Biomechanical Testing of Orthopaedic Implants

[mpfizer]

please let me know the biomechanical standards applicable for testing orthopaedic implants viz plates, screws ,nails, hip and knee joints if any

for ISO 13485 and CE marking of the above what are the mandatory biomechanical tests required

Thanks

michelle

 

[pkost]

Hi

You may want to look at the following

http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=53116
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=53110

There are quite a few standards for joint replacements but there are comparatively few for screws plates etc. Joints replacements are obviously being extensively researched and there may be tests that are state of the art which are yet to be standardised. These would be worth investigating

Hope this helps