CAPINTEC, INC. CAPTUS
®
3000
Regulatory Listings
The CAPTUS
®
3000 has been independently tested and is manufactured in compliance with
the following Standards:
EMC
• IEC 60601-1-2 (2007): Medical Electrical Equipment – Part 1 General
Requirements for Safety – Section 1.2 Collateral Standard: Electromagnetic
Compatibility – Requirements and Tests
Safety
• AAMI ES60601-1 Issued: 2005: Medical electrical equipment Part 1: General
requirements for basic safety and essential performance
• CAN.CSA-C22.2 No. 60601-1:08: Medical electrical equipment – Part 1:
General requirements for basic safety and essential performance
• IEC 60601-1 Issued: 2005 Ed:3: Medical electrical equipment Part 1: General
requirements for basic safety and essential performance
• IEC 60601-1-6 2010 3
rd
Edition: Medical electrical equipment – Part 1-6:
General requirements for basic safety and essential performance – Collateral
Standard: Usability
2-10 FUNCTIONAL & TECHNICAL DESCRIPTION July 14
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