Präklinische Prüfungen chirurgischer Bohrer

Abstract

This Master's thesis describes the preclinical evaluation of surgical drills, which is divided into three categories: the validation of the reprocessing instructions and the con rmation of biocompatibility and usability. The basic regulatory requirements can be found in the Regulation (EU) 2017/745 (Medical Device Regulation, MDR). For more detailed information on the test procedure and the acceptance criteria within which the results must lie, further regulations and applicable standards are consulted. The validation of the reprocessing instruction is carried out by testing the e ectiveness of the parameters for cleaning, disinfection, sterilisation and drying specied in this instruction by an accredited laboratory. The biological risk posed by the products must be assessed by means of a cytotoxicity test, detection of endotoxin residues and determination of chemical information on the material. In the case of the surgical drills, the results of the cleaning validation of the contract manufacturer of the products are included. The formative and summative evaluations for usability testing are designed to con rm that the products meet the users' expectations as well as their intended purpose in the clinical environment. The surgical drills are assessed as safe and e ective after completion of all preclinical tests.

Date of Award	Jun 2024
Original language	German (Austria)
Awarding Institution	FH Gesundheitsberufe OÖ GmbH
Supervisor	Andreas Schrempf (Supervisor)