Medical-Grade Silicone & Body-Safe Materials: A Practical Safety Guide

“Medical-grade silicone” is one of the most common phrases on intimate wellness packaging, and one of the least understood. This guide explains what the term does and does not guarantee, why non-porous materials matter for hygiene, which materials to be cautious about, and how to check a product’s documentation before you buy.

Updated October 2026 ยท General information, not medical advice

The short answer

  • Look for non-porous materials: 100% silicone, ABS plastic, borosilicate glass or stainless steel.
  • Treat “medical-grade” as a marketing term unless the manufacturer documents the material and the standards it was tested against.
  • Be cautious with porous or vague materials: jelly, PVC, TPE/TPR and “silicone blends”.
  • Use a water-based lubricant with silicone products, and follow the manufacturer’s cleaning instructions.

What “medical-grade silicone” actually means

In the medical industry, silicone intended for devices is tested for biocompatibility, meaning how a material behaves in contact with the body. Recognised frameworks for this exist, such as the ISO 10993 series of standards for the biological evaluation of medical devices.

Consumer intimate wellness products are generally not regulated as medical devices, and “medical-grade” is not a protected label for them. A brand can use the phrase without any independent verification. That does not mean the claim is false: many reputable manufacturers do use high-purity silicone. It means the phrase alone is not proof. What matters is whether the brand documents the material and its testing.

An international standard dedicated to the design and safety of intimate wellness products, ISO 3533, now also exists. When a manufacturer states compliance with it, that is more informative than the words “medical-grade” on their own.

Why non-porous materials matter

A non-porous material has a smooth, sealed surface. Fluids and bacteria stay on the surface, where cleaning can remove them. Porous materials contain microscopic gaps that can trap moisture and microorganisms, even after washing, which is why they are harder to keep hygienic over time.

Material Porous? What to know
100% silicone No Flexible, durable and easy to clean. Avoid silicone-based lubricants, which can degrade the surface.
ABS plastic No Rigid plastic often used for housings and handles. Easy to clean.
Borosilicate glass, stainless steel No Non-porous and very easy to clean; heavier and rigid.
TPE / TPR Yes Soft and inexpensive, but harder to keep hygienic. Best kept for personal use only.
Jelly, PVC Yes Porous; some formulations have historically used plasticisers such as phthalates.

Phthalates: why they come up so often

Phthalates are chemical plasticisers that make some plastics, such as PVC, softer and more flexible. Several of them are restricted in certain product categories in some regions because of health concerns. Pure silicone does not need plasticisers to be flexible, which is one reason silicone products are generally preferred. As with “medical-grade”, a “phthalate-free” label is most meaningful when the manufacturer publishes the material composition.

Red flags to watch for

  • No material listed, or vague wording such as “silicone blend”, “sil-a-gel” or “body-friendly material”.
  • A strong chemical smell when the product is unpacked.
  • An oily or sticky surface that does not go away after washing.
  • A price far below comparable silicone products from established brands.
  • No manufacturer contact details or safety documentation.

Some online guides suggest testing silicone at home with a flame. We do not recommend it: it is unreliable and can be unsafe. Checking the manufacturer’s documentation is the better approach.

Caring for silicone devices

  • Clean before and after every use with warm water and a mild, fragrance-free soap or a dedicated cleaner.
  • Check the waterproof rating before rinsing: IPX7 devices tolerate brief immersion, while IPX6 or lower ratings only resist splashes.
  • Do not boil or sterilise devices that contain electronics unless the manufacturer explicitly allows it.
  • Use water-based lubricants; silicone-based lubricants can degrade silicone surfaces over time.
  • Let devices dry completely before charging, and store them separately in a breathable pouch so different materials do not touch.
  • Replace a device if its surface becomes sticky, cracked or discoloured.

How IntimPicks assesses materials

We do not test or certify materials ourselves. In every review, we report the materials the manufacturer declares, favour non-porous options, and avoid repeating certification claims we cannot verify. You can read the full approach in our editorial standards.

To compare devices made from body-safe materials, see our best air-pulse devices guide, our Womanizer Duo 2 vs LELO Sona 2 Cruise comparison, or browse all reviews.

Frequently asked questions

Is “body-safe silicone” the same as “medical-grade silicone”?

Not necessarily. Both describe silicone intended to be safe in contact with the body, but neither is a protected label for consumer products. The useful signal is documentation: a declared material, and ideally the standards it was tested against.

Can I share a silicone device?

Non-porous materials can be cleaned thoroughly, but for hygiene reasons, using a condom over a shared device and cleaning it carefully between uses is generally recommended.

What if I have a skin reaction?

Stop using the product and rinse the area with water. If irritation persists or you have a known allergy or sensitivity, consult a healthcare professional.

This guide provides general information and is not medical advice. Always follow the manufacturer’s instructions for use, cleaning and charging.