
What the End of USP Class VI Means for Medical Manufacturers
For decades, USP Class VI has been a benchmark for material safety among medical device and component manufacturers. This standard
Medical and pharmaceutical device silicone components provide medical-grade reliability for diagnostic equipment, surgical instruments, and fluid delivery systems.
These high-purity, biocompatible elastomers resist repeated sterilization cycles—including autoclave, gamma, and EtO—without degrading physical properties. Device designers and biomedical engineers rely on consistent material purity to satisfy stringent regulatory scrutiny.
Explore our application guides covering platinum-cure silicone advantages, cleanroom manufacturing standards, and regulatory submission support for healthcare OEMs.

For decades, USP Class VI has been a benchmark for material safety among medical device and component manufacturers. This standard

Buying silicone sheeting and uncured compound might seem like a low-risk activity, even when you’re purchasing spec-grade materials. A silicone
Medical silicone sheeting plays a critical role in healthcare applications that require performance, stability, and biocompatibility under demanding conditions. Unlike

Medical grade silicones from ElastaPro are used for sealing and gasketing in medical devices and equipment. These platinum-cured materials meet