NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 15189 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 15190 | 2020-02 | Medical laboratories - Requirements for safety 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 17034 | 2016-11 | General requirements for the competence of reference material producers 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 18113-1 | 2022-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements More |
| ISO 19011 | 2018-07 | Guidelines for auditing management systems More |
| ISO 20166-1 | 2018-12 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA More |
| ISO 20166-2 | 2018-12 | Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 2: Isolated proteins More |
| ISO 20166-3 | 2018-12 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA More |
