Once a newly designed product has undergone proper compliance testing, the dielectric withstand or hipot test is one of the primary safety tests routinely performed as part of the final production process. The intention of the test is to stress a product’s insulation beyond what it would encounter in normal use.

This test is one that has long been required on medical electronic products, as well as on most other electrical devices and appliances before they exit a manufacturer’s production floor. The end goal is to ensure that patients or caregivers never serve as a current path to ground due to faulty insulation or faulty grounding within the product.

Many standards are used to determine how medical products are to be built and tested. The most widely accepted are IEC 60601-1 (the International Electrotechnical Commission’s electrical safety standard for medical electronic equipment) and the U.S. derivation, UL 2601-1. These standards are intended to ensure that safety considerations are taken into account during the design phase of a product. Although most of IEC 60601-1 and UL 2601-1 are applicable to type testing, in the final analysis, safety testing at the production line is the only way manufacturers can be sure that they are shipping safe products. IEC 60601-1 has been used as the basis for many national medical standards worldwide.

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