Iec 60601 2 66 2015

MEDICAL ELECTRICAL EQUIPMENT – Part 2-66: Particular requirements f or the basic saf ety and essential perf ormance of hearing instruments and hearing instrument systems 201.1 Scope, obj

Medical electrical equipment –

Part 2- 66: Part icular requirement s for t he basic safety and essent ial per ormance

of hearing inst rument s and hearing inst rument sy stems

Apparei s élect romédicaux –

Part ie 2- 66: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des inst rument s d'audit ion et sy stèmes d'audit ion

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c c@ie c

Medical elect rical equipment –

Part 2- 66: Part icular requirement s for t he basic safety and essent ial per ormance

of hearing instrument s and hearing instrument sy stems

A pparei s électromédicaux –

Partie 2- 66: Ex igences part icul ères pour la sécurité de base et les per ormances

essentiel es des inst ruments d'audit ion et sy st èmes d'audit ion

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A tt ention! Veui ez vou a s rer q e vou avez o te u c t te publc tion v ia u distribute r a ré

CONTENTS

FOREWORD 3

INTRODUCTION 5

2 1.1 Sco e, o ject an related stan ard 6

2 1.2 Normative ref eren es 8

2 1.3 Terms an def i ition 8

2 1.4 General req irements 10 2 1.5 General req irements f or testin ME EQUIPMENT 10 2 1.6 Clas ifi ation of ME EQUIPMENT an ME SYS EMS 12 2 1.7 ME EQUIPMENT identif i ation, markin an doc ments 13 2 1.8 *Protection again t electrical H ZA DS f rom ME EQUIPMENT 18 2 1.9 *Protection again t MEC A ICAL HAZA DS of ME EQUIPMENT an ME SYS EMS 21

2 1.10 Protection again t u wanted an ex es ive radiation H ZA DS 2

2 1.1 *Protection again t ex es ive temp ratures an other H ZA DS 2

2 1.12 *Ac urac of controls an in truments an protection again t hazardou outputs 2

2 1.13 *HAZA DOUS SITU TIONS an fault con ition for ME EQUIPMENT 2

2 1.14 *PROGR MMABLE ELECTRIC L MEDICAL SYS EMS (P MS) 28 2 1.15 *Con tru tion of ME EQUIPMENT 2

2 1.16 *ME SYS EMS 31

2 1.17 *Electromag etic comp tibi ty of ME EQUIPMENT an ME SYS EMS 31

An exes 3

An ex E (informative) Examples of the con ection of the me s rin device (MD) f or me s rement of THE PATIENT LEA AGE C R ENT an PATIENT A XILIA Y CU RENT 3

An ex G (normative) Protection again t HAZA DS of ig ition of f lamma le ana sthetic mixtures 3

An ex H (informative) PEMS stru ture, P MS DEVELOPMENT LIF -C CLE an doc mentation 32 An ex I (informative) ME SYS EMS asp cts 3

An ex J (informative) Survey of in ulation p th 3

An ex K (informative) Simpl f ied PATIENT LEA AGECU RENT diagrams 3

An ex L (normative) In ulated win in wires for u e without interle ved in ulation 3

An ex AA (inf ormative) Partic lar g idan e an rationale 3

An ex BB (inf ormative) Ab reviation 3

Bibl ogra h 4

In ex of def i ed terms u ed in this p rtic lar stan ard 41

Fig re 2 1.101 – Me s rin circ it f or LEA AGE C R ENT 2

Ta le 2 1.10 – MECH NIC L H ZA DS to b con idered 21

Ta le AA.101 – Summary of the a pro c of this stan ard 3

INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-66: Particular requirements f or the basic saf ety and essential

perf ormance of hearing instruments and hearing instrument systems

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 f i ld 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 f ter refere to a “IEC

Pu lc tio (s)”) Th ir pre aratio is e tru te to te h ic l c mmite s; a y IEC Natio al Commite intere te

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

c n e s s of o inio o th rele a t s bje ts sin e e c te h ic l c mmite h s re re e tatio f rom al

intere te IEC Natio al Commite s

3) IEC Pu lc tio s h v th form of re omme d tio s for intern tio al u e a d are a c pte b IEC Natio al

Commite s in th t s n e Whie al re s n ble eforts are ma e to e s re th t th te h ic l c nte t of IEC

Pu lc tio s is a c rate, IEC c n ot b h ld re p n ible for th wa in whic th y are u e or f or a y

misinterpretatio b a y e d u er

4) In ord r to promote intern tio al u iformity, IEC Natio al Commite s u d rta e to a ply IEC Pu lc tio s

tra s are tly to th ma imum e te t p s ible in th ir n tio al a d re io al p blc tio s An div rg n e

b twe n a y IEC Pu lc tio a d th c r e p n in n tio al or re io al p blc tio s al b cle rly in ic te in

th later

5) IEC its lf d e n t pro id a y ate tatio of c nformity In e e d nt c rtif i atio b die pro id c nformity

a s s me t s rvic s a d, in s me are s, a c s to IEC mark of c nf ormity IEC is n t re p n ible for a y

s rvic s c rie o t b in e e d nt c rtific tio b die

6) Al u ers s o ld e s re th t th y h v th late t e itio of this p blc tio

7) No la i ty s al ata h to IEC or its dire tors, emplo e s, s rv nts or a e ts in lu in in ivid al e p rts a d

memb rs of its te h ic l c mmite s a d IEC Natio al Commite s f or a y p rs n l injury, pro erty d ma e or

oth r d ma e of a y n ture wh ts e er, wh th r dire t or in ire t, or f or c sts (in lu in le al fe s) a d

e p n e arisin o t of th p blc tio , u e of, or rela c u o , this IEC Pu lc tio or a y oth r IEC

Pu lc tio s

8) Ate tio is drawn to th Normativ ref ere c s cite in this p blc tio Us of th refere c d p blc tio s is

in is e s ble f or th c re t a plc tio of this p blc tio

9) Ate tio is drawn to th p s ibi ty th t s me of th eleme ts of this IEC Pu lc tio ma b th s bje t of

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

International Stan ard IEC 6 6 1-2-6 has b en pre ared by IEC tec nical commite 2 :

Electro cou tic

This secon edition can els an re laces the first edition publ s ed in 2 12 It con titutes a

tec nical revision to ada t IEC 6 6 1-2-6 :2 12 to the tec nical cor ection introd ced by

Amen ment 1 (2 12) to IEC 6 6 1-1:2 0 , as wel as to clarify an cor ect the wordin of this

p rtic lar stan ard an to implement minor c an es req ested by interested p rties

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 f ou d in the re ort on

votin in icated in the a ove ta le

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

In this stan ard, the f ol owin print typ s are u ed:

– Req irements an defi ition : roman typ

– Te t s e ific tio s: itali typ

– Informativ material a p arin o tsid of ta le , s c a n te , e ample a d refere c s: in smaler ty e

Normativ te t of ta le is als in a smaler ty e

– TERMS DE INED IN CLA S 3 OF THE GENER L S A D R , IN THIS PA TICULA S A D R OR AS

NOT D:SMAL C PITALS

In refer in to the stru ture of this stan ard, the term

– “clau e” me n one of the sevente n n mb red division within the ta le of contents,

in lu ive of al s bdivision (e.g Clau e 7 in lu es s bclau es 7.1, 7.2, etc.);

– “s bclau e” me n a n mb red s bdivision of a clau e (e.g 7.1, 7.2 an 7.2.1 are al

s bclau es of Clau e 7)

Ref eren es to clau es within this stan ard are preceded by the term “Clau e” fol owed by the

clau e n mb r Referen es to s bclau es within this p rtic lar stan ard are by n mb r only

In this stan ard, the conju ctive “or” is u ed as an “in lu ive or” so a statement is true if an

combination of the con ition is true

The verb l forms u ed in this stan ard conform to u age des rib d in An ex H of the ISO/IEC

Directives, Part 2 For the purp ses of this stan ard, the au i ary verb:

– “s al ” me n that compl an e with a req irement or a test is man atory f or compl an e

with this stan ard;

– “s ould” me n that compl an e with a req irement or a test is recommen ed but is not

man atory for compl an e with this stan ard;

– “may” is u ed to des rib a p rmis ible way to ac ieve complan e with a req irement or

test

An asteris (*) as the first c aracter of a title or at the b gin in of a p ragra h or ta le title

in icates that there is g idan e or rationale related to that item in An ex AA

A l st of al p rts of the IEC 6 6 1 series, publ s ed u der the general title Medic l electric l

e uipme t, can b f ou d on the IEC we site

The commite 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 "htp:/ we store.iec.c " in the data

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

• recon rmed,

• with rawn,

• re laced by a revised edition, or

• amen ed

INTRODUCTION

In 19 8 the HEA ING INS R MENT in u try re resented by the EHIMA atempted to esta l s a

stan ard with the main purp se of providin man facturers with a g ide to demon trate

conformity with the Euro e n Medical Devices Directive 9 /4 /EEC

The doc ment prEN 5 2 0 fai ed CENELEC vote an was publ s ed as “EHIMA stan ard” in

