NA 176
DIN Standards Committee Health Technologies
DIN CEN/TS 17747 references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 15190 | 2020-02 | Medical laboratories - Requirements for safety More |
| DIN EN ISO 17511 | 2021-11 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021 More |
| DIN EN ISO 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More |
| EN ISO 14971 | 2019-12 | Medical devices - Application of risk management to medical devices (ISO 14971:2019) More |
| EN 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 (ISO 20166-1:2018) More |
| EN ISO 20184-1 | 2018-12 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018) More |
| EN ISO 20387 | 2020-09 | Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018) More |
| EN ISO/IEC 17020 | 2012-03 | Conformity assessment - Requirements for the operation of various types of bodies performing inspection (ISO/IEC 17020:2012) More |
| EN ISO/IEC 17025 | 2017-12 | General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017) More |
| ISO Guide 30 | 2015-02 | Reference materials - Selected terms and definitions More |
