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IEC 60601-1, which covers the basic safety and essential performance applicable to medical electrical equipment including surgical, monitoring and hospital devices, has a long history with a number of revisions. The standards follow the same general requirements established in IEC 60950-1, but with increased levels of protection for insulation/isolation, creepage, clearance, and leakage current. Introduced in 1988, the 2nd edition of IEC 60601-1 focused on safety within a 6-foot radius of the patient known as “patient vicinity” and developed three guidelines of increasing severity. This was followed by the 3rd edition in 2005 which looked at different “means of protection” (MOP) for patients and equipment operators. Edition 3.1, introduced in 2012, made over 500 changes and clarifications to the 3rd edition to address ambiguities arising from evolving medical technology. Most recently, in 2014, the 4th edition of collateral standard IEC 60601-1-2, “Electromagnetic disturbances – Requirements and tests,” was published.
