DIN EN ISO 15225:2016
Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016

Standard No.

DIN EN ISO 15225:2016

Release Date

2016

Published By

German Institute for Standardization

Latest

DIN EN ISO 15225:2016

Replace

DIN EN ISO 15225:2010 DIN EN ISO 15225:2015

DIN EN ISO 15225:2016 Referenced Document

• DIN 66303:2000 Information technology - 8 bit code
• DIN EN 60601 Medical electrical equipment - Part 2-8: Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV (IEC 60601-2-8:2010 + A1:2015); German version EN 60601-2-8:2015 + A1:2016
• DIN EN 60601-1-1:2002 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems (IEC 60601-1-1:2000); German version EN 60601-1-1:2001
• DIN EN 60601-1-2:2016 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014); German version EN 60601-1-2:2015
• DIN EN 60601-1-3:2014 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (IEC 60601-1-3:2008 + A1:2013); German version EN 60601-1-3:2008 + Cor.:2010
• 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 60601-1-8:2014 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 60601-1-9:2014 Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design (IEC 60601-1-9:2007 + A1:2013); German version EN 60601-1-9:2008 + A1:2013
• 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 15225:2016 history

• 2016 DIN EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016); German version EN ISO 15225:2016
• 2010 DIN EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010); German version EN ISO 15225:2010
• 2005 DIN EN ISO 15225:2005 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000 + Amd 1:2004); German version EN ISO 15225:2000 + A1:2004 + A2:2005