User's Manual

Clarius Ultrasound Scanner - HD3 Scanners Standards
revision 1 69
Risk, Product Specification, Design Review, & Verification/Validation
Security & Privacy
IEC TR 80002-3:2014 - Medical device software - Part 3: Process reference model of medical
device software life cycle processes.
Reference No. Year Title
21 CFR 11 2014 Part 11 Electronics Records and Electronic Signatures
21 CFR 801 2014 Part 801 Labeling
21 CFR 820 2014 Part 820 Quality System Regulation
21 CFR 821 2014 Part 821 Medical Device Tracking Requirements
21 CFR 822 2014 Part 822 Postmarket Surveillance
21 CFR 830 2014 Part 830 Unique Device Identification
BS EN 1041 2013 Information supplied by the manufacturer of medical devices - Medical Device Information
CMDR SOR/98-282 2021 Canadian Medical Devices Regulations (CMDR):
• Safety and Effectiveness Requirements (Sections 10-20)
• Labeling Requirements (Sections 21-23)
EN ISO 13485
ISO 13485
2016
2016
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
EN ISO 14971
ISO 14971
2019
2019
Medical Devices - Application of Risk Management to Medical Devices
IEC 60529 2013 Degrees of protection provided by enclosures (IP Code)
IEC 62304 2015 Medical device software - Software life cycle processes
IEC 62366 2014 Medical devices - Application of usability engineering to medical devices
IEC/TR 80002-3 2014 Medical device software - Part 3: Process reference model of medical device software life
cycle processes
IEEE 11073- 20601a 2010 Health informatics - Personal health device communication. Part 20601: Application profile -
Optimized Exchange Protocols
ISO 10993-1 2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
ISO 15223-1 2016 Medical devices - Symbols to be used with medical device labels, labeling and information to
be supplied