8.4
EQUIPMENT DESIGN
The Automated Impella® Controller conforms to the applicable requirements of the following
standards:
• IEC 60601-1 (2005/01/01) Ed:3 Medical Electrical Equipment Part 1: General
Requirements for Basic Safety and Essential Performance
• CSA C22.2#60601-1 (2008) Ed:3 Medical Electrical Equipment Part 1: General
Requirements for Basic Safety and Essential Performance
• CENELEC EN60601-1 (2006) Medical Electrical Equipment Part 1: General Requirements
for Basic Safety and Essential Performance. Included when concurrent with IEC 60601
• AAMI ES60601-1 (2005) Medical Electrical Equipment Part 1: General Requirements for
Basic Safety and Essential Performance
• UL 60601-1 (2003), +Revision (2006) 1st Edition Medical Electrical Equipment, Part 1:
General Requirements for Safety
• CAN/CSA C22.2 No 601.1-M90 (1990; Reaffirmed 2005) + Amendment 2 (2006),
Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC 60601-1 (1998) 2nd Edition Medical Electrical Equipment Part 1: General
Requirements for (Amd. 1-1991) (CENELEC EN 60601-1: 1990) + (Amd. 2-1995)
(Corrigendum-1995)
• IEC 60601-1-1 (2000), 2nd Edition Medical Electrical Equipment, Part 1-1: General
Requirements for Safety – Collateral Standard: Safety Requirements for Medical Electrical
Equipment
• IEC 60601-1-4 (2000), Edition 1.1 Consolidated Edition, Medical Electrical Equipment
Part 1-4: General Requirements for Safety – Collateral Standard: Programmable Electrical
Medical Systems
• IEC 60601-1-2:2007 Edition 3, Medical Electrical Equipment – Part 1-2: General
Requirements for Basic Safety and Essential Performance – Collateral Standard:
Electromagnetic Compatibility – Requirements and Tests
• IEC 60601-1-2 (2001), Medical Electrical Equipment, Part 1-2: General Requirements for
Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
• IEC 60601-1-6 (2010) 3rd Edition Medical Electrical Equipment – Part 1-6: General
Requirements for Safety – Collateral Standard: Usability
• IEC 60601-1-6 (2004) Medical Electrical Equipment – Part 1-6: General Requirements for
Safety – Collateral Standard: Usability
• IEC 60601-1-8 (2006) 2nd Edition Medical Electrical Equipment – Part 1-8: General
Requirements for Basic Safety and Essential Performance – General Requirements, Tests
and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical
Systems
• IEC 60601-1-8 (2003) Medical Electrical Equipment – Part 1-8: General Requirements
for Safety – Collateral Standard: General Requirements, Tests and Guidance for Alarm
Systems in Medical Electrical Equipment and Medical Electrical Systems
Instructions for Use & Clinical Reference Manual (US)
