SCS ParyFree Meets ISO 10993 Biocompatibility Testing Requirements

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Specialty Coating Systems, Inc. (SCS), a global leader in Parylene conformal coating services and technology, announced that its newest Parylene variant, ParyFree®, complies with ISO 10993 biocompatibility testing requirements. ParyFree’s conformance demonstrates its ability to serve as a biocompatible surface for direct and indirect tissue contact, and suitability for use in many critical medical applications, including medical electronics. 

Testing in accordance with ISO 10093 was completed at an independent testing facility and included cytotoxicity, acute systemic toxicity, sensitization, irritation/intracutaneous reactivity, hemocompatibility and implantation (2, 12 and 26 weeks). ParyFree also is certified to comply with the biological test requirements for United States Pharmacopeia (USP) Class VI Plastics for use as a polymer to contact and/or contain pharmaceuticals. SCS Parylenes N, C and Parylene HT® also meet the testing requirements of ISO 10993 and USP Class VI Plastics.

In addition to meeting biocompatibility test requirements, SCS ParyFree has been independently tested in accordance with BS EN 14582:2007 to verify its efficacy as a halogen-free material and IEC 60529, test conditions 14.2.7 and 14.2.8 for IPX7 and IPX8 designations, which demonstrates protection from harmful effects due to the ingress of water. 

ParyFree coating offers the same beneficial properties expected from the Parylene family but with improved barrier protection over traditional halogen-free variants. Although there are many non-hazardous uses of halogens, electronics have historically utilized brominated compounds as effective flame retardants, only to later learn of issues created when these electronics were improperly disposed of by incineration. The worldwide effort to minimize the use of halogens, therefore, aims to increase long-term environmental safety.

Uses for ParyFree range across the medical device spectrum and include consumer healthcare devices such as monitors and wearables in addition to critical medical electronics and long-term implants. Additionally, many medical applications include heating and cooling technologies, which take advantage of the improved thermal conductivity of ParyFree over other available Parylene variants.