In regulations, there is usually a basic requirement that any claim of performance (including accuracy of a measurement function) must be verified in both design and regular production. You should meet these requirements even if there is no standard. The requirements can be found in Europe, Australian, Canadian, Japanese and US regulations, as well as in ISO 13485.
For example, in Europe, MDD Annex I, item 3:
"The devices must achieve the performances intended by the manufacturer ...".
Items 4 and 5 then refer to this performance not being adversely affected by conditions of normal use, transport and storage.
The 601 series is not really designed to reflect this basic requirement. The approach of the standard is risk based, which is of course highly subjective. For example, many manufacturers claim their device has no "essential performance". Even particular standards which cover measurements functions tend to be selective in the functions checked.
For me the main mistake in the standard is not to come out and say clearly: "this standard does not necessarily provide evidence of achieving performance as claimed by the manufacturer. Although not covered by this standard, it may be a regulatory requirement".