Sonic Incytes Medical Corp.
Electrical Listing Program
- Sonic Incytes Medical Corp.
- Medical Equipment
- Vancouver, BC
- E11135
- E11135-2404
- May 29th, 2025
- May 29th, 2025
- N/A
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CAN/CSA C22.2 No. 60601-1:14+A2:22 “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (Adopted IEC 60601-1:2005, edition 3:2005 consolidated with amendment 1:2012 and amendment 2:2020, with Canadian deviations)”
CAN/CSA C22.2 No. 60601-1-6:11+A1:15+A2:21 “Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability (Adopted IEC 60601-1-6:2010, edition 3:2010-1 consolidated with amendment 1:2013 and amendment 2:2020, with Canadian deviations)”
CSA C22.2 No. 60601-2-37:08+A1:19 “Medical electrical equipment – Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (Adopted IEC 60601-2-37:2007, edition 2:2007-08 consolidated with amendment 1:2015, with Canadian deviations)”
ANSI/AAMI ES60601-1:2005 & A1:2012, C1:2009 & A2:2010 (Incl. AMD2:2021) – Medical electrical equipment— Part 1: General requirements for basic safety and essential performance
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (Ed. 3.2) – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 (Ed. 3.2) – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
IEC 60601-2-37:2007 + AMD1:2015 (Ed. 2.1) – Medical electrical equipment – Part 2-37: Particular requirements for the basic safety
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Medical Equipment
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Products are marked in a permanent manner where it is readily visible after installation with the following:
a) Manufacturer’s name or trademark
b) Model designation
c) Month and year of manufacture
d) Product ratings: voltage, frequency, watts
e) QAI file Number: E11135
f) The wording “CSA C22.2 No. 60601-1 and CSA C22.2 No. 60601-2-37”
g) Warning markings as required by the standards in English and French
h) QAI logo shown here:
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Series: N/A Model Rating Description Environmental Locations LI-1100 100-240VAC, 47-63Hz, 1.0-2.5A Liver assessment device Indoor
The materials, products or systems listed in this directory have been qualified to bear the QAI Listing Mark under the conditions stated with each Listing. Only those products bearing the QAI Listing Mark are considered to be listed by QAI.
The standard herein listed is the currently accepted version within the relevant certification scheme, code or other requirements unless otherwise noted. Transition periods may apply. Upon request, QAI will provide information about the validity of any of its certifications.
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