Electroacoustics - Audiometric equipment -- Part 5: Instruments for the measurement of aural acoustic impedance/admittance

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. This first edition of EN 60645-5 cancels and replaces the first edition of EN 61027, published in 1991, and constitutes a technical revision.

Akustik - Audiometer -- Teil 5: Geräte zur Messung der akustischen Impedanzen/Admittanzen des Gehörs

Electroacoustique - Appareillage audiométrique -- Partie 5: Instruments pour la mesure de l'impédance ou de l'admittance aurale (impédancemètres ou admittancemètres)

S'applique aux instruments conçus principalement pour la mesure de l'impédance ou de l'admittance acoustiques dans le conduit auditif humain en utilisant une sonde dont le signal présente une fréquence spécifiée. Il est admis que d'autres signaux de sonde peuvent également être utilisés. La norme définit les caractéristiques qui doivent être spécifiées par le fabricant, donne des spécifications concernant trois classes d'instruments et spécifie les possibilités qui doivent être offertes pour ces classes. La présente norme décrit des méthodes d'essai qui doivent être utilisées pour les essais d'approbation de modèle et donne un guide concernant les méthodes à utiliser pour entreprendre l'étalonnage périodique. L'objet de cette norme est de s'assurer que les mesures effectuées dans des conditions d'essais comparables, avec différents instruments satisfaisant à la norme, sont cohérentes. Il n'est pas dans les intentions de cette norme d'empêcher le développement de nouvelles possibilités ni de décourager les innovations. Cette première édition de la EN 60645-5 annule et remplace la première édition de la EN 61027, publiée en 1991, et constitue une révision technique.

Elektroakustika – Avdiometrična oprema – 5. del: Instrumenti za merjenje ušesne akustične impedance/admitance (IEC 60645-5:2004)

General Information

Status
Published
Publication Date
30-Nov-2005
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Dec-2005
Due Date
01-Dec-2005
Completion Date
01-Dec-2005

Relations

Buy Standard

Standard
EN 60645-5:2005
English language
32 pages
sale 10% off
Preview
sale 10% off
Preview
e-Library read for
1 day

Standards Content (Sample)

SLOVENSKI SIST EN 60645-5:2005

STANDARD
december 2005
Elektroakustika – Avdiometrična oprema – 5. del: Instrumenti za merjenje
ušesne akustične impedance/admitance (IEC 60645-5:2004)
Electroacoustics – Audiometric equipment – Part 5: Instruments for the
measurement of aural acoustic impedance/admittance (IEC 60645-5:2004)
ICS 17.140.50 Referenčna številka
SIST EN 60645-5:2005(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD EN 60645-5
NORME EUROPÉENNE
EUROPÄISCHE NORM January 2005

ICS 17.140.50 Supersedes EN 61027:1993


English version


Electroacoustics –
Audiometric equipment
Part 5: Instruments for the measurement
of aural acoustic impedance/admittance
(IEC 60645-5:2004)


Electroacoustique –  Akustik –
Appareillage audiométrique Audiometer
Partie 5: Instruments pour la mesure Teil 5: Geräte zur Messung der
de l'impédance ou de l'admittance aurale akustischen Impedanzen/Admittanzen
(impédancemètres ou admittancemètres) des Gehörs
(CEI 60645-5:2004) (IEC 60645-5:2004)




This European Standard was approved by CENELEC on 2004-12-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2005 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60645-5:2005 E

---------------------- Page: 2 ----------------------

EN 60645-5:2005 - 2 -
Foreword
The text of document 29/563/FDIS, future edition 1 of IEC 60645-5, prepared by IEC TC 29,
Electroacoustics, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC
as EN 60645-5 on 2004-12-01.
This European Standard supersedes EN 61027:1993.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2005-09-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-12-01
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60645-5:2004 was approved by CENELEC as a European
Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
ISO 389-1 NOTE Harmonized as EN ISO 389-1:2000 (not modified).
ISO 389-2 NOTE Harmonized as EN ISO 389-2:1996 (not modified).
__________

