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Dec 2016

FDM type 3D printing is not considered for safe because of the layers and gaps associated with this type of printing there are some good resources online just look for 3d printing and “food safe” Is this for some sort of “body modification” (just guessing as autoclaves are commonly used by piercers and tattooist’s) UV can be used to sterilise but it does break down some plastics such as ABS

Thank you for the input.

My purpose is to 3D print a free form that will come in temporary contact with wounds. Thus it needs to be clinically sterile before use.

Therefore, i would appreciate if someone could give me hints on what printing technology i should use, and what material, in combination with an effective sterilization method.

Formlabs resin can be printed on any SLA or DLP style printer; Formlabs will most likely recommend the Form2, which is the printer I use. I highly recommend it.

Sterilization like for a medical device?

I think this is something you’re going to have to experiment with. Radiation (Gamma or E-Beam) will cause embrittlement and color changes in most plastics as there’s a lot of cross linking of polymer structures. Some people tint polycarbonate plastic an ice blue color because it will turn a sickly yellow otherwise.

I can’t offer anything about Ethelene Oxide except it’s not very practical in small batches, and autoclave is probably not an option for any thermoplastic you can print.

Regards,

Matt

As others here have said, SLA or DLP is far better than FDM printing if you want to reduce surface defects. FDM will leave large spaces for contaminants and bacteria to grow within, but the resin produces a much smoother surface at a microscopic level.

Hi, I know for a fact that you can use PA2200 which is a nylon powder used on EOS Printers. This material can be sterilised, using various methods. Definitely worth looking into, but you may want to have a look around because if it is going to be in contact with an open wound you will want to make sure the manufacturers have the relevant certificates and conform to standards.

12 days later

We’re currently working with both ABS and PETG for a blood-contacting device that will be sterilized prior to packaging. So, we’re needing both sterilizability and hemocompatibility. Depending on your final application, you may want to look at PETG, it’s compatible with both gamma irradiation and EtO (ethylene oxide) sterilization methods. If you need to go with autoclaving, then you may want to look at nylon as it can handle the higher temperature.

Going forward in my project, autoclave seems like one essential requirement… I will definitely look at the possibility to manufacture using Nylon.

Thank you for the input

We decided t go with Autoclave. That forces us to look into Nylon or other material than can handle autoclave temperature.

As mentioned, Taulman’s Nylon 680 is one of your best options - Nylon 680 Spec 117

It’s FDA approved and autoclavable, but may not be approved for your particular use. Taulman may have additional info that may help you decide.

Thank you for the input.

The only medical grade (bio-compatible) material i find from Taulman is Guidel!ne.

And it seems like you can not autoclave it…

Yes! PA2201 and 2200 is biocompatible according to ISO10993 and you can autoclave it.

Thank you for the input. I will check what degree of bio-compatibility is needed exactly for my device.

Also “EOS PEEK HP3” seems like a possible choice.

It’s not a problem, I know that PA2200 can be used in making medical cutting guides, but if you are looking for a material that is implantable you would have to run tests and studies.