Iec 60118 13 2016

13 8 Test proced res for immu ity to radiated RF electromag etic field.. 2 Ta le 1 – Field stren th of RF test sig als to b u ed to establs immu ity for by tan er comp tible an u er comp

Électroacoustique – Apparei s de corr ection auditiv e –

Partie 13: Compatibi ité électromagnétique (CEM)

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Électroacoustique – Apparei s de corr ection auditiv e –

Partie 13: Compatibi ité électromagnétique (CEM)

INT ERNAT IONAL

ELECT ROT ECHNICAL

ELECT ROT ECHNIQUE

INT ERNAT IONALE

® Registered t r demark f the Internat ional Electrotec ica l Com ision

Marq e déosé de la Com ision Elect rtechniq e Int e at iona le

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CONTENTS

FOREWORD 4

INTRODUCTION 6

1 Sco e 7

2 Normative referen es 7

3 Terms an definition 8

4 Op ration an fu ction of the he rin aid 10 5 Sp cification of EMC en ironment 10 6 Req irements for electromag etic emis ion 10 6.1 Req irements for radiated emis ion 10 6.2 Limits of radiated emis ion 10 6.3 Proced re for radiated emis ion 10 7 Req irements for electromag etic immu ity 10 7.1 General 10 7.2 Compl an e criteria 10 7.3 Radiated RF electromag etic field 1

7.3.1 General 1

7.3.2 Req irements 1

7.3.3 Proced re 13 7.4 Electrostatic Dis harge (ESD) 13 7.4.1 Req irements 13 7.4.2 Proced re 13 7.5 Power freq en y mag etic field 13 7.5.1 Req irements 1

3 7.5.2 Proced re 13 8 Test proced res for immu ity to radiated RF electromag etic field 13 8.1 General 13 8 2 Test eq ipment an RF sig al 1

3 8.3 He rin aid test set in 13 8.4 Determination of gain 14 8.5 He rin aid output coupl n d rin immu ity test 14 8.6 Position of the he rin aid d rin immu ity test 15 8.7 Me s rement of the input related ambient noise (I RAN) 17 8.8 Me s rement of the output related interferen e level (ORI L) 17 8.9 Calc lation of the input related interferen e level (IRIL) 18 8.10 Re ort 18 9 Me s rement u certainty for immu ity to radiated RF electromag etic field 18 An ex A (informative) Bac grou d for esta l s in test method , p rforman e criteria an test levels 19 A.1 General 19 A.2 Radiated RF electromag etic field , history of the test method 19 A.3 Performan e criteria 21

A.4 Test field stren th – By tan er comp tibi ty 21

A.5 Field stren th – User comp tibi ty 21

An ex B (informative) Rationale for p rtic lar clau es an s bclau es 2

B.1 Rationale for Clau e 6 Req irements for electromag etic emis ion 2

B.2 Rationale for 6.1 Radiated emis ion 2

B.3 Rationale for Clau e 6 Req irements for RF emis ion an Clau e 7 Req irements for electromag etic immu ity 2

B.4 Rationale for 7.2 Compl an e criteria 2

B.5 Rationale for 7.3 Radiated RF electromag etic field 2

B.6 Rationale for 7.4 Electrostatic dis harge (ESD) 2

B.7 Rationale for 7.5 Power freq en y mag etic field 2

Bibl ogra h 2

Fig re 1 – Examples of input output resp n e c rves at 1 0 0 Hz an the determination of gain at an input level of 5 dB 14 Fig re 2 – Example of a test ar an ement for he rin aid immu ity me s rements u in a GTEM cel 15 Fig re 3 – Positionin of BTE, d rin RF exp s re 16 Fig re 4 – Positionin of BTE with receiver, d rin RF exp s re 16 Fig re 5 – Positionin of IT with receiver, d rin RF exp s re 17 Fig re A.1 – Ratio of 1:2 b twe n field stren th an interferen e level in dB 2

Fig re A.2 – Example of test ar an ement for he rin aid immu ity me s rements u in dip le anten a 2

Ta le 1 – Field stren th of RF test sig als to b u ed to establs immu ity for

by tan er comp tible an u er comp tible he rin aid 12

INTERNATIONAL ELECTROTECHNICAL COMMISSION

ELECTROACOUSTICS – HEARING AIDS –

Part 13: Electromagnetic compatibi ity (EMC)

1) Th Intern tio al Ele trote h ic l Commis io (IEC) is a worldwid org niz tio for sta d rdiz tio c mprisin

al n tio al ele trote h ic l c mmite s (IEC Natio al Commite s) Th o je t of IEC is to promote

intern tio al c -o eratio o al q e tio s c n ernin sta d rdiz tio in th ele tric l a d ele tro ic field To

this e d a d in a ditio to oth r a tivitie , IEC p bls e Intern tio al Sta d rd , Te h ic l Sp cific tio s,

Te h ic l Re orts, Pu lcly Av ia le Sp cific tio s (PAS) a d Guid s (h re fer refere to a “IEC

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in th s bje t d alt with ma p rticip te in this pre aratory work Intern tio al g v rnme tal a d n n

-g v rnme tal org niz tio s laisin with th IEC als p rticip te in this pre aratio IEC c la orate clo ely

with th Intern tio al Org niz tio for Sta d rdiz tio (ISO) in a c rd n e with c n itio s d termin d b

a re me t b twe n th two org niz tio s

2) Th formal d cisio s or a re me ts of IEC o te h ic l maters e pre s, a n arly a p s ible, a intern tio al

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misinterpretatio b a y e d u er

