DB9801 requires NHS departments to do tests that include applied parts leakage where applicable. BS EN 60601, etc, etc are manufacturing standards.
We use safety tests to establish whether equipment is safe on installation, i.e. acceptance, and to give an idea of whether a combination of equipment used in a medical system is safe to use, i.e. baseline insulation resistance, earth-bond and leakage measurements for example.
Leakages vary as interconnected components are changed so we also do standalone and system tests to determine whether we need to fit seperating transformers to medical systems or assess the risk they may present in certain applications.
Devices with Type B applied parts are an example of an applied part that can present a more significant risk when used in certain environments. It's not as cut and dry as implying applied parts tests are "type-tests" thus uneccessary.
Safety testing using a safety analyser shouldn't be used as an excuse for doing basic maintenance checks, i.e. visual and physical inspection, including functional verification.