Ju e 19 8 with almost identical content EHIMA con lu ed in 2 0 that the req irements of

that stan ard were no lon er up to date an an international y ac e ted stan ard for HEA ING

INS R MENT saf ety publ s ed by IEC or ISO to demon trate compl an e with reg latory

req irements s ould b produ ed

This res ltin IEC stan ard amen s an s p lements IEC 6 6 1-1 ( hird edition, 2 0 ):

Medical electrical eq ipment – Part 1: General req irements for saf ety an es ential

p rf orman e, hereinaf ter ref er ed to as ‘the general stan ard’

Fig res in s uare brac ets refer to the Bibl ogra h

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-66: Particular requirements f or the basic saf ety and essential

perf ormance of hearing instruments and hearing instrument systems

201.1 Scope, object and related standards

Clau e 1 of the general stan ard

1

a pl es, ex e t as folows:

2 1.1.1 * Scope

Re lac me t:

This International Stan ard a pl es to the BASIC SAF TY of HEA ING INS R MENT an HEA ING

INS R MENT SYS EMS, here f ter also ref er ed to as ME EQUIPMENT or ME SYS EM

If a clau e or s bclau e is sp cif i aly inten ed to b a pl ca le to HEA ING INS R MENT only,

or to HEA ING INS R MENT SYS EMS only, the title an content of that clau e or s bclau e wi

say so If that is not the case, the clau e or s bclau e a pl es b th to HEA ING INS R MENT

an to HEA ING INS R MENT SYS EMS, as relevant

HAZA DS in erent in the inten ed ph siological f un tion of HEA ING INS RUMENT or HEA ING

INS R MENT SYS EMS within the s o e of this stan ard are not covered by sp cif i

req irements in this stan ard ex e t in 2 1.7.9.2 an 2 1.9.6

NOT Se als 2 1.4.2 (RISK MA AGEMENT)

A CE SORIE to HEA ING INS RUMENT in the HO E HEALTH A E EN IRONMENT (e.g remote

control u its, au io stre mers, b t ery c argers, p wer s p l es) are covered by the most

a pl ca le stan ard, IEC 6 0 5, IEC 6 9 0-1 or other a pl ca le IEC safety stan ard

Alternatively the general stan ard may b a pled HEA ING INS R MENT do not have a MAINS

PA T inten ed for con ection to a.c SUP LY MAINS The con ection to the SUP LY MAINS of a

HEA ING INS R MENT s stem is covered by p wer s p ly, c arger or other typ s of

A CE SORIE

A CE SORIE con ected to a HEA ING INS RUMENT may f orm a HEA ING INS RUMENT SYS EM

Only the HEA ING INS R MENT an its detac a le p rts are s bject to al a plca le clau es of

this p rtic lar stan ard The remainin comp nents of the HEA ING INS RUMENT SYS EM are

s bject to req irements of this p rtic lar stan ard that res lt from their con ection to the

This stan ard do s not a ply to:

– coc le r implants or other implanted HEA ING INS RUMENT ;

– b ne con u tion HEA ING INS R MENT ;

_ _ _ _ _ _

1

Th g n ral sta d rd is IEC 6 6 1 1:2 0 +A1:2 12, M ed i cal ele tri cal eq i pme t – Part 1: Ge eral

req i reme ts for b si c s fet y a d e s nti al p rorma c

– ed cational HEA ING INS RUMENT (i.e group HEA ING INS R MENT , au itory trainers etc.);

– the a plcation of a HEA ING INS R MENT f or the me s rement of he rin levels

IEC 6 6 5-1 a pl es;

– au io-f req en y in u tion-lo p s stems or their comp nent p rts, as des rib d in

IEC 6 1 8-4 an IEC 6 4 9-1;

– as isted HEA ING INS R MENT SYS EMS u in infra- ed or radio;

– the sou d generatin fun tion of a tin itu mas er

2 1.1.2 Obje t

Re lac me t:

The o ject of this p rtic lar stan ard is to esta l s p rtic lar BASIC SAF TY req irements f or

HEA ING INS RUMENT an HEA ING INS RUMENT SYS EMS as defi ed in 2 1.3.2 2 an

2 1.3.2 3

2 1.1.3 * Col ateral sta dards

Additio :

This p rtic lar stan ard refers to those a pl ca le col ateral stan ard that are l sted in

Clau e 2 of the general stan ard

IEC 6 6 1-1-2, IEC 6 6 1-1-3, IEC 6 6 1-1-9, IEC 6 6 1-1-10, an IEC 6 6 1-1-1 do not

a ply Al other publs ed col ateral stan ard in the IEC 6 6 1-1 series a ply as publ s ed

2 1.1.4 Partic lar sta d rd

Re lac me t:

In the IEC 6 6 1 series, p rtic lar stan ard may modif y, re lace or delete req irements

contained in the general stan ard an col ateral stan ard as a pro riate f or the p rtic lar

ME EQUIPMENT u der con ideration, an may ad other BASIC SAF TY an E S NTIAL

P RFORMA CE req irements

A req irement of a p rtic lar stan ard takes priority over the general stan ard

For brevity, IEC 6 6 1-1 is ref er ed to in this p rtic lar stan ard as the general stan ard

Col ateral stan ard are ref er ed to by their doc ment n mb r

The n mb rin of clau es an s bclau es of this p rtic lar stan ard cor esp n s to that of

the general stan ard with the pref i “2 1” (e.g 2 1.1 in this stan ard ad res es the content

of Clau e 1 of the general stan ard) or a pl ca le col ateral stan ard with the pref i “2 x”

where x is the fi al digit s) of the colateral stan ard doc ment n mb r (e.g 2 2.4 in this

p rtic lar stan ard ad res es the content of Clau e 4 of the IEC 6 6 1-1-2 col ateral

stan ard, 2 3.4 in this p rtic lar stan ard ad res es the content of Clau e 4 of the

IEC 6 6 1-1-3 col ateral stan ard, etc.) The c an es to the text of the general stan ard are

sp cif ied by the u e of the f ol owin word :

"Re lacement" me n that the clau e or s bclau e of the general stan ard or a pl ca le

col ateral stan ard is re laced completely by the text of this p rtic lar stan ard

"Ad ition" me n that the text of this p rtic lar stan ard is ad itional to the req irements of

the general stan ard or a plca le col ateral stan ard

"Amen ment" me n that the clau e or s bclau e of the general stan ard or a pl ca le

Subclau es, f i ures or ta les whic are ad itional to those of the general stan ard are

n mb red startin from 2 1.101 However, d e to the f act that def i ition in the general

stan ard are n mb red 3.1 throu h 3.13 , ad itional def i ition in this stan ard are

n mb red b gin in from 2 1.3.2 1 Ad itional an exes are letered AA, BB, etc an

ad itional items a ), b ), etc

Subclau es, f i ures or ta les whic are ad itional to those of a col ateral stan ard are

n mb red startin from 2 x, where “x” is the n mb r of the col ateral stan ard, e.g 2 2 f or

IEC 6 6 1-1-2, 2 3 f or IEC 6 6 1-1-3, etc

The term "this stan ard" is u ed to make ref eren e to the general stan ard, an a pl ca le

col ateral stan ard an this p rtic lar stan ard taken together

Where there is no cor esp n in clau e or s bclau e in this p rtic lar stan ard, the clau e or

s bclau e of the general stan ard or a pl ca le col ateral stan ard, althou h p s ibly not

relevant, a pl es without modif i ation; where it is inten ed that an p rt of the general

stan ard or a pl ca le colateral stan ard, althou h p s ibly relevant, is not to b a pl ed, a

statement to that ef fect is given in this p rtic lar stan ard

201.2 Normative ref erences

Clau e 2 of the general stan ard a pl es ex e t as fol ows:

IEC 6 1 8-0:2 15, Ele tro c u tic – H earing aids – P art 0: M ea ureme t of

electro c u tic l c ara teristic

IEC 6 1 8-13, Ele tro c u tic – H earing aids – P art 13: Ele troma n tic c mp tibility (EMC)

IEC 6 6 1-1:2 0 , Med ic l electric l e uipme t – P art 1: Ge eral re uireme ts for b sic

s fety a d e s ntial p rorma c

IEC 6 6 1-1:2 0 /AMD1:2 12

IEC 6 6 1-1-1 :2 15, Medic l electric l e uipme t – P art 1-1 : Ge eral re uireme ts for

b sic s fety a d e s ntial p rorma c – Co ateral Sta d ard : Re uireme ts for med ic l

ele tric l e uipme t a d med ic l ele tric l s stems u ed in the h me h alth are e viro me t

IEC 6 3 4, M ed ic l d evic s ftware – Software life c cle pro e s s

IEC 6 3 6:2 0 , M ed ic l devic s – Ap li atio ofu a ility e gin ering to medic l devic s

201.3 Terms and def initions

For the purp ses of this doc ment, the terms an defi ition given in IEC 6 6 1-1:2 0 an

IEC 6 6 1-1:2 0 /AMD1:2 12 a ply, ex e t as fol ows:

