Integra CUSA NXT, Operator'S Manual

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Appendix A • Technical Specifications •
93
Standards and IEC Classifications
Quality Systems
The CUSA NXT System is manufactured by Integra LifeSciences
Corporation. Integra LifeSciences Corporation operates a quality system that
complies with ISO 13485, CMDCAS.
International Bodies
The CUSA NXT System has been designed, constructed, and approved to
the requirements of the following international bodies:
•
International Electrotechnical Commission (IEC)
•
Canadian Standards Association (CSA)
Safety Standards
The CUSA NXT System has been independently tested and complies with
the following standards:
•
CAN/CSA-C22.2 NO.60601-1-08 Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance
•
IEC 60601-1:2005 Medical Electrical Equipment: General Requirements
for Basic Safety and Essential Performance
•
IEC 60601-1-8:2006 Medical Electrical Equipment Part 1-8: General
Requirements for Basic Safety and Essential Performance. Collateral
Standard: General requirements, tests and guidance for alarm systems in
medical electrical equipment and medical electrical systems
•
IEC 60601-1-2:2007 Medical electrical equipment: General Requirements
for Basic Safety and Essential Performance. Collateral Standard:
Electromagnetic Compatibility - Requirements and Tests
Note that the Footswitch is additionally rated IPX8 for moisture resistance.