NIOM TESTED: Product categories

 

 

 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:

 

Artificial teeth for dental prostheses

(Polymer teeth)

  Test methods   Requirements
Comparison with shade guide,
ISO 22112 7.3
No perceptible colour difference compared with the manufacturer’s shade guide or nominated shade guide. Multi-layered teeth shall show no line of demarcation between incisal and cervical portions on the facial aspects of the teeth
Porosity of polymer teeth and other defects, ISO 22112 7.7 No porosity or defect, such as rough trimming, rough finish or visible impurities, on the coronal surfaces
Bonding of polymer teeth to denture-base polymers,
ISO 22112 7.11
Capable of being bonded to heat-polymerized denture-base materials which conform to ISO 20795-1
Resistance to blanching, distortion and crazing of polymer teeth,
ISO 22112 7.12
No teeth shall exhibit blanching or distortion. No teeth shall exhibit crazing with the exception of the ridge lap surfaces and the cervical portion of the teeth up to the cervical line

 

Base polymers – Denture base polymers

(Type 1 Heat-polymerizable materials and Type 2 Autopolymerizable materials)

  Test methods   Requirements
Ultimate flexural strength,
ISO 20795-1 8.5.3.5
Not less than 65 MPa (Type 1) and not less than 60 MPa (Type 2)
Flexural modulus,
ISO 20795-1 8.5.3.5
At least 2 000 MPa (Type 1) and at least 1 500 MPa (Type 2)
Residual methyl methacrylate monomer, ISO 20795-1 8.8 Maximum 2.2 % mass fraction (Type 1) and 4.5 % mass fraction (Type 2). If lower values are claimed by the manufacturer: not more than 0.2 % mass fraction higher than stated
Water sorption, ISO 20795-1 8.9 The increase in mass per volume shall not exceed 32 µg/mm³
Water solubility, ISO 20795-1 8.9 The loss in mass per volume shall not exceed 1.6 µg/mm³ (Type 1) and shall not exceed 8.0 µg/mm³ (Type 2)

 

Base polymers – Orthodontic base polymers

(Type 1 Autopolymerizable materials)

  Test methods   Requirements
Fracture toughness with a modified bending test, ISO 20795-2 8.4 The maximum stress intensity factor shall be at least 1.1 MPa m1/2
Fracture toughness with a modified bending test, ISO 20795-2 8.4 The total fracture work shall be at least 250 J/m2
Residual methyl methacrylate monomer, ISO 20795-1 8.5 Maximum 5 % mass fraction The content claimed by the manufacturer shall not exceed the stated value by more than 0.2 % mass fraction
Water sorption, ISO 20795-1 8.7 The increase in mass per volume shall not exceed 32 µg/mm³
Water solubility, ISO 20795-1 8.7 The loss in mass per volume shall not exceed 5 µg/mm³

 

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)

 

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)

 

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, ISO 4823 9.4 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)

 

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

 

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)

 

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)

 

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)

 

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)