NOT An in e of d fin d terms is fo n b gin in o p g 41

Note 1 to e try: In this p rtic lar sta d rd a d in a plyin th re uireme ts of th g n ral sta d rd, th term

P TIE T h s th me nin e plain d in th s c n p ra ra h of 4.1 of th g n ral sta d rd Th P TIE T is als

u u ly th OP RA O

Th term P TIE T is b in u e in this sta d rd in ln with th g n ral termin lo y in th me ic l pro u t field It

is h we er u d rsto d, th t th u er of a H ARING IN TRUME T is ty ic ly n t a i p rs n b t s me n h alth

with a h arin imp irme t in a HO E H ALT CARE E VIR NME T

AP LIED PA T complyin with the sp cif ied req irements of this p rtic lar stan ard to provide

protection again t electric s oc , p rtic larly regardin al owa le PATIENT LEA AGE C RRENT

HEA ING INS RUMENT SYS EM

combination, as sp cif ied by its MA UFA TU ER, of items of eq ipment, at le st one of whic

is a HEA ING INS RUMENT to b inter con ected by FU CTIONAL CON ECTION

pp

where the ref eren e value, p

0, is 2 µPa

Note 1 to e try: Be a s of pra tic l lmitatio s of th me s rin in trume ts, p

Note 2 to e try: This d f i itio is te h ic ly in a c rd n e with ISO 8 0 0-8:2 0 , 8-2

Note 3 to e try: Th n te to e try c n ernin th origin of th En ls a bre iatio “S L” c n ern th Fre c te t

o ly

[SOURCE: ISO/TR 2 417:2 0 , 2.2]

201.4 General requireme ts

Clau e 4 of the general stan ard a pl es, ex e t as fol ows:

2 1.4.1 Con itions f or appl c tion to ME EQUIPMENT or ME SYS EMS

Re lac me t:

Unles otherwise sp cified, the req irements of this stan ard s al a ply in NORMAL US an

re sona ly forese a le mis se

When a plyin this stan ard to HEA ING INS RUMENT or HEA ING INS R MENT SYS EMS, the

def i ition an req irements that u e the term PATIENT s al b con idered as a plyin to the

HEA ING INS R MENT do not have an E S NTIAL P RFORMA CE

2 1.4.6 ME EQUIPMENT or ME SYS EM parts that conta t the PATIENT

Subclau e 4.6 of the general stan ard do s not a ply

2 1.4.10 Power s pply

Subclau e 4.10 of the general stan ard do s not a ply

2 1.4.1 Power input

Subclau e 4.1 of the general stan ard do s not a ply

201.5 General requireme ts f or testing ME EQUIPMENT

Clau e 5 of the general stan ard a pl es, ex e t as fol ows:

2 1.5.2 Number of s mple

Re lac me t:

TYP T S S are p rf ormed on a re resentative sample of the item b in tested If multiple

prod cts are u der con ideration, whic have a simi ar mec anical an electrical arc itecture,

then an en ine rin analy is by the MA UFA TU ER may ju tif y a sin le re resentative sample

, tests are p rformed within the ran e of en ironmental con ition in icated in the

tec nical des ription, as sp cif ied by the MA UFA TU ER

2 1.5.4 Other conditions

Ad ditio :

a ) In entory stoc in con ition are sp cif ied by the MA UFA TU E

R

b ) HEA ING INS R MENT tran p rt con ition are sp cif ied by the MA UFA TU ER

2 1.5.5 Supply volta e , type of c r e t, n ture of s p ly, fre ue c

Re lac me t:

a) Where test res lts are in uen ed by deviation of the s p ly voltage from its rated value,

the ef fect of s c deviation s al b taken into ac ou t

b) HEA ING INS RUMENT an HEA ING INS RUMENT SYS EMS desig ed f or more than one rated

voltage s al b tested in con ition related to the le st f avoura le voltage an nature of

s p ly

c) HEA ING INS R MENT for whic alternative A CE SORIE or detac a le p rts can b

con ected as sp cif ied in the A COMPA YING DOC MENT s al b tested with those

A CE SORIE or detac a le p rts that res lt in the le st favoura le con ition

d) If the in tru tion f or u e sp cif y that a

HEA ING INS R MEN

T or a

HEA ING INS R MENT

SYS EM is inten ed to receive its p wer f rom a se arate p wer s p ly, it s al b

con ected to s c a p wer s p ly

2 1.5.7 Humidity pre onditioning tre tme t

Re lac me t:

Where cl matic con ition could in uen e the saf ety of a HEA ING INS RUMENT or HEA ING

INS R MENT SYS EM or its p rts, it s al b s bjected to a h midity precon itionin tre tment

prior to the tests of 2 1.8.7.4

HEA ING INS RUMENT an HEA ING INS R MENT SYS EMS or theirs p rts s al b set up

completely (or where neces ary p rtial y) Covers u ed d rin tran p rt an storage s al b

detac ed

Parts that can b detac ed without the u e of to ls s al b detac ed, but tested

simultane u ly with the major p rt

A CE S COVERS that can b o ened or detac ed without the u e of to ls s al b o ened an

detac ed

The h midity precon itionin tre tment s al b p rf ormed in a h midity ca inet containin air

with a relative h midity of 9 % ± 3 % where the ME EQUIPMENT or its p rts u der test are

located The h midity con ition at other location in the c amb r may vary by ± 6 % The

temp rature of the air in the ca inet, at al places where HEA ING INS R MENT an HEA ING

INS R MENT SYS EMS can b located, s al b maintained within 2 °C of an con enient value

T in the ran e of + 2 °C to + 3 °C Before b in placed in the h midity ca inet, HEA ING

INS R MENT an HEA ING INS R MENT SYS EMS are brou ht to a temp rature b twe n T an

T + 4 °C, an ke t at this temp rature f or at le st 4 h b f ore the h midity tre tment starts

Ke p HEA ING INS RUMENT an HEA ING INS RUMENT SYS EMS an its p rts, w here t he

EN LOSUR E is c las ified as IPX 0, in the h midity ca inet f or at le st 4 h

201.6 Classif ication of ME EQUIPMENT and ME SYST MS

Clau e 6 of the general stan ard a pl es, ex e t as fol ows:

2 1.6.2 Prote tion a ainst ele tric s oc

Re lac me t:

HEA ING INS RUMENT are INT R AL Y POWERED, but may have con ection to main s p l ed

eq ipment The in ulation b twe n the SUP LY MAINS an the HEA ING INS R MENT s al b

provided within the p wer s p ly, c arger or other typ of A CE SOR

The HEA ING INS R MENT is clas if ied a TYP B AP LIED PA T

2 1.6.3 Prote tion a ainst harmf ul in re s of water or partic late mat er

Re lac me t:

Se 2 1.1 6.5

2 1.6.6 Mode of operation

Re lac me t:

HEA ING INS R MENT are clas if ied f or CONTINUOUS OP R TION

201.7 ME EQUIPMENT identif ication, marking and documents

Clau e 7 of the general stan ard a pl es, ex e t as fol ows:

2 1.7.1 Ge eral

2 1.7.1.1 USABILITY of the ide tific tion, marking a d doc me ts

Re lac me t:

The MA UFA TU ER s al ad res in the RISK MA AGEMENT PROCE S the RISK of p or USABILITY

as ociated with the desig of the HEA ING INS R MENT’S identifi ation, markin an

doc ments

The USABILITY of the identif i ation, markin an A COMPA YING DOC MENT inten ed f or the

PATIENT s al b evaluated b sed on a PATIENT prof ile that in lu es b sic s ho l ed cation

He rin in truments s ould b desig ed to b simple to u e an not req ire referen e to

complex A COMPA YING DOC MENT

Comp a c s a b c e k d b in p ctio of th re ults of th RISK MANAGE M E NT PRO E SS

2 1.7.1.2 Le ibi ty of markings

Re lac me t:

The markin s req ired by 7.2 an 7.3 s al b cle rly legible u der the fol owin con ition :

– Saf ety sig s an identifi ation, on the HEA ING INS R MENT ex e t serial n mb r, s al b

cle rly legible when it is placed in the han of the PATIENT

– The serial n mb r an an other markin s s al b legible uti zin an o tical aid if

neces ary

2 1.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts

2 1.7.2.1 Minimum re uireme ts f or marking on HEA ING INS RUMENT

Re lac me t:

If the size of the HEA ING INS R MENT do s not al ow af f ixation of al markin s sp cif ied in 7.2,

the markin s s al b recorded in ful in the A COMPA YING DOC MENT

– identif i ation of rig t an lef t HEA ING INS R MENT u les a sen e of this markin do s not

present an u ac e ta le RIS

K Rig t is defi ed by the colour red L f t is defi ed by the

colour blue;

– serial n mb r

In case of HEA ING INS R MENT worn in the e r, the markin on the in trument may b

red ced to the serial n mb r an the identifi ation of rig t an lef t

HEA ING INS R MENT s al b marked visibly on the outside or other u er ac es ible location

or on the p c age with:

– the ye r of man f acture

The serial n mb r, lot or b tc identif ier, an the ye r of man facture may b provided in a

h man re da le code or throu h automatic identif i ation tec nolog s c as b rcodes or

