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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PDF Pages	PDF Title
68	National foreword
70	European foreword
73	Foreword
75	1 Scope 2 Normative references 3 Terms and definitions
77	4 Classification of agar hydrocolloid impression materials 5 Requirements — Characteristics and properties 5.1 General
78	6 Pre-test planning approaches 6.1 General 6.2 Sampling
79	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
80	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
81	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
82	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
83	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
84	7.4.2 Examination and conditioning of equipment and accessories 7.4.3 Specimen preparation
86	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
87	7.5.2 Specimen preparation 7.5.3 Test procedure 7.5.4 Pass/fail determination and expression of results
88	7.6 Elastic recovery test 7.6.1 Apparatus and materials 7.6.2 Specimen preparation
89	7.6.3 Test procedure 7.6.4 Calculation of results
90	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
91	7.7.5 Pass/fail determinations and expression of results 7.8 Tear strength test 7.8.1 Apparatus and materials
92	7.8.2 Specimen preparation
93	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
94	7.9.2 Specimen preparation 7.9.3 Test procedure
95	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
96	7.10.3 Specimen preparation steps 7.10.4 Test procedure steps
97	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
98	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
99	8.2.4 Additional instructions for alginate hydrocolloid materials only
100	Annex A (informative) Figures illustrating instruments and accessories used in tests
114	Annex B (informative) Tear test specimen preparation steps for an optional gripping method
119	Bibliography

Published By	Publication Date	Number of Pages
BSI	2021	120


PDF Format	Searchable	Printable	Preview Now

Status	Definitive
Pages	120
Publication Date	2021-09-28
ISBN	978 0 539 19233 9
Standard Number	BS EN ISO 21563:2021 – TC
Title	Tracked Changes. Dentistry. Hydrocolloid impression materials
Descriptors	Specimen preparation, Mathematical calculations, Visual inspection (testing), Dental materials, Compressive strength, Dental impression materials, Compression testing, Marking, Time, Test equipment, Testing conditions, Alginates, Mixing, Dentistry, Instructions for use, Packaging, Performance, Penetration tests, Mechanical testing, Strain
Publisher	BSI
Committee	CH/106/2
ICS Codes	11.060.10 - Dental materials

BS EN ISO 21563:2021 – TC

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