ISO 20795-2:2010
Dentistry — Base polymers — Part 2: Orthodontic base polymers
ISO 20795-2:2010 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. ISO 20795-2:2010 further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.
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Scope
Normative references
Terms and definitions
Classification
Requirements
Unpolymerized material
Liquid component
General
Homogeneity
Solid components
Polymerized material
Biocompatibility
Surface characteristics
Shape capability
Colour
Freedom from porosity
Ultimate flexural strength
Flexural modulus
Maximum stress intensity factor
Total fracture work
Residual methyl methacrylate monomer
Plasticizers
Water sorption
Water solubility
Sampling
Preparation of specimen plates and test specimens
Laboratory environment
Procedures
Special equipment
Test methods
Inspection for compliance determination
Visual inspection
Expression of results
Colour
General
Expression of results
Polishability, freedom from porosity, ultimate flexural stre
Polishability
Materials
Apparatus
Preparation of the mould
Procedure
Pass/fail determination
Expression of results
Freedom from porosity, ultimate flexural strength and flexur
Materials
Apparatus
Preparation of specimen strips
Freedom from porosity
Procedure and pass/fail determination
Expression of results
Ultimate flexural strength and flexural modulus
Procedure
Calculation and expression of results
Ultimate flexural strength
Flexural modulus
Pass/fail determination of ultimate flexural strength
Pass/fail determination of flexural modulus
Expression of results
Fracture toughness with a modified bending test
Materials
Apparatus
Procedure
Calculation and expression of the results
Dimensions
Calculation of the maximum stress intensity factor
Calculation of the total fracture work
Pass/fail determination of maximum stress intensity factor
Pass/fail determination of total fracture work
Expression of results
Residual methyl methacrylate monomer
Principle
Preparation of test specimen discs
Material
Apparatus
8.5.2.2.1 Circular stainless steel mould,�
Procedure
Extraction of monomer
Reagents
Apparatus
Preparation of solutions
Gas chromatography
Reagent
Apparatus
Preparation of calibration solutions for gas chromatography
Gas chromatographic equipment, gases and operating condition
Gas chromatograms of sample and calibration solutions
Evaluation of peaks of gas chromatogram
Calculation and expression of results
Calculation of results from a calibration graph
Drawing of the calibration graph
Precision of measurements
Determination of the percentage of methyl methacrylate
Pass/fail determinations
Expression of results
Plasticiser(s), where applicable
Principle
General
Preparation of test specimen discs
Extraction of plasticizer(s)
Reagents
Apparatus
Preparation of solutions
Internal standard (I.S.) solution
Sample solutions
Gas chromatography
Reagent
Apparatus
Preparation of calibration solutions for gas chromatography
Gas chromatographic equipment, gases and operating condition
Gas chromatograms of sample and calibration solutions
Evaluation of peaks of gas chromatograph
Calculation and expression of results
Calculation of results from calibration graph(s)
Drawing of calibration graph(s)
Precision of measurements
Determination of the percentage of phthalate plasticizer(s)
Pass/fail determination
Expression of results
Water sorption and solubility
Materials
Apparatus
Preparation of test specimens
Procedure
Conditioned specimens
Wet specimens
Reconditioned specimens
Calculation and expression of results
Water sorption
Water solubility
Pass/fail determination of water sorption
Pass/fail determination of water solubility
Expression of results
Requirements for labelling, marking, packaging and instructi
Packaging
Marking of outer packages and containers
Outer packages
All immediate containers
Container of liquid
Manufacturer's instructions
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Related Information
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BS 3520:1962
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BS 4284:1981
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Scope
Normative references
Terms and definitions
Classification
Requirements
Unpolymerized material
Liquid component
General
Homogeneity
Solid components
Polymerized material
Biocompatibility
Surface characteristics
Shape capability
Colour
Freedom from porosity
Ultimate flexural strength
Flexural modulus
Maximum stress intensity factor
Total fracture work
Residual methyl methacrylate monomer
Plasticizers
Water sorption
Water solubility
Sampling
Preparation of specimen plates and test specimens
Laboratory environment
Procedures
Special equipment
Test methods
Inspection for compliance determination
Visual inspection
Expression of results
Colour
General
Expression of results
Polishability, freedom from porosity, ultimate flexural stre
Polishability
Materials
Apparatus
Preparation of the mould
Procedure
Pass/fail determination
Expression of results
Freedom from porosity, ultimate flexural strength and flexur
Materials
Apparatus
Preparation of specimen strips
Freedom from porosity
Procedure and pass/fail determination
Expression of results
Ultimate flexural strength and flexural modulus
Procedure
Calculation and expression of results
Ultimate flexural strength
Flexural modulus
Pass/fail determination of ultimate flexural strength
Pass/fail determination of flexural modulus
Expression of results
Fracture toughness with a modified bending test
Materials
Apparatus
Procedure
Calculation and expression of the results
Dimensions
Calculation of the maximum stress intensity factor
Calculation of the total fracture work
Pass/fail determination of maximum stress intensity factor
Pass/fail determination of total fracture work
Expression of results
Residual methyl methacrylate monomer
Principle
Preparation of test specimen discs
Material
Apparatus
8.5.2.2.1 Circular stainless steel mould,�
Procedure
Extraction of monomer
Reagents
Apparatus
Preparation of solutions
Gas chromatography
Reagent
Apparatus
Preparation of calibration solutions for gas chromatography
Gas chromatographic equipment, gases and operating condition
Gas chromatograms of sample and calibration solutions
Evaluation of peaks of gas chromatogram
Calculation and expression of results
Calculation of results from a calibration graph
Drawing of the calibration graph
Precision of measurements
Determination of the percentage of methyl methacrylate
Pass/fail determinations
Expression of results
Plasticiser(s), where applicable
Principle
General
Preparation of test specimen discs
Extraction of plasticizer(s)
Reagents
Apparatus
Preparation of solutions
Internal standard (I.S.) solution
Sample solutions
Gas chromatography
Reagent
Apparatus
Preparation of calibration solutions for gas chromatography
Gas chromatographic equipment, gases and operating condition
Gas chromatograms of sample and calibration solutions
Evaluation of peaks of gas chromatograph
Calculation and expression of results
Calculation of results from calibration graph(s)
Drawing of calibration graph(s)
Precision of measurements
Determination of the percentage of phthalate plasticizer(s)
Pass/fail determination
Expression of results
Water sorption and solubility
Materials
Apparatus
Preparation of test specimens
Procedure
Conditioned specimens
Wet specimens
Reconditioned specimens
Calculation and expression of results
Water sorption
Water solubility
Pass/fail determination of water sorption
Pass/fail determination of water solubility
Expression of results
Requirements for labelling, marking, packaging and instructi
Packaging
Marking of outer packages and containers
Outer packages
All immediate containers
Container of liquid
Manufacturer's instructions