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Pre-Clinical Testing in the Field of Arthroplasty: Potentials, Limitations and Demands Regarding Test Methodology
Publikationstyp
Book Part
Date Issued
2023-05
Sprache
English
Institut
Citation
1st EFORT European Consensus Medical & Scientific Research Requirements for the Clinical Introduction of Artificial Joint Arthroplasty Devices (2023)
Publisher
Efort
What are potentials and what are limitations of pre-clinical testing in the field of arthroplasty?
1. Which parameters can actually be assessed/evaluated with regard to e.g. device testing (mostly standardized) and functional
testing of the implant (e.g. load transfer, implant stability etc)?
2. Which are the known aspects and failure modes to be tested for providing sufficient pre-clinical evidence?
3. Are there additional alternatives or are there additional ways to generate supplementary data/information?
Which demands must the test methodology of pre-clinical testing in the field of arthroplasty meet?
1. How is the evaluation of safety and performance of an implant possible at an early stage in the development process?
2. With the introduction of a new design principle or material, should there be a risk assessment of potentially new failure modes
and consequently additional testing required for the highest risk mode(s)?
3. Which number of specimens is reasonable in pre-clinical testing and how should the number be determined?
1. Which parameters can actually be assessed/evaluated with regard to e.g. device testing (mostly standardized) and functional
testing of the implant (e.g. load transfer, implant stability etc)?
2. Which are the known aspects and failure modes to be tested for providing sufficient pre-clinical evidence?
3. Are there additional alternatives or are there additional ways to generate supplementary data/information?
Which demands must the test methodology of pre-clinical testing in the field of arthroplasty meet?
1. How is the evaluation of safety and performance of an implant possible at an early stage in the development process?
2. With the introduction of a new design principle or material, should there be a risk assessment of potentially new failure modes
and consequently additional testing required for the highest risk mode(s)?
3. Which number of specimens is reasonable in pre-clinical testing and how should the number be determined?