STN EN ISO 10993-2
| Označenie: | STN EN ISO 10993-2 |
| Platnosť: | Platná |
| Počet strán: | 28 |
| 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 2: Požiadavky na dobré podmienky pre zvieratá (ISO 10993-2: 2022) |
| Anglický názov: | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022) |
| Dátum vydania: | 01. 02. 2023 |
| Dátum zrušenia: | |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 6511 |
| Úroveň zapracovania: | idt EN ISO 10993-2:2022, idt ISO 10993-2:2022 |
| Vestník: | 01/23 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 10993-2:2006-12 (85 6511) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices. It is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves. This document makes recommendations and offers guidance intended to facilitate future further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests. |
| Náhľad normy: | Náhľad normy (PDF) |