DIN EN 62304:2016
Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015

Standard No.

DIN EN 62304:2016

Release Date

2016

Published By

German Institute for Standardization

Latest

DIN EN 62304:2016

Replace

DIN EN 62304:2007 DIN EN 62304:2013 DIN EN 62304 Berichtigung 1:2009

DIN EN 62304:2016 Referenced Document

• DIN EN 60601-1-4:2001 Medical electrical equipment - Part 1-4: General requirements for safety; Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:1996 + A1:1999); German version EN 60601-1-4:1996 + A1:1999
• DIN EN 60601-1-6:2016 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010 + A1:2013); German version EN 60601-1-6:2010 + A1:2015
• DIN EN 60601-1:2013 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
• DIN EN 61010-1:2011 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General requirements (IEC 61010-1:2010 + Cor. :2011); German version EN 61010-1:2010
• DIN EN 61508-5:2011 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (IEC 61508-5:2010); German version EN 61508-5:2010
• DIN EN ISO 12100:2011 Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010); German version EN ISO 12100:2010
• IEC 61508 Functional Safety of Electrical/Electronic/programmable Electronic Safety - Related Systems Set *** Contains IEC 61508-1 Through IEC 61508-7*** (Edition 2.0; ***NOT AVAILABLE FOR CUSTOM COLLECTIONS AT THIS TIME*** All Retail Customer Must Purchase the DVD

DIN EN 62304:2016 history

• 2016 DIN EN 62304:2016 Medical device software - Software life-cycle processes (IEC 62304:2006 + A1:2015); German version EN 62304:2006 + Cor.:2008 + A1:2015
• 2007 DIN EN 62304:2007 Medical device software - Software life-cycle processes (IEC 62304:2006); German version EN 62304:2006
• 0000 DIN EN 62304:2005