[Objectives and limits of test standards].
BACKGROUND
Test standards are developed worldwide by extremely committed expert groups working mostly in an honorary capacity and have substantially contributed to the currently achieved safety standards in reconstructive orthopedics. Independent of the distribution and quality of a test specification, the specialist knowledge of the user cannot replace a well founded risk analysis and if used unthinkingly can lead to a false estimation of safety.


CONCLUSIONS
The limits of standardization are reached where new indications or highly innovative products are concerned. In this case the manufacturer must undertake the time and cost-intensive route of a self-developed testing procedure which in the ideal case leads to a further testing standard.


CONCLUSIONS
Test standards make a substantial contribution to implant safety but cannot replace the expert knowledge of the user. Tests as an end to themselves take the actual objectives of standardization to absurdity.
EndoLab®, Mechanical Engineering GmbH, Seb.-Tiefenthaler-Str. 13, 83101, Thansau, Deutschland, christian.kaddick@endolab.org.
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D019544:Equipment Failure Analysis / Q000592:standards*; D004869:Equipment Safety / Q000592:standards*; D017408:Guidelines as Topic; D038622:Internationality; D007595:Joint Prosthesis / Q000592:standards*; D008422:Materials Testing / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D012015:Reference Standards