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Guideline E-08

Question

Answer

No.

The sentence lists a number of separate possible design principles that could be used to obtain suitable and reliable protection; it is not an exhaustive list. “Self-diagnosis” is for example part of the list of separate possible design principles, not an additional requirement. The design principle to be used for any particular application should be based on the analysis required by Annex I preliminary observation 3 and could indicate that other methods are just as suitable or that more than one design principle should be used.