NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 20387 [CURRENT] 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 9000 | 2015-11 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More |
| DIN EN ISO 9001 | 2015-11 | Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More |
| DIN EN ISO/IEC 17000 | 2020-09 | Conformity assessment - Vocabulary and general principles (ISO/IEC 17000:2020); Trilingual version EN ISO/IEC 17000:2020 More |
| DIN EN ISO/IEC 17021-1 | 2015-11 | Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 1: Requirements (ISO/IEC 17021-1:2015); German and English version EN ISO/IEC 17021-1:2015 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 |
| EGV 765/2008 | 2008-07-09 | Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 More |
| ISO 13485 | 2016-03 | Medical devices - Quality management systems - Requirements for regulatory purposes More |
| ISO 15378 | 2017-09 | Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) More |
