ISO 4823:2015 pdf download

ISO 4823:2015 pdf download.Dentistry — Elastomeric impression materials
1 Scope
This International Standard specifies the requirements and tests that the state-of-the art body of knowledge suggests for helping determine whether the elastomeric impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes.
NOTE This International Standard does not address possible biological hazards associated with the materials. Therefore, interested parties are encouraged to explore ISO 7405 and ISO 10993 for assessment of such hazards.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. 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, Dentistry — 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
DEPRECATED: compression set
DEPRECATED: permanent deformation
DEPRECATED: recovery from deformation
〈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
3.3 extrusion mixing
method by which two or more material components are extruded simultaneously from their separate primary containers through a special mixing tip from which the material 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 primary packaging
container designed to come into direct contact with the product
[SOURCE: ISO 21067:2007, 2.2.2, modified — “packaging” replaced by “container” in the definition.]
5.3.3 Specific instructions for use
Where applicable, the specific instructions for use shall include the following:
a) recommended storage conditions after the initial opening of the primary containers;
b) statements indicating that working time and other characteristics of the material can be affected significantly by the following factors, as may be applicable:
— room temperature variations;
— variations in the speed and friction involved in mixing;
— hand/fingertip temperatures when kneading putty mixes;
— moisture contamination or relative humidity;
— contamination, either due to direct contact with latex dam or gloves used in clinical practice or due to the presence of such contaminants on teeth at the time they are impressed;
c) proportions for hand-spatulated mixes (mass to mass and volume to volume);
d) recommended mixing apparatus and procedures to include the generic identification of any hand coverings (gloves or polymer sheeting) that should be used to avoid contamination of the materials during hand manipulation;