Products

Medical Grade Silicone

Medical silicone from ElastaPro meets ISO 10993 and USP Class VI requirements. This solid silicone sheet and uncured silicone compound is designed for healthcare applications that require a safe, non-toxic, and biocompatible FDA-compliant solution.

ElastaPro’s platinum-cured silicone formulation is durable, provides excellent resistance to extreme temperatures, and meets strict safety standards. Use it for medical gaskets, seals, and other healthcare components because of its its ability to withstand ozone, oxidation, ultraviolet exposure, and harsh environmental conditions.

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Medical Grade Silicone Sheets and Medical Grade Silicone Compound

Medical grade silicone sheets from ElastaPro come in standard sizes from .010” to .500” thick and in widths of up 60”. They are available with a pressure-sensitive adhesive (PSA) backing and support flash cutting, die cutting, laser cutting, and other fabrication processes. In addition to medical grade silicone sheets, ElastaPro offers medical grade uncured silicone compound. When ordering these materials, please indicate whether USP Class VI or ISO 10993 compliance is required.

What is Medical Grade Silicone?

Medical grade silicone is a type of silicone that meets specific quality and safety standards suitable for healthcare applications. These materials are often required to meet USP Class VI or ISO 10993 requirements for biocompatibility. It is made using highly purified compounds for biocompatibility, meaning it is unlikely to cause adverse reactions when in contact with the human body. It is also well-known for its durability and resistance to extreme temperatures, making it ideal for medical devices and implants.

Unlike other types, medical grade silicone is subjected to stringent quality control and testing procedures to guarantee it meets the highest purity standards. This article will explore the properties of this synthetic polymer, highlighting why it is exceptionally valuable in the medical industry.

The following features make this component essential in the healthcare industry, ensuring patient safety and well-being:

Biocompatibility

This property is extremely critical in the medical field, as it ensures that the human body has well-tolerated silicone devices and implants. Whether employed in pacemakers, joint replacements, or catheters, the material’s biocompatibility contributes to the overall success of medical interventions.

Chemical and Fluid Resistance

Medical grade silicone is highly resistant to bodily fluids, chemicals, and the sterilization processes commonly performed in healthcare settings. This resistance ensures the tool remains stable and maintains its structural integrity over extended periods. Moreover, its tolerance to various chemicals means it can withstand exposure to disinfectants and medications without deteriorating.

Electrical Insulation

This feature is useful in medical equipment with electronic components. Silicone can efficiently separate and shield delicate circuitry from moisture and external factors, guaranteeing devices’ safe and dependable operation. Examples include defibrillators, infusion pumps, pacemakers, and other diagnostic machines.

Flexibility and Durability

One of silicone’s characteristics is its capacity to be customized to varying levels of flexibility while keeping structural integrity. This feature enables it to resemble the softness of human tissue in medical procedures like breast implants. Its flexibility is also beneficial in prosthetics and tubing, where it needs to conform to the body’s contours or undergo repeated bending.

Hypoallergenic Nature

Because this silicone is hypoallergenic, it is less likely to cause allergic responses when it comes into contact with the skin. This is critical in situations where the material is near the patient, such as wound dressings or skin-contacting medical devices. Patients can be confident that the equipment is compatible with their bodies, lowering the chance of skin irritations or allergies.

Resistance to Bacteria Growth

The silicone’s resistance to bacteria growth is critical in preventing infections when used in medical devices or prosthetics. Its properties make it less conducive to the attachment and proliferation of harmful microorganisms, reducing the risk of device-related diseases. This is particularly essential in implants like urinary catheters or long-term indwelling instruments.

Thermal Stability

Medical grade silicone can withstand extreme temperature fluctuations without losing its qualities. This is especially important in hospitals where sterilization keeps medical devices clean. Autoclaving is a popular disinfection method that involves subjecting instruments and equipment to high-pressure steam at elevated temperatures.

Transparency and Clarity

Some silicone formulations provide optical clarity and transparency. This unique feature benefits ophthalmic applications such as intraocular and contact lenses. The material’s clearness allows for optimal light transmission, improving the quality of vision correction and minimizing distortion.

ISO 10993 Medical Silicone

ElastaPro’s medical grade silicone passes the following ISO 10993 tests.

  • Cytotoxicity
  • Hemolysis
  • Pyrogenicity
  • Sensitization
  • Dermal Irritation
  • Implantation (90 Days)

The test items showed no relevant biological effects in the studies that were performed.

USP Class VI Medical Silicone

ElastaPro’s medical silicone sheeting complies with the rigorous requirements of the United States Pharmacopeia (USP) Class VI and ISO 10993 designations.

