UNE-EN ISO 18113-3:2025
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
Hardcopy , PDF
Spanish, Castilian, English
22-01-2025
This document specifies requirements for information supplied by the manufacturer of IVD instrumentsintended for professional use.This document also applies to apparatus and equipment intended to be used with IVD instruments forprofessional use.This document can also be applied to accessories.This document does not apply to:a) 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 self-testing.
| Committee |
CTN 129
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 18113-3:2022 | Identical |
| EN ISO 18113-3:2024 | Identical |
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