BS ISO 6474-1:2019 pdf free.Implants for surgery一Ceramic materials.
5 Preparation of specimens Specimens shall be produced equivalent to the regular production of the implants. The same feedstock, 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 of specimens shall be accomplished according to the requirements of the test. The manufacturer shall declare and justify whether the production of the specimens can be assessed as 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 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: a) strength (see 6.4); b) fracture toughness (see 6.6); c) cyclic fatigue (see 6.9).6.2 Chemical composition The chemical composition shall be determined in accordance with EN 725-1 or 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). The upper limits of impurities (total amount of Si02 + CaO + Na2O) shall have a % mass fraction in accordance with the requirements specified in Table 1. 6.3 Microstructure For determination of the alumina grain size, ISO 13 383-1 or EN 623-3 or ASTM E112 shall be applied (linear intercept method). Five test specimens shall be used for the determination of microstructure. NOTE The linear intercept method reveals a nominal average grain size for the selected position of the micrograph, not the distribution of the size of individual grains.The determination of linear intercept grain size shall be organized such that homogeneity of the regular production can be assessed to a sufficient statistical relevance. The manufacturer shall justify the organization of grain size determination for his specific manufacturing process. It is recommended that the manufacturer analyse the reliability, repeatability and maintenance of the manufacturing process with respect to microstructure (e.g. validation) and utilize these data for the organization of the regular production control. If this detailed analysis is accomplished successfully, the regular production control of the microstructure can be performed with a reduced number of specimens and micrographs.BS ISO 6474-1 pdf download.