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th later

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p te t rig ts IEC s al n t b h ld re p n ible for id ntifyin a y or al s c p te t rig ts

International Stan ard IEC 6 1 8-13 has b en pre ared by IEC tec nical commit e 2 :

Electro cou tic

This fourth edition can els an re laces the third edition publ s ed in 2 1 an con titutes a

tec nical revision This edition in lu es the fol owin sig ificant tec nical c an es with

resp ct to the previou edition:

a) introd ction of a new set of general EMC req irements for he rin aid

It has the statu of a prod ct EMC stan ard in ac ordan e with IEC Guide 10 ,

Ele c tro magnetc compatbil y – Guide to th draftn of e le c tromag etc c ompatb il y

The text of this stan ard is b sed on the fol owin doc ments:

Ful information on the votin for the a proval of this stan ard can b fou d in the re ort on

votin indicated in the a ove ta le

This publcation has b en draf ed in ac ordan e with the ISO/IEC Directives, Part 2

A l st of al p rts in the IEC 6 1 8 series, publ s ed u der the general title Ele c troac o ustc –

Hearin aids can b fou d on the IEC we site

The commit e has decided that the contents of this publ cation wi remain u c an ed u ti

the sta i ty date in icated on the IEC we site u der "ht p:/we store.iec.c " in the data

related to the sp cific publ cation At this date, the publ cation wi b

This international stan ard sp cifies EMC req irements of he rin aid Most he rin aid

contain digital sig al proces ors an some can contain wireles tran ceivers

As the generic IEC 6 6 1-1-2 EMC stan ard do s not a ply to he rin aid (ref

IEC 6 6 1-2-6 :2 15, 2 1.17), this revision of IEC 6 118-13:2 1 introd ces ad itional

sp cification for EMC req irements for he rin aid Exp rien e in con ection with the u e

of he rin aid in recent times has identified digital wireles devices s c as wireles

tele hones an GSM mo i e phones as p tential sources of disturb n e for he rin aid

Interferen e in he rin aid de en s on the emit ed p wer from the digital wireles device as

wel as the immu ity of the he rin aid The p rforman e criteria in this stan ard wi not

total y en ure he rin aid u er's interferen e an noise- re u e of wireles tele hones but

wi esta l s u e ble con ition in most situation

In practice, a he rin aid u er, when u in a wireles tele hone, wi se k, if p s ible, to fin

a p sition on the e r that gives minimum or no interferen e in the he rin aid Variou test

method have b en con idered for determinin the immu ity of he rin aid When a digital

wireles device is u ed close to a he rin aid, there is an RF ne r- ield i umination of the

he rin aid However, valdation in estigation in pre arin this stan ard have s own that it is

p s ible to esta l s a cor elation b twe n the me s red far- ield immu ity level an the

immu ity level exp rien ed by an actual he rin aid u ed in conju ction with a digital wireles

device The u e of a far- ield test has s own hig re rod cibi ty, an is con idered s f icient

to verify an expres the immu ity of he rin aid Ne r- ield i umination of the he rin aid

(i.e by generatin an RF field u in a dip le anten a) could however provide valua le

information d rin desig an develo ment of hearin aid

In ad ition the stan ard now contain ESD radiated an immu ity req irements to ad res

the EMC compl an e, b cau e man facturers of he rin aid have faced q estion of

compl an e by agen ies that req ire compl an e to a pl ca le stan ard The lac of an

a pl ca le stan ard can al ow for misinterpretation an /or lac of agre ment of a pl ca le

stan ard Without this revision other EMC stan ard may b a pl ed whic contain

req irements that are not relevant to he rin aid This revision wi now provide

man facturers an test agen ies a compl an e standard that sp cificaly ad res es those

req irements

He rin aid are b tery p wered Therefore, disturb n es related to a.c or d.c p wer inputs

are not relevant an are identified as not a plca le within this doc ment He rin aid are

not normal y con ected to other eq ipment throu h ca les, an therefore common mode

tran ients an common mode s rges are not relevant an also identified as not a pl ca le

He rin aid can now contain RF tran ceivers u ed for wireles commu ication, whic comply

with existin stan ard ad res ed by entities s c as the FCC, R&TTE or other wireles

directives This revision is not inten ed to re lace those stan ard but rather p ints the u er

to those stan ard National authorities on wireles an medical devices s ould b contacted

for ad ice The u ers of this stan ard s ould con ult the publ cation by those entities for

further k owled e to test commu ication of wireles he rin aid an u e this stan ard to

s p lement those ne d

It is recog ized that the introd ction of new wireles prod cts co xists with existin sp ctra,

p tential network an other wireles prod cts (medical as wel as non-medical) This revision

do s not ad res co xisten e an the u er of this stan ard s ould con ult a plca le entities

for g idan e

He rin aid , where the outputs are non-acou tic, e.g b ne con u tion he rin aid , are not

des rib d directly in this stan ard, but the stan ard can b u ed if precise des ription of

me s rement setup for these typ s of he rin aid are given by the man facturer

ELECTROACOUSTICS – HEARING AIDS –

Part 13: Electromagnetic compatibi ity (EMC)

This p rt of IEC 6 1 8 covers relevant EMC phenomena for he rin aid He rin aid

immu ity to hig freq en y field originating from digital wireles devices s c as mo ie

phones was original y identified as the most relevant EMC phenomena imp ctin he rin

aid Sin e the in lu ion of RF generatin comp nents within he rin aid , s c as digital

sig al proces ors or wireles tran ceivers, ad itional EMC complan e req irements a ply

