Instruments for use in association with non-active surgical implants. General requirements
This document specifies the 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 supplied after refurbishment.
NOTE: In this document, unless otherwise specified, the term βinstrumentβ 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:
This document is not applicable to instruments associated with dental implants, transendodontic and transradicular implants, and ophthalmic implants.
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