Informazione tecnica HSE / 25 ° anno
/ Documenti disponibili:
44.814
/ Documenti scaricati: 32.849.410
/ Documenti scaricati: 32.849.410
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.
UNI EN 13525:2020 Macchine forestali - Sminuzzatrici mobili - Sicurezza
Recepisce: EN 13525:2020
Data entrata in vigore: 24 settembre 2020
La norma spe...
Pubblicata in IT: 05.11.2019
Tra gli apparecchi e gli organi di sollevamento certamente possiamo parlare di gru. È questo l’argomento della norma EN 1685...
Testata editoriale iscritta al n. 22/2024 del registro periodici della cancelleria del Tribunale di Perugia in data 19.11.2024