Clarius Scanner HD3 Standards
revision 9 73
Security & Privacy
IEC TR 80002-3:2014 - Medical device software - Part 3: Process reference model of medical
device software life cycle processes.
Wireless
U.S.
• FCC Part 15/C 15.247; Part 15/E 15.407
Canada
• ISED RSS-Gen; RSS-247; RSS-210
Europe
• ETSI EN 300 328:V2.1.1 - Electromagnetic compatibility and Radio spectrum Matters (ERM)
• ETSI EN 301 489-1:V2.1.1- Electromagnetic compatibility and Radio spectrum Matters
(ERM)
• ETSI EN 301 489-17:V3.1.1- Electromagnetic compatibility and Radio spectrum Matters
(ERM)
IEC 60529 2013 Degrees of protection provided by enclosures (IP Code)
IEC 62304 2006
A1:2015
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 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk
management process
ISO 15223-1 2021 Medical devices - Symbols to be used with medical device labels, labeling and information to
be supplied
ISO 20417 2021 Information supplied by the manufacturer of medical devices
EU MDR 2017 European Medical Device Regulation 2017/745
Reference No. Year Title
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