SPECIFICATIONS
48 Model 7600/7800 Operation Manual
Regulatory
Unit meets or exceeds the specifications for:
• ANSI/AAMI ES60601-1:2005
• ANSI/AAMI ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
• UL60601-1 1
st
edition
• IEC 60601-1 Edition 3.1 (2012)/EN 60601-1:2006 + A1:2013 + A12:2014
• IEC 60601-1 3
rd
edition
• IEC 60601-1 2
nd
edition
• IEC 60601-1-2 3
rd
edition
• IEC 60601-1-6:2010 (Third Edition) + A1:2013; IEC 62366:2007 (First Edition) + A1:2014
• IEC 60601-1-8:2006 (Second Edition) + Am.1:2012
• IEC 60601-2-27 (2011)
• IEC 62304:2006
• CAN/CSA C22.2 No. 601.1-M90:2005
• CDN MDR (CMDCAS)
• CAN/CSA-C22.2 No. 60601-1:2008
• CAN/CSA-C22.2 No. 60601-1:2014
• CAN/CSA-C22.2 No. 60601-1-2:2016
• MDD 93/42/EEC
• CE 0413
• ISO 13485:2003
• RoHS 2011/65/EU
• WEEE 2012/19/EU
• FDA/CGMP