Standards Development

Scope

Clause 1 of the general standard[1] applies, except as follows:Replacement:This part of IEC 60601 applies to the basic safety 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.accessories to hearing aids in the home healthcare environment (e.g. remote control units, audio streamers, battery chargers, power supplies) can be tested according to the applicable standard IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied. hearing aids do not have a mains part intended for connection to AC supply mains. The connection to the supply mains of a hearing aid system is covered by power supply, charger or other types of accessories.accessories with functional connection to a hearing aid may form a hearing aid system. hearing aid related accessories that are not physically connected to the hearing aid during normal use are not considered to be applied part, because they do not directly contribute to the intended use of the hearing aid.Wireless programming interfaces are covered by the applicable standard IEC 62368-1 or other applicable IEC safety standards. Alternatively, the general standard may be applied.Programming interfaces with wired connection to the hearing aid are covered by the general standard.NOTE Detachable parts of hearing aids, even if supplied separately (e.g. ear hooks, domes, wax guards etc.), are not considered as accessories, but as component parts. This document does not apply to:–        cochlear implants or other implanted hearing aids;–        bone conduction hearing aids;–        educational hearing aids (i.e. group hearing aids, auditory trainers etc.);–        the application of a hearing aid for the measurement of hearing levels; IEC 60645-1 applies;–        fixed installation audio-frequency induction-loop systems or their component parts, as described in IEC 60118-4 and IEC 62489-1;–        the sound generating function of a tinnitus masker.This document does not address applicable testing for intentional RF radiation of wireless equipment (e.g. maximum radiated output power, modulation bandwidth, etc.).Replacement:The object of this particular standard is to establish particular basic safety requirements for hearing aids and hearing aid systems as defined in 201.3.202 and 201.3.203.Replacement:Collateral standards address specific characteristics of the me equipment not fully addressed by this particular standard and shall apply together with this standard. This particular standard refers to those collateral standards listed in 201.2 Normative references.IEC 60601-1-3, IEC 60601-1-9, IEC 60601-1-10, IEC 60601-1-11 and IEC 60601-1-12 do not apply. When evaluating compliance with IEC 60601-2-66, it is permissible to independently assess compliance with the collateral standards. The collateral standard being used to evaluate compliance shall explicitly be listed.Replacement:In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards as appropriate for the particular me equipment under consideration, and may add other basic safety and essential performance  requirements.A requirement of a particular standard takes priority over the general standard.For brevity, IEC 60601-1 and IEC 60601-1:2005/AMD1:2012/AMD2:2020 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number.The term "this document" is used to make reference to the general standard, any applicable collateral standards and this particular standard taken together.Clauses or subclauses in this particular standard without the prefix “201” refer to the general standard, and the full text of the referenced clause in the general standard applies.Clauses or subclauses in this particular standard with the prefix "201" refer to the corresponding clause or subclause in the general standard with changes to the text of the general standard (e.g. 201.1 in this document addresses the content of Clause 1 of the general standard)The changes to the text of the general standard are specified by the use of the following words:“Replacement" means that the clause or subclause of the general standard or applicable collateral standard, including all its underlying subclauses, is replaced completely by the text of this particular standard, unless any subclauses in the replacement reference the General Standard or an applicable collateral standard"Addition" means that the text of this particular standard is additional to the requirements of the general standard or applicable collateral standard."Amendment" means that the clause or subclause of the general standard or applicable collateral standard is amended as indicated by the text of this particular standard.Where it is intended that any part of the general standard or applicable collateral standard, is not to be applied, a statement to that effect is given in this particular standard.Clauses or subclauses where the full text of the referenced clause in the general standard applies where the text in the general standard further refers to other clauses/subclauses, then the corresponding clauses/subclauses in the particular standard take precedence for those references.Subclauses, figures or tables which are additional to those of the general standard are numbered starting from 201.101. However, due to the fact that definitions in the general standard are numbered 3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201. Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.