We decided not to define the SafetyClassification in our core DevSpecs (see ticket [p11073-10721:#23]. Maybe it can be done in the Conformance Classes (see ticket [p11073-10721:#39])
Thus, we shall describe this decision and our motives. I think we should do this in the introduction of all DevSpecs and if necessary also in ModSpecs.
Currently, the working hypothesis is that we will define no or only a very small number of SafetyClassification values in our standards.
Content Collection
- The SafetyClassification can only be derived from the particular risk management for a particular device by a particular manufacturer.
- For all elements, especially for Metrics and Operations, this has to be done by the manufacturers. PKIP standards and SDC core standards have to be considered as well as particular standards, like IEC 60601, regulatory software life cycle process standards, like IEC 62304 etc.
- Conformance Classes might require minimum requirements.
