Acteon XMIND DC - Standards and Directives

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INSTALLATION & MAINTENANCE MANUAL • XMIND DC • W1100100 • V1 • (15) • 12/2015 • NXDCEN020B
ANNEX 3
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES
“Xmind®dc”: X-ray equipment for dental intraoral radiography, is in compliance with the following:
• In compliance with the classication indicated in the Medical Device Directive 93/42/EEC, Annex IX, article 10:
“Active devices intended to emit ionizing radiation and intended for diagnostic radiology”, the system is classied
as:
CLASS IIb
• CEI EN 60601-1-2: 2007, 3rd edition
• CEI EN 60601-1: 2007, 3rd edition
• CEI EN 60601-1-3: 2009
• CEI EN 60601-1-6: 2011
• IEC 60601-2-65: 2012
• ANSI/AAMI ES60601-1: 2005
• CAN/CSA-C222.2 N. 60601-1: 08
Certications
A3A3