Acteon x-mind ac - Annex 3; A3. List of International Standards and Directives

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OPERATOR’S MANUAL • X-Mind AC • (06) • 05/2018• NXACEN010F
ENGLISH ENGLISH
ANNEX 3
A3. LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES
“x-mind ac”: X-ray equipment for dental intraoral radiography, is in compliance with the following:
• MDD 93/42 EEC and subsequent amendments
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
• DHHS Radiation performance standards 21 CFR Subchapter J, Sec. 1020.30 and 1020.31
• 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