NA 176
DIN Standards Committee Health Technologies
DIN EN ISO 18113-2 [Pre-order] references following documents:
| Document number | Edition | Title |
|---|---|---|
| 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 |
| ISO 8601-1 | 2019-02 | Date and time - Representations for information interchange - Part 1: Basic rules 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 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 |
| DIN EN ISO 17511 | 2021-11 | In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020); German version EN ISO 17511:2021 More |
| DIN EN ISO 18113-3 | 2024-10 | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022); German version EN ISO 18113-3:2024 More |
| DIN EN ISO 18153 | 2003-11 | In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003); German version EN ISO 18153:2003 More |
| DIN ISO 8601-1 | 2020-12 | Date and time - Representations for information interchange - Part 1: Basic rules (ISO 8601-1:2019) More |
