Standardization and patient safety – ensuring that dental materials are safe and effective
Hilde M. Kopperud
Head of Laboratory dr. scient.
When considering patient safety, the quality and adequate function of a material or device is given by its mechanical strength, chemical stability and biocompatibility. 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.
Standardization ensures product quality.
It’s all 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. Within the EU, the so-called harmonized standards are linked to the
Medical Device Regulations, which specifies the requirements for attaining the CE-mark.
In practice, all technical components of a dental treatment are based on standards: the patient chair, the operation lamp, the rotating instruments, the sizes of burs, the restorative materials, the LED-lamp for curing, and the polishing tools. A practical example is the ease of attachment of a bur to a shaft due to standardization of the connections. Along with the ease of use by the dentist follows the fully secured attachment ensuring the safety of the patient during treatment.
Patient safety includes both biological and mechanical properties of dental materials.
Patient safety also includes biocompatibility. Methods for biological evaluations are covered by specific standards, e.g. ISO 7405 Evaluation of biocompatibility of medical devices used in dentistry. In addition, particular requirements are given in product standards. For instance, maximum fractions of hazardous elements, such as nickel and lead, are specified in the standard for metallic materials for fixed and removable restorations. Resistance of dental materials to fracture is also a matter of patient safety. ISO-standards for dental materials include requirements on the physical and mechanical properties of the material, especially their fracture strength.
NIOM participates in the technical committees ISO/TC 106 Dentistry and ISO/TC 194 Biological and clinical evaluation of medical devices. 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 standardization of products.
As a counterbalance, NIOM’s participation supports the interests and safety of the patients.
Digital techniques and modern materials introduce challenges and the need for new standards.
The Digital Workflow
The development of new materials and digitalized preparation introduce challenges and the need for new standards as well as for revisions of existing standards. While the requirements for material properties may remain unchanged (because the clinical situation is similar), methods for preparing materials for testing and measurement techniques may need to be changed as technology advances. NIOM will continue to be the voice of the patients in the preparation of new standards, working to set requirements from the perspective of patient safety.