This document specifies the general requirements for instruments to be used in association with nonactive
surgical implants. These requirements apply to instruments when they are manufactured and
when they are supplied after refurbishment.
NOTE In this document, unless otherwise specified, the term “instrument” refers to an instrument for use in
association with non-active surgical implants.
This document also applies to instruments which can be connected to power-driven systems, but it
does not apply to the power-driven systems themselves.
With regard to safety, this document gives the requirements for intended performance, design
attributes, materials, design evaluation, manufacture, sterilization, packaging, and information
supplied by the instrument manufacturer, hereafter referred to as the manufacturer.
This document is not applicable to instruments associated with dental implants, transendodontic and
transradicular implants and ophthalmic implants.