CLARIUS HD3 - Clarius Scanner EC7 HD3

Clarius Scanner HD3 Standards
revision 9 72
Risk, Product Specification, Design Review, & Verification/Validation
ANSI/AAMI/IEC 62304 2006
A1:2015
Medical device software – Software life cycle processes.
CAN/CSA-C22.2
No. 60601-1-6:11
2011 Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability (Adopted IEC 60601-1-
6:2010, third edition, 2010-01)
CAN/CSA-C22.2
No. 60601-1:14
2014 Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (Adopted IEC 60601-1:2005, third edition, 2005-12,
including amendment 1:2012, with Canadian deviations)
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 Capability -
Requirements and tests
IEC 60601-1-6 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral Standard: Usability
IEC 60601-1-12 2014 Medical electrical equipment - Part 1-12: Requirements for Medical Electrical
Equipment and Medical Electrical Systems Intended For Use in the Emergency
Medical Services Environment
IEC 60601-2-37+ AMD1 2015 Medical electrical equipment - Part 2-37: Particular requirements for the basic
safety and essential performance of ultrasonic medical diagnostic and monitoring
equipment
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
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
Reference No. Year Title