
The SonoSite Regulatory & Compliance web pages provide SonoSite customers information on key elements of medical device compliance.
Regulatory Compliance
Regulatory & Compliance / Documentation / Safety & EMC
SonoSite products are tested for compliance to internationally recognized standards for electromedical equipment safety and electromagnetic compatability (EMC). Compliance documents for SonoSite's devices are available. Use the links below to view them.
Product Name:
SonoSite M Series Ultrasound SystemTrade Names:
SonoSite M-Turbo™ Ultrasound SystemDocuments:
- M-Turbo CSA Certificate Of Compliance And CB Scheme Test Certificate (PDF)
- M-Turbo EMC Standards Classification (PDF)
Product Name:
SonoSite S Series Ultrasound SystemTrade Names:
SonoSite S-Nerve™ Ultrasound SystemSonoSite S-FAST™ Ultrasound System
SonoSite S-ICU™ Ultrasound System
SonoSite S-Cath™ Ultrasound System
SonoSite S-MSK™ Ultrasound System
Documents:
- S Series CSA Certificate Of Compliance And CB Scheme Test Certificate (PDF)
- S Series EMC Standards Classification (PDF)
Product Name:
SonoSite high-resolution ultrasound system (C3 Series)Trade Names:
MicroMaxx® high-resolution ultrasound systemDocuments:
- MICROMAXX (C3) CSA CERTIFICATE OF COMPLIANCE AND CB SCHEME TEST CERTIFICATE (PDF)
- EMC Standards Classification (PDF)
- Wireless Card Industry Canada Certificate for LA4137 (PDF)
- Wireless Card FCC Grant for LA4137 (PDF)
Product Name:
SonoSite high-resolution ultrasound system (C2 Series)Trade Names:
TITAN® high-resolution mobile ultrasound systemDocuments:
- TITAN (C2.X) CSA CERTIFICATE OF COMPLIANCE AND CB SCHEME TEST CERTIFICATE (PDF)
- EMC Standards Classification (PDF)
Product Name:
SonoSite ultrasound system (Power Series)Trade Names:
SonoSite® iLook Personal Imaging Tool, C15SonoSite® iLook Personal Imaging Tool, L25
Documents:
- ILOOK CSA CERTIFICATE OF COMPLIANCE ILOOK CB TEST CERTIFICATE (PDF)
- EMC Standards Classification (PDF)
Product Name:
SonoSite hand-carried ultrasound systemTrade Names:
SonoSite® 180PLUSSonoHeart® ELITE
Documents:
- CSA CERTIFICATE OF COMPLIANCE AND CB SCHEME TEST CERTIFICATE (PDF)
- EMC Standards Classification (PDF)
M-Turbo™
S Series™
M-OB/GYN Office
MicroMaxx®
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