STN EN ISO 14155
| Označenie: | STN EN ISO 14155 |
| Platnosť: | Zrušená |
| Počet strán: | 99 |
| Jazyk: |
EN
|
| Listinná verzia: | 31,80€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
28,62€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 31,80€ c) S možnosťou tlače, prenosu textu a obrázkov: 41,34€ |
| Slovenský názov: | Klinické skúšanie zdravotníckych pomôcok na humánne použitie. Správna klinická prax (ISO 14155: 2020) |
| Anglický názov: | Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020) |
| Dátum vydania: | 01. 11. 2020 |
| Dátum zrušenia: | 01. 02. 2022 |
| ICS: | 11.100.20 |
| Triediaci znak: | 85 4001 |
| Úroveň zapracovania: | idt EN ISO 14155:2020, idt ISO 14155:2020 |
| Vestník: | 10/20 |
| Zmeny: | |
| Nahradzujúce normy: | STN EN ISO 14155:2022-02 (85 4001) |
| Nahradené normy: | STN EN ISO 14155:2012-02 (85 4001) |
| Poznámka vo Vestníku: | |
| Predmet normy: | This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices. For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I). This document specifies general requirements intended to — protect the rights, safety and well-being of human subjects, — ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, — define the responsibilities of the sponsor and principal investigator, and — assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices. |
| Náhľad normy: | Náhľad normy (PDF) |