The EMC req irements now in lu ed are radiated emis ion an immu ity to electrostatic

dis harge, p wer freq en y mag etic field , an radiated RF electromag etic field

Req irements as ociated with con ected p wer an sig al l nes are not in lu ed

2 Normativ references

The folowin doc ments, in whole or in p rt, are normatively referen ed in this doc ment an

are in isp n a le for its a pl cation For dated referen es, only the edition cited ap l es For

u dated referen es, the latest edition of the referen ed doc ment (in lu in an

amen ments) a pl es

IEC 6 1 8-0, Ele ctroa oustc – He arin aids – Part 0: Mea ure me t of th pe rfo rmanc e

charac teristc o f h arin aids

IEC 6 1 8-7:2 0 , Electroacoustc – Hearin aids – Part 7: Mea ureme nt o f th

p e rfo rmance charac te ristc of he arin aids for p roductio , supply and delve ry qual y

a suranc e p urpo se s

IEC 6 1 8-15, Electroacoustc – He arin aids – Part 15: Meth ds for charac te risin signal

p ro ces in in h arin aids wih a sp e ch-ik signal

IEC 6 318-5, Ele ctroa oustc – Simu lato rs o fhu man h ad and e ar – Part 5: 2 cm

3

c o u ple r

fo r th me asure me t o f h arin aids and earp one s coupled to th ear by means of ear

inse rts

IEC 610 0-4-2, Ele ctro magne tic c ompatb il y (EMC) – Part 4-2: Te stn and me asure me t

te c hniques – Ele ctro statc disc harge immu niy te st

IEC 610 0-4-3, Electro magnetc compatb il y (EMC) – Part 4-3: Testn and me asure me t

technique s – Radiate d, radio-fre uency, e le c tromagne tic fie ld immuniy te st

IEC 610 0-4-8, Ele c tro magne tic c ompatbi ty (EMC) – Part 4-8: Te stn and me asureme t

te c hnique s – Po we r fre quency mag etc field immuniy test

IEC 610 0-4-2 , Ele ctromagnetc compatbil y (EMC) – Part 4-20 : Te stn and mea ure me t

te c hnique s – Emis io and immu niy te stn in transve rse electromagnetc (T M) wav gu ides

CISPR 1 :2 15, Industrial, sc ie tfic and me dic al e uipme nt – R adio -fre u ency disturb anc e

charac te ristc – Limis and meth ds o f mea ure me nt

3 Terms and definitions

For the purp ses of this doc ment, the definition given in IEC 6 1 8-0, IEC 6 1 8-7,

IEC 6 1 8-15 an IEC 610 0-4-3 as wel as the fol owin a ply

3.1

he ring aid

we ra le in trument inten ed to aid a p rson with imp ired he rin , u ual y con istin of a

micro hone, ampl fier, sig al proces or an e rphone, p wered by a low-voltage b tery an

p s ibly also containin an in u tion pic -up coi an whic is fit ed u in au iometric an

pres riptive method

Note 1 to e try: He rin aid c n b pla e o th b d (BW), b hin th e r (BT ), in th e r (IT ) or in th

c n l (ITC)

3.2

by tander compatibi ity

immu ity of a he rin aid that en ures it is u a le in en ironments where digital wireles

devices are in o eration in the proximity of the he rin aid we rer

3.3

user compatibi ity

immu ity of he rin aid that en ures that it is u a le when the we rer is u in a digital

wireles device at the we rer's own aided e r

3.4

reference orientation < f a he rin aid>

orientation of the he rin aid with resp ct to the RF emit in source whic cor esp n s to the

orientation of the he rin aid u der actual u e on a p rson facin an RF emitin source

acou tic output level (L

p,o t)

Note 1 to e try: Th g in is d termin d at a Ac u tic In ut So n Pre s re L v l of 5 dB (S L) or (for

in u tio pic -u c is) at a ma n tic field stre gth le el re 1 A/m of -3 dB whic is th Ma n tic Eq iv le t of

5 dB (S L)

Note 2 to e try:

,/

pL

Note 1 to e try: IRIL is u e to c ara teriz th immu ity of th h arin aid.

4 Operation and function of the hearing aid

He rin aid b sical y con ist of a micro hone, an ampl fier, an o tional ind ction pic -up coi

an a smal e rphone (receiver) For b hin the e r (BTE) he rin aid the sou d is of en fed

to the e r canal by me n of an in ivid al y made e r mould (e r in ert , or with the receiver

in the au itory canal (RIT ) In the e r (ITE) he rin aid have the active circ itry located in

the au itory canal

The p wer source normal y u ed is a smal b tery On some he rin aid , the u er can

p rform some adju tments of the controls of the he rin aid

5 Specification of EMC environment

He rin aid are u ed in al en ironments as outl ned in IEC 610 0-4-3

6 Requirements for electromagnetic emissions

6.1 Requirements for radiated emis ions

He rin aid s al comply with CISPR 1 req irements, b sed up n their clas ification

He rin aid are clas ified as group 1, clas B eq ipment ac ordin to CISPR 1

6.2 Limits of radiated emis ion

He rin aid s al comply with the l mits of group 1, clas B eq ipment as sp cified by

CISPR 1

6.3 Proced re for radiated emis ions

To en ure normal o eratin con ition the he rin aid´s wireles l n s al b active (if

provided) an monitored The he rin aid s al b exp sed to an acou tic input ISTS at

6 dB SPL ± 5 dB as defined in IEC 6 1 8-15 s ould b u ed The ex lu ion freq en y b n

