UNE-EN ISO 18113-2:2025
Current
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2022)
Hardcopy , PDF
Spanish, Castilian, English
01-22-2025
This document specifies requirements for information supplied by the manufacturer of IVD reagents,calibrators and controls intended for professional use.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 self-testing.
| Committee |
CTN 129
|
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 18113-2:2022 | Identical |
| EN ISO 18113-2:2024 | Identical |
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