After installation or later modification an ME system creates no unacceptable risk, only the hazards from combining equipment being considered, and it gives, inside the patient environment, the safety level that equipment meeting this standard would give and, outside it, the level set by the equipment's own IEC or ISO safety standards; tests are performed in normal condition unless specified and under the system manufacturer's operating conditions, without repeating safety tests already performed on the individual equipment; the manufacturer of a system the responsible organisation or operator can reconfigure may use risk management to determine the highest-risk configurations and the measures needed so no configuration presents unacceptable risk; non-ME equipment in the system complies with the IEC or ISO safety standards relevant to it; and equipment whose shock protection relies only on basic insulation is not used in a system; documents and certificates are inspected to confirm compliance.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.