Polyester Biocompatibility standards - Anyone here have any experience?

G

gabo1

#1
Dear all,

Does anybody knows about standards on polyester biocompatibility?

My device is an implantable one, constituted by a few components: among the others, there are polyester wovens having the function of connecting the main body of the device to the bone.

My problem is: further to demostrate the biocompatibility of the finished product, is there some astm/iso for the raw material (polyester) in intself?

Thank you in advance!
 
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M

MIREGMGR

#2
Re: Poliyester biocompatibility

The operative standard under both FDA and 13485/MDD of course is ISO 10993.

I don't see how an ASTM standard would be relevant to biocompatibility as defined in ISO 10993, though it might pertain to measurement or qualification of mechanical or biomechanical/biochemical issues such as fabric fiber gauge, weave characteristics, and optimization for biological load-bearing integration and anchoring.

As I'm sure you know, there is no such thing as generic acceptance of a broad chemical class of materials, such as "polyester" or "polyester fabrics". The qualification must be of a particular resin and fiber, and perhaps of a particular weave if the weave process alters the fibers or adds any substances.

Does either the maker of the original resin and/or fiber, or the weaver of the fabric, support the use of their products in implantable applications and already have the ISO 10993 biocompatibility data you need?
 
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