EN-IEC 60601-2-66 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 functi...view more

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    • Standard
      64 pages
      English language
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This part of IEC 60118 covers the relevant EMC phenomena for hearing aids. Hearing aid
immunity to high frequency fields originating from digital wireless devices such as mobile
phones was identified as one of the most relevant EMC phenomena impacting hearing aids.

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    • Standard
      25 pages
      English language
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EN-ISO 24551 specifies ergonomic requirements and recommendations for consumer product spoken instructions that are provided to guide users in the operation of a product and/or as a means of providing feedback to users about the status/state of a product. Such instructions can be used by persons with or without visual impairments, and are useful for users who have difficulty reading and/or cognitive impairments. The applicability of the requirements and recommendations described in this document...view more

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    • Standard
      16 pages
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EN-ISO 24550 specifies design requirements and recommendations for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind. Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, an...view more

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    • Standard
      16 pages
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IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the followi...view more

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    • Standard
      64 pages
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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss. This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hear...view more

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    • Standard
      43 pages
      English language

This Standard specifies methods for the measurement of bone conduction hearing aid characteristics. The methods described will produce a suitable basis for the exchange of information or for direct comparison of the electroacoustical characteristics of bone conduction hearing aids. These methods are chosen to be practical and reproducible and are based on selected fixed parameters. The results obtained by the methods specified in this document express the performance under the conditions of meas...view more

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    • Standard
      29 pages
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This document specifies ergonomic requirements and recommendations for consumer product spoken instructions that are provided to guide users in the operation of a product and/or as a means of providing feedback to users about the status/state of a product. Such instructions can be used by persons with or without visual impairments, and are useful for users who have difficulty reading and/or cognitive impairments.
The applicability of the requirements and recommendations described in this docume...
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    • Standard
      16 pages
      English language
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This document specifies design requirements and recommendations for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind.
Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, ...
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    • Standard
      16 pages
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ISO 24500:2010 specifies the auditory signals used as a means of feedback for operations or conditions of consumer products when used by a person with or without visual or auditory impairment. It is intended to be applied as appropriate to such products depending on the product type and its conditions of use.
It is applicable to auditory signals of a fixed frequency used in general applications (also called “beep sounds”), but not to variable frequency or melodic sounds.
It does not specify ...
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    • Standard
      14 pages
      English language
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This document specifies ergonomic requirements and recommendations for consumer product spoken instructions that are provided to guide users in the operation of a product and/or as a means of providing feedback to users about the status/state of a product. Such instructions can be used by persons with or without visual impairments, and are useful for users who have difficulty reading and/or cognitive impairments. The applicability of the requirements and recommendations described in this documen...view more

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    • Standard
      8 pages
      English language
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    • Standard
      8 pages
      French language

This document specifies design requirements and recommendations for indicator lights, mainly LED sourced, on consumer products for use by older people and people with visual disabilities. It does not consider the needs of persons who are blind. Indicator lights include those that inform users visually about the conditions, changes in functional status and settings, and malfunction of products. They convey information by light on/off, time-modulated intensity, blinking, colour, luminance level, a...view more

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    • Standard
      8 pages
      English language
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    • Standard
      8 pages
      French language

IEC TR 62809:2019 is available as IEC TR 62809:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.
IEC TR 62809:2019 provides an overview of the requirements and tests of IEC 60601-2-66 in combination with the applicable sections of IEC 60601-1, and the collateral standards of the IEC 60601 series. It is intended to assist various groups involved in the product lifecycles process - like desi...
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    • Technical report
      18 pages
      English language

IEC 60601-2-66:2019 is available as IEC 60601-2-66:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-66:2019 applies to the BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66:2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision. This edition includes the followi...view more

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    • Standard
      115 pages
      English and French language

The present document specifies technical characteristics and methods of measurements for audio frequency induction
loop amplifiers and receivers operating from 10 Hz to 9 kHz used in audio frequency induction loop systems (AFILS).
NOTE: The object of an AFILS is to transmit an audio signal to people with hearing difficulties. The receiver in
this case is normally a hearing aid with a built in telecoil.
These radio equipment types are capable of operating in the frequency band within the 10 H...
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    • Standard
      32 pages
      English language
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    • Standard
      32 pages
      English language
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    • Standard
      32 pages
      English language
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    • Standard
      32 pages
      English language