---------------------- Page: 3 ----------------------

- 3 - EN 60645-5:2005
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
1) 2)
IEC 60126 - IEC reference coupler for the HD 305 S1 1977
measurement of hearing aids using
earphones coupled to the ear by means
of ear inserts

1) 2)
IEC 60601-1 - Medical electrical equipment EN 60601-1 1990
Part 1: General requirements for safety

1) 2)
IEC 60601-1-2 - Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety
- Collateral standard: Electromagnetic
compatibility - Requirements and tests

1) 2)
IEC 60601-1-4 - Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety
- Collateral standard: Programmable
electrical medical systems

IEC 60645-1 2001 Electroacoustics - Audiological equipment EN 60645-1 2001
Part 1: Pure-tone audiometers

1)
BIPM/IEC/IFCC/ - Guide to the expression of uncertainty in - -
ISO/IUPAP/OIML measurement (GUM)





1)
Undated reference.
2)
Valid edition at date of issue.

---------------------- Page: 4 ----------------------

NORME CEI
INTERNATIONALE
IEC



60645-5
INTERNATIONAL


Première édition
STANDARD

First edition

2004-11


Electroacoustique –
Appareillage audiométrique –
Partie 5:
Instruments pour la mesure de l'impédance
ou de l'admittance aurale (impédancemètres
ou admittancemètres)

Electroacoustics –
Audiometric equipment –
Part 5:
Instruments for the measurement
of aural acoustic impedance/admittance

 IEC 2004 Droits de reproduction réservés  Copyright - all rights reserved
Aucune partie de cette publication ne peut être reproduite ni No part of this publication may be reproduced or utilized in any
utilisée sous quelque forme que ce soit et par aucun procédé, form or by any means, electronic or mechanical, including
électronique ou mécanique, y compris la photocopie et les photocopying and microfilm, without permission in writing from
microfilms, sans l'accord écrit de l'éditeur. the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: +41 22 919 02 11 Telefax: +41 22 919 03 00 E-mail: inmail@iec.ch Web: www.iec.ch
CODE PRIX
U
PRICE CODE
Commission Electrotechnique Internationale
International Electrotechnical Commission
МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

---------------------- Page: 5 ----------------------

60645-5  IEC:2004 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9
1 Scope.11
2 Normative references.11
3 Terms and definitions .13
4 Requirements for specific instruments .19
5 General specifications.21
5.1 Measuring system.21
5.2 Pneumatic system.23
5.3 Acoustic reflex activating stimulus system .25
6 Demonstration of conformity with specifications.29
6.1 General.29
6.2 Impedance/admittance measuring system .29
6.3 Probe signal.29
6.4 Pneumatic system.31
6.5 Acoustic reflex activating stimulus signals .31
6.6 Maximum permitted expanded uncertainty of measurements .33
7 Calibration cavities.35
7.1 General.35
7.2 Dimensions of calibration cavities.35
7.3 Material of calibration cavity walls .35
7.4 Connection of probe to a calibration cavity .35
8 General requirements.35
8.1 Marking.35
8.2 Instruction manual.35
8.3 Safety requirements.35
8.4 Warm-up time.37
8.5 Supply variation and environmental conditions .37
8.6 Unwanted acoustic signals and radiation .37
9 Symbols, forms and formats for acoustic impedance/admittance data.39
9.1 Symbols for indicating measured quantities.39
9.2 Tympanogram format.39
9.3 Acoustic reflex test format .39
9.4 Eustachian tube function test format.41
10 Additional characteristics to be specified by the manufacturer .41
10.1 Aural impedance/admittance measurement system .41
10.2 Pneumatic system.43
10.3 Acoustic reflex activating stimulus system .45
10.4 Analogue electrical output .45
Annex A (informative) Routine calibration .47
Annex B (informative) Units and terms.49
Annex C (informative) Overall temporal characteristics .53
Bibliography.57

---------------------- Page: 6 ----------------------

60645-5  IEC:2004 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________

ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –

Part 5: Instruments for the measurement
of aural acoustic impedance/admittance


FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60645-5 has been prepared by IEC technical committee 29:
Electroacoustics.
This first edition of IEC 60645-5 cancels and replaces the first edition of IEC 61027, published
in 1991, and constitutes a technical revision.