RFID (radio-f req en y identif i ation)

NOT Se ISO 15 2 - for s mb ls for MA UFA TURER, s rial n mb r, lot or b tc , y ar of ma uf acture a d

u e b d te

2 1.7.2.5 M

E EQUIPME

NT inte de to re eiv power from other e uipme t

Subclau e 7.2.5 of the general stan ard do s not a ply

2 1.7.2.6 Con e tion to the SUP LY MAINS

Subclau e 7.2.6 of the general stan ard do s not a ply

2 1.7.2.7 Ele tric l input power f rom the SUP LY MAINS

Subclau e 7.2.7 of the general stan ard do s not a ply

The colours of in icator l g ts an their me nin s s al b stated in the in tru tion for u e

Comp a c with th re uireme ts is c e k d b in p ction

2 1.7.9 AC OMPANYING DOC MENT

Re lac me t:

HEA ING INS R MENT s al b ac omp nied by doc ments containin at le st the in tru tion

f or u e an a tec nical des ription The tec nical des ription may b in lu ed in the same

doc ment as the in tru tion f or u e The A COMPA YING DOC MENT s al b regarded as a

– model or typ referen e

– f or HEA ING INS R MENT a le to provide more than 13 dB SPL: warnin to the

profes ional OP RATOR f it in the HEA ING INS R MENT that there may b a RISK of

imp irin the remainin he ring of the PATIE

NT;

A COMPA YING DOCUMENT may b provided electronical y, e.g electronic f ile f ormat on C

D-ROM

If the A COMPA YING DOCUMENT are provided electronical y, the USA BILITY ENGINE RING

PROCE S s al in lu e con ideration of whic inf ormation also ne d to b provided as hard

co y

The A COMPA YING DOC MENT s al b writ en at a level con istent with the ed cation,

trainin an an sp cial ne d of the p rson(s) for whom they are inten ed

Comp a c s a b c e k d b in p ctio of the AC OM PAN IN D CUM E NT , a d, wh n

pro ided ele tro ic lly, a s e ified in I EC 60601-1-6

2 1.7.9.2 Instructions f or us

2 1.7.9.2.1 Ge eral

Re lac me t:

The in tru tion for u e s al doc ment:

– the name or trademark an ad res of the

– identif i ation of an k own side ef f ects as ociated with the u e of he rin in trument that

may war ant con ultation with a ph sician e.g ac umulation of cerumen

The in tru tion f or u e s al b in a lan uage that is ac e ta le to the inten ed PATIENT

The in tru tion for u e s al in lu e

– e si y u dersto d diagrams, i u tration , or photogra h of the f uly as embled an

re d -to-o erate HEA ING INS R MENT in lu in al controls, vis al inf ormation sig als, an

• f or as istan e, if ne ded, in setin up, u in or maintainin the HEA ING INS R MENT

or HEA ING INS R MENT SYS EM; or

• to re ort u exp cted o eration or events

The in tru tion f or u e s al in lu e a des ription an i u tration on how to re lace an /or

rec arge b teries

2 1.7.9.2.2 Warning a d s fety notic s

Re lac me t:

The in tru tion for u e s al in lu e al warnin an saf ety notices

General warnin s an saf ety notices s ould b placed in a sp cif i al y identif ied section of the

in tru tion f or u e A warnin or saf ety notice that a pl es only to a sp cif i in tru tion or

action s ould precede the in tru tion to whic it a pl es

Where relevant, the in tru tion for u e s al state:

– f or HEA ING INS R MENT in p ediatric a pl cation : warnin to ke p smal p rts (HEA ING

INS R MENT , b t eries an detac a le p rts) that can b swal owed out of c i dren’s

re c ;

– f or HEA ING INS R MENT that do not comply with req irements f or explosive or ox gen

-enric ed atmospheres: warnin not to u e the HEA ING INS R MENT in s c are s;

– warnin that the sp cif i HEA ING INS R MENT mu t only b u ed by the inten ed p rson

an not by others;

– f or HEA ING INS R MENT with wireles tran mis ion: warnin to c ec f irst b fore u in

the HEA ING SYS EM in are s where electronic or wireles devices are restricted;

– statement req ired a out the sp cial ne d of p rtic lar PATIENT groups e.g smal c i dren

or mental y disa led p rson ;

– warnin a out common con ition that could damage the HEA ING INS RUMENT s c as

dro pin , immersin in l q id, stron electromag etic f ield or ex es ive he t;

– other warnin s that may res lt from the ris as es ment, e.g a warnin if p rts could

remain in the e r an what to do;

– the p rmis ible en ironmental con ition of tran p rt an storage of a HEA ING

INS R MENT af ter it has b en removed f rom its protective p c agin an s bseq ently

b twe n u es;

– f or e c warnin an safety sig , the nature of the H ZA D, l kely con eq en es that could

oc ur if the ad ice is not f ol owed, an the precaution f or red cin the RISK

2 1.7.9.2.4 Ele tric l power sourc

Re lac me t:

If le kage from a b tery would res lt in an u ac e ta le RISK, the in tru tion for u e s al

in lu e a warnin to remove the b t ery to avoid this from ha p nin

If the HEA ING INS RUMENT can b external y con ected, the in tru tion f or u e s al state a

warnin only to con ect to eq ipment that conf orms to relevant international safety stan ard

2 1.7.9.2.9 Operating instructions

Re lac me t:

The in tru tion for u e s al contain al information neces ary to o erate the HEA ING

INS R MENT in ac ordan e with its sp cif i ation This s al in lu e explanation of the

f un tion of controls, b t ery comp rtment an sig als as wel as con ection an

dis on ection of u er detac a le p rts an A CE SORIE

The me nin s of lef t an rig t in icator s mb ls, warnin statements, a breviation an

in icator l g ts on the HEA ING INS R MENT s al b explained in the in tru tion f or u e

2 1.7.9.2.12 Cle ning, disinf ection a d steri ization

Re lac me t:

The in tru tion f or u e s al contain inf ormation a out cle nin an maintenan e of the

HEA ING INS R MENT where a pl ca le:

– the proced re to fol ow for was in the e r mould;

– re lacin tubin , f ilters an other re lace ble p rts;

– storin the HEA ING INS R MENT;

– sp cial adeq ate maintenan e f or rec arge ble b t eries;

– information on how an where to o tain re air services

2 1.7.9.2.14 AC E SORIE , s ppleme tary e uipme t, us d material

NT is rec arge ble, the in tru tion f or u e s al s f f iciently sp cif y

the rec arger eq ipment to en ure compl an e with the req irements of this stan ard

2 1.7.9.2.15 Environme tal prote tion

Re lac me t:

The in tru tion for u e s al provide inf ormation a out

– how to disp se of b t eries;

– how to disp se of the HEA ING INS R MENT;

– how to disp se of an p rt that may provide a RISK as ociated with the disp sal

2 1.7.9.2.16 Ref ere c to the te hnic l d s ription

Re lac me t:

The in tru tion for u e s al contain the inf ormation sp cif ied in 2 1.7.9.3 or a referen e to

where the inf ormation sp cif ied in 2 1.7.9.3 is to b fou d (e.g in a service man al)

Comp a c with the re uireme ts of 2 1.7 9.2 is c e k d b ins e tio ofthe in tru tio s for

u e in a lan u g s ita le for th intended PATIE NT

– tec nical c aracteristic ac ordin to IEC 6 1 8-0

– a u iq e version identifier s c as its date of is ue

– a warnin statement that ad res es the HAZARDS that can res lt from u authorized

– modif i ation of the HEA ING INS R MENT , e.g a statement to the ef fect:

• “WARNING: No modif i ation of this eq ipment is al owed.”

• “WARNING: Do not modif y this eq ipment without authorization of the man facturer.”

• “WARNING: If this eq ipment is modif ied, a pro riate in p ction an testin mu t b

con u ted to en ure contin ed safe u e of the eq ipment.”

