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Standards Development
This document specifies polymers commonly used in manufacturing dental instruments. It is applicable to polymer materials used to manufacture either an entire instrument or a part of the instrument.
It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system.
This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of polymer materials. It contains a current selection of polymers suitable for use in the manufacture of dental instruments.
There is an increasing number of newly developed dental surgical techniques with an increasing number of procedures such as dental implant placements. The market for dental instruments is also rapidly growing with demands for new and better instruments.
This document is intended to harmonize the approval procedures and to reduce the costs caused by repeated approval and test procedures in different countries with regard to polymer materials used in dental instruments.
The proposal has been discussed in ISO/TC 106 meeting in Osaka followed by positive CIB voting for PWI stage.
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