ISO 14949:2001 pdf download

ISO 14949:2001 pdf download.lmplants for surgery —Two-part addition-cure silicone elastomers.
6.5 Physicomechanical properties and characterization
Each production lot of addition-cure silicone elastomer shall be tested for its mechanical properties after cure. The test slab shall be prepared in accordance with the supplier’s recommended procedure.
The cure schedule (time and temperature) shall be specified as well as the post-cure schedule if needed.
The supplier shall indicate the following mechanical characteristics, which shall be measured in accordance with ISO 527-2, ISO 34-1 and ISO 48 as appropriate:
— elongation at break (%);
tensile strength at break (MPa);
modulus at 100 % elongation (MPa);
— tear strength, die B (kN/m); hardness (IRHD);
relative density, or specific gravity (kg/rn3).
7 Documentation
7.1 Data sheet
The supplier shall provide, upon request and for each type of two-part addition-cure silicone elastomer, a data sheet including at least the following information:
a) the raw material supplier’s name, address and telephone number;
b) the product reference;
c) the recommended procedure and conditions to store the non-crosslinked material in its original unopened container and the shelf-life expected under these conditions;
d) the recommended cure procedure, including the recommended mixing procedure with ratio of part A to part B, the recommended cure schedule (time and temperature) and recommended post-cure schedule if needed;
e) the range of properties, with defined specification limits and test methods, including cure/post-cure conditions;
f) the recommended sterilization methods, including the method(s) that is (are) not recommended;
g) any known restriction of use and/or statement about applications that are not recommended;
h) the biological and physical properties of the cured silicone elastomer, including conditions of sample preparation. Biological properties should be addressed by supplying compatibility test data summaries;
i) the time needed to reach 90 % of the final torque shall be part of the product specification (see ISO 3417).
7.2 Certificate of analysis
For each production lot of addition-cure silicone elastomer, the supplier shall provide a certificate of analysis that lists the results of the testing performed in accordance with the specifications and requirements listed in clause 6 of this International Standard, and a statement that: “This two-part addition-cure silicone elastomer meets the requirements for qualification testing as described in ISO 14949, Implants for surgery— Two-part addition-cure silicone elastomers”.
A.1 Objective
The “Substances soluble in hexane” test is described in summary in the European Pharmacopoeia [1] and allows the determination of hexane extractables in silicone elastomer.
This annex provides a more detailed standardized quantitative procedure (adapted from the European Pharmacopoeia text) in order to ensure reproducible and comparable results.
A.2 Principle
The extraction of substances soluble in hexane from cured material (silicone elastomer) is carried out using reflux condensation, and the results reported as the percent mass fraction of residue.
A.3 Sample preparation
A.3.1 General
Two cases shall be considered:
— non-cured elastomer (non-processed);
— cured elastomer already processed (tubing, etc.).
A.3.2 Non-cured elastomer
The material shall be cured in order to obtain a slab of homogeneous thickness of (2,0 ± 0,2) mm which allows physical testing (tear strength, for instance, in accordance with ISO 34).
Conditions used for curing (temperatures, time, pressure, post-cure) having direct influence on results shall be recorded and given with results.
Once cured, the slab shall be cut into 5 mm x 5 mm pieces, observing the experimental precautions given in A.6. The sample geometry has a direct influence on the test results; therefore it is recommended to follow the dimensions above for comparison. If another geometry is chosen, it shall be reported in the results.
A.3.3 Already processed “cured” elastomer
In the case of tubing or another processed material, it is recommended that the sample dimensions be identical to those indicated above. In all cases the dimensions shall be reported.
A.4 Reagents
All reagents shall be of at least “reagent grade” or “for analysis” purity.