ISO 21563:2021
Dentistry — Hydrocolloid impression materials
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.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification of agar hydrocolloid impression materials
5 Requirements — Characteristics and properties
6 Pre-test planning approaches
6.1 General
6.2 Sampling
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
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
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
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
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
7.4.2 Examination and conditioning of equipment and accessories
7.4.3 Specimen preparation
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
7.5.2 Specimen preparation
7.5.3 Test procedure
7.5.4 Pass/fail determination and expression of results
7.6 Elastic recovery test
7.6.1 Apparatus and materials
7.6.2 Specimen preparation
7.6.3 Test procedure
7.6.4 Calculation of results
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
7.7.5 Pass/fail determinations and expression of results
7.8 Tear strength test
7.8.1 Apparatus and materials
7.8.2 Specimen preparation
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
7.9.2 Specimen preparation
7.9.3 Test procedure
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
7.10.3 Specimen preparation steps
7.10.4 Test procedure steps
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
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
8.2.4 Additional instructions for alginate hydrocolloid materials only
Annex A (informative) Figures illustrating instruments and accessories used in tests
Annex B (informative) Tear test specimen preparation steps for an optional gripping method
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Classification of agar hydrocolloid impression materials
5 Requirements — Characteristics and properties
6 Pre-test planning approaches
6.1 General
6.2 Sampling
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
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
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
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
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
7.4.2 Examination and conditioning of equipment and accessories
7.4.3 Specimen preparation
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
7.5.2 Specimen preparation
7.5.3 Test procedure
7.5.4 Pass/fail determination and expression of results
7.6 Elastic recovery test
7.6.1 Apparatus and materials
7.6.2 Specimen preparation
7.6.3 Test procedure
7.6.4 Calculation of results
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
7.7.5 Pass/fail determinations and expression of results
7.8 Tear strength test
7.8.1 Apparatus and materials
7.8.2 Specimen preparation
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
7.9.2 Specimen preparation
7.9.3 Test procedure
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
7.10.3 Specimen preparation steps
7.10.4 Test procedure steps
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
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
8.2.4 Additional instructions for alginate hydrocolloid materials only
Annex A (informative) Figures illustrating instruments and accessories used in tests
Annex B (informative) Tear test specimen preparation steps for an optional gripping method
Bibliography