Biomedical Engineering Reference
In-Depth Information
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Intended use of the device
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Measurements and measuring instruments to be used
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Sterility requirements
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Lifetime of the device
In addition one should consider the following joint implant system criteria:
a)
Medical and Engineering Criteria
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Material and wear product compatibility
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Adequate mechanical strength
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Minimization of the joint reaction forces
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Minimization of fixation interface tension
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Avoidance of fixation interface shear
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Uniformity of interface compression
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Duplication of anatomical function
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Adequate fit for the patient population
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Manufacturability
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Inventory costs
b)
Medical and Surgical Criteria
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Treatment of a broad variety of pathologies
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Maximal preoperative options
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Maximal intraoperative options
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Maximal postoperative options in case of failure
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Salvagability
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Tolerance for misalignment
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Ease of implantation
3.2.3.6 Verification
Verification of the design should be performed at designated phases of the design
process, to verify that the design output is consistent with the required input, using
methods appropriate to the design as determined by the Design Committee and
defined in the Design Plan. These methods may include:
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Determination of motion
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Stress analysis
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Simulator testing for loading and wear
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Manufacture and testing of prototypes
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Testing of materials
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Biocompatibility studies
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Comparison of the proposed design to similar approved
devices on the market, including any clinical investigations
