Hoffrichter point 2 - Compliance with Standards

96 Annex
Compliance with standards
The device satisfies the following standards:
• DIN EN ISO17510-1:2009-07
Sleep apnea respiratory therapy - Part 1: Sleep apnoea respiratory therapy devices
(ISO 17510-1:2007); German version EN ISO 17510-1:2009
• DIN EN 60601-1:2013-12
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005 + Cor. :2006 + Cor. :2007 + A1:2012);
German version EN 60601-1:2006 + Cor. :2010 + A1:2013
• EN 60601-1-2:2007
Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests (IEC 60601-1-2:2007, modified)