Certifications - GE Vscan Extend User Manual

Table i-1:
Standard/Directive
ISO10993-1
EN 300 328
ISO 14971
IEC* 62304
IEC* 62366
IEC* 60601-1-11
IEC* 60601-1-12
* including national deviations

Certifications

i-4
Regulatory Requirements (Continued)
Biological evaluation of medical devices
Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems
Medical devices - Application of risk management to medical
devices
Medical device software - Software life-cycle processes
Medical devices - Application of usability engineering to
medical devices
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency
medical services environment
• GE Vingmed Ultrasound is ISO 13485 certified.
Scope
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Vscan Extend User Manual
5721203-100 Rev. D