(if ne ded) s al b doc mented in the test res lts

The me s rement can b car ied out u ing a TEM waveg ide in ac ordan e with

IEC 610 0-4-2

7 Requirements for electromagnetic immunity

7.1 General

This clau e sp cifies the EMC immu ity req irements that are a pro riate for he rin aid

covered by this stan ard Durin al immu ity tests the he rin in trument s al comply with

the immu ity compl an e criteria des rib d in 7.2

7.2 Compl ance criteria

Un er the immu ity test con ition sp cified in Clau e 8, the he rin aid s al b a le to

provide b sic safety an maintain p rforman e The fol owin degradation , if as ociated with

b sic safety, s al not b al owed:

• comp nent fai ure;

• c an es in programma le p rameters;

• reset to factory defaults;

• false alarms (b t ery an “los of he rin aid at other side” alarms);

• er ors in a calc lated, stored or displayed n merical value s f iciently large to af ect

diag osis or tre tment;

• output a ove the inten ed (programmed) maximum p wer output

L s of fu ction d rin test is al owed, but the he rin aid s al return to normal state with no

los of data (e.g by switc in in trument of an on again)

In ad ition d rin exp s re to radiated RF electromag etic field :

• IRIL SPL s al not ex e d 5 dB SPL

7.3 Radiated RF electromagnetic fields

7.3.1 General

For the purp se of the radiated RF electromag etic field immu ity test, two immu ity clas es

of he rin aid are defined (se 3.2 an 3.3) related to their u e

7.3.2 Requirements

He rin aid s al comply with the criteria of 7.2 at immu ity test levels as sp cified in

Ta le 1

Ta le 1 states the field stren th of RF test sig als to b u ed esta ls immu ity for

by tan er comp tible an u er comp tible he rin aid By tan er comp tibi ty s al b

fulfi ed as a minimum req irement, where s u er comp tibi ty is an ad itional fe ture, whic

can b claimed if the requirement is met by the he rin aid

As sources of disturb n e in the freq en y ran e 0,9 GHz to 1,4 GHz b low 0,7 GHz an

b yon 2,7 GHz are actual y not k own to af ect he rin aid , testin for u er comp tibi ty in

these freq en y ran es is not neces ary, but may b con idered in future If the he rin aid

provides an ad itional micro hone input mode – directional micro hone – u er comp tibi ty is

not con idered relevant in this p sition Comp tibi ty in in u tion pic -up coi mode is

con idered imp rtant to esta l s interferen e fre con ition in in u tion lo p en ironments,

an to en ure the a i ty to u e the in u tion pic -up coi as an input tran d cer for as istive

l stenin devices for digital wireles devices, e.g p rta le han s fre kits

7.3.3 Procedure

Test method an eq ipment sp cified in Clau e 8 a ply

The req irements to generate hig field stren th mig t drive the RF p wer amplfier to

generate distortion Care s ould b taken to en ure that distortion do s not af ect the

me s rement res lts

7.4 Electrostatic Dis harge (ESD)

7.4.1 Requirements

He rin aid s al b tested for immu ity to electrostatic dis harges He rin aid s al

comply with the criteria of 7.2 at immu ity test levels of + kV, +4 kV, – kV an – kV for air

dis harge an + kV an – kV for in irect contact dis harge The he rin aid s al b

dis harged b twe n every ESD exp s re Use of a carb n fib r bru h or other mec anism to

remove the resid al c arge is al owed

Hearin aid s al b tested for immu ity to p wer freq en y mag etic field He rin aid

s al comply with the req irements of 7.2 at an immu ity test level of 3 A/m for the

The he rin aid gain control s al b adju ted to the referen e test set in (RTS), an the

other controls s al b set to the b sic setin s as des rib d in 7.3.3 in IEC 6 1 8-7:2 0

8.4 Determination of gain

For the determination of gain u e the same acou tic coupler an tubin (se 8.5) as u ed for

the ORI L me s rement (se b low) together with an anec oic c amb r

The gain of a he rin aid in micro hone mode is determined by a plyin a sin soidal 1 kHz

sig al with a sou d pres ure level (L

p,n) to b swe t from (prefera ly) 3 dB to 8 dB at the

micro hone referen e p int of the he rin aid, me s rin the resp ctive acou tic sou d

pres ure level (L

p,o t) at its output

From this input output resp n e c rve take the acou tic sou d pres ure level (L

p,o t) at 5 dB

input level Se examples in Fig re 1

For the gain of a he rin aid in directional mode u e the gain o tained in micro hone mode

The gain of a he rin aid in in u tion pic -up coi mode is determined by a plyin a

sin soidal 1 kHz sig al with a mag etic field stren th level (L

H ,in) re 1 A/m in dB to b swe t

from -6 dB to –10 dB at the in u tion pic -up coi referen e p int of the he rin aid,

me s rin the respective acou tic sou d pres ure level (L

p,o t) at its output

From this input output resp n e c rve take the acou tic sou d pres ure level (L

p,o t) re 1 A/m

at − 5 dB input level (whic is eq ivalent to the acou tic sou d pres ure level of 5 dB)

Calc late gain an in u tive pic -up coi gain by:

