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BS EN ISO 4823:2021

$167.15

Dentistry. Elastomeric impression and bite registration materials

Published By Publication Date Number of Pages
BSI 2021 42
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This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.

NOTE

This document does not address possible biological hazards associated with the materials. Assessment of these hazards is addressed in ISO 7405 and the ISO 10993 series .

PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Classification
11 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
12 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
13 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
14 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
15 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
16 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
17 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
18 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
19 7.3.2 Working time test
20 7.4 Detail reproduction
7.4.1 Apparatus and materials
7.4.2 Specimen preparation
21 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
22 7.5.2 Test block line-length measurement procedure
7.5.3 Specimen preparation
7.5.4 Test specimen measurement
23 7.6 Compatibility with gypsum
7.6.1 Apparatus and materials
24 7.6.2 Specimen preparation
7.6.3 Test procedure
7.6.4 Pass/fail determination and expression of results
25 7.7 Elastic recovery
7.7.1 Apparatus and materials
7.7.2 Specimen preparation
26 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
27 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
28 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
29 7.10.4 Evaluation
7.10.5 Pass/fail determination and expression of results
30 Annex A (normative) Figures
38 Annex B (normative) Standardized hand mixing methods
41 Bibliography
BS EN ISO 4823:2021
$167.15