ISO 7488:2018
Dentistry — Mixing machines for dental amalgam
ISO 7488:2018 specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam.
ISO 7488:2018 specifies the test methods used to determine conformity with these requirements.
ISO 7488:2018 refers to those machines that mix by an oscillating action and which are sold by the manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing any other type of product.
ISO 7488:2018 does not specify requirements for removable mixing-capsules, as are used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Safety
4.1.1 Electrical
4.1.2 Mechanical
4.2 Stability
4.3 Sound pressure
4.4 Frequency
4.4.1 General
4.4.2 Variable-power machines
4.5 Amplitude
4.6 Mixing time
4.6.1 Timing device
4.6.2 Timing settings
4.7 Coherence time
4.8 Long-term test
5 Sampling
5.1 Mixing machine
5.2 Mixing-capsules
5.2.1 General
5.2.2 Mixing-capsule selection
5.3 Test components
6 Measurement and test methods
6.1 Test conditions
6.1.1 General
6.1.2 Reference charge mass, mref
6.1.3 Minimum charge mass, mmin
6.1.4 Maximum charge mass, mmax
6.1.5 Maximum running duration, tmax
6.1.6 Power supply conditions and apparatus
6.1.7 Equipment setup
6.2 Visual inspection
6.3 Sound pressure
6.3.1 Apparatus and setup
6.3.2 Procedure
6.3.3 Variable-power machines
6.4 Frequency tests
6.4.1 Measurement of mixing-capsule oscillation frequency
6.5 Working length
6.5.1 Principle
6.5.2 Apparatus
6.5.3 Procedure
6.6 Amplitude
6.6.1 Apparatus
6.6.2 Procedure
6.7 Mixing time
6.7.1 Apparatus
6.7.2 Procedure
6.8 Coherence time
6.8.1 Apparatus and materials
6.8.2 Procedure
6.9 Long-term test
7 Instructions for use
7.1 General
7.2 Identification
7.3 Safety
7.4 User maintenance
7.5 Other maintenance
7.6 Mixing-capsule requirements
7.7 Mixing-capsule amplitude
7.8 Operational limitations
7.8.1 Mixing machine limitations
7.8.2 Mass and frequency
8 Packaging
9 Marking
9.1 On the mixing-machine
9.2 On the packaging
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 Safety
4.1.1 Electrical
4.1.2 Mechanical
4.2 Stability
4.3 Sound pressure
4.4 Frequency
4.4.1 General
4.4.2 Variable-power machines
4.5 Amplitude
4.6 Mixing time
4.6.1 Timing device
4.6.2 Timing settings
4.7 Coherence time
4.8 Long-term test
5 Sampling
5.1 Mixing machine
5.2 Mixing-capsules
5.2.1 General
5.2.2 Mixing-capsule selection
5.3 Test components
6 Measurement and test methods
6.1 Test conditions
6.1.1 General
6.1.2 Reference charge mass, mref
6.1.3 Minimum charge mass, mmin
6.1.4 Maximum charge mass, mmax
6.1.5 Maximum running duration, tmax
6.1.6 Power supply conditions and apparatus
6.1.7 Equipment setup
6.2 Visual inspection
6.3 Sound pressure
6.3.1 Apparatus and setup
6.3.2 Procedure
6.3.3 Variable-power machines
6.4 Frequency tests
6.4.1 Measurement of mixing-capsule oscillation frequency
6.5 Working length
6.5.1 Principle
6.5.2 Apparatus
6.5.3 Procedure
6.6 Amplitude
6.6.1 Apparatus
6.6.2 Procedure
6.7 Mixing time
6.7.1 Apparatus
6.7.2 Procedure
6.8 Coherence time
6.8.1 Apparatus and materials
6.8.2 Procedure
6.9 Long-term test
7 Instructions for use
7.1 General
7.2 Identification
7.3 Safety
7.4 User maintenance
7.5 Other maintenance
7.6 Mixing-capsule requirements
7.7 Mixing-capsule amplitude
7.8 Operational limitations
7.8.1 Mixing machine limitations
7.8.2 Mass and frequency
8 Packaging
9 Marking
9.1 On the mixing-machine
9.2 On the packaging
Bibliography