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BS EN ISO 4823:2021 Dentistry. Elastomeric impression and bite registration materials, 2021
- undefined
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Classification
- 5 Requirements
- 5.1 Packaging requirements
- 5.2 Labelling requirements
- 5.2.1 Outer packages (containing one or more primary containers)
- 5.2.2 Primary containers within outer packaging
- 5.3 Requirements for information in the manufacturer's instructions
- 5.3.1 General
- 5.3.2 Identifying information
- 5.3.3 Specific instructions for use
- 5.4 Requirements for characteristics and properties
- 5.4.1 Component colours (hand-spatulated or hand-kneaded mixes)
- 5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes)
- 5.4.3 Consistency
- 5.4.4 Working time
- 5.4.5 Detail reproduction
- 5.4.6 Linear dimensional change
- 5.4.7 Compatibility with gypsum
- 5.4.8 Elastic recovery
- 5.4.9 Strain in compression
- 5.4.10 Minimum time in the oral cavity for bite registration materials
- 5.4.11 Compression set of bite registration materials
- 5.4.12 Hardness of bite registration materials
- 6 Pre-test planning approaches
- 6.1 Sampling
- 6.2 Pre-test product examinations
- 6.2.1 Examinations for compliance with labelling requirements
- 6.2.2 Examinations for effectiveness of the packaging
- 6.2.3 Examinations for compliance with requirements for instructions for use
- 6.3 Essential pre-test preparatory practices
- 6.3.1 Laboratory conditions
- 6.3.2 Apparatus function verification steps
- 6.3.3 Volume of materials to be mixed for each specimen
- 6.3.4 Standardized approaches to proportioning, mixing, and handling of hand mixed materials to be tested
- 6.3.5 Timing for the specimen preparation and test procedures
- 6.3.6 Simulated oral time/temperature treatment of specimens formed in completely closed mould assemblies
- 6.4 Pass/fail determinations
- 6.5 Expression of test results
- 7 Test methods — Specific
- 7.1 Mixing time
- 7.1.1 Apparatus
- 7.1.2 Specimen preparation and test procedure (five specimens)
- 7.1.3 Pass/fail determination and expression of results
- 7.2 Consistency
- 7.2.1 Apparatus and materials
- 7.2.2 Advance preparation steps
- 7.2.3 Specimen preparation and test procedure (5 specimens)
- 7.2.4 Pass/fail determination and expression of results
- 7.3 Working-time
- 7.3.1 Apparatus
- 7.3.2 Working time test
- 7.4 Detail reproduction
- 7.4.1 Apparatus and materials
- 7.4.2 Specimen preparation
- 7.4.3 Test procedure
- 7.4.4 Pass/fail determination and expression of results
- 7.5 Linear dimensional change
- 7.5.1 Apparatus and materials
- 7.5.2 Test block line-length measurement procedure
- 7.5.3 Specimen preparation
- 7.5.4 Test specimen measurement
- 7.6 Compatibility with gypsum
- 7.6.1 Apparatus and materials
- 7.6.2 Specimen preparation
- 7.6.3 Test procedure
- 7.6.4 Pass/fail determination and expression of results
- 7.7 Elastic recovery
- 7.7.1 Apparatus and materials
- 7.7.2 Specimen preparation
- 7.7.3 Test procedure
- 7.7.4 Calculation of results
- 7.7.5 Pass/fail determination and expression of results
- 7.8 Strain in compression
- 7.8.1 Apparatus
- 7.8.2 Specimen preparation
- 7.8.3 Test procedure
- 7.8.4 Calculation of results
- 7.8.5 Pass/fail determination and expression of results
- 7.9 Minimum time in the oral cavity and compression set for bite registration materials
- 7.9.1 Apparatus
- 7.9.2 Specimen preparation
- 7.9.3 Test procedure
- 7.9.4 Evaluation
- 7.9.5 Pass/fail determination and expression of results
- 7.10 Hardness of bite registration materials
- 7.10.1 Apparatus
- 7.10.2 Specimen preparation
- 7.10.3 Test procedure
- 7.10.4 Evaluation
- 7.10.5 Pass/fail determination and expression of results
- Annex A (normative) Figures
- Annex B (normative) Standardized hand mixing methods
- Bibliography [Go to Page]
