20.
Standards and Compliance
The ZS3 system has been designed, manufactured, tested, and certified to comply with the
following internationally recognized standards:
IEC 60601-1: 2012: Medical electrical equipment part 1: General requirements for basic
safety and essential performance.
IEC 60601-1-2: 2014: Medical electrical equipment part 1-2: General requirements for
basic safety and essential performance. Collateral standard: Electromagnetic
disturbances - Requirements and tests.
IEC 60601-2-37: 2015: Medical electrical equipment Part 2-37: Particular requirements
for the basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment issued by IEC in 2015.
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