Endorsement of ISO Standards

ADOPTED by FDI General Assembly September, 2004 in New Delhi, India
REVISED by FDI General Assembly September, 2025 in Shanghai, People's Republic of China

Context

Standards, specifications or guidelines aim to provide high quality and reliable results. They define certain methods or procedures, usually along relevant definitions and criteria1. International standards relevant to dental practices have been developed since the 1960s by ISO (International Organization for Standardization), an independent, non-governmental international organization with close to 175 members (national standards bodies). ISO standards support global trade, promote inclusive and equitable economic growth, encourage innovation, and promote health and safety to achieve a sustainable future2. Standards and related documents are developed by over 300 ISO Technical Committees (TC), each representing a specific area of ​​activity.

“ISO/TC 106 (Dentistry)” develops oral healthcare standards to include terms and definitions; performance, safety and specification requirements for dental products; and clinically relevant laboratory test methods. This contributes to improved global oral health3  by determining the quality level of dental devices primarily, but not exclusively, relative to safety and performance and therefore can be a basis for high-quality care in dental practices. 

Scope

ISO standards provide a basis to certify and harmonize products which help oral health professionals achieve high quality treatment and thus improve oral health worldwide1,3. This policy statement provides support for the development and use of ISO documents that fall within the scope of ISO/TC 106. 

Definitions

ISO Standards: international documents created by experts “as a formula that describes the best way of doing something”. This includes managing processes, delivering a service or supplying materials, products and devices4.

Principles

FDI and ISO/TC 106 (Dentistry) share the same mission and values focused on improving oral health worldwide and creating norms and standards for dentistry in order to provide guidelines for delivering optimal oral health. ISO standards provide tools that complement and aid the FDI World Dental Federation (FDI) mission. Therefore, a strong relationship between the FDI and ISO/TC 106 is highly beneficial for achieving organizational goals5.

Policy

FDI will support collaboration with ISO/TC 106 and appropriate use of ISO standards especially highlighting the following points:

  • FDI will include and reference ISO standards in the development of oral healthcare guidance documents, whenever appropriate.
  • FDI will encourage National Dental Associations to use appropriate ISO standards in creating national policy relative to the pursuit of optimal oral healthcare delivered in a sustainable manner.
  • FDI will actively pursue educational opportunities for member organizations and oral healthcare providers that emphasize the importance of standards, specifications and guidelines.

Keywords

ISO Standards, oral healthcare, guidelines, quality.

Disclaimer

The information in this Policy Statement was based on the best scientific evidence available at the time. It may be interpreted to reflect prevailing cultural sensitivities and socio-economic constraints. 

References

  1. Schmalz G, Jakubovics N, Schwendicke F. Normative Approaches for Oral Health: Standards, Specifications, and Guidelines. J Dent Res. 2022 May;101(5):489-494.
  2. International Standards Organization (ISO). About ISO Strategy 2030. Geneva (Switzerland): ISO Central Secretariat. Available from: https://www.iso.org/strategy2030.html#mission [Accessed 6 October 2025]
  3. International Standards Organization (ISO). ISO TC 106 Dentistry. Geneva (Switzerland): ISO Central Secretariat. Available from: https://www.iso.org/committee/51218.html [Accessed 6 October 2025].
  4. International Standards Organization (ISO). Standards. Geneva (Switzerland): ISO Central Secretariat. Available from: https://www.iso.org/standards.html [Accessed 6 October 2025].
  5. FDI World Dental Federation. Strategic Plan. Available from: https://www.fdiworlddental.org/sites/default/files/2024-01/FDI-Strategic-Plan_2024-2027_Final.pdf [Accessed 6 October 2025].

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