EN IEC 60645 Electroacoustics - Audiometric Equipment

The “ EN IEC 60645 Electroacoustic - Audiometric equipment” standard, which is based on a European standard and subsequently published by the International Electrotechnical Commission (IEC) , consists of the following sub-sections published under the same title:

• The standard “EN IEC 60645-1 Part 1: Equipment for pure tone and speech audiometry” describes the general requirements for audiometers designed to be used to determine hearing threshold levels based on standard reference threshold levels established by means of psychoacoustic testing methods and for audiometers designed to perform psychoacoustic tests using speech material.

The purpose of this standard is to ensure that:

• To ensure that hearing tests in the frequency range 125 Hz to 16 kHz in a given human ear, performed with different pure tone audiometers conforming to this standard, will produce essentially the same results.
• To ensure that the results obtained represent a valid comparison between the hearing of the tested ear and the hearing reference threshold.
• To ensure that a means of presenting speech material to a subject is provided in a standardised way. This ensures that hearing tests using a given speech signal and a given form of signal presentation will yield essentially the same results when performed on different audiometers conforming to that standard.
• To ensure that audiometers are classified according to the range of test signals they present, their mode of operation, or their assumed primary application.

Audiometers are divided into four types: Type A devices provide a wide range of capabilities, while Type B devices provide only basic capabilities. For both types, the audiometer can be calibrated for the free-field equivalent output level of the headphones and is then designated as either type AE or type BE.

This standard excludes requirements for speech audiometers provided with frequency response adjustments intended to determine an optimum intelligibility frequency response curve for each subject.

The purpose of this standard is to ensure that hearing tests performed using speech as the test stimulus in a given human ear with different audiometers conforming to this standard will yield essentially the same results for a given calibration method.

Two specifications, calibration, and testing methods are given for the output levels produced by the headphones and bone vibrator:

• Free field equivalent output level method for AE and BE type audiometers
• Uncorrected coupler output level method for type A and B audiometers.

Results depend on factors other than the audiometer, such as test material, testing room, and loudspeakers.

• The standard "EN IEC 60645-3 Part 3: Short-term auditory test signals for audiometric and neuro-otological purposes" describes a method for describing the physical characteristics of short-term audiometric test and reference signals and methods for their measurement. This standard also defines a psychoacoustic method for determining the level of the test signal in terms of hearing level. Requirements for the information to be provided in a user manual are also included.

This standard does not define the method of using short-duration test signals or specify the waveforms to be used in clinical practice. The purpose of this standard is to ensure that short-duration audiometric stimuli are uniformly defined and measured, and that calibrations are performed using defined methods.

• The standard "EN IEC 60645-4 Part 4: Equipment for extended high-frequency audiometry" specifies requirements for audiometric equipment designed for use in pure-tone audiometry in the frequency range 8.000 Hz to 16.000 Hz, in addition to those applicable and specified in EN IEC 645-1. The purpose of this standard is to ensure that extended high-frequency audiometry performed on a given human ear with different types of equipment conforming to this standard will yield essentially similar results.

The EN IEC 60645 set of standards is essential because it ensures consistency, safety, and reliability in the design and use of audiometric equipment. The primary reasons for its importance are:

• Interdevice standardization: This set of standards defines the performance specifications and testing requirements for audiometers and related audiological equipment. This ensures that devices from different manufacturers produce comparable results, which is important for accurate hearing assessments and follow-up treatment.
• Accuracy in hearing assessment: By specifying requirements for frequency accuracy, sound pressure levels, distortion, and calibration, the standard ensures that audiometers provide valid and reproducible results, which are critical for diagnosing hearing loss.
• Patient safety: This standard includes features that help prevent exposure to harmful sound levels or other unsafe conditions during testing and protect patients from injury.
• Global consistency: Helps promote international harmonization, ensuring that audiological data and equipment are used and trusted across countries. This is important for multinational medical practices, equipment manufacturers, and research studies.
• Regulatory compliance: This standard serves as a benchmark for regulatory approval in many countries, making it a fundamental requirement for devices to enter the market and be used in clinical settings.

Our organization, which has been supporting businesses across all sectors for years through a wide range of testing, measurement, analysis, and evaluation activities, has a strong team of employees who closely follow global developments in science and technology and are constantly improving themselves. In this context, we also provide testing services in accordance with the EN IEC 60645 Electroacoustic - Audiometric Equipment standard.