IEC 60601-1-11, which became mandatory in the European Union on 1 June 2012, outlines new requirements for the design and verification of a range of home use and point-of-care medical devices, notes SGS Medical Devices Services. The new standard differs from the general IEC 60601-1 in relation to requirements for construction and testing of the device, adds the inspection, verification, testing and certification company.
The IEC 60601-1-11 standard defines the Home Healthcare Environment as the “dwelling place in which a patient lives or other places where patients are present, excluding professional healthcare facility environments where operators with medical training are continually available when patients are present.” (The definition of the US national version differs slightly and its implementation date is 30 June 2013.)
Medical devices typically mandated to use the new standard include oxygen concentrators, body-worn nerve and muscle stimulators, beds, sleep apnea monitors and battery chargers prescribed for use at home, according to SGS.
For devices intended for home use, the new standard requires the use of a two-prong (unearthed) plug and water-resistant casings. Also, parts that are applied to a patient must be isolated from other parts of the device. The devices also must be tested to withstand mechanical shock, vibration, impact from dropping and a range of environmental conditions. These requirements go beyond the general 60601-1 standard, and a design review is recommended to ensure compliance across the entire range of new requirements. Simply addressing the general risk concerns of ISO 14971 is no longer adequate to comply with the specific hardware-related aspects of IEC 60601, says SGS.
IEC 60601 3rd edition series has, and still is, undergoing changes with a recent amendment to the general requirements standard IEC 60601-1, which modifies and clarifies some of the existing requirements. SGS recommends that manufacturers perform a thorough review of any new, or existing, devices intended for the European or North American markets.