UNE-EN ISO 18113-4:2025
Current
The latest, up-to-date edition.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022)
Hardcopy , PDF
Spanish, Castilian, English
22-01-2025
This document specifies requirements for information supplied by the manufacturer of IVD reagents,calibrators, and controls intended for self-testing.This document can also be applied to accessories.This document applies to the labels for outer and immediate containers and to the instructions for use.This document does not apply to:a) IVD instruments or equipment;b) IVD reagents for professional use.
| Committee |
CTN 129
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 18113-4:2022 | Identical |
| EN ISO 18113-4:2024 | Identical |
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