Voluntary Standards; Statutory And Regulatory Classification - Integra CUSA Clarity Operator's Manual

Voluantary Standards

Voluntary Standards

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The CUSA Clarity system meets the following standards:
• IEC 60601-1:2005 +CORR. 1:2006 + CORR.2:2007 + AM1:2012
Medical Electrical Equipment Part 1: General Requirements for Basic
Safety and Essential Performance, Third Edition Amendment 1
• ANSI/AAMI ES60601-1:2012 Medical Electrical Equipment Part 1:
General Requirements for Basic Safety and Essential Performance
• CSA C22.2 No. 60601-1:2012 Medical Electrical Equipment Part 1:
General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-6:2010+AMD1:2013 Medical Electrical Equipment - Part
1-6: General requirements for basic safety and essential performance
- Collateral Standard: Usability
• IEC 60601-1-8:2006+AMD1:2012 Collateral Standard - General
requirements for alarm systems in Medical Electrical Equipment
• EN 60601-1-2:2007 and IEC 60601-2:2007 (3
Standard Electromagnetic Compatibility Medical Electrical Equipment
• IEC 60601-1-2:2014 (4
Electromagnetic Compatibility Medical Electrical Equipment

Statutory and Regulatory Classification

• Class II (FDA) Medical Device (General Controls and Special
Controls)
• Class IIb (EU)
• Class III (EU)
• Class 4 (Canada)
EMC Information
NOTE
The CUSA Clarity system should not be used adjacent to or stacked with
equipment other than the equipment specified in the CUSA Clarity
Ultrasonic Surgical Aspirator System Operator's Manual. If adjacent or
stacked use is necessary, the CUSA Clarity system should be observed
to verify normal operation in the configuration in which it will be used.
The use of accessories, other than the accessories specified in this
manual, may result in increased emissions or decreased immunity of the
CUSA Clarity system.
CUSA
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Clarity Ultrasonic Surgical Aspirator System Operator's Manual
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