BS EN IEC 80601 discusses medical electrical equipment. BS EN IEC 80601‑2‑49 applies to basic safety and essential performance requirements of multifunction patient monitors as defined in 201.3.201, hereafter referred to as ME equipment or medical electrical systems.
BS EN IEC 80601‑2‑49 helps in standardising basic safety and essential performance requirements for multifunction patient monitors as defined in 201.3.201.
BS EN IEC 80601‑2‑49 applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment.
The scope of BS EN IEC 80601‑2‑49 is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units.
BS EN IEC 80601‑2‑49 addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply.
Note 1: For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient.
Note 2: BS EN IEC 80601‑2‑49 does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure, and pulse oximetry.
Note 3: BS EN IEC 80601‑2‑49 does not apply to implantable parts of multifunction patient monitors.
BS EN IEC 80601‑2‑49 on multifunction patient monitoring equipment is useful for:
The multifunction patient monitor’s intended function is the monitoring of a single patient, has more than one physiological monitoring unit, either displays that information or distributes the information for remote display, and either includes an alarm system or is a component of a distributed alarm system.
BS EN IEC 80601‑2‑49 guidelines help you with essential performance requirements and protection against electrical hazards, mechanical hazards, unwanted and excessive radiation hazards, excessive temperatures, and other hazards for multifunction patient monitoring equipment.
This improves the performance and safety of multifunction patient monitoring equipment. In addition, minimizes hazards to the patient and operator.
BS EN IEC 80601‑2‑49:2019 supersedes IEC 80601‑2‑49:2019, which has been withdrawn. BS EN IEC 80601‑2‑49:2019 has technical revision to align with the current edition and amendment to IEC 60601-1, new versions of collateral standards, and amendments with respect to IEC 80601‑2‑49:2019.
EN 60601-2-49 Ed 3.0
EN 62271-203:2012
IEC 80601-2-49:2018