EN ISO 18113-5:2024
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)
12-06-2024
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.This document can also be applicable 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 professional use.
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
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| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 18113-5:2024 | Identical |
| ÖNORM EN ISO 18113-5:2024 10 01 | Identical |
| SS-EN ISO 18113-5:2024 | Identical |
| DS/EN ISO 18113-5:2024 | Identical |
| SN EN ISO 18113-5:2024 | Identical |
| NF EN ISO 18113-5:2024 | Identical |
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