,/

o t

pL

No o jects other than the he rin aid, whic could distort the RF- ield, s al b present in the

test volume: In order to remove the metal c coupler as sp cified in IEC 6 318-5 from the test

volume, the normal tubin b twe n the he rin aid an the coupler s al b re laced by

tubin of 2 mm b re an with a len th typical y b twe n 5 0 mm an 1 0 0 mm

For in- he-e r in truments the outlet from the receiver s al b coupled to the tubin by a

s ita le ada ter This ada ter an the len th of the tubin are not critical, as the he rin aid

gain is determined in e c in ivid al test config ration

An example of a s ita le test ar an ement is given in Fig re 2

He rin aid whose outputs are non-acou tic, e.g b ne con u tion he rin aid wi req ire

u e of a pro riate lo d an coupln device Precise des ription of me s rement set ups for

these typ s of he rin aid s ould b given by the man facturer

Figure 2 – Example of a test ar angement for he ring aid

immunity me s rements u ing a GTEM cel

8.6 Position of the he ring aid during immunity test

The he rin aid s al b placed in the RF field in the referen e orientation (se Fig res 3, 4

an 5 an 3.4) an then b rotated in ste s of 9 ° in the horizontal plane to me s re ORIL at

Figure 5 – Positionin of ITE with receiver, during RF exp s re

8.7 Me s rement of the input related ambient noise (IRAN )

Perform an ORI L me s rement with RF sig al switc ed of to get ORI L

RF of

Determine IRAN by s btractin gain (G) from ORIL

RF ofIRAN = ORIL

RF of–G

8.8 Me s rement of the output related interference level (ORIL)

For e c orientation (0, 9 , 18 , 2 0)° me s re the sou d pres ure level (‘ORI L’) at the

:

• a ply the 1 kHz 8 % ampltu e mod lated RF sig al with the field stren th ac ordin

to Ta le 1,

• me s re the sou d pres ure level (‘ORI L’) at the output of the he rin aid u in a

1 kHz b n -p s fi ter with a maximum b n width of one- hird octave

Me s res s ould b taken to en ure that the b c grou d noise level of the test config ration

is at le st 10 dB lower than the acou tic output (ORIL) from the he rin aid

Gain c an es in the he rin aid may oc ur d e to RF car ier ef ects This phenomenon can

b in estigated by a plyin in re sin field stren th levels u ti he rin aid interferen e

oc urs, an comp re the in re se in me s red interferen e level to the in re se in field

stren th, or by a plyin a 1 3 0 Hz acou tic bias sig al to the micro hone input tub , whic

sets the he rin aid to a k own acou tic output level With a freq en y analy er the he rin

aid acou tic output at 1 3 0 Hz can b me s red to reve l gain c an es in the he rin aid If

gain c an es are o served d rin the me s rement it s al b stated in the test re ort, an

res lts s ould b interpreted with care as the RF car ier efects may have activated the sig al

proces in in the he rin aid in an u predicta le way

Me s rements for u er comp tibi ty an by tan er comp tibi ty can b car ied out as two

se arate tests ac ordin to Ta le 1 There is no ne d to p rform a by tan er comp tibi ty

test if u er comp tibi ty is demon trated The me s rements s al b car ied out with the

micro hone, directional micro hone (if provided) an in u tion pic -up coi (if provided)

NOT Rotatio of th h arin aid in 4 dis rete p sitio s c re p n in to th h arin aid pla eme t u d r a tu l

u e is fo n to b s ita le for h arin aid immu ity te tin (s e An e A)

8.9 Calc lation of the input related interference level (IRIL)

For e c input mode – micro hone mode, in u tive pic -up coi mode

resp ctive gain (G) determined in 8.4 an calc late

maIRIL=ORIL -G

8.10 Re ort

The res lts s al b re orted as I RIL values for al input modes an car ier freq en y ran es

(0,0 8 0,7, 0,7 0,9 , 1,4 2,0, 2,0 2,7, 2,7 6,0) GHz

For in tan e, if IRI L ≤ 5 dB SPL f or a f ield stren th of 9 V/m in the feq en y ran e 7 0

MHz to 9 0 MHz in micro hone mode, the res lt s al b re orted as fol ows: 'User

comp tible 7 0 MHz to 9 0 MHz, micro hone mode'

User comp tibi ty can b re orted for freq en y ran es more nar ow than the complete test

ran e, e.g u er comp tible 1 714 MHz to 1 8 6 MHz

Con eq ently, u er comp tibi ty to up-ln freq en ies in certain digital wireles devices

network can b claimed even if the he rin aid is not u er comp tible in the complete test

ran e

9 Measurement uncertainty for immunity to radiate RF electromagnetic fields

The me s rement u certainty of the method in Clau e 8 is comp sed of several comp nents:

– u certainty derived from the eq ipment u ed, s c as sou d generators, sou d level

meters, me s rin micro hones, coupler, RF pro e placement etc

– varian e in the acou tic coupln of the he rin aid to the coupler, for example relatin to

NOT It is g o pra tic to v ld te th u c rtainty b c mp rin me s reme t re ults with a a cre ite te t

la oratory

Man facturers an purc asers may uti ze the u certainty dif erently Man facturers s al

en ure that their prod ction test res lts fal within pres rib d toleran es that are red ced by

the me s rement u certainty

Purc asers may make their decision b sed on the nominal data exp n ed by the

me s rement u certainty

In 19 4, the Euro e n He rin In trument Man facturers As ociation (EHIMA) u derto k a

series of me s rements to esta l s a b sis for me s rin the ef ects of interferen e on

he rin aid , an for q antifyin practical l mits of immu ity In Au trala simi ar work was

u dertaken at arou d the same time This work con entrated on providin the b sis for

me s rin an sp cifyin what is now k own as the by tan er pro lem At that time, the

is ue of u er comp tibi ty an the ne d to de l with it was l mited by the lac of k owled e

on the s bject an the low u e of digital wireles devices in most cou tries

However, the ra id growth in the u e of digital wireles devices prod ced an urgent ne d to

ad res the is ue of the he rin aid we rer who wanted to u e a digital wireles device Work

on this pro lem commen ed in the USA in 19 7 an led to pro osals for method of

me s rement for b th he rin aid an mo i e phones This work led to the ANSI C6 19 [3]

