I don’t like “risk assessment.” It is highly subjective and not scientific. Read ISO 14971 or any treatise on risk assessment.
I use the “energy transfer model.” This is not subjective and highly scientific. It was first proposed by James J. Gibson in 1961: “Injuries to a living organism can be produced only by some energy interchange.” The first step is to identify the energy sources within a product. The second step is to class the energy sources as capable of causing injury or not. The third step is to provide the energy sources capable of causing injury with one or more safeguards to prevent the transfer of energy to a body part. The fourth step is to test the adequacy of the safeguards. Easy and straight-forward. Not subjective. Rich - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
