STN EN ISO 18113-1
| Name: | STN EN ISO 18113-1 |
| Validity: | Valid |
| Number of pages: | 68 |
| Language: |
EN
|
| Paper: | 24,40€ |
| Electronic version |
a) Only read (without ability to print and copy)
21,96€ b) Without ability to print, with ability to copy (printscreen) 24,40€ c) With ability to print and copy (printscreen) 31,72€ |
| Slovak title | Diagnostické zdravotnícke pomôcky in vitro. Informácie dodávané výrobcom (označovanie). Časť 1: Termíny, definície a všeobecné požiadavky (ISO 18113-1: 2022) |
| English title | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022) |
| Release Date: | 01. 09. 2024 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1001 |
| Level of incorporation: | idt ISO 18113-1:2022, idt EN ISO 18113-1:2024 |
| Official Journal | 08/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 18113-1:2012-02 (85 1001) |
| Note in Official Journal: | |
| Subject of the standard: | This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not address language requirements since that is the domain of national laws and regulations. This document does not apply to: a) IVD medical devices for performance evaluation (e.g. for investigational use only); b) shipping documents; c) material safety data sheets / Safety Data Sheets; d) marketing information (consistent with applicable legal requirements). |
| Preview: | Náhľad normy (PDF) |