How to Check if Silicone is Body-Safe: ISO 10993, FDA Tips, and Lab Tests

 

Silicone is everywhere now—pacifiers, hospital tubes, even in wearable gadgets. But here’s the tricky part: not every silicone you see is really body-safe. Some is, some isn’t. And figuring that out matters a lot. It’s not just about rules; it’s also about keeping people safe and making sure products don’t fail.

So, how do you check? The answer is a mix of science, paperwork, and a bunch of lab work. It sounds complicated, but once you break it down, it’s not too bad.

What Makes Silicone Body-Safe?

What Does “Body-Safe” Mean?

“Body-safe” is just a way of saying the silicone won’t cause trouble—no rashes, no irritation, no weird reactions. It should sit against skin or even tissue without breaking down. Think about baby products, or the band on your smartwatch. You don’t want something cheap rubbing off chemicals onto your skin.

Why Silicone Works Well

Silicone is kind of special. Chemically it’s mSiO₂ · nH₂O, but in simple words, it’s stable. It doesn’t dissolve in water. It doesn’t smell. It doesn’t let germs grow. Only really strong stuff, like certain acids or bases, can attack it. That’s why you find it in sensitive products—medical, food, even electronics.

ISO 10993 Testing for Safety

What is ISO 10993?

ISO 10993 is the big name in biocompatibility. It’s the standard labs use to check if a material is okay for the body. It looks at cell health, allergies, DNA damage, and general toxicity.

Types of Tests Done

Here are a few tests labs do on silicone:

• Cytotoxicity: does it kill cells?
• Sensitization: does it cause allergies?
• Irritation: does it make skin flare up?
• Short- and long-term toxicity checks
• Blood contact and implant studies

These aren’t just theory—they mimic real situations.

How to Read ISO 10993 Reports

Reports can look heavy, but the key parts are simple:

• Which sections of ISO 10993 were tested
• How samples were handled
• Pass/fail marks
• Whether the lab is accredited

If it’s from a trusted third-party lab, you can rely on it more.

FDA Tips on Silicone Safety

How the FDA Handles Materials

Here’s a point many people miss: the FDA doesn’t approve raw silicone. It only clears finished devices that use silicone. So when a supplier says “FDA compliant,” it usually means the material matches a regulation. But that’s not the same as FDA stamping approval on the silicone itself.

Key FDA Documents to Know

• 21 CFR 177.2600: rubber in food-contact products
• FDA guidance on ISO 10993 testing for devices

What Buyers Should Ask For

Ask suppliers if their silicone has been used in FDA-cleared devices. Check if it meets USP Class VI standards too. And don’t just take a brochure’s word—ask for the actual papers.

Lab Tests Beyond the Basics

Chemical and Strength Tests

Some suppliers dig deeper. They use FTIR or GC-MS to catch hidden fillers. They test how much the material stretches or resists pressure. For instance, silicone that shows 500 PSI tensile strength and holds up to 88 lbs isn’t likely to fail under stress.

Extractables and Leachables

Two terms you’ll hear a lot: extractables (chemicals pulled out in extreme lab setups) and leachables (stuff that might leak out slowly in daily use). For products that stay on the body, these tests matter.

Using Trusted Labs

Look for labs with ISO/IEC 17025 accreditation. CASINDA works with such labs and also uses its own testing gear—like Shore hardness meters and adhesive testers.

Checklist for Verifying Body-Safe Silicone

Documents to Ask For

• ISO 10993 results
• FDA compliance notes
• MSDS sheets
• COA certificates

CASINDA has ISO 9001:2015 and ISO 14001:2015 and keeps clear records.

Checking Supplier Quality

If possible, visit the supplier. If not, ask for a video tour. Check their quality steps: IQC (incoming), IPQC (in-process), and OQC (outgoing). CASINDA has people assigned to each stage for our products service.

Questions to Ask Your Supplier

• Did the silicone pass ISO 10993?
• Has it gone into FDA-cleared products?
• Can I see independent lab reports?
• How do you trace batches?
• Can you run extra tests if I ask?

CASINDA offers fast quotes (1–3 days), samples in a week, and tech support usually in a couple of hours with OEM/ODM.

 

You can’t just trust a sticker that says body-safe. You need real proof: ISO 10993, FDA guidance, lab data, and supplier transparency. That’s how you know silicone is safe. CASINDA supplies silicone for many industries—medical, electronics, automotive—with products like seals, pads, bands, and thermal parts.

FAQ

Q: What’s the difference between medical-grade and food-grade silicone?

A: Medical-grade passes ISO 10993 or USP Class VI. Food-grade follows 21 CFR 177.2600 for food contact. Different tests, different uses.

Q: Is all silicone body-safe?

A: Nope. Only tested and certified silicone is truly body-safe. Always check the reports.

Q: How do I know if silicone is safe for my project?

A: Match the material to the use. Ask for ISO 10993 or FDA documents. Confirm the lab’s credibility. Reliable suppliers explain their process.