---------------------- Page: 7 ----------------------

60645-5  IEC:2004 – 7 –
The text of this standard is based on the following documents:
FDIS Report on voting
29/563/FDIS 29/567/RVD

Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
IEC 60645 consists of the following parts:
Part 1: Pure tone audiometers
Part 2: Equipment for speech audiometry
Part 3: Auditory test signals of short duration for audiometric and neuro-otological purposes
Part 4: Equipment for extended high-frequency audiometry
1
Part 5: Instruments for the measurement of aural acoustic impedance/admittance
The committee has decided that the contents of this publication will remain unchanged until
the maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in
the data related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.


___________
1
  Future editions of all parts of this series will appear under the new general title Electroacoustics – Audiometric
equipment.

---------------------- Page: 8 ----------------------

60645-5  IEC:2004 – 9 –
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.

---------------------- Page: 9 ----------------------

60645-5  IEC:2004 – 11 –
ELECTROACOUSTICS –
AUDIOMETRIC EQUIPMENT –

Part 5: Instruments for the measurement
of aural acoustic impedance/admittance



1 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.
2 Normative references
The following referenced documents are indispensable for the application of this document.
For dated references, only the edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.
IEC 60126, IEC reference coupler for the measurement of hearing aids using earphones
2
coupled to the ear by means of ear inserts
IEC 60601-1, Medical electrical equipment – Part 1: General requirements for safety
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for safety –
Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-4, Medical electrical equipment – Part 1: General requirements for safety –
Collateral standard: Programmable electrical medical systems
IEC 60645-1:2001, Electroacoustics – Audiological equipment – Part 1: Pure-tone audio-
meters
BIPM/IEC/IFCC/ISO/IUPAC/IUPAP/OIML, Guide to the expression of uncertainty in
measurement (GUM)
___________
2
To be revised as IEC 60318-5.

---------------------- Page: 10 ----------------------

60645-5  IEC:2004 – 13 –
3 Terms and definitions
For the purposes of this document the following terms and definitions apply.
NOTE The units in this standard conform to the International System of Units (SI). However, for audiological
measurements test results have traditionally often been reported in other units. To provide information on the
conversion from such units to SI units, Annex B has been compiled.
3.1
aural impedance/admittance
general term covering all aspects of acoustic impedance/admittance of the ear
NOTE Throughout this standard the term aural impedance/admittance will be employed as a general term
covering all aspects of acoustic impedance/admittance of the ear, except where reference is made to specific
derivatives.
3.2
acoustic impedance
at a specified surface, quotient of sound pressure by volume velocity through the surface
3
NOTE 1 The symbol is Z and the unit is the pascal second per metre to the third power (Pa⋅s/m )
a
NOTE 2 The quantity usually measured is the modulus.
3.3
acoustic resistance
real component of complex acoustic impedance
3
NOTE The symbol is R and the unit is the pascal second per metre to the third power (Pa⋅s/m ).
a
3.4
acoustic reactance
imaginary component of complex acoustic impedance
3
NOTE The symbol is X and the unit is the pascal second per metre to the third power (Pa⋅s/m ).
a
3.5
acoustic admittance
at a given surface, the reciprocal of acoustic impedance at the same surface
3
NOTE 1 The symbol is Y and the unit is the metre to the third power per pascal second (m /Pa⋅s).
a
NOTE 2 Thus, the acoustic admittance at a given surface is the complex ratio of the volume velocity through the
surface of the sound pressure averaged over the surface. The quantity usually measured is the modulus.
3.6
acoustic conductance
real component of complex acoustic admittance
3
NOTE The symbol is G and the unit is the metre to the third power per pascal second (m /Pa⋅s).
a
3.7
acoustic susceptance
imaginary component of complex acoustic admittance
3
NOTE The symbol is B and the unit is the metre to the third power per pascal second (m /Pa⋅s).
a
3.8
acoustic inertance
ratio of the driving sound pressure to the resulting rate of change in volume velocity
NOTE The symbol is M and the unit is the pascal second to the second power per metre to the third power
a
2 3
(Pa⋅s /m ).

