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Screen gasket standards - USP Class VI, EP 3.1.9, FDA

U.S. Pharmacopoeia Class VI Certification

The United States Pharmacopeia (USP) establishes standards to ensure the quality of medicines and other healthcare technologies. These include biological reactivity tests for "Elastomeric plastics and other polymeric material with direct or indirect patient contact", which are divided into six classes. Class VI has the most stringent testing and is widely used and accepted in the medical products industry.

EP 3.1.9

The European Pharmacopoeia (EP) of the Council of Europe is a listing of a wide range of active substances used to prepare pharmaceutical products in Europe. Monograph 3.1.9 "Silicone elastomer for closures and tubing" includes specific tests such as the level of residual peroxide and mineral oil content.

FDA

The U.S. Food & Drug Administration (FDA) "ensures that the food we eat is safe and wholesome, that the cosmetics we use won't harm us, and that medicines, medical devices, and radiation-emitting consumer products such as microwave ovens are safe and effective". Although not strictly a medical grade standard, FDA Food Grade is often used when selecting a silicone rubber for a medical application. This standard refers to "Rubber articles intended for repeated use with food".

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