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The company I work for was recently asked by our notified body to assess the acceptability of all the residual risks that we categorized as ALARP (as low as reasonably possible) in our risk management document. One of the potential hazards in our document assigned a residual risk of ALARP is environmental contamination (our device is an active implantable with external hardware components that are RoHS compliant). My question is: What does environmental contamination mean in terms of harm?