Many of the medical and healthcare products we use require the use of specific medical-grade elastomers. The elastomers often need to be odourless, be latex-free, and contain no phthalates. Phthalates have primarily be used to help soften Polyvinyl Chloride, but are being phased out in the United States, Canada and EU due to health concerns.
There are a host of companies that produce medical-specific elastomers, all meeting different requirements.
Many elastomers now are formulated specifically for skin contact applications, in accordance with standard EN ISO 10993:10: Tests for sensitisation and Irritation. This is particularly relevant for respiratory equipment and wound care products.
Sterilisation by a number of methods such as gamma or Beta irradiation, as well as the use of ethylene oxide and steam is also an important requirement for medical products and there are a number of elastomers that are specifically designed to allow these forms of sterilisation without having a negative effect on the material properties.
Gm Design & Development has experience in working with medical grade elastomers over the years and has a pool of knowledge and contacts that will reduce development time and ensure the correct material is chosen for your application.