Enhance your product reliability
– with confidence and ease!
Confidence in your products and innovations is crucial for market performance and sales. When you document your products’ reliability and quality you are taking the obvious steps towards this belief. Label your products with this confidence – and you are one step ahead!
The NIOM TESTED program consists of these product categories:
Composites
(Light-cured, polymer-based)
| Test methods | Requirements |
|---|---|
| Flexural strength, ISO 4049 7.11 |
Minimum 80 MPa (Type 1), minimum 100 MPa (Type 1, Class 2, Group 3) or minimum 50 MPa (Type 2) (ISO 4049 5.2.9) |
| Colour stability, ISO 4049 7.13 | Not more than a slight change in colour upon visual inspection after water sorption and irradiation (ISO 4049 5.4) |
| Depth of cure, ISO 4049 7.10 | Minimum 1.5 mm or not more than 0.5 mm below the value stated by the manufacturer, minimum 1 mm if the material is labelled as opaque (ISO 4049 5.2.8) |
| Water sorption and solubility, ISO 4049 7.12 |
Sorption: ≤ 40 μg/mm³, Solubility: ≤ 7,5 μg/mm³ (ISO 4049 5.2.10) |
Luting materials
(Dual-cured or chemical cured, polymer-based)
| Test methods | Requirements |
|---|---|
| Film thickness, ISO 4049 7.5 | Not more than 10 μm above the value claimed by the manufacturer, or in any event not greater than 50 μm (ISO 4049 5.2.2) |
| Working time, ISO 4049 7.7 | At 60 seconds starting after the completion of mixing: the material shall be capable of forming a thin layer with no detectable change in homogeneity (ISO 4049 5.2.4) |
| Setting time, ISO 4049 7.8 | Not more than 5 minutes (Class 1) or not more than 10 minutes (Class 3) (ISO 4049 5.2.5 and 5.2.6) |
| Water sorption and solubility, ISO 4049 7.12 | Sorption: ≤ 40 μg/mm³, Solubility: ≤ 7,5 μg/mm³ (ISO 4049 5.2.10) |
Root-canal sealers
(Dual-cured or chemical cured)
| Test methods | Requirements |
|---|---|
| Flow, ISO 6876 5.2 | Diameter not less than 17 mm for the prepared disc (ISO 6876 4.3.1) |
| Working time, ISO 6876 5.3 | Diameter from the flow test shall be not less than 17 mm at 15 seconds before the end of the stated working time (ISO 6876 4.3.2) or at 30 minutes if not stated |
| Film thickness, ISO 6876 5.5 | Not more than 50 μm (ISO 6876 4.3.4) |
| Solubility, ISO 6876 5.6 | Not more than 3.0% by mass (ISO 6876 4.3.5) |
Elastomeric impression materials
|
Test methods |
Requirements |
|---|---|
| Working time, ISO 4823 9.3 | Not less than stated in manufacturer’s instructions, and at least 30 seconds longer than the time required to obtain a homogenous mix (ISO 4823 6.3) |
|
Detail reproduction test, |
Line width 75 μm (Type 0), 50 μm (Type 1), 20 μm (Type 2 and 3) (ISO 4823 Table 1) |
|
Linear dimensional change test, ISO 4823 9.5
|
Maximum 1.5% (ISO 4823 Table 1) |
| Elastic recovery test, ISO 4823 9.7 |
Minimum 96.5% (ISO 4823 Table 1) |
Metallic materials – Noble alloys (Type 3)
| Test methods | Requirements |
|---|---|
| Chemical composition, ISO 22674 8.2 |
To a precision of 0.1% (mass fraction) for all elements present and declared by the manufacturer in excess of 1.0%, and for Ni in excess of 0.1%. Identification of other elements present in excess of 0.1% (mass fraction) (ISO 22674 5.1). Not more than 0.02% (mass fraction) of cadmium or beryllium (ISO 22674 5.2.2) |
| Corrosion resistance, ISO 22674 8.5 |
Total metal ion release of maximum 200 μg cm-2 (ISO 22674 5.6) |
| Proof strength of 0.2% non-proportional extension, ISO 22674 8.3.3 |
Minimum 270 MPa (ISO 22674 Table 1) |
| If indicated for metal-ceramic restorations: Linear thermal expansion, ISO 22674 8.8 |
Shall not differ by more than 0.5 × 10-6 K-1 from the value stated by the manufacturer (ISO 22674 5.9) |
Metallic materials – Base-metal alloys (Type 5)
| Test methods | Requirements |
|---|---|
| Chemical composition, ISO 22674 8.2 |
To a precision of 0.1% (mass fraction) for all elements present and declared by the manufacturer in excess of 1.0%, and for Ni in excess of 0.1%. Identification of other elements present in excess of 0.1% (mass fraction) (ISO 22674 5.1). Not more than 0.02% (mass fraction) of cadmium or beryllium (ISO 22674 5.2.2) |
| Corrosion resistance, ISO 22674 8.5 |
Total metal ion release of maximum 200 μg cm-2 (ISO 22674 5.6) |
| Proof strength of 0.2% non-proportional extension, ISO 22674 8.3.3 |
Minimum 500 MPa |
| If indicated for metal-ceramic restorations: Linear thermal expansion, ISO 22674 8.8 |
The value shall not differ by more than 0.5 × 10-6 K-1 from the value accompanying the package (ISO 22674 5.9) |
Dental ceramics
| Test methods | Requirements |
|---|---|
| Flexural strength, ISO 6872 7.3 |
As given in Table 1 in ISO 6872 according to the clinical indication of the product |
| Chemical solubility, ISO 6872 7.6 |
As given in Table 1 in ISO 6872 according to the clinical indication of the product |
| Radioactivity, ISO 6872 7.2 | Not more than 1.0 Bq/g of U238 (ISO 6872 5.2.2) |
| If indicated for metal-ceramic or zirconia-ceramic restorations: Metal-ceramic bond characterization, ISO 9693-1 6.4 |
The debonding/crack-initiation strength of the combination of zirconia material and veneering ceramic, or metallic material and veneering ceramic shall be greater than 25 MPa (ISO 9693-1 4.2) |
Eye protection filters for use with curing lamps
| Test methods | Requirements |
|---|---|
| Light transmittance | Less than 0.1% light transmittance in the wavelength region 390–525 nm |
