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Technology Glossary

IEC 60601 (Medical Standard)

IEC 60601 is the international standard for the safety, essential performance and EMC of medical electrical equipment, including medical displays.

Also known as: EN 60601, IEC 60601-1, IEC 60601-1-2

IEC 60601 is an international standard defining safety, performance, and electromagnetic compatibility (EMC) requirements for electrical medical equipment and systems. It applies to medical displays, patient monitors, infusion pumps, hospital beds with electronics, and diagnostic devices. The standard specifies criteria such as surge resistance, galvanic isolation, leakage current limits, and immunity to electromagnetic disturbances. Its European equivalent is EN 60601, required for CE marking. Compliance ensures safety for both patients and medical staff and is mandatory for clinical use.

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