Medical Grade ISO 10993 Silicone
Medical Grade Silicone Sheeting is a specialized material developed for healthcare applications requiring a non-toxic, FDA-compliant solution with excellent resistance to extreme temperatures. The platinum-cured silicone formulation provides durability while meeting strict safety standards. This material is particularly suited for medical gaskets, seals, and other healthcare components due to its ability to withstand ozone, oxidation, ultraviolet exposure, and harsh environmental conditions.
USP Class VI Certification & Compliance
ElastaPro’s Class VI silicone sheeting complies with the rigorous requirements of the United States Pharmacopeia (USP) Class VI and ISO 109930 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.
Product Specifications
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.
Why Choose ElastaPro’s Medical Grade Silicone?
ElastaPro provides high-quality Class VI silicone sheeting 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.
