Testing of product quality

 

knekk800x600NIOM delivers high-quality, accurate and independent results using established methods. Our experienced staff will also set up test designs customized to your specifications and needs.

NIOM has 40 years’ experience in the field of dental biomaterials. Our interdisciplinary expertise also applies to medical biomaterials, such as cardiac and orthopedic implants and surgical instruments.

 

Accredited testing of product quality

NIOM is accredited for quality testing of dental materials and holds accreditation for a broad range of physical, mechanical and chemical test methods. NIOM maintains accreditation according to ISO 17025 General requirements for the competence of testing and calibration laboratories with the Norwegian Accreditation. This ensures independent, reliable and high-quality test results.

Independent testing according to an appropriate ISO standard is a means to determine compliance with statutory requirements. NIOM’s test reports are recognized by regulatory agencies worldwide and as evidence for compliance with the EU Medical Device Directive and US FDA regulatory requirements (“the least burdensome approach”).

 

Dynamic testing of dental materials

NIOM offers dynamic testing of dental materials and restorations. See the video “Tyggemaskina” (the chewing machine) where senior scientist John Tibballs demonstrates dynamic testing of dental restorations (text in Norwegian). The dynamic test machine is also applicable for fatigue testing of different materials.

 

Toxicological evaluation

Toxicological evaluation is undertaken by our Eurotox certified toxicologists.

 

Technical file preview

Our experienced scientists evaluate your documentation for compliance with the Medical Device Directive and assist in correcting any deficiencies prior to or during the CE marking process.

 

Testing of hand pieces and burs

NIOM has long experience in testing dental rotary instruments.

 

 

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Accredited and non-accredited (*) test methods performed according to ISO standards

ISO 3107:2011 Dentistry – Zinc oxide/eugenol and zinc oxide/non-eugenol cements *

7.2          Determination of setting time *
7.3          Determination of compressive strength *
7.4          Determination of film thickness *
7.5          Determination of acid-soluble arsenic fraction *

ISO 4049:2009 Dentistry – Polymer-based restorative materials

7.5         Measurement of film thickness of luting materials *
7.6         Working time, Class 1 and Class 3 restorative materials, excluding luting materials *
7.7         Working time, Class 1 and Class 3 luting materials *
7.8         Setting time, Class 1 and Class 3 materials *
7.9         Sensitivity to ambient light, Class 2 materials
7.10       Depth of cure, Class 2 materials
7.11       Flexural strength
7.12       Water sorption and solubility
7.13       Shade and colour stability after irradiation and water sorption
7.14       Radio-opacity *

ISO 4823:2015 Dentistry – Elastomeric impression materials *

9.2          Consistency *
9.3          Working-time *
9.4          Detail reproduction *
9.5          Linear dimensional change *
9.6          Compatibility with gypsum *
9.7          Elastic recovery *
9.8          Strain-in-compression *

ISO 6872:2015 Dentistry – Ceramic materials

7.2          Radioactivity of dental ceramics *
7.3.1       Three-point and four-point bending tests
7.3.2       Biaxial flexural strength (piston-on-three-ball test)
7.4          Linear thermal expansion coefficient
7.5          Glass transition temperature
7.6          Chemical solubility

ISO 6874:2015 Dentistry – Polymer-based pit and fissure sealants *

6.4          Working time, Class 1 sealant *
6.5          Setting time, Class 1 sealant *
6.6          Depth of cure, Class 2 sealant *

ISO 6876:2012 Dentistry – Root canal sealing materials *

5.2          Flow *
5.3          Working time *
5.4          Setting time *
5.5          Film thickness *
5.6          Solubility *
5.7          Radio-opacity *

ISO 9693-1:2012 Dentistry – Compatibility testing
Part 1: Metal-ceramic systems

6.1.1       Linear thermal expansion – Procedure for ceramic materials (Reference to ISO 6872:2008)
6.1.2       Linear thermal expansion – Procedure for metallic materials (Reference to ISO 22674:2006)
6.2          Glass transition temperature (Reference to ISO 6872:2008)
6.4          Metal-ceramic bond characterization (Schwickerath crack initiation test)

ISO 9693-2:2016 Dentistry – Compatibility testing
Part 2: Ceramic-ceramic systems

6.1          Linear thermal expansion (see ISO 6872: 2015, 7.4)
6.2          Glass transition temperature (see ISO 6872: 2015, 7.5)
6.3          De-bonding/crack-initiation test (zirconia-porcelain only) *
6.4          Thermal shock testing *

