NA 176

DIN Standards Committee Health Technologies

DIN CEN ISO/TS 7552-1 references following documents:

Document number Edition Title
DIN EN ISO 20186-2 2019-08 Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 2: Isolated genomic DNA (ISO 20186-2:2019); German version EN ISO 20186-2:2019 More 
DIN EN ISO 20186-3 2020-04 Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma (ISO 20186-3:2019); German version EN ISO 20186-3:2019 More 
DIN EN ISO 20387 2020-11 Biotechnology - Biobanking - General requirements for biobanking (ISO 20387:2018); German version EN ISO 20387:2020 More 
DIN EN ISO/IEC 17020 2025-03 Conformity assessment - Requirements for bodies performing inspection (ISO/IEC DIS 17020:2025); German and English version prEN ISO/IEC 17020:2025 More 
DIN EN ISO/IEC 17025 2018-03 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More 
DIN EN ISO/IEC 17043 2023-10 Conformity assessment - General requirements for the competence of proficiency testing providers (ISO/IEC 17043:2023); German and English version EN ISO/IEC 17043:2023 More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 14971 2019-12 Medical devices - Application of risk management to medical devices 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 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