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IEC 60601-2-49 Multiparameter Patient Monitoring Equipment Testing

Medical electrical equipment – Part 2-49: the basic safety and essential performance of multifunction patient monitoring equipment

IEC 60601-2-49 Scope:

IEC 60601 2 49 and EN 60601 2 49 testing applies to basic safety and essential performance requirements of multifunction patient monitoring equipment as defined in 201.3.63, hereafter referred to as medical electronic equipment. This particular standard applies to medical electronic equipment used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.

Medical electronic equipment intended for use under extreme or uncontrolled environmental conditions outside the hospital environment, such as in ambulances and air transport, shall comply with this particular standard. Additional standards may apply to medical electronic equipment for those environments of use.

The scope of IEC 60601-2-49 is restricted to medical electronic equipment intended for connection to a single patient that has either two or more applied parts or multiple functions on an applied part.

EN 60601-2-49 does not specify requirements for individual monitoring functions such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological parameters specify requirements from the perspective of stand-alone medical electronic equipment. IEC 60601-2-49 testing addresses the differences related to multifunction patient monitoring equipment, since such equipment has a broader intended use than this stand-alone medical electronic equipment.

Keystone Compliance assists manufacturers with IEC 60601-2-49 and EN 60601-2-49 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-49 test lab needs.