201.8 *Protection against electrical HAZARDS f rom ME EQUIPMENT

Clau e 8 of the general stan ard a pl es, ex e t as fol ows:

2 1.8.1 Fundame tal rule of prote tion a ainst ele tric s oc

Re lac me t:

a) HEA ING INS R MENT are con idered saf e if s p l ed by an internal p wer source

b) HEA ING INS R MENT with external con ection to medical electrical eq ipment in

compl an e with IEC 6 6 1-1 an the a plca le p rtic lar stan ard are con idered saf e

c) HEA ING INS RUMENT that are normal y u ed in a HOME HEALTH A E EN IRONMENT are

con idered saf e when con ected to electrical eq ipment in compl an e with the relevant

stan ard IEC 6 0 5, IEC 6 9 0-1, or other a pl ca le IEC saf ety stan ard These

prod cts s al p s the PATIENT LEA AGE C RRENT req irements des rib d in 2 1.8.7

The l mits sp cif ied in 2 1.8.4.2 s al not b ex e ded for A CE SIBLE PA T an AP LIED

PA T in NORMAL CON ITION

2 1.8.2.1 Con e tion to a s parate power sourc

Re lac me t:

If a HEA ING INS R MENT is sp cif ied f or con ection to a se arate p wer source, other than

the SUP LY MAINS, the se arate p wer source s al b in complan e with the relevant

stan ard IEC 6 6 1-1, IEC 6 0 5, IEC 6 9 0-1, or other a pl ca le IEC saf ety stan ard

If a p rtic lar se arate power s p ly is sp cified then the relevant tests s al b p rf ormed

with the HEA ING INS RUMENT con ected to it If a generic se arate p wer s p ly is sp cified,

then the sp cifi ation in the A COMPA YING DOC MENT s al b in p cted

a) The req irements to PATIENT A XILIA Y C R E

NT of the general stan ard a ply

Ac es ible contacts of internal y s p l ed HEA ING INS R MENT rated at 1,6 V d.c or les

are exempt from these req irements as lon as the d.c c r ent flowin in a re l stic worst

case con g ration b twe n those contacts do s not ex e d 10 A an the ris

as es ment covers the p rtic lar desig an a plcation

b) HEA ING INS RUMENT con ected to electrical eq ipment in compl an e with stan ard

other than IEC 6 6 1 s al p s the LEA AGE C R ENT req irements des rib d in 2 1.8.7

a) The electrical isolation providin protection again t electric s oc s al b of s c q al ty

that c r ents f lowin throu h it are l mited to the values sp cif ied in 2 1.8.7.3

b) The sp cif ied values of this LEA AGE CU RENT, a ply in an combination of the fol owin

con ition :

– at o eratin temp rature an f olowin the h midity precon itionin tre tment, as

des rib d in 5.7;

– in NORMAL CONDITION;

– with HEA ING INS R MENT energized in stan -by con ition an f ul y o eratin

2 1.8.7.2 SINGL FAUL CON ITIONS

Subclau e 8.7.2 of the general stan ard do s not a ply

2 1.8.7.3 Al owable v lue

Re lac me t:

The al owa le value of

PATIENT LEA AGE CU R

ENT is 10 µA rms This value a pl es to c r ent

f lowin throu h the network of Fig re 12 of the general stan ard an me s red as s own in

Fig re 2 1.101 The nominal output voltage from the isolation tran f ormer is 2 5 V a.c at

5 Hz or 6 Hz

2 1.8.7.4 Me s reme ts

2 1.8.7.4.1 Ge eral

Re lac me t:

Th PATIE NT LE AKAGE C R E NT s a b me s red after th h arin in trume t h s b e

bro g t u to o eratin temp rature

Sin le- or p ly h s is latio tra sf ormers with s ff i ie t p wer ratin a d a ju ta le o tp t

v lta e (s e als ratio ale for 8.7.4.2 of th g n ralsta d rd)

V Voltmeter in ic tio r.m.s v lu , u in , if ele a t a d p s ible, o e meter with c mmutator switc

MD Me s rin d vic (s e Fig re 12 of th g n ral sta d rd)

Figure 2 1.101 – Me s ring circ it f or L A A E C RRENT

(se 2 1.8.7.4.7)

2 1.8.7.4.6 Me s reme t of the TOU H CUR ENT

Re lac me t:

This s bclau e is covered by the req irements of 2 1.8.7.4.7

2 1.8.7.4.7 Me s reme t of the PATIENT L A AGE C R ENT

Re lac me t:

The HEA ING INS R MENT is tested ac ordin to Fig re 2 1.101 at 1 0% of the hig est

sp cif ied main voltage, u in the a pro riate me s rin s p ly circ it

For he rin in truments that have an en los re or a p rt of the EN LOSURE made of in ulatin

material, metal f oi of maximum 2 cm × 10 cm is a pl ed in intimate contact with the

EN LOSU E or relevant p rt of the EN LOSU E

If p s ible, the metal f oi s al b manipulated to ena le the hig est value of the PATIENT

LEA AGE CU RENT to b determined

Metal p rts of the ENCLOSU E can b covered p rtly or total y by the metal f oi

This test ne d not b con u ted if it can b demon trated that there is adeq ate se aration of

Ad ditio :

Ac es ible contacts of internal y s p l ed HEA ING INS R MENT rated at 1,6 V d.c or les are

exempt from these req irements as lon as the d.c c r ent f lowin in a re lstic worst case

con g ration b twe n those contacts do s not ex e d 10 µA an the ris as es ment covers

the p rtic lar desig an a pl cation

2 1.8.8 INSULATION

Re lac me t:

Th te t a c rdin to 8.7 s a b mad e after the dro test of 2 1.15.3.4

Subclau e 8.9 of the general stan ard do s not a ply

2 1.8.10 COMPONENT a d WIRING

Subclau e 8.10 of the general stan ard do s not a ply

2 1.8.1 MAINSPA T , comp ne ts a d la out

Subclau e 8.1 of the general stan ard do s not a ply

201.9 *Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYS EMS

Clau e 9 of the general stan ard a pl es, ex e t as fol ows:

2 1.9.1 MEC ANICAL HAZA DS of ME EQUIPMENT

Re lac me t:

General y HEA ING INS R MENT with A CE SORIE do not p se mec anical hazard Ta le

2 1.10 b low l sts hazard that s al b con idered

Table 2 1.10 – MEC ANICAL HAZA DS to be considere

Parts remainin in th e r c n l 2 1.9.10

2 1.9.2 MEC ANICAL HAZA DS a sociate with moving parts

Subclau e 9.2 of the general stan ard do s not a ply

2 1.9.3 MEC ANICAL HAZA D a sociate with s rf ac s, corners a d e g s

Re lac me t:

Rou h s rf aces, s arp corners an ed es of HEA ING INS R MENT an HEA ING INS R MENT

SYS EMS

that could cau e injury or damage s al b avoided or covered

In p rtic lar, atention s al b p id to moulded ed es, b tery do rs an con ector f lan es

INS R M E NT SYS E M S

2 1.9.4 Instabi ity HAZA DS

Subclau e 9.4 of the general stan ard do s not a ply

2 1.9.5 Expel e parts HAZA D

Subclau e 9.5 of the general stan ard do s not a ply

2 1.9.6 *Acoustic e ergy (including infra- a d ultra ound) a d vibration

Re lac me t:

HEA ING INS R MENT with a p s ible maximum output SOUN PRE SU E LEVEL a ove 13 dB

req ire a sp cial warnin notice (se 2 1.7) HEA ING INS R MENT s al b desig ed in a way

that u ers can ot b u intentional y exp sed to a SPL a ove 13 dB in N

ORMAL an

SINGLE

FA LT con ition

2 1.9.7 Pre s re v s els a d parts s bje t to pne matic a d hy ra l c pre s re

Subclau e 9.7 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do not

have s c p rts

2 1.9.8 MEC ANICAL HAZA DS a sociate with s pport s stems

Subclau e 9.8 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do not

have s c p rts

Ad ditio al s b lau e :

2 1.9.101 HAZA D of e ta gleme t

Ca les an lan ard of HEA ING INS R MENT or A CE SORIE worn by the PATIENT arou d the

nec s al not p se a RISK of injury or stran ulation The dis on ection force s al b no

gre ter than 4 N

Comp a c s a b c e k d b a plyin the p ll forc

2 1.9.10 HAZA DS of parts of a HEA ING INS RUMENT remaining in the e r c nal

A HEA ING INS RUMENT that can b worn in the e r canal s al b saf ely retrieva le by the

PATIE

NT If s c

HEA ING INS RUME

NT is dif f ic lt to retrieve, a method to detect its location an

to retrieve it s al b provided in the in tru tion f or u e

HEA ING INS RUMENT s al b desig ed in a way that p rts do not come lo se d rin u e,

in ertion or retrieval from the e r canal

An p rt whic is exp sed to a pul f orce d rin the removal of a HEA ING INS R MENT f rom

the e r canal s al resist a f orce of at le st 3 N without comin lo se f rom the in trument

Comp a c s a b c e k d b a plyin the p ll forc te t

201.10 Protection against unwante and e cessive radiation HAZARDS

Clau e 10 of the general stan ard do s not a ply, ex e t for s bclau e 10.4

NOT HE RING IN TRUME T d n t emit s c ra iatio oth r th n visible lg t in s me c s s

201.11 *Protection against exces ive temperatures and other HAZARDS

Clau e 1 of the general stan ard a pl es, ex e t as f ol ows:

2 1.1 1 Ex e siv temperature in ME EQUIPMENT

2 1.1 1.1 Ma imum temperature d ring NOR AL US

Re lac me t:

The maximum temp rature of the HEA ING INS R MENT s al not ex e d 4 °C If the s rf ace

temp rature of an AP LIED PA

T ex e d 41 °C, the maximum temp rature s al b dis losed

in the in tru tion f or u e Where 41 °C is not ex e ded, no ju tif i ation is req ired

2 1.1 1.2 Temperature of AP LIED PA T

Re lac me t:

The req irements of this s bclau e are in lu ed in 2 1.1 1.1

2 1.1 1.3 Me s reme ts

Ad ditio :

