NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18113-5 [Pre-order] references following documents:
| Document number | Edition | Title |
|---|---|---|
| IEC 61010-1 | 2010-06 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements More |
| IEC 61010-2-101 | 2018-10 | Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment More |
| IEC 61326-2-6 | 2020-10 | Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment More |
| IEC 62366-1 | 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices 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 |
| ISO 18113-1 | 2022-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements 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 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 |
| DIN EN ISO 15223-1 | 2022-02 | Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021); German version EN ISO 15223-1:2021, with CD-ROM More |
