Acteon X-MIND unity - List of International Standards and Directives

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Operator’s manual • X-Mind unity • VH • (15) • 09/2017 • NUN0EN010H
A.4 LIST OF INTERNATIONAL STANDARDS AND DIRECTIVES
The X-MIND unity: 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
• IEC 60601-1:1988, 2nd edition
• IEC 60601-1/A1
• IEC 60601-1/A2
• CSA C22.2#601.1-M90 and S1+A2
• UL 60601-1: 2003
• AS/NZS 3200.1.0
• IEC 60601-1-3:1994, 1st edition
• IEC 60601-1-4:1996, 1st edition
• IEC 60601-1-4/A1
• IEC 60601-2-7:1998, 2nd edition
• IEC 60601-2-28:1993, 1st edition
• IEC 60601-2-32:1994, 1st edition
• IEC 60601-1:2005, 3rd edition
• IEC 60601-1-3:2008,
• IEC 60601-1-6:2010.
• IEC 60601-2-65:2012
• ANSI/AAMI ES60601-1:2005
• CAN/CSA-C222.2 N. 60601-1:08
• IEC 60601-1-2:2007, 3rd edition
Certications
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ETL