NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18113-1 [New] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 15197 | 2013-05 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus More |
| ISO 15198 | 2004-07 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer More |
| ISO 17511 | 2020-04 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples 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 20417 | 2021-04 | Medical devices - Information to be supplied by the manufacturer More |
| ISO 23640 | 2011-12 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents More |
| ISO 3534-1 | 2006-10 | Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability More |
| ISO 3534-2 | 2006-09 | Statistics - Vocabulary and symbols - Part 2: Applied statistics More |
| ISO 5725-1 | 2023-07 | Accuracy (trueness and precision) of measurement methods and results - Part 1: General principles and definitions More |
| ISO 5725-2 | 2019-12 | Accuracy (trueness and precision) of measurement methods and results - Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method More |
