Silicones are soft and flexible materials, suitable for use in clean environments because the polymer does not support microbiological growth. Silicones satisfy the highest quality standards demanded by medical and health care standards. Medical grade silicones are silicones tested for biocompatibility (according to USP Class VI or ISO 10993) and are appropriate to be used for medical applications and implantations for less than 29 days. Unlike latex, which may cause allergic reactions, silicone is hypoallergenic.
Since silicones are composed of only a few, defined ingredients, they constitute a clean, plasticizer-free and flexible elastomer with low extractable content and clean aesthetic appearance, suitable for any medical of helthcare and comfort application. Unlike plastic or rubber, they also do not contain phthalates (used as plasticizers), leach out of tubing when heated and have been found to disrupt the endocrine system and cause other undesirable effects.
Gomline can provide you sutable material and certificates.
Being inherently water repellent and having an inorganic backbone that makes them resistant to UV rays and coupled with high resistance to detergents and cleaning agents, as well as being extremely resistant to hot water and hot air makes them an ideal choice for medical applications.
Medical grade silicones come into direct contact with human skin. Consequently, silicone-based products for this application area must satisfy the most stringent of demands on quality, reliability and safety. Medical products include tubing, drains, feeding tubes, catheters, implants for long and short term use, seals and gaskets, etc. Most processing methods (CM, TM, IM) can be used for producing medical articles, provided they are carried out in a suitably clean environment