ISO 16061: Instruments for use in association with non-active surgical implants — General requirements
DIN EN ISO 16061: Instrumente, die in Verbindung mit nichtaktiven chirurgischen Implantaten verwendet werden – Allgemeine Anforderungen
This standard addresses the general requirements for non-active surgical instruments. For special requirements for groups of instruments or individual instruments, reference is made to so-called level 2 and level 3 standards. Design attributes and materials are listed to serve as a basis for risk analysis.
EndoLab will support you in the pre-clinical evaluation. We have a large number of test protocols to prove the durable function of your instrument in clinical practice.
