Slide background




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

ID 11308 | | Visite: 5751 | 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

ISO 16733 1 2024   FSE   Selection of design fire scenarios
Ott 30, 2024 112

ISO 16733-1:2024

ISO 16733-1:2024 / FSE Fire Safety Engineering - Selection of design fire scenarios (Edition 2, 2024) ID 22830 | 30.10.2024 / Preview attached ISO 16733-1:2024Fire safety engineering - Selection of design fire scenarios and design firesPart 1: Selection of design fire scenarios Publication… Leggi tutto
UNI EN 14717 2024   Lista di controllo aspetti ambientali processi di saldatura
Ott 17, 2024 106

UNI EN 14717:2024

UNI EN 14717:2024 / Lista di controllo aspetti ambientali processi di saldatura ID 22750 | 17.10.2024 / Preview allegata Saldatura e processi correlati - Lista di controllo per gli aspetti ambientali_______ La norma fornisce un elenco per la verifica degli aspetti ambientali nella fabbricazione… Leggi tutto
Ott 17, 2024 269

UNI ISO 15176:2024

UNI ISO 15176:2024 / Guida caratterizzazione suolo da escavazione ID 22747 | 17.10.2024 UNI ISO 15176:2024 - Guida sulla caratterizzazione del suolo da escavazione ed altri materiali destinati al riuso Data disponibilità: 16 ottobre 2024 La norma fornisce le linee guida sulla tipologia dei test… Leggi tutto

Più letti Normazione