NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 17511 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO/IEC 17025 2018-03 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More 
DIN ISO 5725-1 1997-11 Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions (ISO 5725-1:1994) 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 
ISO Guide 35 2017-08 Reference materials - Guidance for characterization and assessment of homogeneity and stability More 
ISO 15195 2018-12 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures More 
ISO 17034 2016-11 General requirements for the competence of reference material producers More 
ISO 18153 2003-08 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials More 
ISO 20391-1 2018-01 Biotechnology - Cell counting - Part 1: General guidance on cell counting methods More 
ISO 20395 2019-08 Biotechnology - Requirements for evaluating the performance of quantification methods for nucleic acid target sequences - qPCR and dPCR More