When considering patient safety, the quality and adequate function of a material or device is given by its mechanical strength, chemical stability and biocompatibility. Acceptance and certification of dental biomaterials are often based on compliance with international standards. When a medical device conforms to the appropriate ISO-standard, the dentist will know that the material, instrument or equipment complies with essential requirements of quality and function. 

Standards allow for ease of trade, since the product or service is well described, so that the manufacturer and the consumer have a common understanding of its expected performance. NIOM sees the need for relevant methods and reasonable requirements and participates in European and international standardisation in CEN and ISO.

Some of our standardisation activities

NIOM participates as experts and conveners in several working groups the technical committees related to biomaterials. Our participation supports our vision: ensuring that dental materials are safe and effective. Many of the participants in the development of ISO-standards are manufacturers who may have commercial interests in the standardisation of products.

As a counterbalance, NIOM’s participation supports the interests and safety of the patients. Standards Norway is the national member body in the European and international standardisation organisations.

Standards Norway


Examples of standardisation activities

  • ISO/TC 106 Dentistry
  • ISO/TC 194 Biological and clinical evaluation of medical devices
  • Quality of medical devices used in dentistry
  • Inclusion of new materials and techniques in standards
  • Revision and modernisation of methods