STN EN ISO 10993-9
| Označenie: | STN EN ISO 10993-9 |
| Platnosť: | Platná |
| Počet strán: | 24 |
| 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 9: Osnova na identifikáciu a kvantifikáciu potenciálnych degradačných výrobkov (ISO 10993-9: 2019) |
| Anglický názov: | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
| Dátum vydania: | 01. 01. 2022 |
| Dátum zrušenia: | |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 6510 |
| Úroveň zapracovania: | idt EN ISO 10993-9:2021, idt ISO 10993-9:2019 |
| Vestník: | 12/21 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 10993-9:2010-05 (85 6510) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document provides general principles for the systematic evaluation of the potential and observed degradation of medical devices through the design and performance of in vitro degradation studies. Information obtained from these studies can be used in the biological evaluation described in the ISO 10993 series. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. This document is not applicable to: a) the evaluation of degradation which occurs by purely mechanical processes; methodologies for the production of this type of degradation product are described in specific product standards, where available; NOTE Purely mechanical degradation causes mostly particulate matter. Although this is excluded from the scope of this document, such degradation products can evoke a biological response and can undergo biological evaluation as described in other parts of ISO 10993. |
| Náhľad normy: | Náhľad normy (PDF) |