What certifications should medical silicone parts comply with?
In the medical industry, safety and compliance aren't optional—they're the baseline. Medical silicone parts must meet strict regulatory standards before they’re allowed into real-world applications.Medical silicone parts should comply with ISO 10993, USP Class VI, and often ISO 13485 for manufacturing, to ensure biocompatibility, safety, and regulatory readiness.
May 23,2025