Kvalitet på medinsk utstyr benyttet i tannlegevirksomhet


Fra NIOMs nettsider

The quality of dental products has been under discussion for more than a century. The discussion has centered on determining which qualities are important and how they can be assured in the design and in the manufacturing process. The longevity and efficacy of dental restorative procedures is to a great extent related to the quality of the products used. The quality and use of medical devices has a direct impact on health issues and health economics.

The increasing focus on consumer protection related to the safety and efficacy of medical device has led to a more cautious attitude towards accepting new products at face value. The use of internationally accepted product standards has been very useful for developing safe products as well as for the international trade. International standards in dentistry (ISO/TC 106) promote quality ISO/TC 106, the International Organization for Standardization’s Technical Committee 106 Dentistry, has developed more than 140 standards in dentistry during the last 52 years. The development of requirements and specifications is based on scientific data obtained during the year. The final work is performed at the annual meetings of the 8 subcommittees:

  • Subcommittee 1 (SC 1) Filling and restorative materials
  • SC 2 Prosthodontic materials
  • SC 3 Terminology
  • SC 4 Dental instruments
  • SC 6 Dental equipment
  • SC 7 Oral care products
  • SC 8 Dental implants
  • SC 9 Dental CAD-CAM systems