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IEC 60601-2-49

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

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Organization: IEC
Publication Date: 1 February 2011
Status: active
Page Count: 110
ICS Code (Diagnostic equipment): 11.040.55
scope:

Replacement:

This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME EQUIPMENT. This particular standard applies to ME EQUIPMENT used in a hospital environment as well as when used outside the hospital environment, such as in ambulances and air transport.

ME 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 ME EQUIPMENT for those environments of use.

The scope of this standard is restricted to ME EQUIPMENT intended for connection to a single PATIENT that has either two or more APPLIED PARTS or MULTIPLE FUNCTIONS on an APPLIED PART.

This standard 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 ME EQUIPMENT. This particular standard addresses the differences related to MULTIFUNCTION PATIENT MONITORING EQUIPMENT, since such equipment has a broader INTENDED USE than this stand-alone ME EQUIPMENT.

Document History

IEC 60601-2-49
February 1, 2011
Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
Replacement: This particular standard applies to BASIC SAFETY and ESSENTIAL PERFORMANCE requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in 201.3.63, hereafter referred to as ME...
July 1, 2001
Medical electrical equipment – Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment
This Particular Standard applies to the safety requirements of MULTIFUNCTION PATIENT MONITORING EQUIPMENT as defined in subclause 2.2.101. The scope of this standard is restricted to EQUIPMENT...

References

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