NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 20387 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| ISO Guide 30 | 2015-02 | Reference materials - Selected terms and definitions 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 |
| ISO 17034 | 2016-11 | General requirements for the competence of reference material producers More |
| ISO 17100 | 2015-05 | Translation services - Requirements for translation services 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 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 |
