This standard specifies requirements for characteristics and properties and test methods for evaluating elastomeric dental impression materials.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942 Dentistry - Vocabulary
ISO 6873:1998 Dental gypsum products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
consistency
degree of firmness with which particles of a material, prepared for use, cohere so as to allow the material to flow, or resist flow, as required to achieve the purpose for which it is intended
3.2
elastic recovery test
(elastic impression materials) method of determining whether the materials possess the elastic properties required to recover adequately after deformation occurring when the materials, used for forming impressions, are removed from the mouth
Note: The terms "compression set", "permanent deformation", and "recovery from deformation" are deprecated here.
3.3
extrusion mixing
method by which two or more material components are extruded from their separate immediate containers through a special mixing tip, from which the components emerge as a homogeneous mixture
3.4
hand mixing
method of mixing the components of a material by means of manual kneading or spatulation
3.5
immediate container
container which is in direct contact with a material or a component thereof
Note: An immediate container may be an unlabelled container protected by a more durable labelled outer package component such as a can, carton or drum. If it is strong enough to protect its contents without outer package, an immediate container can also serve as a primary container on which labelling shall be required.
3.6
mixing time
time, measured from first contact between different components of a material being mixed, required to achieve a homogeneous mixture when the components are mixed according to the manufacturer’s instructions
Note: The time of first contact between extrusion-mixed material components is defined as the time when the material components can be seen entering into the mixing nozzle.
3.7
outer package
wrapping or carton, which may be required by law or a standard to bear specified labelling, used to cover one or more immediate or primary containers in preparation for retail marketing
3.8
primary container
retail marketing packaging component, such as a bottle, carton, drum, jar, and tube, which may be required by law or a standard to bear specified labelling
Note: A primary container may also be an immediate container.
3.9
strain-in-compression test
(elastic impression materials) method of measuring the flexibility/stiffness property ranges of materials so as to determine whether the set materials, when formed as impressions
a) can be removed from the mouth without injury to impressed oral tissues, and
b) will have adequate stiffness, in the more flexible portions of impressions, to resist deformation when model-forming products are poured against them
3.10
working time
period of time, beginning with the commencement of mixing and ending before the material being mixed has begun to exhibit elastic properties that will prevent the material from being manipulated as required to form an impression or a mould having the desired surface detail and dimensional characteristics
4 Classification
Materials are classified according to consistencies determined immediately after completion of mixing according to the manufacturer’s instructions (10.3):
——Type 0: Putty consistency;
——Type 1: Heavy-bodied consistency;
——Type 2: Medium-bodied consistency;
——Type 3: Light-bodied consistency.
5 Biocompatibility advisory
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this standard. It is recommended that, in assessing possible biological or toxicological hazards, reference be made to YY/T 0268 and GB/T 16886.1 (see Bibliography).
6 Requirements for characteristics and properties
6.1 Component colours
Different components intended for use in the same mixture shall be supplied in contrasting colours to provide a means of determining when the components have been thoroughly mixed.
Foreword II 1 Scope 2 Normative references 3 Terms and definitions 4 Classification 5 Biocompatibility advisory 6 Requirements for characteristics and properties 6.1 Component colours 6.2 Mixing time (hand-spatulated or hand-kneaded mixtures) 6.3 Working time (Types 1, 2 and 3 only) 6.4 Consistency 6.5 Detail reproduction 6.6 Linear dimensional change 6.7 Compatibility with gypsum 6.8 Elastic recovery 6.9 Strain-in-compression 7 Sampling 8 Test methods - General 8.1 Laboratory conditions 8.2 Apparatus function verification 8.3 Material manipulation and specimen preparation 8.4 Pass/fail determinations 8.5 Expression of test results 9 Test methods - Specific 9.1 Mixing-time test 9.2 Consistency test 9.3 Working-time test 9.4 Detail reproduction test 9.5 Linear dimensional change test 9.6 Test for compatibility with gypsum 9.7 Elastic recovery test 9.8 Strain-in-compression test 10 Requirements for information in manufacturer's instructions 10.1 General 10.2 Identifying information 10.3 Instructions for use 11 Requirements for packaging and labelling 11.1 Packaging requirements 11.2 Labelling requirements Annex A (Informative) Working-time test apparatus components - Possible sources Bibliography Forew
YY 0493-2011 Dentistry - Elastomeric impression materials
1 Scope
This standard specifies requirements for characteristics and properties and test methods for evaluating elastomeric dental impression materials.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942 Dentistry - Vocabulary
ISO 6873:1998 Dental gypsum products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
consistency
degree of firmness with which particles of a material, prepared for use, cohere so as to allow the material to flow, or resist flow, as required to achieve the purpose for which it is intended
3.2
elastic recovery test
(elastic impression materials) method of determining whether the materials possess the elastic properties required to recover adequately after deformation occurring when the materials, used for forming impressions, are removed from the mouth
Note: The terms "compression set", "permanent deformation", and "recovery from deformation" are deprecated here.
