NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18113-1 [CURRENT] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices 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 15223-1 | 2021-07 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements More |
| DIN EN IEC 61010-2-101 ; VDE 0411-2-101:2023-12 | 2023-12 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Safety requirements for in vitro diagnostic (IVD) medical equipment (IEC 61010-2-101:2018, modified); German version EN IEC 61010-2-101:2022 + A11:2022 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 15193 | 2009-10 | In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009); German version EN ISO 15193:2009 More |
| DIN EN ISO 15197 | 2015-12 | In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013); German version EN ISO 15197:2015 More |