Due to the low energ at internal y p wered HEA ING INS R MENT , this test can typicaly b

waived Where en ine rin ju gment by the

in icates that temp rature l mits

can ot b ex e ded, no me s rement is req ired However, the rationale for s c ju gment

s al b doc mented in the RISK MA AGEMENT FILE

For HEA ING INS R MENT p rts that are l kely to b tou hed, the pro a i ty of oc ur en e of

contact an of the d ration of contact s al b determined an doc mented in the RISK

MA AGEMENT FILE

Comp a c with th re uireme ts of 2 1.1 1.1 s a b c e k d b in p ction of the RISK

MANAGE M E NT FILE a d th instru tio s for u e Op ratio of the HE ARIN INS RUME NT a d

temp rature me s reme ts wh re n c s ary

2 1.1 2 Fire pre e tion

Subclau e 1 2 of the general stan ard do s not a ply

NOT Th re uireme ts for HE RINGIN TRUME T th t are inte d d to b u e in e plo iv a d o y e -e ric e

atmo p ere are n t c ntain d in this p rtic lar sta d rd

2 1.1 3 Con tructional re uireme ts f or fire ENCLOSURE of ME EQUIPMENT

Subclau e 1 3 of the general stan ard do s not a ply

2 1.1 6 Ov rflow, spi a e, le k ge, ingre s of water or partic late mat er,

cle ning, disinf ection, steri zation a d compatibi ty with s bsta c s us d with

th ME EQUIPMENT

2 1.1 6.2 Ov rf low in ME EQUIPMENT

Subclau e 1 6.2 of the general stan ard do s not a ply

2 1.1 6.3 Spi a e on ME EQUIPMENT a d MESYS EMS

Subclau e 1 6.3 of the general stan ard do s not a ply

2 1.1 6.4 Le k ge

Subclau e 1 6.4 of the general stan ard do s not a ply

2 1.1 6.5 Ingre s of water or partic late mat er into ME EQUIPMENT a d ME SYS EMS

Re lac me t:

Normal y internal y p wered HEA ING INS R MENT do not cau e electrical RISKS an do not

ne d to b clas ified again t the in res of water If the ris as es ment req ires protection

again t harmf ul in res of water or p rtic late mat er the IP clas of the

HEA ING INS R ME

NT

s al b not les than the level req ired for safe o eration as detai ed in IEC 6 5 9

Comp a c s a b c e k d b th tests ofI EC 6052 with th HE ARIN INS R M E NT

pla ed

in th lea t fa o ra le p sitio of NORM AL USE a d b in p ctio

2 1.1 6.6 Cle ning a d disinf ection of ME EQUIPMENT a d ME SYS EMS

s al b ca able of with tan in , without damage or deterioration, the cle nin or disinfection

proces es (s c as cerumen removal), as sp cif ied in the in tru tion f or u e The

MA UFA TU ER s al evaluate the ef fects of multiple cle nin s durin the EXP CT D S R ICE

A CE SORIE an as ure that these PROCE S S do not res lt in the los of BASIC SAF TY

2 1.1 6.7 Steri ization of ME EQUIPMENT a d ME SYS EMS

Subclau e 1 6.7 of the general stan ard do s not a ply

201.12 *Accuracy of controls and instrume ts and protection against

hazardous outputs

Clau e 12 of the general stan ard a pl es, ex e t as f ol ows:

2 1.12.2 Us bi ty of ME EQUIPMENT

Ad ditio :

PRIMA Y OP RATING FU CTIONS of HEA ING INS RUMENT an SYS EMS are identified d rin

USABILITY ENGINE RING Typical PRIMA Y OP R TING FUN TIONS are:

– critical f un tion :

• adju t volume, program an other es ential p rameters;

NOT Se IEC 6 6 1 1 6 for e pla atio of th term " e u ntly u e fu ctio s"

2 1.12.4 Prote tion a ainst hazardous output

2 1.12.4.2 Indic tion rele a t to s f ety

Subclau e 12.4.2 of the general stan ard do s not a ply

2 1.12.4.4 Incor e t output

Re lac me t:

When a control adju ts the inten ed maximum p wer output, output p wer s al not in re se

if the control is dis on ected or defective Sof tware control ed maximum p wer setin s s al

not ex e d the selected value as a res lt of cor upt data tran f er b twe n programmer an

HEA ING INS R MENT

Comp a c s a b c e k d b in p ctio of the RISK MAN AGE M E NT FILE

2 1.12.4.5 Dia nostic or th rape tic ra iation

Subclau e 12.4.5 of the general stan ard do s not a ply

201.13 *HAZARDOUS SITUATIONS a d f ault conditions for ME EQUIPMENT

Clau e 13 of the general stan ard a pl es, ex e t as f ol ows:

2 1.13.1.2 Emis ions, def ormation of ENCLOSURE or e c e ing ma imum temperature

Re lac me t:

The f ol owin H ZA DOUS SITUATIONS s al not oc ur:

– u intentional exp s re to a SPL a ove 13 dB;

– emis ion of f lames, molten metal, p isonou or ig ita le s bstan e in hazardou

q antities;

– deformation of ENCLOSU E to s c an extent that complan e with 2 1.15.3.1 is imp ired;

– temp ratures of HEA ING INS R MENT that are l kely to b tou hed, ex e din 5 °C when

me s red an adju ted as des rib d in 2 1.1 1.3 of the general stan ard;

– ex e din the al owa le values for “other comp nents an materials” identif ied in Ta le 2

of the general stan ard times 1,5 min s 12,5 °C

The SINGLE FA LT CONDITIONS in 4.7 of the general stan ard with regard to the emis ion of

f lames, molten metal or ig ita le s bstan es, s al not b a pl ed to p rts an comp nents

where:

– The con tru tion of the s p ly circ it l mits the p wer dis ip tion in SINGLE FA LT

CON ITI

ON to les than 15 W or the energ dis ip tion to les than 9 0 J;

Comp a c s a b c e k d b drawin 15 W fom th s p ly circ it for 1 min I f, after

1 min the s p ly circ it c n ot s p ly 15 W, th circ it s al b c n idered to limit p wer

d is ip tio to le s tha 15 W Th related desig doc me tatio is also re iewed

or

– Secon ary circ its me t al of the folowin con ition :

• mou ted on material with a f lamma i ty clas if i ation of FV1 in ac ordan e with

IEC 6 6 5-1 -10 or b t er;

• they are energized at a voltage of 6 V d.c or 4 ,2 V p ak or les in NORMAL an

SINGLE FA LT CON ITION;

• they are l mited to 10 VA or are l mited to 6 0 0 J in SINGLE FA LT CONDITION;

• they employ wire in ulation of typ s PVC, TFE, PTFE, FEP, p ly hloro rene or

p lybromide

Comp a c is c e k d b e aluatio of the d esig doc me tatio

Or

– The comp nent is a COMPONENT WITH HIGH-INT GRITY C A A T RIS ICS as des rib d in 4.9

of the general stan ard

Comp a c is c e k d b e aluatio of the d esign do ume tatio

or

– They are completely contained within a fire en los re ac ordin to 1 3 of the general

stan ard

After the te ts of this s b lau e, thermal c t-o ts a d o er-c re t rele s s s a b

ins e ted to determin that their s ttin h s n t c a g d (b h atin , vibratio or oth r

c u e ) s ficie tly to afe t their s fety fu ctio

2 1.13.2 SINGL FAUL CON ITIONS

2 1.13.2.1 Ge eral

Re lac me t:

Durin the a plcation of the SINGLE FA LT CON ITIONS lsted in 13.2.2 to 13.2.13 (in lu ive),

the NORMAL CON ITIONS identified in a) s al also b a pled in the le st f avoura le

combination

a) NORMAL CONDITION in lu es al of the f ol owin simultane u ly:

– the presen e on an SIGN L INPUT/OUT UT PA T of an voltage or c r ent f rom other

electrical eq ipment that is p rmited to b con ected ac ordin to the

– s ort circ it of an one in ulation that compl es with the req irements f or one MEA S OF

PROT CTION as sp cif ied in 8.8 of the general stan ard;

NOT This in lu e s ort circ itin of eith r c n titu nt p rt of DOUBLE INSULATION th t c mple with 8.8

– s ort circ it of an one CRE PAGE DIS A CE or AIR CLEA A CE that compl es with the

req irements for one MEA S OF PROT CTION as sp cif ied in 8.9 of the general stan ard;

– s ort circ it an o en circ it of an comp nent other than a COMPONENT WITH HIGH

INT GRITY CH R CT RIS ICS that is con ected in p ral el with in ulation, with an AIR

CLEA A CE or with a C E PAGE DIS A CE u les s ortin can b s own not to b a

f ai ure mode f or the comp nent (se also 4.8 an 4.9 of the general stan ard);

– o en circ it of an one PROT CTIVE EA TH CON U TOR or internal PROT CTIVE EA TH

CON ECTION

that compl es with the req irements of 8.6 of the general stan ard: this

do s not a ply to a PROT CTIVE EA TH COND CTOR of P RMA ENTLY INS AL ED ME

EQUIPMENT, whic is con idered u lkely to b come dis on ected;

