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Quality is important in just about every industry, but when it comes to medical devices, quality is a life-and-death consideration. Low-quality or incompatible materials can cost lives and cause illnesses.
That’s why the U.S. Food and Drug Administration (FDA) has stepped in to regulate which materials can be used in medical devices. One of the most common materials involved in these devices, for which the FDA has issued clear standards and regulations, is silicone.
So, which silicones are FDA-approved for use in medical devices? Which other standards govern whether and how these materials may be used? And what properties do these materials have? We explore all that and more in this blog post. Read on to learn more.
You can’t take risks on quality when you’re making medical devices. That’s why so many engineers and designers partner with Modus Advanced for their medical device projects. We promise premier quality for every project. Contact us to learn more.
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About FDA CFR 177.2600
As you likely know, the FDA regulates foods, drugs and medical devices. It’s a federal government agency, and many of its directives are encoded in the Code of Federal Regulations (CFR). It’s in that lengthy tome that you will find CFR 177.2600, the statute that regulates the materials that can be used in medical devices intended for repeated use.
To simplify what is kind of a long read, any silicone you intend to use in a medical device must comply with CFR 177.2600. The regulation discusses the specific materials cleared for use in devices that are intended for medical use or that will touch food that will be consumed, including the properties of those approved materials.
About USP Class VI
USP material testing classes are broken into six groups of standards, with Class VI being the most stringent. This is the testing class you will need any silicone you use in a medical device to pass.
That’s because USP Class VI ensures that the tested material is biocompatible with use in humans, meaning it will not cause harm. That is determined in a few ways:
- Systemic injection. In this part of the USP Class VI testing, a test subject is injected with an extract derived from the material being tested and monitored for signs of toxicity.
- Intracutaneous testing. This portion of the testing monitors skin reactions to the extract from the material under testing.
- Implantation testing. This part of the testing looks for any reactions in the test subject’s tissue after being in constant contact with the material for several days.
As you can see, USP Class VI testing is rigorous — which is exactly what you need to ensure that all FDA-approved materials used in your medical devices are truly safe for use.
About RoHS Compliance
In the European Union, which materials can be used in medical devices is governed under a directive titled Restriction of Hazardous Substances in Electrical and Electronic Equipment (gracefully shortened to RoHS). While compliance with RoHS isn’t required for all silicones meant for medical use, it is still an important consideration for the overall quality of your design even if you aren’t making something for use in the EU.
Examples of FDA/USP VI Silicones
Some silicones are compliant with FDA CFR 177.2600, while others are compliant with USP Class VI or RoHS. But few are compliant with all three regulations. Those silicones that are compliant with this trio of guidelines are among the highest quality materials available.
Here’s an example of such a silicone: the SSP-2390 Series of silicones. Specialty Silicone Products (SSP) is known for its high-quality silicones, and the SSP-2390 Series certainly exemplifies that attribute.
All silicones in the SSP-2390 Series are translucent silicone elastomers that comply with FDA CFR 177.2600, USP Class VI and RoHS. They are heat-cured, platinum-catalyzed and available in durometers that range from 10 to 80.
Platinum-cured silicones like these are cleaner and more pure than those cured with peroxide, making them ideal for use in medical devices. The other benefits of platinum curing include more robust physical properties and lower shrinkage.
Modus: High-Quality Materials and Manufacturing for Medical Devices
Even if you have the perfect FDA-approved materials picked out for your medical device, your project can fall completely flat if you pick the wrong manufacturing partner. Small, careless mistakes on the shop floor can lead to stalled projects or, worse, faulty medical devices. And you can’t have that.
You can’t have that, so don’t. Don’t partner with a manufacturer who puts profit or anything else ahead of quality. At Modus, we put quality first in everything we do, from medical devices to aerospace and defense devices, because we want to work with customers like you — customers who value the kind of quality we offer.
Interested in learning more? We’re ready to tell you everything you need to know about working with us. All you have to do is reach out to our team. Give us a call at 925-960-8700 or contact us online today.