STN EN ISO 10993-1
| Označenie: | STN EN ISO 10993-1 |
| Platnosť: | Platná |
| Počet strán: | 52 |
| Jazyk: |
EN
|
| Listinná verzia: | 21,40€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
19,26€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 21,40€ c) S možnosťou tlače, prenosu textu a obrázkov: 27,82€ |
| Slovenský názov: | Biologické hodnotenie zdravotníckych pomôcok. Časť 1: Hodnotenie a skúšanie v systéme manažérstva rizika (ISO 10993-1: 2018, vrátane opravenej verzie 2018-10) |
| Anglický názov: | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10) |
| Dátum vydania: | 01. 06. 2021 |
| Dátum zrušenia: | |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 6510 |
| Úroveň zapracovania: | idt EN ISO 10993-1:2020, idt ISO 10993-1 Corrected version 2018-10:2018 |
| Vestník: | 05/21 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 10993-1:2010-05 (85 6510) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). |
| Náhľad normy: | Náhľad normy (PDF) |