3

stan ard, whic provided the imp tu for further work in Euro e to evaluate the pro osals

A.2 Radiated RF electromagnetic fields, history of the test method

The EHIMA GSM project final re ort [4] presents the res lts of the develo ment phase of the

EHIMA GSM project, whic is a comprehen ive project set up by EHIMA to esta l s a test

en ironment ena l n the GSM interferen e pro lems to b ad res ed by the memb r

comp nies

It also in lu es res lts from other in estigation car ied out in con ection with the EHIMA

GSM project

The relevant parts of the project are s mmarised b low

Five he rin aid typ s were selected for a la oratory investigation, re resentin dif erent

electro cou tic c aracteristic , interferen e levels an interferen e sp ctra The overal input

related interferen e level (OIRIL), expres ed as SPL in decib ls, was c osen to c aracterise

the interferen e p rforman e of the he rin aid

First, the aid were tested acou tical y ac ordin to IEC 6 1 8-0 To ena le the metal c e r

simulator to b removed from the RF- ield, coupl n b twe n the he rin aid an e r

simulator was modified by u in 5 0 mm lon tubin Relatively large variation in the

acou tical efect of this modification were se n This me n that the he rin aid gain s ould

b me s red for the in ivid al he rin aid u der test in the determination of OIRI L

The he rin aid were then exp sed to a simulated GSM RF- ield in an RF anec oic room

placed in a p sition cor esp n in to normal u e A test sig al havin a p ak field stren th of

10 V/m was u ed This cor esp n s to a digital wireles device havin a p wer of 8 W at a

distan e of 2 m, or a 2 W wireles device at a distan e of 1 m

The freq en y sp ctrum of the interferen e sig al at the orientation cau in maximum

interferen e was determined The input related sp ctrum was then calc lated by s btractin

the he rin aid gain, an final y the OI RIL was determined

The input related spectra a p ared almost identical for al the he rin aid tested, the level of

the harmonic decre sing with in re sin freq en y This me n that only the low freq en y

p rt of the spectrum is ne ded to determine OIRI L with s f icient ac urac for the purp se of

me s rin immu ity

It was se n that rotation of the he rin aid in the horizontal plane af ected the interferen e

p rforman e to some degre an that maximum interferen e oc urs at diferent an les for

dif erent he rin aid In practical y al cases, vertical E-p larisation of the RF- ield, as u ed

in the GSM s stem, gave rise to the hig est interferen e levels

Relatively large dif eren es in OIRI L b twe n dif erent he rin aid typ s were se n, an also

in a smal n mb r of cases b twe n samples of the same typ

A ratio of 1:2 b twe n field stren th an interferen e level, expres ed in dB, was se n for a

field stren th ran e where the interferen e sig al is a ove the noise flo r of the (l ne r)

he rin aid an do s not saturate it (Fig re A.1)

Figure A.1 – Ratio of 1:2 betwe n field strength and interference level in dB

Exp riments were car ied out to determine the ef ect of placin the he rin aid b hin the e r

an in the e r It turned out that the h man he d sig ificantly at en ated the GSM sig al

when the he d was b twe n the tran mitin source an the he rin aid, where s no

sig ificant diferen e was se n when the he rin aid was facin the tran mit in source

Based on these fin in s, it was therefore decided that no “h man- actor cor ection to the

me s rin res lts was req ired

The in estigation also s owed that the u e of 8 %, 1 00 Hz sine mod lation with the same

"p ak r.m.s" level of the car ier as the simulated GSM sig al prod ced a proximately the

same input related interferen e level in the he rin aid This is in agre ment with the

con lu ion an recommen ation of IEC 610 0-4-3 It was therefore decided to recommen

sine mod lation for testin of he rin aid The me s rement res lt is denoted IRI L (input

related interferen e level) It is determined in the same way as OIRIL, but only the freq en y

A.3 Performance criteria

To esta l s a b sis for pro osin ac e tan e levels a series of l stenin tests were car ied

out As the input related sp ctrum of the interferen e sig al was almost identical for al the

he rin aid , only one of the sig als was presented to a group of five p o le of normal

he rin in tru tin them to ju ge the interferen e as "not an oyin ", "sl g tly an oyin ",

"an oyin " an "very an oyin " The interferen e sig als were presented at diferent levels

together with thre dif erent noise an sp ec sig als to simulate dif erent lstenin situation

From the res lts of these tests, ac e tan e levels expres ed as fre field SPLs, are

pro osed

Based on the res lts of these l stenin tests an the la oratory in estigation, it is con lu ed

that an ac e tan e SPL arou d 5 dB wi pro a ly en ure ac e ta le con ition for the

he rin aid u er in most practical situation This value has be n c osen as the p rforman e

criterion in this International Stan ard The c oice was confirmed by an ad itional

in estigation u in he rin imp ired s bjects

To s mmarise, I RIL – the input related interferen e level at 1 0 0 Hz me s red as a sou d

pres ure level in decib ls – s ould b u ed to c aracterise the immu ity of the he rin aid

