M
I could use some advice regarding selection of materials given that our device will eventually be tested for ISO 10993-1 biocompatibility.
We are presently in the design/development stage, and do not yet have a prototype, however the specifications we're working from have stipulated that all materials must be "ISO 10993 compliant".
What does this even mean?
As far as my understanding of ISO10993, devices are subjected to a battery of tests depending on the final application (duration of contact, breached/in-tact skin, implantable/surface).
So to say that selected materials are ISO10993 compliant (some of our material suppliers have made this claim) before knowing the final application is questionable, no?
That being said, assuming that we do intend to get the final prototype tested, are there any guidelines that we can follow when selecting materials? Ideally we'd like to find a predicate device, but so far have been unsuccessful as companies are reluctant to divulge their own material specs and suppliers.
As always, any advice greatly appreciated.
Thanks in advance,
M
We are presently in the design/development stage, and do not yet have a prototype, however the specifications we're working from have stipulated that all materials must be "ISO 10993 compliant".
What does this even mean?
As far as my understanding of ISO10993, devices are subjected to a battery of tests depending on the final application (duration of contact, breached/in-tact skin, implantable/surface).
So to say that selected materials are ISO10993 compliant (some of our material suppliers have made this claim) before knowing the final application is questionable, no?
That being said, assuming that we do intend to get the final prototype tested, are there any guidelines that we can follow when selecting materials? Ideally we'd like to find a predicate device, but so far have been unsuccessful as companies are reluctant to divulge their own material specs and suppliers.
As always, any advice greatly appreciated.
Thanks in advance,
M