BS EN ISO 4049:2019

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Dentistry. Polymer-based restorative materials

Published By	Publication Date	Number of Pages
BSI	2019	38

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Categories: 11.060.10 - Dental materials, BSI

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Description

This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting.

The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).

The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).

PDF Catalog

PDF Pages	PDF Title
2	National foreword
4	European foreword
7	Foreword
8	Introduction
9	1 Scope 2 Normative references 3 Terms and definitions
10	4 Classification 4.1 Type 4.2 Class 5 Requirements 5.1 Biocompatibility 5.2 Physical and chemical properties 5.2.1 General
11	5.2.2 Film thickness, luting materials 5.2.3 Working time, Class 1 and Class 3 restorative materials, excluding luting materials 5.2.4 Working time, Class 1 and Class 3 luting materials 5.2.5 Setting time, Class 1 materials 5.2.6 Setting time, Class 3 materials 5.2.7 Sensitivity to light, Class 2 materials 5.2.8 Depth of cure, Class 2 materials excluding luting materials
12	5.2.9 Flexural strength 5.2.10 Water sorption and solubility 5.3 Shade of restorative materials 5.4 Colour stability after irradiation and water sorption 5.5 Radio-opacity
13	6 Sampling 7 Test methods 7.1 General reagent — Water 7.2 Test conditions
14	7.3 Inspection 7.4 Preparation of test specimens 7.5 Measurement of film thickness of luting materials 7.5.1 Apparatus
16	7.5.2 Test procedure
17	7.5.3 Treatment of results
18	7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials 7.6.1 Apparatus
19	7.6.2 Procedure 7.6.3 Treatment of results
20	7.7 Working time, Class 1 and Class 3 luting materials 7.7.1 Apparatus 7.7.2 Procedure 7.7.3 Treatment of results 7.8 Setting time, Class 1 and Class 3 materials 7.8.1 Apparatus for the determination of setting time of Class 1 and Class 3 restorative materials 7.8.2 Apparatus for the determination of setting time of Class 1 and Class 3 luting materials 7.8.3 Procedure
21	7.8.4 Treatment of results 7.9 Sensitivity to light, Class 2 materials
22	7.9.1 Apparatus 7.9.2 Procedure
23	7.9.3 Treatment of results 7.10 Depth of cure, Class 2 materials excluding luting materials 7.10.1 Apparatus 7.10.2 Procedure
24	7.10.3 Treatment of results 7.11 Flexural strength 7.11.1 Apparatus
25	7.11.2 Preparation of test specimens
26	7.11.3 Procedure 7.11.4 Treatment of results
27	7.12 Water sorption and solubility 7.12.1 Apparatus
28	7.12.2 Preparation of test specimens
29	7.12.3 Procedure 7.12.4 Treatment of results
30	7.13 Shade and colour stability after irradiation and water sorption 7.13.1 General 7.13.2 Apparatus 7.13.3 Preparation of test specimens
31	7.13.4 Procedure 7.13.5 Colour comparison for shade 7.13.6 Colour comparison for colour stability 7.14 Radio-opacity 7.14.1 Perform the test in accordance with ISO 13116 7.14.2 Preparation of test specimens 7.14.3 Treatment of results
32	8 Packaging, marking, instructions and information to be supplied by the manufacturer 8.1 Packaging 8.2 Marking and instructions for use
36	8.3 Declaration of components
37	Bibliography

Additional information

Status	Definitive
Pages	38
Publication Date	2019-06-27
ISBN	978 0 580 51421 0
Standard Number	BS EN ISO 4049:2019
Title	Dentistry. Polymer-based restorative materials
Identical National Standard Of	ISO 4049, EN ISO 4049
Replaces	BS EN ISO 4049:2009
Descriptors	Physical property measurement, Performance testing, Dentistry, Chemical properties, Classification systems, Plastics, Polymers, Marking, Dental materials, Physical properties of materials, Dental filling materials
Publisher	BSI
Committee	CH/106/1
ICS Codes	11.060.10 - Dental materials

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BS EN ISO 4049:2019

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