Standards under preparation

Scope:

This part of International Standard IEC 61094

– is applicable to laboratory standard microphones meeting the requirements of IEC 61094-1 and other types of condenser microphone having the same  mechanical dimensions;

– specifies a primary method of determining the complex pressure sensitivity so as to establish a reproducible and accurate basis for the measurement of sound pressure.

All quantities are expressed in SI units.

Scope:

This document specifies performance specifications for personal sound exposure meters, details of the tests necessary to verify conformance to all mandatory specifications for the purpose of pattern evaluation, and procedures for periodic testing of a personal sound exposure meter.

Personal sound exposure meters conforming to the requirements of this standard have a specified frequency response for sound incident on the microphone from all directions.

This document is applicable to instruments that are designed to be worn on a person in a configuration specified by the manufacturer for the measurement of sound immission resulting from steady, intermittent, fluctuating, irregular, or impulsive sounds. For reproducibility of results, specifications and tests for the response to sound waves apply without an operator present in the sound field.

This document specifies performance requirements for personal sound exposure meters of one performance class. The specifications generally correspond to those for a class 2 integrating-averaging sound level meter as given in IEC 61672 1 for an A-weighted sound pressure level range from 70 dB to 137 dB and a nominal frequency range from 20 Hz to 8 kHz. The design goals and the acceptance limits for deviations from the design goals are representative of the performance of practical instruments. Personal sound exposure meters are unlikely to be suitable for measurement of sound levels outside these ranges.

Pattern evaluation tests and periodic tests described in this edition of this document apply to personal sound exposure meters for which the manufacturer claims conformance to the specifications given in this edition of this document.

The purpose of pattern evaluation is to determine whether a model of personal sound exposure meter conforms to all the performance specifications given in this document.

The purpose of periodic testing is to assure the user that the individual personal sound exposure meter conforms to the applicable performance specifications for a limited set of key tests and for the environmental conditions under which the tests are performed. The extent of the periodic tests is deliberately restricted to the minimum considered necessary. Because of the limited extent of the periodic tests, evidence of pattern approval is necessary to state that the individual personal sound exposure meter conforms to the complete set of specifications of this document.

The aim is to ensure that pattern evaluation and periodic testing are performed in a consistent manner by all laboratories.

Scope

This document is applicable to Assistive Listening Systems for hearing aid users based on broadcasting streaming audio in the ISM band.

This document covers the properties of the hearing aids as receivers of broadcasted streaming audio transmissions, the properties of the broadcasting streaming audio transmitters as well as methods for verifying the proper performance of the system. Furthermore, a method for measuring the coverage of a broadcasting streaming audio transmitters is specified.

This document applies to single transmitter systems only. This document specifies the signal levels for the audio signals to be transmitted for hearing aid purposes. This includes both average and peak input signal levels. Throughout this standard it is assumed that the hearing aids used conform to all relevant parts of IEC 60118.

Introduction:

In 1998, the hearing aid industry represented by the European hearing instrument manufacturers association (EHIMA) attempted to establish a standard with the main purpose of providing manufacturers with a guide to demonstrate conformity with the European Medical Devices Directive 93/42/EEC.

The draft document prEN 50220 failed CENELEC vote and was published as “EHIMA standard” in June 1998 with almost identical content. EHIMA concluded in 2009 that the requirements of that standard were no longer up to date and an internationally accepted standard for hearing aid safety published by IEC or ISO to demonstrate compliance with regulatory requirements should be produced.

This particular standard amends and supplements IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, hereinafter referred to as the “general standard”.

A general guidance and rationale for the requirements of this particular standard are given in Annex AA. It is considered that knowledge of the reasons for these requirements will not only facilitate the proper application of this particular standard but will, in due course, expedite any revision necessitated by changes in clinical practice or as a result of developments in technology. However, Annex AA does not form part of the requirements of this document.

Scope:

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 except in 201.7.9.2 and 201.9.6.

NOTE See also 4.2 of the general standard.

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 60065, IEC 60950-1, 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 60065, IEC 60950-1, 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;

–    fix installed 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.).

Introduction:

Developments in the field of diagnostic hearing measurement have resulted in a number of instruments designed to evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals having different frequencies and temporal characteristics.

The practical use of such instruments concerns to a large extent the measurement of changes in acoustic impedance/admittance caused either by varying the air pressure in the external acoustic meatus or by activating the middle ear muscle reflex.

Scope:

This part of IEC 60645 applies to instruments designed primarily for the measurement of acoustic impedance/admittance in the human external acoustic meatus using a stated probe tone. It is recognized that other probe signals may also be used. The standard defines the characteristics to be specified by the manufacturer, lays down performance specifications for three types of instruments and specifies the facilities to be provided on these types. This standard describes methods of test to be used for approval testing and guidance on methods for undertaking routine calibration.

The purpose of this standard is to ensure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. The standard is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches.

Introduction:

Developments in the field of diagnostic hearing measurement have resulted in a number of instruments designed to evaluate the auditory evoked potentials of the human hearing system which can be evoked by acoustic or vibratory signals having different spectral and temporal characteristics. The practical use of such instruments concerns the measurement of these electric potentials and their separation from electric signals emerging from other physiological or artificial sources.

Scope:

This part of IEC 60645 applies to instruments designed for the measurement of auditory evoked potentials from the inner ear, the auditory nerve and the brainstem, evoked by acoustic and/or vibratory stimuli of short duration. This part of IEC 60645 defines the characteristics to be specified by the manufacturer, specifies performance requirements for two types of instrument, screening and diagnostic, and specifies the functions to be provided on these types.

The purpose of this part of IEC 60645 is to ensure that measurements made under comparable test conditions with different instruments complying with this standard will be consistent. This part of IEC 60645 is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches.

The application of electric stimuli for special purposes is beyond the scope of this standard.

Scope:

This part of IEC 60118 gives recommendations for the measurement of the performance characteristics of  ir conduction hearing aids measured with an acoustic coupler or occluded ear simulator.

This document is applicable to the measurement and evaluation of the electroacoustical characteristics of hearing aids, for example for type testing and manufacturer data sheets.

This document is also applicable for the measurement of the performance characteristics of hearing aids  or production, supply and delivery quality-assurance purposes.

The measurement results obtained by the methods specified in this document will express the performance under conditions of the measurement and can deviate substantially from the performance of the hearing aid under actual conditions of use.

This document primarily uses an acoustic coupler according to IEC 60318-5 which is only intended for loading a hearing aid with specified acoustic impedance and is not intended to reproduce the sound pressure in a person’s ear. For measurements reflecting the output level in the normal human ear the occluded ear simulator according to IEC 60318-4 can be used. For extended high-frequency measurements and for deep insert hearing aids, the acoustic coupler according to IEC 60318-8 can be used.

This document also covers measurement of hearing aids with non-acoustic inputs, such aswireless, inductive or electrical input.

This document does not cover the measurement of hearing aids for simulated in situ working conditions, for which IEC 60118-8 can be applied.

This document does not cover the measurement of hearing aids under typical user settings and using a speech-like signal, for which IEC 60118-15 can be applied.