Replacement:
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM.
If a clause or subclause is specifically intended to be applicable to HEARING AIDS only, or to HEARING AID SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to HEARING AIDS and to HEARING AID SYSTEMS, as relevant.
HAZARDS inherent in the intended physiological function of HEARING AIDS or HEARING AID SYSTEMS within the scope of this document are not covered by specific requirements in this document.
This document does not specify any acoustical gain or output limits, as these depend on the individual needs of the user, which are determined by THE HEARING AID FITTING PROCESS. The HEARING AID FITTING PROCESS is not within the scope of this document. Requirements or limits related to the BASIC SAFETY of normal-hearing users relate to external references.
This document contains criteria for acoustical SAFETY for DIRECT-to-CONSUMER HEARING AIDS.
Required fields are indicated with *
