User Manual

i-4 Vscan Extend – User Manual
5721203-100
Rev. D
Certifications
• GE Vingmed Ultrasound is ISO 13485 certified.
ISO10993-1 Biological evaluation of medical devices
EN 300 328 Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems
ISO 14971 Medical devices - Application of risk management to medical
devices
IEC* 62304 Medical device software - Software life-cycle processes
IEC* 62366 Medical devices - Application of usability engineering to
medical devices
IEC* 60601-1-11 Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment
IEC* 60601-1-12 Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency
medical services environment
* including national deviations
Table i-1: Regulatory Requirements (Continued)
Standard/Directive Scope