This International Standard gives recommendations and requirements for the measurement
and estimation of the real-ear acoustical performance characteristics of air-conduction
hearing aids and for the measurement of certain acoustic properties of the ear related to the
application of hearing aids.
Measurements of real-ear acoustical characteristics of hearing aids which apply non-linear or
analytical processing techniques are valid only for the test signals used and conditions
employed.
Th...
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    • Standard
      38 pages
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Standard applies to the BASIC SAFETY of HEARING INSTRUMENTS and HEARING INSTRUMENT SYSTEMS, hereafter also referred to as ME EQUIPMENT or ME SYSTEM. If a clause or subclause is specifically intended to be applicable to HEARING INSTRUMENTS only, or to HEARING INSTRUMENT 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 INSTRUMENTS and to HEARING INSTRUMENT SYSTEMS, as relevant. HAZARDS inherent in ...view more

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    • Standard
      61 pages
      English language
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ISO 19029:2016 specifies the sound characteristics of auditory guiding signals for persons with seeing impairment and blindness to provide the location and direction information of particular public facilities. The public facilities include facilities such as railway stations, airports, ports, bus terminals, government offices, libraries, community centres, parks, schools, hospitals, theatres, large supermarkets, and its toilets, stairs, etc. EXAMPLE As an auditory guiding signal, a chime sound ...view more

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    • Standard
      6 pages
      English language

IEC 60601-2-66:2015 applies to the basic safety of hearing instruments and hearing instrument systems, hereafter also referred to as ME equipment or ME system. This second edition cancels and replaces the first edition published in 2012. It constitutes a technical revision to adapt IEC 60601-2-66:2012 to the technical corrections introduced by Amendment 1 (2012) to IEC 60601-1:2005, as well as to clarify and correct the wording of this particular standard and to implement minor changes requested...view more

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    • Standard
      61 pages
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This part of IEC 60118 gives recommendations for the measurement of the performance
characteristics of air conduction hearing aids based on a free field technique and measured
with an acoustic coupler.
This part of IEC 60118 is applicable to the measurement and evaluation of the
electroacoustical characteristics of hearing aids, for example for type testing and
manufacturer data sheets.
The test results obtained by the methods specified in this part of IEC 60118 will express the
performan...
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      39 pages
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This part of IEC 60118 is applicable to audio-frequency induction-loop systems producing an
alternating magnetic field at audio frequencies and intended to provide an input signal for
hearing aids operating with an induction pick-up coil (telecoil). Throughout this standard, it is
assumed that the hearing aids used with it conform to all relevant parts of IEC 60118.
This standard specifies requirements for the field strength in audio-frequency induction loops
for hearing aid purposes, which...
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This part of IEC 62489 applies to audio-frequency induction-loop systems for assisted
hearing. It may also be applied to such systems used for other purposes, as far as it is
applicable. The standard is intended for assessment of human exposure to low-frequency
magnetic fields produced by the system, by calculation and by in-situ testing.
This standard does not deal with other aspects of safety, for which IEC 60065 applies, or with
EMC.

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    • Standard
      17 pages
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IEC 60118-15:2012 specifies a test signal designed to represent normal speech, the International Speech Test Signal (ISTS), together with the procedures and the requirements for measuring the characteristics of signal processing in air-conduction hearing aids. The measurements are used to derive the estimated insertion gain (EIG). For the purposes of characterizing a hearing aid for production, supply and delivery, the procedures and requirements to derive the coupler gain on a 2 cm3 coupler as ...view more

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      35 pages
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This part of IEC 60118 in principle covers all relevant EMC phenomena for hearing aids. EMC phenomena, such as RF emission and electrostatic discharge, are not currently known to be a significant problem in connection with hearing aids and are therefore not dealt with. Based on new knowledge, they could be considered in connection with future revisions or extensions of this standard. Hearing aid immunity to high frequency electromagnetic fields originating from digital wireless devices operating...view more

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    • Standard
      24 pages
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ISO 24501:2010 specifies methods for determining the sound pressure level range of auditory signals so that the users of consumer products, including people with age-related hearing loss, can hear the signal properly in the presence of interfering sounds.
Auditory signals, in ISO 24501:2010, refer to sounds with a fixed frequency (also called beep sounds) and do not include variable frequency sounds, melodic sounds, or voice guides.
ISO 24501:2010 is applicable to auditory signals which are he...
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    • Standard
      29 pages
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ISO 24501:2010 specifies methods for determining the sound pressure level range of auditory signals so that the users of consumer products, including people with age-related hearing loss, can hear the signal properly in the presence of interfering sounds. Auditory signals, in ISO 24501:2010, refer to sounds with a fixed frequency (also called beep sounds) and do not include variable frequency sounds, melodic sounds, or voice guides. ISO 24501:2010 is applicable to auditory signals which are hear...view more

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    • Standard
      21 pages
      English language
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    • Standard
      22 pages
      French language

Defines a method of expressing the input/output ratio as an acousto-mechanical sensitivity level measured on a mechanical coupler according to the second edition of HD 590. Provides a suitable basis for the exchange of information or for direct comparison of the electroacoustic characteristics of hearing aids using bone vibrator outputs. The methods chosen are practical and reproducible and are based on selected fixed parameters.

