Slide background




ISO 14155

ID 7642 | | Visite: 824 | 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

Radon 222
Gen 23, 2020 26

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
Serie UNI TS 11291 12
Gen 14, 2020 87

Intercambiabilita’ Smart meter gas | Serie UNI/TS 11291-12

Intercambiabilita’ Smart meter gas: pubblicata la nuova serie UNI/TS 11291-12 È stata pubblicata a catalogo UNI la nuova serie UNI/TS 11291-12 Sistemi di misurazione del gas – Dispositivi di misurazione del gas su base oraria – Intercambiabilità contatori con portata ≤ 10 m3/h con comunicazione… Leggi tutto
Gen 08, 2020 115

ISO Update 2020

ISO Update 2020 International Standards in process List of CD (committee draft) registered; DIS (draft International Standard) circulated, FDIS (final draft International Standard) circulated and Standards published, confirmed and withdrawn for a given period.____View Safety of machinery ISO/TC 199 Leggi tutto
Dic 26, 2019 104

IEC 60300-3-4:2007

IEC 60300-3-4:2007 Edition 2.0 2007-09 Dependability management - Part 3-4: Application guide - Guide to the specification of dependability requirements Gives guidance on specifying required dependability characteristics in product and equipment specifications, together with specifications of… Leggi tutto
Rettifica decisione di esecuzione  2019 451
Dic 10, 2019 230

Rettifica decisione di esecuzione (UE) 2019/451

Rettifica decisione di esecuzione (UE) 2019/451 Rettifica della decisione di esecuzione (UE) 2019/451 della Commissione, del 19 marzo 2019, relativa alle norme armonizzate per i prodotti da costruzione elaborate a sostegno del regolamento (UE) n. 305/2011 del Parlamento europeo e del Consiglio GU L… Leggi tutto

Più letti Normazione