DIN EN 62366-1:2017
Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015

Standard No.

DIN EN 62366-1:2017

Release Date

2017

Published By

German Institute for Standardization

Status

Be replaced 2021-08

Replace By

DIN EN 62366-1:2021

Latest

DIN EN 62366-1:2021

DIN EN 62366-1:2017

Replace

DIN EN 62366:2016 DIN EN 62366-1:2014

DIN EN 62366-1:2017 Referenced Document

• DIN EN 1041:2013 Information supplied by the manufacturer of medical devices; German version EN 1041:2008+A1:2013
• DIN EN 60601-1-11:2016 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 6060
• 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 60601-1-8:2014 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (IEC
• 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 ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016
• DIN EN ISO 14971:2013 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012
• DIN EN ISO 7010:2012 Graphical symbols - Safety colours and safety signs - Registered safety signs (ISO 7010:2011); German version EN ISO 7010:2012
• DIN EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015
• DIN EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015
• DIN EN ISO 9241-11:1999 Ergonomic requirements for office work with visual display terminals (VDTs) - Part 11: Guidance on usability (ISO 9241-11:1998); German version EN ISO 9241-11:1998

DIN EN 62366-1:2017 history

• 2021 DIN EN 62366-1:2021 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020
• 0000 DIN EN 62366-1/A1:2019
• 2017 DIN EN 62366-1:2017 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016); German version EN 62366-1:2015 + AC:2015
• 2016 DIN EN 62366:2016 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007 + A1:2014); German version EN 62366:2008 + A1:2015
• 0000 DIN EN 62366-1:2014
• 0000 DIN EN 62366/A1:2012
• 2008 DIN EN 62366:2008 Medical devices - Application of usability engineering to medical devices (IEC 62366:2007); German version EN 62366:2008