3.3
extrusion mixing
method by which two or more material components are extruded from their separate immediate containers through a special mixing tip, from which the components emerge as a homogeneous mixture
3.4
hand mixing
method of mixing the components of a material by means of manual kneading or spatulation
3.5
immediate container
container which is in direct contact with a material or a component thereof
Note: An immediate container may be an unlabelled container protected by a more durable labelled outer package component such as a can, carton or drum. If it is strong enough to protect its contents without outer package, an immediate container can also serve as a primary container on which labelling shall be required.
3.6
mixing time
time, measured from first contact between different components of a material being mixed, required to achieve a homogeneous mixture when the components are mixed according to the manufacturer’s instructions
Note: The time of first contact between extrusion-mixed material components is defined as the time when the material components can be seen entering into the mixing nozzle.
3.7
outer package
wrapping or carton, which may be required by law or a standard to bear specified labelling, used to cover one or more immediate or primary containers in preparation for retail marketing
3.8
primary container
retail marketing packaging component, such as a bottle, carton, drum, jar, and tube, which may be required by law or a standard to bear specified labelling
Note: A primary container may also be an immediate container.
3.9
strain-in-compression test
(elastic impression materials) method of measuring the flexibility/stiffness property ranges of materials so as to determine whether the set materials, when formed as impressions
a) can be removed from the mouth without injury to impressed oral tissues, and
b) will have adequate stiffness, in the more flexible portions of impressions, to resist deformation when model-forming products are poured against them
3.10
working time
period of time, beginning with the commencement of mixing and ending before the material being mixed has begun to exhibit elastic properties that will prevent the material from being manipulated as required to form an impression or a mould having the desired surface detail and dimensional characteristics
4 Classification
Materials are classified according to consistencies determined immediately after completion of mixing according to the manufacturer’s instructions (10.3):
——Type 0: Putty consistency;
——Type 1: Heavy-bodied consistency;
——Type 2: Medium-bodied consistency;
——Type 3: Light-bodied consistency.
5 Biocompatibility advisory
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this standard. It is recommended that, in assessing possible biological or toxicological hazards, reference be made to YY/T 0268 and GB/T 16886.1 (see Bibliography).
6 Requirements for characteristics and properties
6.1 Component colours
Different components intended for use in the same mixture shall be supplied in contrasting colours to provide a means of determining when the components have been thoroughly mixed.
Contents of YY 0493-2011
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Classification
5 Biocompatibility advisory
6 Requirements for characteristics and properties
6.1 Component colours
6.2 Mixing time (hand-spatulated or hand-kneaded mixtures)
6.3 Working time (Types 1, 2 and 3 only)
6.4 Consistency
6.5 Detail reproduction
6.6 Linear dimensional change
6.7 Compatibility with gypsum
6.8 Elastic recovery
6.9 Strain-in-compression
7 Sampling
8 Test methods - General
8.1 Laboratory conditions
8.2 Apparatus function verification
8.3 Material manipulation and specimen preparation
8.4 Pass/fail determinations
8.5 Expression of test results
9 Test methods - Specific
9.1 Mixing-time test
9.2 Consistency test
9.3 Working-time test
9.4 Detail reproduction test
9.5 Linear dimensional change test
9.6 Test for compatibility with gypsum
9.7 Elastic recovery test
9.8 Strain-in-compression test
10 Requirements for information in manufacturer's instructions
10.1 General
10.2 Identifying information
10.3 Instructions for use
11 Requirements for packaging and labelling
11.1 Packaging requirements
11.2 Labelling requirements
Annex A (Informative) Working-time test apparatus components - Possible sources
Bibliography
Forew
