BS ISO 6474-2:2019 pdf free.Implants for surgery一Ceramic materials .
Specimens shall be produced in a similar way to the regular production of implants. The same feedstock and comparable shaping technology (e. g. axial pressing, isostatic pressing), high-temperature process (e. g. sintering, hot isostatic pressing) and hard machining [e. g. grinding, polishing) shall be applied.
The shaping and surface finishing of the specimens shall be accomplished according to the requirements of the test. The manufacturer shall declare and justify that the production of the specimens is equivalent to the regular production. Finished products or portions of them can be used for the evaluation of material properties. However, due to geometric restrictions and to the risk of damage during specimen preparation, it is not recommended to produce specimens as portions of finished products for evaluation of the following material properties: strength (6.4); fracture toughness (6.6); cyclic fatigue (6.9). .Produce at least 10 test pieces by sintering and hot isostatic pressing. Choose the sintering and hot isostatic pressing conditions according to the experience of the manufacturer in order to achieve the highest possible density. Analyse the microstructure after this process for any evidence of residual pores.  If no pores can be detected, measure the density according to ISO 18754. The outer surface of the  test pieces shall be ground or polished. Round off the density of each test piece to two decimal places (x,Xx g/cm3). Declare the highest value of all individual density values as the ultimate density.The chemical composition shall be determined either by X-Ray fluorescence in accordance with ISO 12677 or by Inductively Coupled Plasma-Optical Emission Spectroscopy ([ICP-OES) or Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS). If applicable, the manufacturer shall document all inorganic additives which are intentionally added to the composition. Upper and lower limits for these additives shall be defined by the manufacturer. The total amount of these additives is limited to a mass fraction of 10 %. The manufacturer shall identify elements that have an adverse impact on the properties of the composite . as“impurities”. The upper limit of the total amount of these impurities has a mass fraction of 0,2 %. It is recommended that the manufacturer define the upper and lower limits for the amount of alumina and zirconia which shall be measured in accordance with the definition of category 1 (see 4.2.2).BS ISO 6474-2 pdf download.