STN EN ISO 14971
| Označenie: | STN EN ISO 14971 |
| Platnosť: | Zrušená |
| Počet strán: | 50 |
| Jazyk: |
EN
|
| Listinná verzia: | 18,90€ |
| Elektronická verzia: |
a) Bez možnosti tlače, prenosu textu a obrázkov:
17,01€ b) Bez možnosti tlače, s prenosom textu a obrázkov: 18,90€ c) S možnosťou tlače, prenosu textu a obrázkov: 24,57€ |
| Slovenský názov: | Zdravotnícke pomôcky. Aplikácia manažérstva rizika pri zdravotníckych pomôckach (ISO 14971: 2019) |
| Anglický názov: | Medical devices - Application of risk management to medical devices (ISO 14971:2019) |
| Dátum vydania: | 01. 04. 2020 |
| Dátum zrušenia: | 01. 04. 2021 |
| ICS: | 11.040.01 |
| Triediaci znak: | 85 5231 |
| Úroveň zapracovania: | idt EN ISO 14971:2019, idt ISO 14971:2019 |
| Vestník: | 03/20 |
| Zmeny: | |
| Nahradzujúce normy: | STN EN ISO 14971:2021-04 (85 5231) |
| Nahradené normy: | STN EN ISO 14971:2013-02 (85 5231) |
| Poznámka vo Vestníku: | Norma rozpracovaná prekladom. |
| Predmet normy: | This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all phases of the life cycle of a medical device. The process described in this document applies to risks associated with a medical device, such as risks related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. |
| Náhľad normy: | Náhľad normy (PDF) |