NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 18113-1 [New] references following documents:

Document number Edition Title
DIN ISO 5725-5 2002-11 Accuracy (trueness and precision) of measurement methods and results - Part 5: Alternative methods for the determination of the precision of a standard measurement method (ISO 5725-5:1998) More 
EN 13612 2002-03 Performance evaluation of in vitro diagnostic medical devices More 
EUV 2017/746 2017-04-05 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU More 
IEC 60050-300 2001-07 International Electrotechnical Vocabulary - Electrical and electronic measurements and measuring instruments - Part 311: General terms relating to measurements; Part 312: General terms relating to electrical measurements; Part 313: Types of electrical measuring instruments; Part 314: Specific terms according to the type of instrument More 
IEC 60359 2001-12 Electrical and electronic measurement equipment - Expression of performance More 
IEC 62366-1 AMD 1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices; Amendment 1 More 
IEC 80416-1 2008-11 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration More 
ISO 10241-2 2012-08 Terminological entries in standards - Part 2: Adoption of standardized terminological entries More 
ISO 15190 2020-02 Medical laboratories - Requirements for safety More 
ISO 15193 2009-05 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures More