Historical
DIN EN ISO 14155:2012
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
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 medicaldevices.*The standard specifies the formal requirements for the performance of clinical investigation of medical devices. It serves particularly for the protection of study populations employed in the investigation. It shall also contribute to scientifically tenable investigation results. This standard is essentially different from the currently applicable standard in the following points. It includes the hitherto independent part 2 of the standard, which specifies the content of the investigation plan. The standard is based closely, as far as it makes sense, on the regulations on clinical investigation of medicinal products, in order to relieve the application for institutions which investigate both medicinal products and medical devices. The responsibility of the sponsors, the doctors (monitors) assigned by the sponsors and the clinical investigator are summarised in separate clauses. This relieves the fulfilment of each task and thereby contributes to correct performance and cost reduction. This standard is directed at manufacturers of medical devices and doctors as well as institutions which perform clinical investigation of medical devices. The European Standard has been prepared by ISO/TC 194 "Biological evaluation of medical devices" (secretariat: DIN) in collaboration with CEN/TC 258 "Clinical investigations of medical devices" (secretariat: DIN) with the essential contribution of German experts. At DIN, the responsible Working Committee is NA 027-02-20 AA "Klinische Prüfungen" ("Clinical investigations") of NAFuO.
Content Provider
Deutsches Institut für Normung [din]
