M00001351
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ISO 13504 1st Edition, July 15, 2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
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Availability date: 07/13/2021
Description / Abstract:
This International Standard specifies general requirements for
the manufacture of instruments and related accessories used in the
placement of dental implants and further manipulations of
connecting parts in the craniofacial area.
It is applicable to single-use and reusable instruments,
regardless of whether they are manually driven or connected to a
power-driven system.
It is not applicable to the power-driven system itself, nor to
the dental implant or to parts intended to be connected to the
dental implant.
With regard to safety, this International Standard gives
requirements for classification, intended performance, performance
attributes, material selection, performance evaluation,
manufacture, sterilization and information to be supplied by the
manufacturer.