Importance

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Abstract

Embodiments of the invention are directed to manufacturing a medical device in a way that minimizes the possibility of defects. Because of the general increasing desire to eliminate lead from the environment, electronic producers are removing lead from their manufacturing processes. The lead had beneficial qualities, however, in that it prevented other metals, in particular tin, from developing “whiskers,” believed to be caused from thermal and mechanical stress of the tin parts or components. Removing the lead has caused an increasing incidence of failure in electronic devices. Many vendors, believing that lead-free devices are universally desirable, routinely substitute lead-free components for components that previously contained lead. Oftentimes these substitutions are made without knowledge of the buyer. Some devices, in particular life-saving devices, may be adversely affected by such a substitution. Embodiments of the invention prevent non-specified goods from being assembled into the medical device by generating evidence or requiring that vendors generate evidence of component composition for particular components that may be at risk for premature failure in the medical device.

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First Claim