Norm

NEN-ISO 18192-1:2011 en

Chirurgische implantaten - Slijtage van totale tussenwervelschijfprotheses - Deel 1: Belasting en verplaatsingsparameters voor slijtagebeproeving met verplaatsingscontrole en corresponderende omgevingscondities voor beproeving

106,87

Over deze norm

Status Definitief
Aantal pagina's 26
Commissie Chirurgische implantaten
Gepubliceerd op 01-03-2011
Taal Engels
This part of ISO 18192 defines a test procedure for the relative angular movement between articulating components, and specifies the pattern of the applied force, speed and duration of testing, sample configuration and test environment for use for the wear testing of total intervertebral spinal disc prostheses. Both lumbar and cervical prostheses are addressed. This part of ISO 18192 is not applicabe to partial disc replacements, such as nucleus replacements or facet joint replacements. The test method focuses on wear testing. Additional mechanical tests, such as fatigue testing, can be required. This part of ISO 18192 does not reproduce the complex in vivo loads and motions. The wear data obtained with this test method enables comparison between different types of implants, but can differ from the clinical wear performance. The user of this part of ISO 18192 can consider running additional wear tests addressing specific safety issues of the individual implant design under test. This second edition cancels and replaces the first edition (ISO 18192-1:2008), of which it constitutes a minor revision. The main modifications are the introduction of the term "cycle limit" (an explicit statement that a different cycle limit can be used with appropriate justification) and the change of the required concentration of calf serum in the fluid test medium to 20 g protein/l.

Details

ICS-code 11.040.40
Nederlandse titel Chirurgische implantaten - Slijtage van totale tussenwervelschijfprotheses - Deel 1: Belasting en verplaatsingsparameters voor slijtagebeproeving met verplaatsingscontrole en corresponderende omgevingscondities voor beproeving
Engelse titel Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
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