STN EN ISO 18113-4
| Name: | STN EN ISO 18113-4 |
| Validity: | Valid |
| Number of pages: | 28 |
| 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 4: Diagnostické činidlá in vitro na samotestovanie (ISO 18113-4: 2022) |
| English title | In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2022) |
| Release Date: | 01. 09. 2024 |
| Date of withdrawal: | |
| ICS: | 11.100.10 |
| Sorting character/National clasification code | 85 1001 |
| Level of incorporation: | idt ISO 18113-4:2022, idt EN ISO 18113-4:2024 |
| Official Journal | 08/24 |
| Amendments | |
| Replaced by: | |
| Repleces: | STN EN ISO 18113-4:2012-02 (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) reagents, calibrators, and controls intended for self-testing. This document can also be applicable to accessories. This document is applicable 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 professional use. |
| Preview: | Náhľad normy (PDF) |