BS EN ISO 4823:2015 pdf free
BS EN ISO 4823:2015 pdf free.Dentistry一Elastomeric impression materials
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:
一room temperature variations;
一variations in the speed and friction involved in mixing;
一hand/fingertip temperatures when kneading putty mixes;
一moisture contamination or relative humidity;
一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;
e) mixing time required to obtain a homogeneous mixture of an amount of the material having a volume of 15 ml (see 5.3 and Annex B);
f) working time;
g) minimum time the impression should remain in the mouth before removal;
h) minimum or maximum time lapse, or both, permitted between removal of the impression from the mouth and pouring the gypsum product into the impression;
i) identification of at least two gypsum products, complying with requirements of ISO 6873, which the impression material manufacturer has found to be compatible with the impression material being tested: one Type 3 product (dental stone, model) and either one Type 4 product or one Type 5 product (dental stone, high strength);
j) when the manufacturer’s instructions state that an impression made of a material may be disinfected, the disinfecting procedure shall be described in detail and a reference indicating that the disinfection procedure will not alter the potential of the impression for optimum performance shall also be identified;
k) when a manufacturer claims that a material in itself is antimicrobial and will remain so without further treatment after the impression is removed from the mouth, the manufacturer shall identify the reference on which the claim is based.BS EN ISO 4823 pdf free download.
