DIN EN ISO 16061:2015-09

This standard specifies general requirements for instruments to be used in association with non-active surgical implants. These requirements apply to instruments when they are manufactured and when they are resupplied after refurbishment. This document also applies to instruments which may be connected to power-driven systems, but does not apply to the power-driven systems themselves. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, and information supplied by the manufacturer. This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants. The committee responsible for this standard is NA 027-02-17 AA "Chirurgische Implantate" ("Implants for surgery") at DIN.