IEC 60601-1-8 recommendations

Reservations

Relying on the Instructions for Use might be unsafe

Section 5.2.1 of IEC 60601-1-8 - Instructions for use, provides a list of requirements about information that should be included in the instructions for use, with reference to table B.3 for additional requirements, which also refers to section 7.9.2 and Table C.5 of the general standard.

Also section 5 instructs that compliance of the system with the instructions for use should be checked by inspection.

Most likely:

• The users will not be able to read all of the instructions,
• when the users will need the instructions, they will forget most of them, and they will not have the time to go through them.

Relying on the standard might be unsafe

A2SubCl-6-3-3-1-c2f-Other-Sets of IEC 60601-1-8 comments: "VALIDATION by USABILITY testing is not required if each set complies with Table 3 and Table 4 (or Annex F)".

However,

Research has shown that users fail to recognize the situation risks based on the standard. This means that the manufacturers do not need to prepare their systems for the unexpected, implying that the customers should test the actual sound perception by users.