ISO 9917-1:2007 Dentistry – Water based cements
Part 1: Powder/liquid acid-base cements *

Annex A     Determination of net setting time *
Annex C     Determination of film thickness (luting cements only) *
Annex D     Determination of compressive strength *
Annex E     Determination of acid erosion *
Annex F     Determination of optical properties (polyalkenoate restorative cements only) *
Annex G     Determination of acid-soluble arsenic and lead contents *
Annex H     Determination of radio-opacity *

ISO 9917-2:2010 Dentistry – Water-based cements
Part 2: Resin-modified cements

Annex A     Determination of working time and setting time *
Annex B     Determination of film thickness – Luting materials only *
Annex C     Determination of flexural strength
Annex D     Determination of radio-opacity *
Annex E     Determination of shade and colour stability – Restorative and luting materials only

ISO 10477:2004 Dentistry – Polymer-based crown and bridge materials

7.3          Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials
7.4          Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials *
7.5          Surface finish
7.6          Flexural strength
7.7          Bond strength *
7.8          Water sorption and solubility
7.9          Shade consistency and colour stability

ISO 10993-5:2009 Biological evaluation of medical devices
Part 5: Tests for in vitro cytotoxicity

8.4.1      Agar diffusion *
8.4.2      Filter diffusion *
Annex C   MTT Cytotoxicity test

ISO 20795-1:2013 Dentistry – Base polymers
Part 1: Denture base polymers

5.2.2     Surface characteristics
8.2        Packing plasticity
8.3        Colour
8.4        Colour stability
8.5.1     Polishability
8.5.2     Translucency
8.5.3     Freedom from porosity, ultimate flexural strength, and flexural modulus
8.6        Fracture toughness with a modified bending test *
8.7        Bonding to synthetic polymer teeth
8.8        Residual methyl methacrylate monomer *
8.9        Water sorption and solubility

ISO 20795-2:2013 Dentistry – Base polymers
Part 2: Orthodontic base polymers

5.2.2    Surface characteristics
8.2       Colour
8.3       Polishability, freedom from porosity, ultimate flexural strength, and flexural modulus
8.4       Fracture toughness with a modified bending test *
8.5       Residual methyl methacrylate monomer *
8.6       Plasticiser(s), where applicable *
8.7       Water sorption and solubility

ISO 21563:2013 Dentistry – Hydrocolloid impression materials *

7.1       Working time test (alginate materials only) *
7.2       Initial setting time test (alginate impression materials only) *
7.3       Detail reproduction test before and after specimen disinfection *
7.4       Compatibility with gypsum test *
7.5       Elastic recovery test *
7.6       Strain-in-compression test *
7.7       Tear strength test *
7.8       Linear dimensional change test (Type 3A agar materials with companion alginate only) *
7.9       Tensile bond strength test (Type 3A agar/companion alginate material specimen only) *

ISO 22112:2017 Dentistry – Artificial teeth for dental prostheses

7.2       Dimensions of teeth
7.3       Comparison with shade guide
7.5       Surface finish of polymer teeth
7.7       Porosity of polymer teeth and other defects
7.11     Bonding of polymer teeth to denture-base polymers
7.12     Resistance to blanching, distortion and crazing of polymer teeth
7.13     Colour stability of polymer teeth
7.14     Dimensional stability of polymer teeth

ISO 22674:2016 Dentistry – Metallic materials for fixed and removable restorations and appliances

8.2       Chemical composition
8.4       Proof stress of 0,2% non-proportional extension
8.5       Percentage elongation after fracture
8.8       Density
8.9       Corrosion resistance by the static immersion procedure of ISO 10271:2011
8.10     Sulfide tarnish test (cyclic immersion) *
8.12     Solidus and liquidus temperatures (dental casting alloys) or melting point (commercially pure metals) *
8.13     Linear thermal expansion

ISO 24234:2015 Dentistry – Dental amalgam *

6.1       Chemical composition and purity of the dental amalgam alloy *
6.2       Foreign material and large particles in the dental amalgam alloy powder *
6.3       Determination of the accuracy and variability of pre-proportioned masses*
6.4       Preparation of test-pieces to determine compliance with the requirements for creep, dimensional change during hardening, and compressive strength *
6.5       Determination of creep *
6.6       Determination of dimensional change during hardening *
6.7       Determination of compressive strength *
6.8       Appearance of the mixed dental amalgam before setting *

ISO 29022:2013 Dentistry – Adhesion – Notched-edge shear bond strength test

7         Notched-edge shear test