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Normas DIN – AENOR
DIN EN ISO 14155:2018-08

DIN EN ISO 14155:2018-08

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2018); German and English version prEN ISO 14155:2018 / Note: Date of issue 2018-06-29

Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques (ISO/DIS 14155:2018); Version allemande et anglaise prEN ISO 14155:2018 / Attention: Date de parution 2018-06-29

Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO/DIS 14155:2018); Deutsche und Englische Fassung prEN ISO 14155:2018 / Achtung: Erscheinungsdatum 2018-06-29

Fecha Anulación:
2020-12 /Withdrawn
Equivalencias internacionales:

ISO/DIS 14155 (2018-06)

prEN ISO 14155 (2018-06)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 14155:2020-12

Resumen:
This standard addresses the technical aspects of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes by defining good clinical practices for their design, conduct, recording and reporting of clinical investigations. It 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 investigation results, - assist sponsors, monitors, investigators, ethics committees, regulatory authorities and bodies involved in the conformity assessment of medical devices. This standard 14155 is not applicable to in vitro diagnostic medical devices.
Keywords:
CE marking, Clinical investigations, Clinical testing, Control charts, Definitions, Dental equipment, Dental instruments, Documentation, Efficiency, Enterprises, Ethics, Evaluations, Human body, Implants (surgical), Information, Inspectors, Law, Medical devices, Medical equipment, Medical products, Medical sciences, Medical technology, Monitoring, People, Performance testing, Reports, Results, Safety, Specification (approval), Surgical implants, Surgical instruments, Surveillance (approval), Systemology, Test persons, Testing, Trials, Utilization
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