Capintec CAPRAC-t - Regulatory Listings

CAPINTEC, INC. CAPRAC
®
-t
April 2021 FUNCTIONAL & TECHNICAL DESCRIPTION 2-9
Regulatory Listings
The CAPRAC
®
-t has been independently tested and is manufactured in compliance with the
following Standards:
• ANSI/AAMI ES60601-1: 2005 / I2012 – Medical Electrical Equipment – General
Requirements for Basic Safety and Essential Performance
• CAN/CSA-C22.2 No. 60601-1:14, Third Edition– Medical Electrical Equipment –
General Requirements for Basic Safety and Essential Performance
• CENELEC EN 60601-1: 2006 + A1: 2013– Medical Electrical Equipment – General
Requirements for Basic Safety and Essential Performance
• IEC 60601-1: 2005 + A1: 2012, Third Edition– Medical Electrical Equipment –
General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2 ed 4.0 (2014-02), Medical Electrical Equipment - Part 1-2:
General Requirements for Basic Safety and Essential Performance –
Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
LIFE TIME (END OF LIFE)
The CAPRAC
®
-t Well Counter System’s life time (End of Life) is considered to be ten years
after date of shipment. Service, support, and spare parts will be provided for this time. After
ten years, the system is no longer considered “state of the art” and should be replaced.