NA 176
DIN Standards Committee Health Technologies
DIN CEN ISO/TS 7552-1 references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO 15189 | 2022-12 | Medical laboratories - Requirements for quality and competence More |
| ISO 15190 | 2020-02 | Medical laboratories - Requirements for safety More |
| DIN CEN ISO/TS 7552-3 | 2025-03 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood - Part 3: Preparations for analytical CTC staining (ISO/TS 7552-3:2024); German version CEN ISO/TS 7552-3:2024 More |
| DIN EN ISO 13485 | 2021-12 | Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021 More |
| DIN EN ISO 14971 | 2022-04 | Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021 More |
| DIN EN ISO 15189 | 2024-08 | Medical laboratories - Requirements for quality and competence (ISO 15189:2022); German version EN ISO 15189:2022 + A11:2023 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 20166-3 | 2019-04 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue - Part 3: Isolated DNA (ISO 20166-3:2018); German version EN ISO 20166-3:2019 More |
| DIN EN ISO 20184-1 | 2019-06 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA (ISO 20184-1:2018); German version EN ISO 20184-1:2018 More |
| DIN EN ISO 20186-1 | 2019-08 | Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA (ISO 20186-1:2019); German version EN ISO 20186-1:2019 More |