---------------------- Page: 11 ----------------------

60645-5  IEC:2004 – 15 –
3.9
acoustic compliance
ratio of volume displacement to sound pressure
3
NOTE The symbol is C and the unit is the metre to third power per pascal (m /Pa).
a
3.10
equivalent volume
volume of an air-filled hard-walled cylindrical cavity that offers the equivalent acoustic
impedance/admittance
NOTE 1 The volume is given by the formula:
2
V = γ ⋅ p ⋅ C = ρ ⋅ c ⋅ C
e s a a
where
3
V is the equivalent volume in m ;
e
γ is the ratio of specific heat for air at constant pressure to that at constant volume (approximately 1,40);
p is the barometric air pressure in Pa;
s
3
ρ is the ambient density of air in kg/m , at the temperature and pressure of the measurement;
c is the speed of sound in m/s at the temperature and pressure of the measurement;
3
C is the acoustic compliance in m /Pa.
a
NOTE 2 It has been practice to refer to aural impedance/admittance at the probe tone frequency of 226 Hz as an
equivalent volume of air.
NOTE 3 For a probe tone frequency of 226 Hz, the equivalent volume of air is equal to its physical volume
3
provided the latter does not exceed 5 cm .
3.11
relative pressure in the external acoustic meatus
difference between the pressure in the external acoustic meatus and the ambient barometric
pressure in daPa
3.12
probe
coupling device that is inserted into the external acoustic meatus to connect the instrument to
the ear
3.13
ear tip
device used to provide a seal between the probe and the external acoustic meatus
3.14
probe signal
acoustic signal that is emitted into the external auditory meatus by means of a probe
NOTE The signal is used to measure acoustic impedance/admittance.
3.15
probe ear
ear into which the probe in inserted
3.16
measurement plane
plane located at the frontal surface of the probe perpendicular to the volume velocity vector

---------------------- Page: 12 ----------------------

60645-5  IEC:2004 – 17 –
3.17
tympanometry
measurement of change of aural impedance/admittance as a function of air pressure in the
external acoustic meatus
NOTE The measured acoustic impedance/admittance values may depend on rate and direction of change of air
pressure as well as time spent with a certain constant air pressure in the external acoustic meatus.
3.17.1
measurement plane tympanometry
measurement of change of the aural impedance/admittance at the measurement plane,
comprising the combined impedance/admittance of the middle ear and part of the external
acoustic meatus
3.17.2
meatus-compensated tympanometry
measurement of the vector difference between the aural impedance/admittance obtained at
the test pressure and that obtained at a specific reference pressure in the external acoustic
meatus for a given fitting of the probe
NOTE 1 The reference pressure should be such as to effectively eliminate the influence of the middle ear.
NOTE 2 The reference pressure will normally be 200 daPa different from the indicated pressure, which gives
maximum admittance or minimum impedance indication, or fixed at 200 daPa relative to ambient pressure.
3.18
tympanogram
graphical display of some quantity related to aural impedance/admittance as a function of air
pressure in the external acoustic meatus
3.19
middle-ear muscle reflex
change in tonus of muscles of the middle ear in response to stimulation
NOTE The change may be measured as a variation in the acoustic impedance/admittance within the external
auditory meatus
3.19.1
acoustic reflex
middle-ear muscle reflex elicited by an acoustic stimulus
3.19.2
non-acoustic reflex
middle-ear muscle reflex elicited by a non-acoustic stimulus
3.20
acoustic reflex activating stimulus
acoustic stimulus that is used to elicit an acoustic reflex
3.21
stimulus ear
ear to which a reflex activating stimulus is presented in order to elicit a middle ear muscle
reflex
3.22
ipsilateral reflex
middle ear muscle reflex elicited in the stimulus ear

