Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
This International Standard specifes 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 classifcation, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.
ΚΩΔΙΚΟΣ ΠΡΟΪΟΝΤΟΣ:
CYS EN ISO 13504:2012
This International Standard specifes 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 classifcation, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.
