ISO 10993 Silicones
ISO 10993 silicones meet the requirements of an international standard for evaluating the biocompatibility of medical grade silicones. ISO 10993 contains more extensive testing requirements than USP Class VI and ensures that medical devices don’t cause adverse biological reactions in the people who use them.
ElastaPro is a Made in USA manufacturer of ISO 10993 silicones. We offer these materials as solid silicone sheets, continuous rolls, and uncured compound. Our medical grade silicones also meet FDA Title 21 CFR 177.2600, USP Class VI, and European Pharmacopoeia requirements. Contact us to request a quote or discuss your medical device or equipment application.
What is ISO 10993?
ISO 10993 is a standard from the International Standards Organization (ISO) that provides a framework for evaluating a silicone’s suitability for medical uses. More specifically, it covers risk management, material characterization, testing protocols, and device categories. Compliant materials are biologically inert and pass specific tests for cytotoxicity and irritation/sensitization.
Ultimately, ISO 10993 is designed to ensure that medical grade silicones won’t harm patients through toxicity or immune system reactions. It’s testing standards for the biological evaluation of medical devices are more extensive than those of USP Class VI, but testing medical silicones to ISO 10993 is more than most non-implantable applications require.
Ask ElastaPro for ISO 10993 Silicones
Do you need ISO 10993 silicones for medical devices or equipment? Contact ElastaPro for specifications grade solid silicone sheets, continuous rolls, and ready-to-mold compounds. Our medical grade elastomers meet ISO 10993 requirements and they also comply with FDA Title 21 CFR 177.2600 regulations and USP Class VI and European Union Pharmacopeia standards.
