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BS EN ISO 21563:2021

BS EN ISO 21563:2021

$198.66

Dentistry. Hydrocolloid impression materials

Published By Publication Date Number of Pages
BSI 2021 54
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This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use. 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 National foreword
4 European foreword
7 Foreword
9 1 Scope
2 Normative references
3 Terms and definitions
11 4 Classification of agar hydrocolloid impression materials
5 Requirements — Characteristics and properties
5.1 General
12 6 Pre-test planning approaches
6.1 General
6.2 Sampling
13 6.3 Pre-test product examinations
6.3.1 General
6.3.2 Examinations for compliance with labelling requirements
6.3.3 Examinations for effectiveness of the packaging
6.3.4 Examinations for compliance with requirements for instructions for use
14 6.4 Essential pre-test preparatory practices
6.4.1 Laboratory conditions
6.4.2 Apparatus function verification steps
6.4.3 Test material handling and use
15 6.4.4 Simulated oral time/temperature treatment of specimens formed in completely closed moulds
6.4.5 Order of conducting tests
6.4.6 Test schedules timing
6.4.7 Pass/fail determinations
6.4.8 Expression of test results
16 7 Test methods
7.1 General
7.2 Working time test (alginate materials only)
7.2.1 Apparatus and materials (the array of devices or materials used or available for an undertaking)
7.2.2 Specimen preparation
17 7.2.3 Test procedure
7.2.4 Pass/fail determinations/and expression of results
7.3 Initial setting time test (alginate impression materials only)
7.3.1 Apparatus
7.3.2 Specimen preparation
7.3.3 Test procedure
7.3.4 Pass/fail determinations and expression of results
7.4 Detail reproduction test before and after specimen disinfection
7.4.1 Apparatus and materials
18 7.4.2 Examination and conditioning of equipment and accessories
7.4.3 Specimen preparation
20 7.4.4 Test procedure steps
7.4.5 Pass/fail determination and expression of results
7.5 Compatibility with gypsum test
7.5.1 Apparatus and materials
21 7.5.2 Specimen preparation
7.5.3 Test procedure
7.5.4 Pass/fail determination and expression of results
22 7.6 Elastic recovery test
7.6.1 Apparatus and materials
7.6.2 Specimen preparation
23 7.6.3 Test procedure
7.6.4 Calculation of results
24 7.6.5 Pass/fail determinations and expression of results
7.7 Strain-in-compression test
7.7.1 Apparatus and materials
7.7.2 Specimen preparation
7.7.3 Test procedure
7.7.4 Calculation of results
25 7.7.5 Pass/fail determinations and expression of results
7.8 Tear strength test
7.8.1 Apparatus and materials
26 7.8.2 Specimen preparation
27 7.8.3 Test procedure
7.8.4 Calculation of results
7.8.5 Pass/fail determinations and expression of results
7.9 Linear dimensional change test (Type 3A agar materials with companion alginate only)
7.9.1 Apparatus and materials
28 7.9.2 Specimen preparation
7.9.3 Test procedure
29 7.9.4 Calculation of results
7.9.5 Pass and fail determinations and expression of results
7.10 Tensile bond strength test (Type 3A agar/companion alginate material specimen only)
7.10.1 Apparatus
7.10.2 Specimen preparation
30 7.10.3 Specimen preparation steps
7.10.4 Test procedure steps
31 7.10.5 Calculation of results
7.10.6 Pass/fail determination and expression of results
8 Requirements — Labelling and instructions for use
8.1 Labelling
32 8.2 Requirements — Instructions for use
8.2.1 General
8.2.2 For all hydrocolloid impression materials covered by this document — Agar and alginate
8.2.3 Additional instructions for agar hydrocolloid impression materials only
33 8.2.4 Additional instructions for alginate hydrocolloid materials only
34 Annex A (informative) Figures illustrating instruments and accessories used in tests
48 Annex B (informative) Tear test specimen preparation steps for an optional gripping method
53 Bibliography

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BS EN ISO 21563:2021
$198.66