BS EN ISO 4823-2015 pdf download.Dentistry一Elastomeric impression materials (ISO 4823:2015).
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 light- bodied (see Clause 4) (the type number may also be included);
e) manufacturer’s batch 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 primary containers shall bear the following information:
a) brand name;
b) name o[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 ofan 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 elastomeric system: for example. polyether, polysulfide, silicone (condensation type), or silicone (vinyl polysiloxane, addition type).BS EN ISO 4823 pdf download.