– inter uption of an one p wer car yin con u tor b twe n ME EQUIPMENT p rts in

se arate EN LOSU E , if the RISK A ALYSIS in icates that this con ition mig t cau e

p rmited l mits to b ex e ded;

– u inten ed movement of a comp nent; but only if the comp nent is not mou ted

sec rely enou h to en ure that s c movement wi b very u l kely to oc ur d rin the

PROCE S (se also 8.10.1 of the general stan ard);

– ac idental detac ment of con u tors

2 1.13.2.2 Ele tric l SINGL FAUL CON ITION

Re lac me t:

Req irements an tests relatin to this SINGLE FA LT CON ITION are fou d in 2 1.13.2.1

2 1.13.2.3 Ov rhe ting of tra sformers in MEEQUIPMENT

Subclau e 13.2.3 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not have tran f ormers

2 1.13.2.4 Fai ure of THER OS AT

Subclau e 13.2.4 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not have THERMOS AT

2 1.13.2.5 F i ure of temperature l miting d vic s

Subclau e 13.2.5 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not have temp rature l mitin devices

2 1.13.2.6 Le k ge of l quid

Subclau e 13.2.6 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not contain l q id

2 1.13.2.7 Impairme t of cool ng that could re ult in a HAZA DOUS SITUATION

Subclau e 13.2.7 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

neither de en on venti ation nor u e co l n s stems

2 1.13.2.8 Loc ing of moving parts

Subclau e 13.2.8 of the general stan ard do s not a ply, b cau e

HEA ING INS R MENT

do

not have s c movin p rts

2 1.13.2.9 Inter uption a d s ort circ iting of motor c pa itors

Subclau e 13.2.9 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not have motors

2 1.13.2.10 Additional te t criteria for motor o erate ME EQUIPMENT

Subclau e 13.2.10 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not have motors

2 1.13.2.1 Fai ure of compon nts in ME EQUIPMENT us d in conjun tion with OX GEN

RICH ENVIR NMENT

Subclau e 13.2.1 of the general stan ard do s not a ply

NOT Th re uireme ts f or HE RINGIN TRUME T th t are inte d d to b u e in e plo iv a d o y e e ric e

atmo p ere are n t c ntain d in this p rtic lar sta d rd

Subclau e 13.2.13 of the general stan ard do s not a ply, b cau e HEA ING INS R MENT do

not have motors or he tin elements an can ot b overlo ded

201.14 *PROGRAMMABL E ECTRICAL MEDICAL SYS EMS (P MS)

Clau e 14 of the general stan ard do s not a ply, ex e t as fol ows:

2 1.14.1 Ge eral

Re lac me t:

Emb d ed an fitin sof tware s al conform to IEC 6 3 4

The clas ifi ation of sof tware ac ordin to IEC 6 3 4 s al b the res lt of the RISK

AS E SM

ENT

Comp a c s a b determin d b a p c tion of the re uireme ts in 2 1.14.2 to 14.13

(in lusiv ), b ins e tio of the RISK M ANAGE ME NT F ILE Comp a c with the I EC 62 0

s ftware d esig pro e s s a b b in p ctio of ex tern l or intern l a d it re orts or

c rtific tes

NOT Fitin s ftware is u u ly cla sif i d a d tre te a a me ic l d vic

2 1.14.2 Doc me tation

Subclau e 14.2 of the general stan ard a pl es

2 1.14.3 RISK MANA EMENT pla

Subclau e 14.3 of the general stan ard a ples

2 1.14.6 RISK MANA EMENT PR CE S

2 1.14.6.1 Ide tif ic tion of k own a d f ore e able HAZA DS

Subclau e 14.6.1 of the general stan ard a pl es

2 1.14.1 PEMS v l dation

Subclau e 14.1 of the general stan ard a ples

201.15 *Construction of ME EQUIPMENT

Clau e 15 of the general stan ard do s not a ply, ex e t as fol ows:

2 1.15.2 Servic abi ty

Re lac me t:

Parts of HEA ING INS RUMENT s bject to mec anical we r, electrical an en ironmental

degradation or agein that could res lt in an u ac e ta le RISK if al owed to contin e

u c ec ed f or to lon a p riod s al b ac es ible for in p ction, re lacement an

HEA ING INS R MENT or their p rts s al have adeq ate mec anical stren th an s al not

res lt in los of BA SIC SA FE Y d e to mouldin stres or when s bjected to mec anical stres

cau ed by pu hin , imp ct, dro pin , an rou h han ln

For HEA ING INS R MENT- elated A CE SORIE IEC 6 0 5, IEC 6 9 0-1 or other a pl ca le

IEC safety stan ard a ply

Mec anical desig req irements f or in truments inten ed for u e by infants u der 3 month :

a) Batery do rs s al b con tru ted to:

– req ire a to l to remove the b t ery; or

– req ire a force of at le st 10 N in the le st f avoura le direction to remove the b t ery

b) An detac a le p rt of the HEA ING INS RUMENT (e.g e r ho k, tub , typ plate,

programmin cover) s al not b remova le:

– without a to l; or

– with a f orce lower than 10 N in the direction of le st resistan e

Comp a c s a b c e k d b in p ctio of the product a d the a p c tion of the de crib d

forc s (s e also 2 1.15.3.4)

2 1.15.3.4 Drop te t

Re lac me t:

HEA ING INS R MENT s al not res lt in an u ac e ta le RISK as a res lt of a fre f al

Th s mple s a b tested , with a y s fe working load in pla e, b allowin it to fa fe ly,

o c fom e c of six difere t starting orie tatio s fom a h ig t of1,5 m o to a h rd wo d

s ra e

After the test, the HE ARIN INS R M E NT s a n t re ult in a u a c pta le RISK, s c a

in re s d LE AKAGE C R E NT ad dre s d in 2 1.8.7 or me h nic l h z rds s e 2 1.9

2 1.15.3.7 Environme tal inf lue c s

Re lac me t:

The selection an tre tment of materials u ed in the con tru tion of HEA ING INS R MENT

s al take ac ou t of the INT N ED US , the EXP CT D S R ICE LIF an the con ition f or

tran p rt an storage

The HEA ING INS RUMENT s al b so desig ed an con tru ted that d rin its EXP CT D

S R ICE LIF an cor osion, agein , mec anical we r, or degradation of biological materials

d e to the in uen e of moisture, swe t, h midity, hair care prod cts or toi etries s al not

red ce its mec anical pro erties in a way that res lts in an u ac e ta le RI

SK Se also 15.2

– of the HE ARIN INS R ME NT , of the ACC MPAN ING DOC M E NT a d of th M AN F ACTU E R’S

s e ific tio s of materials u ed a d ofthe pro e sin s e ific tio s for the e materials;

– of the M AN FACTU E R’S relev nt te ts or c lc latio s

2 1.15.4 ME EQUIPMENT compon nts a d ge eral a s mbly

2 1.15.4.3 Bat erie

2 1.15.4.3.1 Hou ing

Re lac me t:

Batery comp rtments s al b desig ed to prevent ac idental s ort circ itin of the b t ery

where s c s ort circ its could res lt in a

H ZA DOUS SITUATI

ON

If a H ZA DOUS SITU TION mig t develo by the in or ect con ection or re lacement of a

b t ery, the eq ipment s al b f it ed with a me n of preventin in or ect p larity

2 1.15.4.3.3 Prote tion a ainst ov rc argin

Subclau e 15.4.3.3 of the general stan ard a pl es

2 1.15.4.3.101 HEA ING INS RUMENT bat erie

Bateries, u ed to s p ly

HEA ING INS R MENT

, s al comply with the relevant international

stan ard The desig of the electronic circ it s al avoid overhe tin of the wron in erted

b t ery a ove 5 °C

2 1.15.4.4 Indic tors

Re lac me t:

HEA ING INS R MENT do not req ire an in icators for the PATIENT

For HEA ING INS RUMENT- elated A CE SORIE , IEC 6 9 0-1, IEC 6 0 5 or the a pl ca le

relevant IEC stan ard a ples

201.16 *ME SYST MS

Re lac me t:

The voltage to e rth or to A CE SIBLE PA T other than HEA ING INS R MENT s al not ex e d

4 ,4 V p ak a.c or 6 V d.c in NORMAL CON ITION or in SINGLE FA LT CON ITION The d.c l mit

of 6 V a pl es to d.c with not more than 10% p ak-to-p ak rip le If the rip le ex e d that

amou t, the 4 ,4 V p ak l mit a ples The p wer s al not ex e d 2 0 VA f or lon er than 6 s

or the stored energy avai a le s al not ex e d 2 J at a p tential of 2 V or more

The voltage an energ l mits sp cif ied a ove also a ply to:

– internal p rts, other than contacts of plu s, con ectors an soc et-outlets, that can b

tou hed by the test pin s own in Fig re 8 of the general stan ard in erted throu h an

o enin in an en los re;

– internal p rts that can b tou hed by a metal test rod with a diameter of 4 mm an a

len th of 10 mm, in erted throu h an o enin in the to of an en los re or throu h an

o enin provided f or the adju tment of pre-set controls that may b adju ted by the

