Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root

S

srinu

Registered
#1
#1
Dear All,
We would like to do the Biocompatibility test for our Knee implant system (Femoral component-Cobalt chrome),so I would like to know the Sub chronic toxicity test(ISO 10993-11) choice of root ..
We have 1.Dermal 2.Implantation 3.Inhalation 3.Intradermal 4.Intramuscular 5.Intraperitoneal 6.Intravenous 7.Oral 8. Subcutaneous roots
which root is suitable for the device femoral component for Sub chronic toxicity test?

Please have a look and give us your valuable suggestions and any evidence data.

Thanks in advance.
 
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planB

planB

Super Moderator
#2
#2
srinu,

ISO 10993-11:2006 says in section 4.3 "The test route of exposure shall be the most clinically relevant to the use of the device, where possible. If an alternative route of exposure is necessary, it shall be justified." and in Annex A.1: "Expert consultation is suggested when designing appropriate studies." So "implantation" would be an obvious clinically relevant route, but you may also chose another clinically relevant route - and you may talk back to your test house to design the most appropriate study.

Hope this helps,
 
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