Slide background




ISO 14155:2020 | Clinical investigation of medical devices for human subjects

ID 11308 | | Visite: 5418 | News NormazionePermalink: https://www.certifico.com/id/11308

14155

ISO 14155:2020 | Clinical investigation of medical devices for human subjects

ISO 14155:2020 Clinical investigation of medical devices for human subjects - Good clinical practice

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.

NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.

NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.

This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

_____

In allegato Preview Riservata Abbonati

...

Fonte: ISO

Collegati:

Descrizione Livello Dimensione Downloads
Allegato riservato Preview ISO 14155 2020 .pdf
 
527 kB 7

Tags: Normazione Abbonati Normazione

Articoli correlati

Ultimi archiviati Normazione

UNI EN ISO 56000 2021 Gestione innovazione
Lug 06, 2024 146

UNI EN ISO 56000:2021

UNI EN ISO 56000:2021 / Gestione dell'innovazione ID 22197 | 06.07.2024 / Preview allegata UNI EN ISO 56000:2021Gestione dell'innovazione - Fondamenti e vocabolario Data disponibilità: 18 febbraio 2021 La norma, parte della serie ISO 56000, fornisce il vocabolario, i concetti fondamentali ed i… Leggi tutto
Giu 17, 2024 249

CEI EN 50110-2:2024

CEI EN 50110-2:2024 / Allegati nazionali esercizio impianti elettrici ID 22078 | 17.06.2024 / Preview allegata CEI EN 50110-2:2024Esercizio degli impianti elettrici - Parte 2: Allegati nazionali Classificazione CEI: 11-49Pubblicazione: 05.2024_______ La presente Parte 2 della Norma CEI EN 50110 è… Leggi tutto
Giu 17, 2024 350

CEI EN 50110-1:2024

CEI EN 50110-1:2024 / Prescrizioni generali esercizio impianti elettrici ID 22077 | 17.06.2024 / Preview allegata CEI EN 50110-1:2024Esercizio degli impianti elettrici - Parte 1: Prescrizioni generali Classificazione CEI: 11-48Pubblicazione: 05.2024_______ La Norma CEI EN 50110-1 si applica a tutte… Leggi tutto
Giu 15, 2024 267

UNI EN ISO 7730:2006

UNI EN ISO 7730:2006 / Benessere termico con il calcolo degli indici PMV e PPD ID 22068 | 15.06.2024 / Preview in allegato Ergonomia degli ambienti termici - Determinazione analitica e interpretazione del benessere termico mediante il calcolo degli indici PMV e PPD e dei criteri di benessere… Leggi tutto

Più letti Normazione