BS EN ISO 4823:2015 pdf download
BS EN ISO 4823:2015 pdf download.Dentistry — Elastomeric impression materials (Iso4823:2015).
5.2 Labelling requirements
5.2.1 Outer packages (containing one or more primary containers)
Labelling of the outer packaging prepared for retail marketing containing one or more primary containers shall bear the following information:
a) recommended storage conditions for the unopened package;
b) brand name;
c) name and address of the manufacturer or the name of another company authorized by the manufacturer to market the material under a different brand name;
d) identification of the consistency of the material as putty, heavy-bodied, medium-bodied, or lightbodied (see Clause 4) (the type number may also be Included);
e) ma nu facturer’s hatch reference(s);
f) USE BEFORE DATE, identified as such, beyond which the material may not exhibit its best properties. The date shall be expressed as a six-digit number, for example. 2014-09, where the first four digits indicate the year (2014) and the last two digits Indicate the month (September);
g) minimum volume that would result from mixing the entire component contents included in the outer package.
5.2.2 Primary containers within outer packaging
Labels for phmary containers shall bear the following information:
a) brand name;
b) name of the manufacturer or name of another company authorized to market the material under a different brand name;
c) component identification (not required when the components for extrusion mixing are supplied in separate but joined primary containers);
d) manufacturer’s batch references.
5.3 Requirements for information in manufacturer’s instructions
5.3.1 General
Each package in which the components olan Impression material are prepared for retail marketing shall be accompanied by the instructions and other information needed to ensure optimum performance of the material in clinical practice
5.3.2 Identifying information
The following identifying information is required:
a) trade-name or brand-name of the product;
b) chemical nature of the elastumeric system: for example, polycther, polysulfide, silicone (condensation type), or silicone (vinyl polysiloxane, addition type).
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;
— moistLare 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 Identilicatlon 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 £3 and AnnexE):
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 lype 3 product (dental stone, model) and either one lype 4 product or one ‘Type S 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 he 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.
