Hello all, thanks in advance for any insight provided.
I am trying to find a list of specific ISO 10993 / medical device approved plastics for a project we are working on.
The device could be:
"in contact with a potential wound (portal of entry) and never left in place, then materials tested for short term implant ISO 10993 should be suitable. Depending on the durability needed, numerous polymers have been developed for medical instruments to be left in place for a few seconds to a few hours, such as catheter tubing. The ISO 10993 series of standard tests for biocompatibility should be your guide for selecting materials that meet your need. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM348890.pdf
"
in my searches I have mostly run across “branded” plastics or polymers from specific manufacturers, but I am looking for a more general list of the plastics such as polypropylene that are considered viable for above use and certified as ISO compatible under these considerations AND will function for injection mold manufacturing. My thanks.
I have had some experience with medical products in the past. What I have found is that lots of polymers have medical grade versions. e.g.
PC
PC/ABS
TPE
PP
PE
PPSU
In the book “The plastics handbook by Chris Leftri” (All of his books are great reference books) PPSU is refereed as a good replacement for stainless steel in certain areas of medical. The material can with stand high temperatures which is great due to constant sterilisation in the form of steam cleaning or chemical.
Just search for some of the plastic manufactures and include medical: Polyone, Dupont. Also Matweb maybe of assistance.
If you read the ISO 10993 certification process, it is done on the finished good, not on the resin itself.
Also, by the looks of the testing necessary, I have only done testing for temporary contact with skin or mucous membranes, your cost is going to be well into the 6 figures (and you will need to kill many hamsters).
The resin manufacturer would have to do that testing for every different product made from the resin at 6 figures each. They would never take on that cost.
The finished good manufacturer is under no obligation to publish what specific resin they used and what manufacturing process, or post process they may have used. They will not give you a “hint”. They will not lower a competitor’s barrier to entry.
So such a list you specified doesn’t exist. But I think most plastics will pass, especially your basics like PE, PP, PC and ABS. They are generally pretty inert to these tests.
There is no such thing as a general list, as much as that would make life easy, as how a polymer is produced has a large effect on what residual chemicals are left in it, many of these chemicals are not nice. This is why producers will often have a list of products that are suitable for healthcare use and a note saying “you must contact us if you plan on using this for blah blah blah”. What they’re trying to convey is that they can produce said material with controls in place to ensure low quantities of specific residuals that are known to be problematic for humans. Some companies do sell products where just that specific product has passed several specified 10993 tests. This will of course not guarantee that your final article is going to pass all of the relevant 10993 tests, as someone else mentioned the focus of 10993 is on the finished article and not the component polymers, but it will build your confidence that your finished article has a good chance of being non toxic/carcinogenic etc.
This, and the other replies, are obviously not the replies you were hoping for, but hey, welcome to my life!
I dug out my chart for evaluation tests. From the OP, it sounds like you have a “External communicating device” and the contact duration is “Limited, <24h”.
Then it depends on body contact - “Blood path, indirect”, “Tissue/bone/dentin communicating”, or “Circulating blood”.
For “Blood path, indirect” and “Circulating blood”, you will need to run cytotoxicity, sensitization, irritation and systemic toxicity. I’d ballpark that at about $30K.
For “Tissue/bone/dentin communicating”, you will only need to run cytotoxicity, sensitization and irritation. I’d ballpark that at $15K.
If you are doing “Prolonged, >24h to 30 days”, you may need to run genotoxicity and haemocompatibility. Those could tip you into the six figures area.