BS ISO 5834-2-2011 pdf download.Implants for surgery 一 Ultra-high-molecular-weight polyethylene Part 2: Moulded forms.
7.3 Ash
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, , 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) mm/mm. 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, R’ 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.
7.6 Elongation at break
The elongation at break, , 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.
7.7 Notched impact strength
The double-notched impact strength, UCN, shall be determined by the impact test specified in either ISO 11542-2:1998, Annex B (Charpy) or ASTM F648:2007 (Izod).
In case of doubt or dispute, the test method specified in ISO 11542-2 shall be used as the reference method.
7.8 Sample area for extraneous matter
A total machined surface area of (500 x 10) mm2 shall be taken from locations within the fabricated form. The area examined shall include both transverse and longitudinal samples, or it may be produced by repeated sectioning through the thickness of the fabricated form.
8 Identification marking
Each item supplied shall be identified with at least a lot identification. A marking, which can also be a serial identification, with reference to the lot identification, may be repeated at intervals along the length of the item.
9 Test certificate
Each lot shall be supplied with a test certificate stating the results of the tests conducted and conformance with
the requirements of this part of ISO 5834. The test certificate shall include the following information:
a) reference to this part of ISO 5834. i.e. ISO 5834-2:2011;
b) statement of material type, i.e. Type 1 or Type 2 or Type 3;
C) lot number or serial number with reference to the lot number;
d) number of items;
e) test values in accordance with the appropriate clauses of this part of ISO 5834;
f) description of the UIMWPE annealing treatment as agreed by the purchaser and the vendor.BS ISO 5834-2 pdf download.