The United States Pharmacopeia (USP) Class VI designation is a strict biocompatibility standard for materials used in medical and pharmaceutical applications. It guarantees that materials meet high safety levels by undergoing a series of biological tests to confirm their non-toxicity and suitability for prolonged human contact. To meet this certification, the material undergoes multiple safety tests, including:

  • Systemic Toxicity Test: Evaluates the potential for adverse effects when the material comes into contact with biological systems.
  • Intracutaneous Test: Assesses potential irritation when exposed to human tissue.
  • Implantation Test: Determines biocompatibility for long-term medical applications.

This certification makes sure that the material meets safety and performance standards necessary for medical devices and healthcare applications requiring prolonged human contact.

Medical Silicone Sheeting from ElastaPro

ElastaPro offers Medical Grade Silicone Sheeting in various configurations to meet diverse application needs. This material is available in thicknesses ranging from 0.010” to 0.500”, with custom width options up to 60 inches. To support a broad range of healthcare applications, color-matching capabilities are also offered. For applications requiring easy adhesion, sheets can be supplied with Pressure Sensitive Adhesive (PSA) backing.

The sheeting is available in multiple durometer ratings to accommodate different performance requirements. Options include:

  • 30 Durometer Healthcare Grade
  • 40 Durometer Healthcare Grade
  • 50 Durometer Healthcare Grade
  • 60 Durometer Healthcare Grade
  • 70 Durometer Healthcare Grade

Lower durometer ratings provide flexibility, while higher durometer options offer increased stiffness and support for structural applications.

Benefits of Medical Grade Silicone

Medical applications require materials that deliver consistent performance under demanding conditions. ElastaPro’s Medical Grade Silicone Sheeting is designed for durability, offering high resistance to environmental factors such as temperature fluctuations, oxidation, and UV exposure. The platinum-cured silicone base minimizes the risk of contamination, making it an excellent choice for medical devices, pharmaceutical processing, and laboratory equipment. This material also provides reliable sealing properties, making it ideal for gaskets and enclosures that require a dependable barrier against moisture, chemicals, and biological contaminants.

Applications in Healthcare & Medical Devices

Medical Grade Silicone Sheeting is widely used in healthcare and medical device manufacturing. Its compliance with USP Class VI silicone standards allows for safe use in various critical applications, including:

  • Gaskets and seals for medical devices.
  • Protective barriers for diagnostic and laboratory equipment.
  • Components for pharmaceutical and biotechnology industries.
  • Medical enclosures that require long-term biocompatibility.

Frequently Asked Questions about Medical Silicone

What is medical silicone?

Medical silicone is a biocompatible, non-toxic elastomer. It is engineered to safely interact with human tissue and bodily fluids without causing adverse reactions.

Why is silicone used in medical devices?

Silicone provides high biocompatibility, chemical inertness, flexibility, thermal stability, and durability. These properties make it ideal for tubing, catheters, and wearable medical devices.

Is medical silicone FDA approved?

Not necessarily. In the United States, medical grade silicone needs to meet FDA requirements. In other parts of the world, such as Europe, other standards apply.

Can medical silicone be sterilized?

Yes. It withstands common sterilization methods such as autoclaving, gamma radiation, and ethylene oxide without degrading.

What are the main types of medical silicone?

There are three main types of medical grade silicone.

  • Liquid Silicone Rubber (LSR): Used for precision molding of implants and seals.
  • High-Consistency Rubber (HCR): Used in extrusion for tubing and gaskets.
  • Room-Temperature Vulcanizing (RTV): Used for coatings and adhesives.

Is medical silicone safe for implants?

Not necessarily. Some medical-grade silicones are safe for implants. Others are not.

What certifications apply to medical silicone?

  • ISO 10993: Biological evaluation of medical devices.
  • USP Class VI: Biocompatibility testing for plastics.
  • FDA 21 CFR compliance: For materials in contact with food or the human body.
  • Bgvv: This is a German standard.

How long does medical silicone last in the body?

It is highly durable and can remain functional for years, depending on the application.

Are there risks or limitations?

Yes. With USP Class VI silicones, for example, materials are considered safe for contact with human skin or bodily fluids for less than 29 days.

Why Choose ElastaPro’s Medical Silicone?

ElastaPro provides high-quality USP Class VI silicone sheeting that designed to meet the needs of the medical industry. With precise material formulations and a commitment to compliance, this silicone sheeting is an ideal choice for manufacturers looking for a reliable, FDA-compliant material.  For more information or to request a quote, contact ElastaPro today.