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ISO 5834-2-2011 pdf free download
ISO 5834-2-2011 pdf free download.Implants for surgery Ultra-highmolecular-weight polyethylene Part 2:Moulded forms.
Implants chirurgicaux — PolyéthylOne a trés haute masse molOculaire — Partie 2: Produits sous forme moulée.
In the moulding process, no liquid or powdery release agents shall be used (such as silicon or talc-based release agent) in order to avoid contamination, migration and moulding defects.
6.1 Physical properties
When measured using the appropriate test method, as defined in Table 1. the physical properties of the moulded material shall conform to the relevant values given in Table I for each type of material.
The physical properties shall be measured on material in the consolidated and annealed state before further processing. Subsequent manufacturing processes can influence the comparison of test results.
6.2 Particulate matter
When visually inspected using normal or corrected vision with no magnification, not more than ten particles shall be visible on the surface of a sample or samples prepared in accordance with 7.8.
CAUTION — The UHMWPE powder and the semi-finished and finished products for this application are not equipped with light stabilizers and should therefore be protected against the influence of ultraviolet radiation.
7.1 Test conditions
Unless otherwise specified, the testing specified in 7.2 and 7.4 to 7.7 shall be conducted under standard conditions of (23 ± 2) °C after storage of the test specimen for at least 16 h under these conditions.
The density shall be measured by means of method A (immersion method) specified in ISO 1183.1, using at least three specimens. The mean of the results on the three test specimens shall not exceed the value given in Table 1.
The ash shall be measured in accordance with ISO 3451-1:2008. method A. performing duplicate tests on each of two test specimens at (700 ± 50) C. The mean of the results on the two test specimens shall be less than the value given in Table 1.
7.4 Tensile stress at yield
The tensile stress at yield. cry, shall be determined by the tensile test specified in ISO 527-1. using an extensometer to measure the strain and applying a test speed of (100 ± 10) mmlmin. At least five test specimens of thickness (1,5 ± 0,5) mm shall be tested. The mean of the results on the five test specimens shall not be less than the values given in Table 1.
7.5 Tensile stress at break
The tensile stress at break, °A shall be measured during the test described In 7.4. The mean of the results on the five test specimens shall not be less than the values given in Table 1.ISO 5834-2-2011 pdf free download.
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