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IEC 60601-2-37

Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

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Organization: IEC
Publication Date: 1 June 2015
Status: active
Page Count: 214
ICS Code (Electroacoustics): 17.140.50
ICS Code (Diagnostic equipment): 11.040.55
scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of this standard.

NOTE See also subclause 4.2 of this standard.

This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.

Document History

IEC 60601-2-37
June 1, 2015
Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter referred to as ME EQUIPMENT. If a clause or...
June 1, 2015
AMENDMENT 1 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
A description is not available for this item.
August 1, 2007
IEC 60601-2-37 Edition 2.0 2007-08 Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
Addition: This Particular Standard specifies particular safety requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 2.1.145. This standard does not cover ultrasonic therapeutic equipment;...
November 1, 2005
Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment Amendment 2
Addition: This Particular Standard specifies particular safety requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 2.1.145. This standard does not cover ultrasonic therapeutic equipment;...
October 1, 2004
Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Addition: This Particular Standard specifies particular safety requirements for ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 2.1.145. This standard does not cover ultrasonic therapeutic equipment;...
August 1, 2004
Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
A description is not available for this item.
July 1, 2001
Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
A description is not available for this item.

References

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