Iec 60601 is a series of technical standards for the safety and essential performance of medical electrical equipment published by the international electrotechnical commission first published in 1977 and regularly updated and restructured as of 2011 it consists of a general standard about 10 collateral standards and about 80 particular standards.
Electrical safety test medical equipment.
There are general and specific standards for medical device electrical safety.
Patient treatment areas for all doctors physiotherapists dentists chiropractors and aged care facilities require specialised electrical work and stringent medical equipment testing which is compliant against as nzs 3003.
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.
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Iec 60601 1 medical electrical equipment part 1.
Ground wire or protective earth resistance.
The esa609 integrates all functions needed to test medical devices when patient lead testing is not required including.
These include standards for electro medical equipment.
The esa612 electrical safety analyzer for medical devices combines the power of a ecg simulator electrical safety tester in a single rugged portable device.
Ground wire earth leakage.
General connections to an electrical safety analyzer.
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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.
Esa612 electrical safety analyzer.
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Please note that although hei 95 and db9801 are no longer current they are referred to in the text since many medical electronics departments have used them as a basis for local acceptance testing and even routine testing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.
Although this standard is primarily concerned with safety it contains some requirements regarding reliable operation where this is connected with safety.
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It includes two electrical safety test load selections for global use and is compatible with the ansur software.
Iec60601 aami nfpa 99 the primary standard for medical devices is iec 60601.
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Basic electrical safety testing with the esa609.
General requirements for protection against electric shock hazards are covered in iec 60601 1 section 3.