Decre sin values of IRI L in icate in re sin immu ity The ac e tan e level cor esp n in

to IRI L eq al to or les than 5 dB SPL wi pro a ly en ure ac e ta le con ition for the

he rin aid u er in most practical situation an is recommen ed as the p rforman e

criterion

A.4 Test field stre gths – Bystander compatibility

To b a le to s g est re l stic field stren th for testin hearin aid , i.e field stren th

whic simulate situation where the he rin aid u er is disturb d by a ne rby p rson u in a

digital wireles device, a n mb r of p ints s ould b taken into ac ou t

Firstly, the pro osed test proced re is b sed on a n mb r of worst case con ideration :

– The maximum interferen e level is fou d in e c of four dif erent orientation of the

he rin aid relative to the disturbin field, an out of these four maxima the hig est is

u ed to c aracterise the interferen e level in the he rin aid

– If ful compl an e to the stan ard is doc mented, the maximum interferen e level within a

– The field stren th cor esp n in to maximum tran mitin p wer is u ed, despite the fact

that digital wireles devices only tran mit with maximum p wer in certain situation

(b t ery ful y c arged, large distan e an /or o stacles b twe n the digital wireles device

an the b se station)

Secon ly, another practical circ mstan e s ould b noted: Users of digital wireles devices

wi pro a ly ten to obtain as mu h privac as p s ible an there y in re se the distan e to

ne rby p rson as mu h as p s ible The field stren th given for by tan er comp tibi ty in

Ta le 1 cor esp n to a the retical protection distan e of a proximately 2 m for an digital

wireles device

A.5 Field stre gths – User compatibility

As a fol ow-up on the EHIMA stu ies con lu ed in 19 5, a project fu ded by the Euro e n

Union ISIS programme was con u ted in 19 9 This project "He rin Aid an Mo i e Phones

Immu ity an Interferen e Stan ard – HAMPI S" was con u ted to esta l s sp cification

for a revision of this p rt of IEC 6 1 8 regardin criteria for he rin aid we rers to u e digital

wireles devices themselves A test method pro osed in the ANSI C6 19 stan ard with ne

r-field exp s re of he rin aid u in a dip le anten a was verified d rin the project Ne

r-field-exp s re of he rin aid u in a dip le anten a (or a digital wireles device) was fou d

to b valua le d rin desig an develo ment of new he rin aid , where it can brin

valua le information An example of a s ita le test ar an ement u in a dip le anten a is

therefore given in Fig re A.2

Figure A.2 – Example of test ar an ement for he ring aid

immunity me s rements usin dip le antenna

However, as a stan ardised method for test an clas ification of he rin aid , the dip le test

was rejected Rejection of the dip le method was primari y d e to the ne d for a s ielded test

en ironment an p or rel a i ty in the test method from one test ar an ement to another

Ad itional y, an improved cor elation b twe n me s red p rforman e an re l-l fe

p rforman e could not b fou d, despite the fact that the he rin aid u er situation in re l-l fe

is a ne r- ield i umination of the he rin aid

The test field stren th for ne r field u e of digital wireles devices with he rin aid was

esta l s ed by a stu y on he rin aid immu ity in u er situation Twelve he rin aid havin

Input Related Interferen e L vels (I RIL) from b low 2 dB to more than 7 dB when tested in

a GTEM cel at 9 0 MHz, 3 V/m an I RIL values from b low 2 dB to more than 10 dB at

1 8 0 MHz, 2 V/m were u ed for the stu y The stu y was car ied out as a l stenin test

where 9 0 MHz an 1 8 0 MHz GSM phones were ru on maximum p wer level, controled by

a mo ie phone b se station simulator The outcome of the stu y s owed eviden e that a

he rin aid wi b u e ble in the u er situation if I RIL SPL is b low 5 dB for a field stren th

of 7 V/m or hig er at 9 0 MHz an of 5 V/m or hig er at 1 8 0 MHz when me s red in a

GT M cel – a test field stren th 2 times hig er (a proximately 2 dB) than u ed for

verification of the by tander clas ification

In this 4

th

edition of IEC 6 1 8-13, test field stren th have b en updated for con isten y with

IEEE/ANSI C6 19 (se [6] an [7]), an test field stren th for freq en ies a ove 2 GHz

have b en ad ed Wireles services lke Blueto th o erate in the 2,0 GHz to 2,6 GHz ran e

Services in this freq en y ran e are typical y ru nin at lower p wer levels comp red to

services b low 1 GHz TDMA mod lation (e.g u ed in GSM mo i e phones an DECT

wireles phones) has s own to generate the most ag res ive interferen e in he rin aid to

date, whi e CDMA an other mod lation s hemes are les ag res ive The test levels u ed

sin e the first edition of IEC 6 1 8-13 in 199 have demon trated throu h testin of more

than 1.0 0 he rin aid models (ref Euro e n He rin Aid Man facturers As ociation –

EHIMA) to b s ficiently hig to en ure wel - u ctionin he rin aid in every ay u e, with

only a smal exp ctation of a few complaints regardin interferen e from digital wireles

devices A test field stren th 3 dB b low the l mit for the 1,4 GHz to 2,0 GHz ran e is

con idered s f icient to s stain wel - u ctionin he rin aid in dai y lfe regardin

interferen e in the 2,0 GHz to 2,6 GHz ran e

The p rforman e criteria wi not en ure total y interferen e- re an noise- re u e of digital

wireles devices but esta l s es lmits that wi b ef ective in most situation In practice

he rin aid u ers wi themselves fin a p sition of the digital wireles device by the e r that

Annex B

(informativ )

