NIOM - Standardization Dentistry ISO TC 106

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ISO/TC 106 Dentistry

The standards developed within ISO/TC 106 are “product performance standards”. The main focus in the Medical Device Directive is on health and safety issues. There is a concern that the health and safety aspects are not sufficiently incorporated into product standards, and CEN has urged these standards to be improved in this respect. In dentistry standards, requirements for composition, packaging, marking and “instructions for use” do correspond to several of the Essential Requirements for health and safety, but there is still room for improvements.

Information for Manufacturers

Standardization
Importance
Dentistry
Biocompatibility