NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18113-5 [New] references following documents:
| Document number | Edition | Title |
|---|---|---|
| DIN EN ISO 18113-1 | 2024-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022); German version EN ISO 18113-1:2024 More |
| DIN EN ISO 18113-4 | 2024-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022); German version EN ISO 18113-4:2024 More |
| DIN EN 61010-1 ; VDE 0411-1:2023-08 | 2023-08 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (IEC 66/769/CD:2022); Text in German and English More |
| DIN EN 62366-1 ; VDE 0750-241-1:2021-08 | 2021-08 | Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020 More |
| ISO 15197 | 2013-05 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus More |
| ISO 15198 | 2004-07 | Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer More |
| ISO 17593 | 2022-03 | Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy More |
| ISO 18113-4 | 2022-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing More |
| ISO/IEC 15415 | 2011-12 | Information technology - Automatic identification and data capture techniques - Bar code symbol print quality test specification - Two-dimensional symbols More |
