Norm

ISO/DIS 14243-5:2017 en

Chirurgische implantaten - Slijtage van totale kniegewricht-prothesen - Deel 5:..................

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Over deze norm

Status Ontwerp
Aantal pagina's 15
Commissie Chirurgische implantaten
Gepubliceerd op 03-01-2017
Taal Engels
This part of ISO 14243 specifies the relative angular movement between articulating patellofemoral joint components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the durability testing of total knee-joint prostheses in wear-testing machines with load control and displacement. This part of ISO 14243 is applied for the qualitative visual assessment of durability of an ultra-high molecular weight polyethylene patella when articulating against a femoral component by observing the occurrence of delamination, cracking, or other damage characteristics that occur as a result of the specified displacement and loading inputs. This standard test method is comprehensive, but it must be noted that it is complex to implement - maybe the most complex in its particular field. The reader/user needs to note that: 1) The main compressive force waveforms are to be calculated to suit the individual implant (size). 2) The waveforms for the kinematics on two testing actuators are calculated to suit the particular geometry of the implant tested involving sophisticated CAD measurements, and in each case thorough care is needed when using degrees or radians for the angle computations in setting up the test. 3) Intricate friction sensitive medial-lateral force imposing fixtures are involved, with measurement needed of such force to be provided on the testing machines.

Details

ICS-code 11.040.40
Nederlandse titel Chirurgische implantaten - Slijtage van totale kniegewricht-prothesen - Deel 5:..................
Engelse titel Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint - Loading and displacement parameters for testing machines and corresponding environmental conditions for test

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