IEC 60601-1: “Medical electrical equipment,” edition 3.1, is the base medical-device standard to ensure “basic safety and essential performance” of medical electrical equipment. It is used by medical device regulators but also recognized by some other regulatory authorities as a regulatory instrument for gauging electrical safety approval.

IEC 60601-1 is considered one of the most costly standards to comply with that has ever been published. Older versions of the standard were expensive, costing $10,000 to $20,000 for relatively low-risk products to get certified. The newer versions doubled and even quadrupled some of those costs. The costs of compliance with edition 3.2 of the standard is likely to create significant challenges for manufacturers of medical devices powered by electricity, but not all countries require it, and some countries have more than one authority that applies it differently, and have different allowances for adopting or keeping superseded versions of IEC 60601-1.

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