STN EN ISO 10993-4/Zmena A1
| Označenie: | STN EN ISO 10993-4/Zmena A1 |
| Platnosť: | Platná |
| Počet strán: | 20 |
| Jazyk: |
EN
|
| Listinná verzia: | 14,10€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
12,69€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 14,10€ c) S možnosťou tlače, prenosu textu a obrázkov: 18,33€ |
| Slovenský názov: | Biologické hodnotenie zdravotníckych pomôcok. Časť 4: Výber skúšok na interakcie s krvou (ISO 10993-4: 2017/Amd 1: 2025, opravená verzia 2025-04) |
| Anglický názov: | Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017) |
| Dátum vydania: | 01. 06. 2025 |
| Dátum zrušenia: | |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 6513 |
| Úroveň zapracovania: | idt EN ISO 10993-4:2017/A1:2025, idt ISO 10993-4:2017/Amd 1 Corrected version:2025 |
| Vestník: | 05/25 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | |
| Poznámka vo Vestníku: | |
| Predmet normy: | ISO 10993-4:2017 specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device. The changes in this document do not indicate that testing conducted according to prior versions of this document is invalid. For marketed devices with a history |
| Náhľad normy: | Náhľad normy (PDF) |