BS EN ISO 4823:2021
$167.15
Dentistry. Elastomeric impression and bite registration materials
Published By | Publication Date | Number of Pages |
BSI | 2021 | 42 |
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 |