Patient protection at risk in IEC 60601-1 3rd edition.
Engineers developing medical electrical equipment in accordance with IEC 60601-1 3rd edition are in immediate need of short- and long-term solutions to avoid potentially hazardous designs as a result of misinterpretation of the requirements. Several options are described to ensure consistency and safety of devices.
UL International Demko A/S, Herley, Denmark. ken.dybdahl@dk.ul.com
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D002568:Certification / Q000592:standards*; D018795:Device Approval / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards*; D038622:Internationality