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Standards
ANSI/AAMI EC57:2012
Testing and Reporting
Performance Results of: Cardiac
Rhythm and ST Segment
Measurement Algorithms
IEC 60601-1:2005 3rd
edition / Cor. 1:2006,
Cor. 2:2007
Medical electrical equipment - Part
2: Particular requirements for the
safety of electrocardiographic
monitoring equipment
IEC 60601-1-2,
Edition 4.0 (2014)
Medical electrical equipment, Part
1-2; Electromagnetic compatibility -
Requirements and tests
ISO 10993-1:2009
Biological evaluation of medical
devices Part 1: Evaluation and
testing
FCC
Tested for compliance with FCC 47
CFR Part 15, subpart B and
subpart C