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IEC 62304

Safety classifications of medical devices and the possible risk of software errors are hidden behind IEC 62304, which requires manufacturers to adapt the effort for software documentation to the degree of possible damage that could occur due to a software error. Medical device manufacturers are required to classify their products and medical devices into one of three safety classes. These are differentiated into:

  • Safety Class A: includes software systems that may contribute to the hazard but carry a low risk that can be remedied by external control measures and thus do not expose a health risk.
  • Safety class B: involves software systems that can contribute to the hazard but, as in safety class A, the risk can be limited by external control measures so that they can only contribute to minor health hazards as a result.
  • Safety class C: includes software systems that can contribute to health hazards. Unlike in safety classes A & B, the risk can be partially limited by external control measures, but serious damage to health and fatalities cannot be ruled out.