NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 22367 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 18113-1 2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 More 
DIN EN ISO 18113-2 2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011 More 
DIN EN ISO 18113-3 2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009); German version EN ISO 18113-3:2011 More 
DIN EN ISO 18113-4 2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011 More 
DIN EN ISO 18113-5 2013-01 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011 More 
DIN EN ISO 9000 2015-11 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More 
DIN EN 60812 2006-11 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) (IEC 60812:2006); German version EN 60812:2006 More 
DIN EN 61025 2007-08 Fault tree analysis (FTA) (IEC 61025:2006); German version EN 61025:2007 More 
IEC 60601-1 2005-12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More 
IEC 61025 2006-12 Fault tree analysis (FTA) More