In the fields of medical devices, pharmaceutical processing and biological engineering there has been an increasing demand for sealing with biocompatability
However, O-rings and the standards for biocompatable rubber products are unfamiliar to many designers.
A new website has been created to provide a central location for this information.
When rubber is required to be biocompatable, the best materials are classified as USP Class VI.
This term is reserved for materials that have passed a battery of tests showing that the materials do not generate reactions in mammals.
The USP procedure, 'Biological Reactivity Tests, In Vivo' contains tests for six different levels of biocompatability.
The very most stringent requirements are designated Class VI.
Materials that meet this USP Class VI are materials that have passed tests of biological reaction to extractions and an implantation test.
Without consideration of the final application, USP Class VI is the best indicator that a material will be biologically neutral.
Designers of medical devices are frequently concerned with their device meeting the requirements of ISO 10993.
For a rubber material to meet ISO 10993 requires consideration of the exact end usage of the product in order to determine the appropriate tests.
Designers have found that the USP Class VI designation is their best indicator that materials will pass the required tests in ISO 10993.
In order to allow users of these products a single resource for information associated with USP Class VI O-rings, Molding Solutions has created a website dedicated to this product.
Molding Solutions has been providing USP Class VI O-Rings since 1998.
This gives Molding Solutions the necessary experience to provide guidance in the selection of appropriate products.
The new website contains information about the US and international standards applicable to these O-rings, O-ring dimensional data, product information and available sizes.