EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Incorporates Amendment A1: 2015)
European Committee for Electrotechnical Standardization（CENELEC）
Latest
EN 60601-2-37:2008
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.
EN 60601-2-37:2008 history
2008EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Incorporates Amendment A1: 2015)
2001EN 60601-2-37:2001 Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment (Incorporates Amendments A1: 2005 and A2: 2005)