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Normas DIN – AENOR
DIN EN ISO 14155:2012-01

DIN EN ISO 14155:2012-01

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2011 + Cor. 1:2011); German version EN ISO 14155:2011 + AC:2011 / Note: To be replaced by DIN EN ISO 14155 (2018-08).

Investigation clinique des dispositifs médicaux pour sujets humains - Bonnes pratiques cliniques (ISO 14155:2011 + Cor. 1:2011); Version allemande EN ISO 14155:2011 + AC:2011 / Attention: À remplacer par DIN EN ISO 14155 (2018-08).

Klinische Prüfung von Medizinprodukten an Menschen - Gute klinische Praxis (ISO 14155:2011 + Cor. 1:2011); Deutsche Fassung EN ISO 14155:2011 + AC:2011 / Achtung: Vorgesehener Ersatz durch DIN EN ISO 14155 (2018-08).

Fecha:
2012-01 /Active
Equivalencias internacionales:

EN ISO 14155 (2011-10)

EN ISO 14155/AC (2011-07)

ISO 14155 Technical Corrigendum 1 (2011-07)

ISO 14155 (2011-02)

Relación con otras normas DIN:
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, People, Performance testing, Reports, Results, Safety, Specification (approval), Surgical implants, Surgical instruments, Surveillance (approval), Systemology, Test persons, Testing, Trials, Utilization
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