I’m considering using Nylon 12 Powder for a medical device application and saw on the TDS that it has passed several ISO 10993 biocompatibility tests. That’s great news, but I was hoping to get more insights. Specifically, I’d like to know about sterilization – Has anyone successfully sterilized Nylon 12 Powder parts using autoclaving, ethylene oxide (EtO), or irradiation? How does it hold up? Any other insights into Nylon 12 biocompatibility for medical devices that interact with (non-skin) tissue would be appreciated. Thank you!
Hi @minaschaafsma! You can find a breakdown of Nylon 12 Powder’s sterilization compatibility in this document: Sterilization Results for Nylon 12 Powder.
Based on the document, Nylon 12 Powder parts have been tested with autoclave (steam), gamma, e-beam, and ethylene oxide (EtO) sterilization. Across all methods, there were no significant losses in mechanical properties, deformations, cracking, or color changes.
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Autoclave (Steam): Nylon 12 parts were subjected to five cycles at 132°C, and no appreciable change in tensile strength, modulus, or strain at break was observed.
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Gamma & E-Beam Radiation: Parts exposed to 25-40 kGy of gamma radiation and 35 kGy of e-beam radiation also retained their mechanical integrity.
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Ethylene Oxide (EtO): Exposed to 762 mg/L EtO at 55°C, Nylon 12 parts showed no degradation.
Additionally, all sterilized parts passed ISO 10993-5 cytotoxicity testing, meaning they did not cause cell lysis or cytotoxicity. However, as with any medical application, application-specific testing is always recommended to ensure the material performs as needed in your exact use case.
Hope this helps! Let us know if you have any other questions.
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