STN EN ISO 18113-5
| Name: | STN EN ISO 18113-5 |
| Validity: | Valid |
| Number of pages: | 24 |
| Language: |
EN
|
| Paper: | 14,10€ |
| Electronic version |
a) Only read (without ability to print and copy)
12,69€ b) Without ability to print, with ability to copy (printscreen) 14,10€ c) With ability to print and copy (printscreen) 18,33€ |
| Slovak title | Diagnostické zdravotnícke pomôcky in vitro. Informácie dodávané výrobcom (označovanie). Časť 5: Diagnostické prístroje in vitro na samotestovanie (ISO 18113-5: 2022) |
| English title | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2022) |
| Release Date: | 01. 09. 2024 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1001 |
| Level of incorporation: | idt ISO 18113-5:2022, idt EN ISO 18113-5:2024 |
| Official Journal | 08/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 18113-5:2012-02 (85 1001) |
| Note in Official Journal: | |
| Subject of the standard: | 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. |
| Preview: | Náhľad normy (PDF) |