Medical & Food-Grade Silicone: Platinum Cure, Biocompatibility and Certification
Platinum-cure vs tin-cure silicone, ISO 10993, USP Class VI, FDA 21 CFR 177.2600 and what documentation medical and food-contact silicone parts need.
September 7, 20262 min read
Written by Konstantin Dolgan, Ph.D., NPDP
Founder & CEO, Product Development Engineer
Published September 7, 2026
Medical and food-grade silicones are not just cleaner versions of industrial rubber. They are formulated, cured, tested and documented to meet specific regulatory requirements. Skipping any of those steps can turn a promising product into a recall risk.
Platinum cure vs tin cure
Platinum-cure silicones use a platinum-based catalyst and cure at moderate temperatures without byproducts. They are preferred for medical and food-contact applications because they are purer and less likely to leach residues. Tin-cure silicones use an organotin catalyst, cure at room temperature and are cheaper, but they are generally not suitable for skin contact or food contact.
Biocompatibility testing families
- ISO 10993 series: the standard framework for evaluating biological risk of medical devices.
- USP Class VI: a United States Pharmacopeia test for plastics in drug and medical applications.
- FDA 21 CFR 177.2600: regulation covering rubber articles intended for repeated food contact.
The exact tests depend on contact type and duration. A short-term skin-contact device may need cytotoxicity, sensitization and irritation tests. A long-term implantable device needs a much broader battery.
Food-grade requirements
Food-contact silicone must meet FDA 21 CFR 177.2600 for repeated use, or equivalent state and international rules. Pigments, fillers and additives must also be food-contact compliant. Dishwasher and sterilization durability must be tested because heat and detergent can degrade non-compliant formulations.
Documentation for production
- Material data sheet with lot number and cure system.
- Biocompatibility or food-contact test summary.
- Certificate of conformance for each production lot.
- Process validation records for molding, post-cure and cleaning.
Cleaning and sterilization
Medical silicone parts must survive the intended cleaning method without degrading, discoloring or losing mechanical properties. Common methods include autoclave, gamma irradiation, ethylene oxide and chemical disinfection. Each can affect pigmentation and surface finish, so we validate the chosen method on production-equivalent samples.
Case examples from our work
Our Burple burp catcher uses food-grade silicone chosen for dishwasher safety and soft skin contact. The Dignity & Empowerment nurse-call cover uses medical-grade silicone with glow pigment, validated for cleaning and hospital use.
Standards and documents at a glance
Reference | What it covers | Typical use case |
|---|---|---|
ISO 10993 | Biological evaluation of medical devices, including cytotoxicity, sensitization and irritation testing | Devices with patient or skin contact |
USP Class VI | Biological reactivity testing of plastics and elastomers | Supplier grade selection for medical parts |
FDA 21 CFR 177.2600 | Rubber articles intended for repeated food contact | Food-contact silicone parts sold in the US |
Platinum cure vs tin cure | Cure chemistry; platinum systems avoid tin catalyst byproducts | Skin, food and medical contact parts |
Related reading
See silicone rubber prototyping and manufacturing for process options, Burple for a food-contact baby product, and medical product development for hospital-facing work.
Developing a medical or food-contact silicone product?
Start the validation pathFrequently asked questions
Is all platinum-cure silicone medical grade?
No. Platinum cure is a curing chemistry, not a grade. A platinum-cure silicone still needs biocompatibility testing and proper documentation to be used in a medical device.
Can food-grade silicone be used for medical devices?
Generally no. Food-contact compliance does not replace medical biocompatibility testing. The intended use and contact duration determine the required tests.
How long does material validation take?
Simple cytotoxicity and sensitization screens can take a few weeks. Full ISO 10993 batteries can take several months and may require animal testing or validated alternatives. We plan the test path before tooling so it does not delay launch.
Does LA NPDT manage testing?
We help clients select the right test plan and coordinate with accredited labs. We do not run animal or clinical studies in house, but we prepare samples, documentation and traceability for the lab.
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