UNE-EN ISO 18113-5:2025
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022)
Hardcopy , PDF
Spanish, Castilian, English
22-01-2025
This document specifies requirements for information supplied by the manufacturer of IVD instrumentsintended for self-testing.This document also applies to apparatus and equipment intended to be used with in vitro diagnostic(IVD) instruments for self-testing.This document can also be applied to accessories.This document does not apply toa) instructions for instrument servicing or repair;b) IVD reagents, including calibrators and control materials for use in control of the reagent;c) IVD instruments for professional use.
| Committee |
CTN 129
|
| DocumentType |
Standard
|
| Pages |
23
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 18113-5:2024 | Identical |
| ISO 18113-5:2022 | Identical |
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