Platinum-Cured Silicones for Medical Devices and EquipmentOct 31, 2017
Silicone elastomers are formed into solids by curing or cross-linking. In medical applications, the most common curing systems use either peroxide or platinum. The free radical or peroxide system is the oldest cross-linking chemistry for silicones, but requires post-baking to remove byproducts such as volatile organic acids. By contrast, the addition or platinum curing system doesn’t require post-curing because there are no by-products.
SSP-2390 Series silicones are platinum-cured for the highest purity. Consequently, these medical silicones have lower levels of extractables, chemical compounds that migrate from a material under conditions such as elevated temperature or surface exposure. Compared to peroxide systems, platinum curing also offers greater control over cure rates and crosslinking. This means that platinum-cured silicones are more consistent in terms of appearance, an important consideration with medical cables and tubing.
FDA, USP, and RoHS Compliant Materials
SSP-2390 Series silicones comply with FDA CFR 177.2600 requirements for high-purity rubber articles intended for repeated use. This part of the U.S. Code of Federal Regulations (CFR) is reserved for rules established by the Food and Drug Administration (FDA). Section 177.2600 lists allowable materials such as elastomers and additives, and sets the extraction limits.
SSP-2390 Series silicones also comply with USP Class VI requirements for the biocompatibility of materials. used in medical devices and equipment. Part of the U.S. Pharmacopeial Convention (USP), USP Class VI is regarded as one of the most stringent requirements in medical device manufacturing. SSP-2390 silicones also comply with the European Union’s Restriction of Hazardous Substances (RoHS) Directive 2002/95/E.
Material Costs, Product Specifications, and Fabrication Methods
SSP-2390 Series silicones are cost-effective compounds that are available in durometers ranging from 10 to 80 (Shore A). They are normally translucent, but can be colored with FDA compliant pigments to meet your product or equipment designs. Examples of these custom colors include gray, white, red, plumb, olive drab, and salmon.
Sheets of SSP-2390 Series silicones support precision die-cutting for tight tolerances and cost-effective material conversion. These medical silicones are also supplied as ready-to-mold compounds and used with extrusion equipment. Applications include power cables, endoscope cables, and X-ray equipment.
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