient lead testing is not required including. The main purpose of performing an electrical safety test on medical equipment is to ensure patient safety.

There are general and specific standards for medical device electrical safety. The maximum acceptable limit of a leakage current is generally 210 micro amperes. General requirements for protection against electric shock hazards are covered in iec 60601 1 section 3. It includes two electrical safety test load selections for global use and is compatible with the ansur software.

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.