STN EN ISO 18113-3
| Name: | STN EN ISO 18113-3 |
| 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 3: Diagnostické prístroje in vitro na profesionálne používanie (ISO 18113-3: 2022) |
| English title | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022) |
| Release Date: | 01. 09. 2024 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1001 |
| Level of incorporation: | idt ISO 18113-3:2022, idt EN ISO 18113-3:2024 |
| Official Journal | 08/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 18113-3:2012-02 (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 professional use. This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use. 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 self-testing. |
| Preview: | Náhľad normy (PDF) |