Rationale for particular clauses and subclauses

B.1 Rationale for Clause 6, Re uirements for electromagnetic emissions

As he rin aid are medical electronic eq ipment, the req irements regardin emis ion have

b en derived from relevant p rts of IEC 6 6 1-1-2 He rin aid covered by this stan ard are

internal y p wered They do not have an con ection to s p ly main or other external p wer

source, an do not have ca les that are a ove 3 m of len th Con eq ently, no other EMC

req irements other than the req irement sp cified in 6.1 a ply

B.2 Rationale for 6.1, Radiated emissions

He rin aid s al comply with the CISPR 1 req irements regardin radiated emis ion

He rin aid covered by this stan ard in lu e wireles receivers or tran miters, an are

clas ified as group 1 eq ipment ac ordin to 5.1 of CISPR 1 :2 15 He rin aid are

inten ed to b u ed in al en ironments in lu in the domestic en ironment an are clas ified

as clas B ac ordin to 5.2 of CISPR 1 :2 15

B.3 Rationale for Clause 6, Re uirements for RF emissions and Clause 7

Re uirements for ele tromagnetic immunity

As he rin aid are medical electronic eq ipment, the req irements regardin emis ion have

b en derived from relevant p rts of IEC 6 6 1-1-2 He rin aid covered by this stan ard are

internal y p wered They do not have an con ection to s p ly main or other external p wer

source, an do not have ca les that are a ove 3 m of len th Con eq ently no other EMC

req irements other than the req irement sp cified in 6.1, 7.3, 7.4 and 7.5 a ply

B.4 Rationale for 7.2, Compliance criteria

The compl an e criteria for the immu ity testin of he rin aid have b en identified b sed on

the relevant b sic complan e criteria in Clau e 8 of IEC 6 6 1-1-2:2 14 an IEC 6 6 1-2-6

in general, together with the sp cific req irement for ac e ta le p rforman e des rib d in

Clau e A.3 The lsted complan e criteria are adeq ate for en urin the b sic safety of the

Throu h historical u e, he rin aid have not had k own fai ure is ues d e to ESD dis harge

In irect contact dis harge re resents the most l kely u e case: some od we rin a he rin

aid gets tou hed by some ody else an the c arge flows ne rby the hearin aid

The relevant req irements of IEC 6 6 1-1-2 regardin ESD have b en ado ted into this

stan ard, as he rin aid are medical electronic eq ipment

B.7 Rationale for 7.5, Power frequency magnetic fields

The relevant req irements of IEC 6 6 1-1-2 regardin power freq en y mag etic field have

b en ado ted into this stan ard, as he rin aid are medical electrical eq ipment

Bibl ography

[1] IEC 6 1 8-4:2 14, Electro ac oustc – Hearin aids – Part 4: Inducto -oo p systems

fo r h aring aid purp ses – System p rfo rmanc e re u ireme ts

[2] IEC 6 6 1-1-2:2 14, Medic l ele c tricalequ ipme nt – Part 1-2: Ge neral re u ire me ts fo r

b asic s fe ty and es e tal p erformance – C olateral Standard: Electromagnetc

disturb ance s – Re u ireme nts and te sts

[3] ANSI C6 19:2 01, Americ n Nato al Standard fo r Meth ds o f Mea ureme t o f

Comp atb il y betwee n Wireles C ommu nic to s Devic e s and Hearin Aids

[4] EHIMA GSM project, final re ort:19 5, He arin aids and GSM mo bie tele pho ne s:

Inte rfe re c e p ro blems, me tho ds of me asureme t and le vels ofimmu niy

[5] EHIMA, Tec nical Note 2 0 , C ompariso n of IEC 60 118-13 and ANSI C 63.19 EMC

mea ure me ts (e rl er version of 2 13)

[6] IEEE C.6 19:2 1 , Meth ds of Mea ureme t o f Comp atbi ty b e twe n Wireles

Commu nic ato n De vic e s and Hearin Aids, Me asureme ts of wirele ss tele ph n

e mis io s and h arin aid immu niy, wih p redic ted pe rfo rmanc e b ased o mea ure s

[7] EU ISIS Programme project:19 9, He arin Aids and Mob ile Ph ne s Immu niy and

Inte rfe re ce Standards – HAMPIS, avai a le from EHIMA, Bru sels

[8] NAL re ort No 131:19 5, Inte rfe re c e to Hearin Aids by th Dig ital Mob ile Tele pho ne

System, Glo al System fo r Mob ile C o mmu nic to s (GSM), National Acou tic

L b ratories, Au tral a

[9] IEC 6 6 1-2-6 :2 15, Medic al ele ctric al e u ipme t – Part 2-66: Partc u lar

re qu ireme ts fo r th b asic s fety and e sse tal p e rfo rmanc e of he arin instru me nts

and h arin instru me t systems

4 Uti sation et fon tion de l a p rei de cor ection au itive 3

5 Sp cification de l en iron ement CEM 3

6 Exigen es relatives au émis ion électromag étiq es 3

7.2 Critères de conformité 3

7.3 Champs électromag étiq es RF rayon és 3

8.7 Mes re d nive u d’ nterféren e ramené à l entré (IRAN) 4

8.8 Mes re d nive u d’ nterféren e ramené à la sortie (ORI L) 4

8.9 Calc l d nive u d’ nterféren e ramené à lentré (I RIL) 4

A.2 Champs électromag étiq es RF rayon és, historiq e de la méthode d’es ai 4

A.3 Critères de p rforman e 5

A.4 Inten ités d c amp d'es ai – Comp tibi té avec la présen e 5

A.5 Inten ités d c amp d'es ai – Comp tibi té avec u e uti sation p rson el e 51