STN EN ISO 10993-1
| Označenie: | STN EN ISO 10993-1 |
| Platnosť: | Platná |
| Počet strán: | 64 |
| Jazyk: |
EN
|
| Listinná verzia: | 24,40€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
21,96€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 24,40€ c) S možnosťou tlače, prenosu textu a obrázkov: 31,72€ |
| Slovenský názov: | Biologické hodnotenie zdravotníckych pomôcok. Časť 1: Požiadavky a všeobecné princípy na hodnotenie biologickej bezpečnosti v rámci procesu manažérstva rizika (ISO 10993-1: 2025) |
| Anglický názov: | Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process (ISO 10993-1:2025) |
| Dátum vydania: | 01. 04. 2026 |
| Dátum zrušenia: | |
| ICS: | 11.100, 11.100.20 |
| Triediaci znak: | 85 6510 |
| Úroveň zapracovania: | idt EN ISO 10993-1:2025, idt ISO 10993-1:2025 |
| Vestník: | 03/26 |
| Zmeny: | |
| Nahradzujúce normy: | |
| Nahradené normy: | STN EN ISO 10993-1:2021-06 (85 6510) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document specifies the requirements and general principles governing the biological evaluation of medical devices within a risk management process according to ISO 14971. This document applies to the biological evaluation of medical devices that have direct contact or indirect contact with either: — a patient's body during intended use or reasonably foreseeable misuse; or — the body of other users who are not patients, if the medical device is intended for personal protection (e.g. medical gloves, surgical masks). Biological evaluation assesses the biological safety of the medical device by considering the biological risks associated with: — constituents of a medical device; and — tissue-device interactions (including physical effects). The biological evaluation specified in this document can address the biological safety of the medical device, considering the life cycle from design and development through initial use of the finished medical device to final decommissioning or ... |
| Náhľad normy: | Náhľad normy (PDF) |