Slide background




ISO 14155

ID 7642 | | Visite: 915 | Documenti ISOPermalink: https://www.certifico.com/id/7642

ISO 14155:2011

Clinical investigation of medical devices for human subjects -- Good clinical practice

ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in ISO 14155:2011 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

ISO 14155:2011 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 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.

ISO 14155:2011 does not apply to in vitro diagnostic medical devices.

Pin It


Tags: Normazione Norme ISO Abbonati Normazione

Articoli correlati

Ultimi archiviati Normazione

ISO 37123 2019
Feb 13, 2020 112

ISO 37123:2019

ISO 37123:2019 Sustainable cities and communities - Indicators for resilient cities This document defines and establishes definitions and methodologies for a set of indicators on resilience in cities. This document is applicable to any city, municipality or local government that undertakes to… Leggi tutto
Gen 29, 2020 274

Norme CEI: Status 2020

In attesa di prima pubblicazione Leggi tutto
Norme tecniche UNI  pubblicazioni mese
Gen 29, 2020 351

Norme tecniche UNI: Pubblicazioni mensili 2020

Norme tecniche UNI: pubblicazioni mensili 2020 Pubblicazioni mensili 2020 delle nuove norme tecniche da UNI. Allegati al presente articolo un elenco di tutte le novità di ogni mese. Gli elenchi intendono essere uno strumento di rapida consultazione dei titoli di nuove norme introdotte. 01 Gennaio… Leggi tutto
Gen 26, 2020 168

IEC TS 62998-1:2019

IEC TS 62998-1:2019 Safety of machinery - Safety-related sensors used for the protection of persons IEC TS 62998-1:2019 gives requirements for the development and integration of safety related sensors (SRS) and safety related sensor systems (SRSS) used for protection of persons with special… Leggi tutto
Radon 222
Gen 23, 2020 167

ISO 11665-8:2019

ISO 11665-8:2019 Measurement of radioactivity in the environment - Air: radon-222 - Part 8: Methodologies for initial and additional investigations in buildings This document specifies requirements for the determination of the activity concentration of radon in all types of buildings. The buildings… Leggi tutto

Più letti Normazione