Especially for organic materials such as hydroxyapatite, TCP, Collagen etc.
Dear Umbu,
For HA based coatings you can check, ISO 13779-1, 13779-2, 13779-3, 13779-4.
Regards,
Fatih.
Hello - If you are developing a new medical device please look at ISO 10993 and determine which of the tests apply to your device. I would also recommend looking at the FDA Guidance for using ISO 10993 (just put that phrase into google or go to the FDA website). They break the different implants into 3 tiers of risk and contact duration then provide recommendations (requirements?) for the tests they would like to see. If this is an animal derived material you will also need to consider ISO 22442, which includes controls for TSE transmission and viral transmission. If you have a purely synthetic material you can leave out the 22442 or if you are getting your collagen from a supplier they may have the applicable safety data for the right price.
Good luck!
Thanks for the suggestion, really helpful. Incidentally my research relates to the use of cuttlefish shells as a source of hydroxyapatite and b-tricalcium phosphate I will then combine with type I collagen.
Trimkasih this advice is very helpful.
Regards
Krisman
Indonesia
The plan of my research is the extraction of type I Collagen from stingray skin
OK, then your risk analysis through 22442 should be relatively straightforward then. There is no prion disease likely in stingrays (mad stingray disease??) and you can likely eliminate the need for any viral inactivation testing based on no known zoonotic diseases transmissible from stingrays to humans. You will still need to do a risk analysis in line with the standard and will certainly need to perform testing in line with 10993
Good luck.
Well, thanks for the suggestion. If later I encounter obstacles. Of course I will discuss again.
regards
Krisman
Indonesia
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