P61
Safety Conformance
Conforms to the following safety standards
Performance
IEC 60601-1:2005+AMD1:2012 / EN 60601-1 :2006+ A1 2013 CSV Medical electrical equipment -
Part 1:
General requirements for basic safety and essential performance
IEC 60601-1-2: 2014 / EN 60601-1-1 :2015 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
Capability - Requirements and tests
EN IEC 60601-2-37 2007 Medical electrical equipment - Part 2-37: Particular requirements for the
basic safety and essential performance of ultrasonic medical
diagnostic
and
monitoring
equipment
ISO 10993-1 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a
risk management process
AIUM/NEMA UD 2- 2004 2009 NEMA Standards Publication UD 2-2004 (R2009) Acoustic Output
Measurement Standard for Diagnostic Ultrasound Equipment,
Revision 3. (Radiology)
AIUM/NEMA UD 3- 2004 2009 NEMA Standards Publication UD 3-2004 (R2009) Standard for Real-
Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound
Equipment
Product Specification, Design Review, Verification/Validation and Risk
EN IEC 62304 2006 Medical device software - Software life cycle processes
IEC 62366-1: 2015/EN 62366-1:2015 Medical devices - Application of usability engineering to
medical devices
IEC 60601-1-6 / EN 60601-1-6 Usability
ISO 15223-1 2016 Medical devices - Symbols to be used with medical device labels, labeling and
information to be supplied
ISO 13485 2016 Medical Devices - Quality Management Systems - Requirements for Regulatory
Purposes
EN ISO 14971:2012-Medical devices. Application of risk management to medical devices
