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iNEMI » cms » projects » medical
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Projects
Medical TIG iNEMI organized the Medical TIG at the request of several of our OEM and EMS members associated with the medical electronics product sector. This TIG is proposing an initial project that will establish baseline reliability requirements for implantable electronics. Component suppliers for the implantable market are being held to many different standards because there is no industry minimum guideline. In addition, Pb-free requirements for the medical sector are not well-addressed or understood. Although medical products are exempt from RoHS, manufacturers are, nonetheless, being pushed to move toward Pb-free. The proposed project will address Pb-free and general reliability specifications for implantable medical products and external support equipment. It will focus on minimum standards for medical product reliability to enable (1) easier entry into the market for parts suppliers (because they will know what the requirements are) and (2) easier and faster OEM supply chain management (because requirements for supplier companies are standardized). The switch to Pb-free will eventually affect the medical industry, and the Medical TIG is expected to address such areas as: chip/PWB finish (e.g., 100% tin finishes have caused failures and recalls of implanted devices), PWB reliability requirements (driven by cleanliness issues, process concerns etc.), and chip/component qualification standards (e.g., defining specifications for incoming reliability). PRESENTATIONS: iNEMI Medical TIG Forum, hosted by the US FDA (November 14) Initiatives Medical Components Reliability Specifications Project
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