NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18113-1 [Withdrawn] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 18153 | 2003-11 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003 More |
| EN 13612 | 2002-03 | Performance evaluation of in vitro diagnostic medical devices 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 60601-1-6 | 2010-01 | Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Usability 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 |
| ISO 15194 | 2009-05 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation More |
| ISO 15198 | 2004-07 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer 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 3534-1 | 2006-10 | Statistics - Vocabulary and symbols - Part 1: General statistical terms and terms used in probability More |