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    • Standardization document
      14 pages
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Describes a method of determining the overall electro-acoustical performance of hearing aid equipment used in the rehabilitation of persons having impaired hearing.

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    • Standardization document
      8 pages
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Applicable to insert earphones which can be fitted to an earmould inserted into the ear canal. Defines those dimensions which are essential in order to ensure interchangeability of insert earphones as used with earmoulds or other attachments to the ear.

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    • Standardization document
      6 pages
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ISO 24500:2010 specifies the auditory signals used as a means of feedback for operations or conditions of consumer products when used by a person with or without visual or auditory impairment. It is intended to be applied as appropriate to such products depending on the product type and its conditions of use. It is applicable to auditory signals of a fixed frequency used in general applications (also called “beep sounds”), but not to variable frequency or melodic sounds. It does not specify fire...view more

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    • Standard
      7 pages
      English language
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    • Standard
      7 pages
      French language

This European Standard applies to the services offered by hearing aid professionals in their efforts to provide benefit for their clients. This European Standard specifies the process of hearing aid provision from the first client contact to the long term follow-up. This European Standard also defines requirements for education, facilities, equipment and code of conduct. A quality management system with the overall objective of securing client satisfaction and covering the elements of the servic...view more

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    • Standard
      26 pages
      English language
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This European Standard applies to the services offered by hearing aid professionals in their efforts to provide benefit for their clients.
This European Standard specifies the process of hearing aid provision from the first client contact to the long term follow up. This European Standard also defines requirements for education, facilities, equipment and code of conduct. A quality management system with the overall objective of securing client satisfaction and covering the elements of the servi...
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    • Standard
      26 pages
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This part of the IEC 62489 series applies to the components of audio-frequency inductionloop systems for assisted hearing. It may also be applied to such systems used for other purposes, as far as it is applicable. This standard is intended to encourage accurate and uniform presentation of manufacturers' specifications, which can be verified by standardized methods of measurement. It is intended for type testing. The components considered are the following: - amplifiers; - microphones; - other c...view more

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      24 pages
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ISO 23600:2007 specifies requirements for acoustic and tactile signals for pedestrian traffic lights to assist in safe and independent mobility of persons with vision impairments and persons with vision and hearing impairments. It is applicable to design, installation and operation of acoustic and tactile signals for pedestrian traffic lights.

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    • Standard
      8 pages
      English language

The purpose of this part of IEC 60118 is to describe methods for a test which simulates the acoustical effects of a median adult wearer on the performance of a hearing aid. It establishes certain guidelines for simulated in situ measurements of hearing aids; it describes a simplified method for simulated in situ measurements of hearing aids and a description for determination of the directivity index (DI) of directional microphones in hearing aids in the horizontal plane. In addition this second...view more

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    • Standard
      35 pages
      English language
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This part of IEC 60118 gives recommendations for the measurement of the performance characteristics of air-conduction hearing aids of a particular model for production, supply and delivery quality assurance purposes. The manufacturer will normally assign nominal values. This standard does not relate to mechanical or environmental tests. It should not be used as the basis for the exchange of information about hearing aid characteristics in general, nor is it intended to be used as a predictor for...view more

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    • Standard
      26 pages
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EN following parallel vote

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    • Amendment
      13 pages
      English language
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A1 incorporated into EN * Implementation dates changed * Former HD 450.2 S1

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    • Standard
      20 pages
      English language
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This document specifies a set of symbols to identify telecommunication facilities for deaf and hard of hearing people. The symbols defined in this standard  will be applicable to all telecommunication equipment, related signage and publications, that provide or reference the defined facilities and assistive technologies which are intended to support telecommunications by deaf and hard of hearing people.

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    • Standard
      21 pages
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To specify characteristics & related test methods for an electrical interface between telephone receivers & hearing aids. Applicable to both analogue telephony terminals & digital telephony terminals.

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    • Standard
      16 pages
      English language
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To specify characteristics and related test methods for a magnetic field generated by telephone terminals for coupling to hearing aids with magnetic pick-up coils. Applicable to both analogue & digital telephony terminals

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    • Standard
      20 pages
      English language
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To specify extra audio amplification & related characteristics of telephony terminals to meet the need of hard-of-hearing people.

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    • Standard
      16 pages
      English language
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EN following parallel vote * A1 published as new edition of EN

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    • Standard
      8 pages
      English language
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EN following parallel vote

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    • Standard
      14 pages
      English language
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EN following parallel vote

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    • Standard
      6 pages
      English language
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EN following parallel vote * Supersedes HD 304 S1

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    • Standard
      13 pages
      English language
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This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hea...
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    • Draft
      49 pages
      English language
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