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The move to 3rd edition brought many changes to the standard. Some of the major differences are the introduction of a formal risk management process to the equipment to ensure safe and reliable operation. Equipment has also been broken out into that which could come into contact with an operator or a patient under normal use. The standard has also expanded past just general safety to now also require essential performance which helps to ensure a product behaves as it’s expected to during a problem and not just “fail safe” as the old standard required. In an effort to help make life easier for manufacturers and safety compliance people the standard also attempted to harmonize terminology with other safety standards. There are also now altitude multiplication factors for determining clearance distances required at different operational altitudes. Finally, the requirements for surface temperature limits have been updated.
