Medical Device Seal Components | USP Class VI ISO 10993 Compliant

A medical O-ring is a toroidal sealing component manufactured from biocompatible elastomeric materials—such as silicone (VMQ), EPDM, or PTFE—that comply with standards like USP Class VI and ISO 10993. They are used in medical devices, drug delivery systems, surgical instruments, and pharmaceutical processing equipment to provide reliable, leak-free seals that are safe for patient and drug contact.

Several elastomeric materials are widely accepted for FDA-regulated applications, including Silicone (VMQ/LSR), EPDM, PTFE, and certain grades of FKM and NBR. The key requirement is that materials must pass USP Class VI cytotoxicity testing and/or ISO 10993 biocompatibility assessment. DSC can supply gaskets in all of these materials with full compliance documentation.

USP Class VI is a biological test classification defined by the United States Pharmacopeia (USP) for plastics and elastomers used in pharmaceutical and medical applications. It involves a series of in-vivo biocompatibility tests—including systemic injection, intracutaneous, and implantation tests—to confirm that a material is non-toxic and safe for use in drug contact or patient-contacting medical device components.

ISO 10993 is an internationally recognized series of standards for evaluating the biocompatibility of medical device materials. For seal components, compliance means the elastomeric material has been assessed for cytotoxicity, sensitization, irritation, and other biological risks. DSC supplies seals with materials tested and documented to ISO 10993 requirements, supporting your device's regulatory submission.

DSC offers a broad range of biocompatible seal materials including Silicone (VMQ), Liquid Silicone Rubber (LSR), EPDM, FKM (Fluorocarbon), PTFE, and TPE/TPU. Material selection depends on the specific application—chemical media, temperature range, sterilization method, and regulatory requirements. Our technical team can assist in selecting the optimal compound for your application.

Yes. Detroit Sealing Components manufactures LSR (Liquid Silicone Rubber) components in a Class 1000 cleanroom using automated, closed-loop production processes. This minimizes contamination risk and ensures maximum product purity—critical for medical device and pharmaceutical applications requiring stringent cleanliness standards.

Absolutely. DSC specializes in custom sealing solutions using computer-aided design (CAD) and finite element analysis (FEA). We work with medical OEMs to develop seals to exact design parameters, selecting from hundreds of biocompatible compounds and validating performance in our ISO 17025 accredited lab supported by an ISO 9001:2015 certified quality system. Prototypes can be bench-tested under customer conditions prior to full production.

DSC operates as a stocking warehouse and distributor with a strategic location and established supply chain, enabling swift delivery of standard medical-grade seal components. For custom solutions, lead times depend on complexity and tooling requirements. Contact our team for specific availability and delivery estimates for your application.