STN EN ISO 10993-23/Zmena A1
| Name: | STN EN ISO 10993-23/Zmena A1 |
| Validity: | Valid |
| Number of pages: | 20 |
| 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 | Biologické hodnotenie zdravotníckych pomôcok. Časť 23: Skúšky dráždivosti. Zmena A1: Ďalšie rekonštruované modely ľudskej epidermy in vitro (ISO 10993-23: 2021/Amd 1: 2025) |
| English title | Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models (ISO 10993-23: 2021/Amd 1: 2025) |
| Release Date: | 01. 11. 2025 |
| Date of withdrawal: | |
| ICS: | 11.100.20 |
| Sorting character/National clasification code | 85 6510 |
| Level of incorporation: | idt EN ISO 10993-23:2021/A1:2025, idt ISO 10993-23:2021/Amd 1:2025 |
| Official Journal | 10/25 |
| Amendments | |
| Replaced by: | |
| Repleces: | |
| Note in Official Journal: | |
| Subject of the standard: | This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993-1 and ISO 10993-2. This document includes: — pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure; — details of in vitro and in vivo irritation test procedures; — key factors for the interpretation of the results. |
| Preview: | Náhľad normy (PDF) |