ISO 14233:2003 pdf download

ISO 14233:2003 pdf download.Dentistry – Polymer-based die materials.
6.5.2 Procedure
Use the same three polymer-based die material specimens as specified in 6.3. At 24 h after the preparation of the polymer-based die material specimens, make five indentations with a loading time of 30 s on the surface of each specimen that has set against the impression of the ruled test block (see 6.3.2.1). For measuring the indentations, use low-angle illumination. Complete the test within one hour.
6.5.3 Treatment of results
Determine the mean hardness value for each of the three specimens. Each mean shall be in accordance with
4.6.
If one specimen fails to comply, repeat the test with three new polymer-based die material specimens. All three new specimens shall be in accordance with 4.6.
7 Manufacturer’s instructions and user information
Instructions for use, together with the description of the product, shall be provided by the manufacturer with each set or package of polymer-based die material, together with at least the following information:
a) name and address of manufacturer and/or distributor;
b) trade name of the polymer-based die material;
c) method of polymerization;
d) range of application of the polymer-based die material;
e) type of impression material (according ISO 4823) with which the polymer-based die material is compatible;
f) principal components;
g) method of proportioning the components and mixing, and temperature, humidity and ambient light conditions during mixing, if relevant;
h) any special precautions regarding the manipulation;
i) procedure for the application;
j) working time in minutes;
k) setting time or polymerization procedure;
l) Vickers hardness HV 0,2 at 24 h after mixing;
m) recommended conditions for storage of components and shelf-life under those conditions.
8 Packaging and marking
8.1 Packaging
The polymer-based die material shall be supplied in packaging such that the contents are adequately protected [see 8.2.1 f) and 8.2.2 e)].
An outer pack may also be used to present the containers or a set as a single unit.
NOTE The containers are the immediate wrapping of the polymer-based die material.
8.2 Marking
8.2.1 Outer pack
Each outer pack shall be marked with at least the following information:
a) name and address of manufacturer and/or distributor;
b) trade name of the polymer-based die material;
c) method of polymerization;
d) net content of the components in grams or millilitres;
e) recommended storage conditions;
f) expiry date expressed as year and month in accordance with ISO 8601 when stored according to the recommended conditions;
g) batch identification.
8.2.2 Containers
Each container shall be marked with at least the following information:
a) name of the manufacturer and/or distributor;
b) trade name of the polymer-based die material;
c) net contents in grams or millilitres;
d) recommended storage conditions;
e) expiry date expressed as year and month in accordance with ISO 8601 when stored according to the recommended conditions;
f) batch identification.