STN EN ISO 10993-15
| Označenie: | STN EN ISO 10993-15 |
| Platnosť: | Platná |
| Počet strán: | 32 |
| Jazyk: |
EN
|
| Listinná verzia: | 17,20€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
15,48€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 17,20€ c) S možnosťou tlače, prenosu textu a obrázkov: 22,36€ |
| Slovenský názov: | Biologické hodnotenie zdravotníckych pomôcok. Časť 15: Identifikácia a kvantifikácia degradačných produktov z kovov a zliatin (ISO 10993-15: 2019) |
| Anglický názov: | Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019) |
| Dátum vydania: | 01. 08. 2023 |
| Dátum zrušenia: | |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 6510 |
| Úroveň zapracovania: | idt EN ISO 10993-15:2023, idt ISO 10993-15:2019 |
| Vestník: | 07/23 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 10993-15:2009-11 (85 6510) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies general requirements for the design of tests for identifying and quantifying degradation products from final metallic medical devices or corresponding material samples finished as ready for clinical use. This document is applicable only to those degradation products generated by chemical alteration of the final metallic device in an in vitro degradation test. Because of the nature of in vitro tests, the test results approximate the in vivo behaviour of the implant or material. The described chemical methodologies are a means to generate degradation products for further assessments. This document is applicable to both materials designed to degrade in the body as well as materials that are not intended to degrade. |
| Náhľad normy: | Náhľad normy (PDF) |