Integra CUSA Clarity - Voluntary Standards Compliance; Regulatory Classification; EMC Information

CUSA
®
Clarity Ultrasonic Surgical Aspirator System Operator’s Manual
A-6
Voluantary Standards
NOTE
The CUSA Clarity system should not be used adjacent to or stacked with
equipment other than the equipment specied 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 conguration in which it will be used.
The use of accessories, other than the accessories specied in this
manual, may result in increased emissions or decreased immunity of the
CUSA Clarity system.
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
rd
edition) Collateral
Standard Electromagnetic Compatibility Medical Electrical Equipment
• IEC 60601-1-2:2014 (4
th
edition) Collateral Standard
Electromagnetic Compatibility Medical Electrical Equipment
Statutory and Regulatory Classication
• Class II (FDA) Medical Device (General Controls and Special
Controls)
• Class IIb (EU)
• Class III (EU)
• Class 4 (Canada)
EMC Information
Voluntary Standards