---------------------- Page: 13 ----------------------

60645-5  IEC:2004 – 19 –
3.23
contralateral reflex
middle ear muscle reflex elicited in the ear contralateral to the stimulus ear
4 Requirements for specific instruments
Three different types of aural acoustic impedance/admittance instruments are specified by the
requirements for minimum mandatory facilities (see Table 1). Other facilities are not
precluded. The three types relate to their presumed primary application.
Table 1 – Mandatory functions for aural impedance/admittance instruments
Type

1 2 3
Diagnostic/ clinical Tympanometry/ Tympanometry
reflex screening screening
Probe signal frequency 226 Hz x x x
Aural impedance/admittance measuring system
a a a
Measurement plane tympanometry x x x
a a a
Meatus compensated tympanometry x x x
Pneumatic system

Manual change of pressure x
Automatic change of pressure x x x
Acoustic reflex activating system
Contralateral routing x
Ipsilateral routing x x
Acoustic stimuli:
Pure tones x x
Broad-band noise x
Stimulus level control x
Presentation of results
Display or visual indicator x x x
Printout x
Data interface x
a
Indicating that either of the two alternatives shall be provided.

---------------------- Page: 14 ----------------------

60645-5  IEC:2004 – 21 –
5 General specifications
5.1 Measuring system
5.1.1 Units of measurement
The instruments may be designated to measure one or more components of aural
impedance/admittance. SI units or derived SI units shall be used. The units of measurement
shall be indicated on the front panel of the instrument.
5.1.2 Probe signal
A probe signal in the form of a pure tone with a frequency of 226 Hz shall be provided in
instruments of Types 1, 2 and 3. The actual frequency shall differ from its nominal frequency
by less than ±1 % for Type 1 instruments and by less than ± 2 % for Types 2 and 3. The total
harmonic distortion shall be less than 1 % for Type 1 and less than 3 % for Types 2 and 3,
when measured as specified in Clause 6. If pure tones of frequencies other than 226 Hz are
available, the same requirements with regard to frequency accuracy and harmonic distortion
shall apply.
NOTE When tests such as multi-frequency tympanometry are performed which require frequency accuracy better
than the 1 % specified, the manufacturer should state the accuracy of the frequency used for that test.
5.1.3 Probe signal level
For pure tones of any frequency, for stationary broadband and for non-stationary probe
signals the level shall be such that the probability of activating the middle ear muscle reflex by
the probe signal is acceptably small. For a 226 Hz pure tone probe signal, the sound pressure
level shall be 90 dB or less as measured according to Clause 6.
NOTE This requires a level less than the mean value minus two standard deviations for the threshold level of the
acoustic middle ear reflex in a sufficiently large otologically normal young adult population when the probe signal is
used as a reflex activating stimulus. A population of 25 persons is considered to be sufficiently large. ISO 389-1
defines an "otologically normal person" as "a person in a normal state of health who is free from all signs or
symptoms of ear disease and from obstructing wax in the ear canals and who has no history of undue exposure to
noise, exposure to potentially ototoxic drugs or familial hearing loss".
5.1.4 Measurement range
For a 226 Hz probe tone the minimum ranges expressed as equivalent volume of air shall be:
3 3
for measurement plane tympanometry, from 0,2 cm to 5 cm ; for meatus compensated
3 3 3 3
tympan
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.