Liveo? MDX4-4210 BioMedical Grade Elastomer is a pourable two- component product which, when combined, cures to a translucent silicone rubber over several hours at room temperatures, but may be more rapidly cured by application of heat (see Curing).

The elastomer component consists of a dimethylsiloxane polymer, a reinforcing silica and a platinum catalyst. The curing agent component consists of a dimethylsiloxane polymer, an inhibitor and a siloxane crosslinker. Liveo? MDX4-4210 BioMedical Grade Elastomer is made to exacting specifications to meet high quality standards for medical applications.

Composition

Two-part silicone elastomer

Applications

Liveo? MDX4-4210 BioMedical Grade Elastomer is designed for use in medical device encapsulating and moldmaking applications where cure is at room temperature or slightly elevated temperatures. It has for example, been used as a flexible mold to facilitate the encapsulation of electronic components of biomedical devices.

Can be used for general prototyping, molding and fabrication of medical device components. Can also be used as a drug matrix for controlled release drug delivery systems.

- Room temperature and heat accelerable cure

- Good thick section cure - Excellent dielectric properties

- Essentially no shrinkage when cured at room temperature

- Contains no peroxides, peroxide by

- products, chlorophenyls or PCBs

- Contains no organic plasticizers, phthalates or latex additives

- Non-blooming - Pigmentable

Qualified to address the tests described in ISO 10993-1 for "limited" ( 24 h) and "prolonged" ( 30 d) contact duration: Meets or exceeds acceptance criteria for Cytotoxicity, Sensitization, Irritation Intracutaneous reactivity,  Systemic toxicity (acute) and Subchronic toxicity (as tested by implantation)

Meets requirements of screening tests described by specific ISO standards for Hemocompatibility and Genotoxicity Meets or exceeds testing requirements of: United States Pharmacopeia (USP) Class VI European Pharmacopoeia (Ph. Eur. or EP ) silicone elastomers for closures and tubing-"Substances soluble in hexane" and "Volatile matter" Batch-to-batch consistency