PATIENT in NORMAL US by u in a to l

Comp a c s al b c e k d b in ertin the test pin or the test rod thro g relev nt

o e in s

Th te t pin s a b in erted in e ery p s ible p sitio with minimal forc (n t more tha 1 N )

Th te t rod s a b in erted in e ery p s ible p sitio thro g o e in s pro ided for the

adju tme t of pre-s t c ntrols that c n b ad ju ted b th p tient in n rmal u e, in c s of

d ou t with a forc of 10 N

If the in tru tion for u e s e ify th t a p rtic lar tool s to b u ed , the test is re e ted with

that to l

NOT Al oth r s stem a p cts are a dre s d in th in ivid al cla s s of this p rtic lar sta d rd

201.17 *Electromagnetic compatibi ity of ME EQUIPMENT and ME SYS EMS

Re lac me t:

The MA UFA TU ER s al ad res in the RISK MA AGEMENT PROCE S the RISKS as ociated with

the introd ction by the HEA ING INS R ME

NT of electromag etic phenomena into the

en ironment that mig t degrade the p rforman e of other devices, electrical eq ipment an

s stems

Electromag etic comp tibi ty s al b tested ac ordin to IEC 6 1 8-13 Furthermore if the

HEA ING INS RUMENT has a wireles tran miter, emis ion s a b tested ac ordin to

relevant international radio stan ard

Comp a c s a b c e k d b in p ctio of the RISK MAN AGE M E NT FILE

Annex s

Th a n x es of the g n ral standard a ply, ex ce t a fo ows:

Annex E

(informativ )

Examples of the connection of the measuring device (MD) f or

measurement of THE PATIENT LEAKAGE CURRENT and

PATIENT AUXILIARY CURRENT

An ex E of the general stan ard do s not a ply

Annex G

(normativ )

Protection against HAZARDS of ignition of f lammable

anaesthetic mixtures

An ex G of the general stan ard do s not a ply

Annex H

(informativ )

PEMS structure, PEMS DEVELOPMENT LIFE-CYCLE and documentation

An ex H of the general stan ard do s not a ply

Survey of insulation paths

An ex J of the general stan ard do s not a ply

Annex K

(informativ )

Simpl f ied PATIENT LEAKAGE CURRENT diagrams

An ex K of the general stan ard do s not a ply

Annex L

(normativ )

Insulated winding wires f or use without interleaved insulation

An ex L of the general stan ard do s not a ply

Annex AA

(inf ormativ )

Particular guidance and rationale

AA.1 Rationale and back round

This stan ard was cre ted in order to f il a ga in stan ardization for HEA ING INS R MENT

HEA ING INS R MENT have b en con idered in erently saf e in the p st In order to f ulf il

reg latory req irements, man f acturers a pled reg lation directly by pro rietary test

sp cif i ation b sed on ris as es ment an exp rien e from trials or f ield data, as wel as

a pl cation of normative referen es Due to a close co p ration of man f acturers in in u trial

as ociation these req irements were in p rt co rdinated an alre d stan ardized in the

p st In order to cre te an in u try stan ard to ad res reg latory req irements an at empt

was made in the 19 0s, whic res lted in CENELEC draft prEN 5 2 0 in 19 8 No p sitive

votin was ac ieved an the EU OP A HEA ING INS R MENT MA UFA TU ERS AS OCIATION

(EHIMA) rele sed an in u trial stan ard u der its own name in te d, with ne rly identical

content, however this doc ment has lac ed bro d ac e tan e Con eq ently EHIMA decided

in 2 0 to en this u certainty an a pro c ed IEC with the req est to prod ce an

international y ac e ted HEA ING INS RUMENT safety stan ard

It is general y recog ised by the HEA ING INS RUMENT in u try an by reg lators that

IEC 6 6 1-1 is not s ita le to b a pled to HEA ING INS RUMENT For this re son the

HEA ING INS RUMENT in u try has not b en p rticip tin in the activities of IEC/TC 6 an its

s bcommite s previou ly As a res lt the sp cif i ation of saf ety req irements for

HEA ING

INS R MENT have develo ed in a f un amental y dif f erent way comp red to IEC 6 6 1

Therefore, the initial a pro c was to cre te a new IEC stan ard outside the IEC 6 6 1

series The tas was as ig ed to TC 2 ‘Electro cou tic ’ an in p rtic lar its WG 13 ‘He rin

Aid ’ in whic the stakeholders in the f ield of au iological tec nolog are re resented TC 6

was a pro c ed with the req est f or as istan e an s g ested the integration of this

doc ment into the IEC 6 6 1 series in order to b in l ne with the stru tures in IEC

stan ardization The f un amental diff eren e in the a pro c safety sp cif i ation could b

ac ommodated by the cre tion of a p rtic lar stan ard that provides f or con ideration of the

in ivid al req irements d e to the p rtic lar a plcation of the prod cts in the s o e The

integration of esta l s ed HEA ING INS RUMENT saf ety req irements into the IEC 6 6 1 series

res lted in a relatively hig n mb r of re lacements of p rts of the general an colateral

stan ard

AA.2 Def inition of saf ety requirements f or HEARING INSTRUMENT

Due to the a pl cation an INT N ED US of HEA ING INS R MENT , the ris s are in man cases

not comp ra le with those of medical prod cts typical y covered by the s o e of IEC 6 6 1

This doc ment re resents c r ent b st practices in the HEA ING INS R MENT in u try This

stan ard is b sed on MA UFA TURER’S ris as es ments, internal stan ard , field trials an

the evaluation of e orted an k own in idents an lon -term exp rien e

The OP R TOR an the PATIENT are one an the same d e to the INT N ED US of a HEA ING

INS R MENT in a HOME HEALTH A E EN IRONMENT

Ta le AA.101 s mmarizes in s ort the a pro c of this stan ard.

Table AA.101 – Summary of th approa h of this sta dard

Ele tric l Th re is n ele tric l h z rd d e to a intern l s p ly with low v lta e a d low

e erg (ty ic ly b low 1,6 V a d cle rly within th lmits of 2 1.8.4.2).A lmit for

a c s ible c nta ts at b tery v lta ewa n wly intro u e in this d c me t

Co n ctio to e tern ld vic s: Historic ly th re are (e re e tin th stateof

th art) c n e tio s to a) c n umer pro u ts (a dio in ut) or b) me ic l pro u ts

(or pro rammin )

Th RIS pre e te b u in a H ARING IN TRUME T is c mp ra le with th t of

u in a a dio h a p o e Re uireme ts of IEC 6 0 5 or IEC 6 9 0- (or oth r

wh re rele a t) c v r this ris s ff i ie tly Th ris is e tremely low, a d n

k own in id nts with H ARING IN TRUME T or h a p o e h v b e re orte

Warnin : Co n ct o ly to c mpla t pro u ts

An a ditio alle k g c re t te t to pro id a minimum in ulatio b twe n a dio

in ut a d u er wa n wly intro u e in this d c me t

Ac e ta le with ut f urth r re uireme ts

Me h nic l Sh rp e g s to b a oid d (als after dro te t)

Bio omp tibi ty te tin for materials in c nta t with th p tie t

Warnin re ardin th e p n io or le k g of b terie if c arg d in ore tly

Markin a d c n tru tio al re uireme ts to b tery d or

He t, Fire Th re is n u a c pta le ris d e to a intern l s p ly with low v lta e a d low

e erg Fa lt te ts in this d c me t v ld te this a p ct

Warnin re ardin th e p n io or le k g of b terie if c arg d in ore tly

Markin a d c n tru tio al re uireme ts to b tery d or

Ac u tic l Fa lt tolera t d sig of h rdwarea d s ftware (P MS re uireme ts) a wel a

pro rammin a d wirele s intera e to a oid u inte tio al e p s re to hig er

le els EMC te tin re uire

Warnin to th u er a d h alth c re profe sio al for in trume ts inte tio aly

Interere c EMC a d ra io te tin

Warnin s to u er a o t s e ial ris s, lk p c ma ers, aircraft or e plo iv

e viro me t

Us bi ty Markin in blu / re o th in trume tto in ic te left / rig t

U A ILIT E GIN ERING a d id ntific tio of PRIMARY OP RA ING FU CTION

AC E SO Y 1 Remote c ntrol a d b tery c arg r h v ris s c mp ra le to IT or c n umer

g o s (Mo ie p o e, TV remote, etc.) a d c n th refore b c v re

s ff i ie tly b th re uireme ts of IEC 6 0 5 or IEC 6 9 0- (or oth r wh re

rele a t)

2) Pro rammin Intera e s al c mply with IEC 6 6 1

AA.3 Rationale f or particular clauses and subclauses

The f ol owin are rationales f or sp cif i clau es an s bclau e in this p rtic lar stan ard, with

clau e an s bclau e n mb rs p ral el to those in the b d of the doc ment

Cla s 2 1.1.1 – Scope

In general A CE SORIE to HEA ING INS RUMENT lke remote control u its, au io stre mers,

b t ery c argers, p wer s p l es an simi ar items are u ed in the same en ironment, by the

same u ers as entertainment, IT or hou ehold prod cts s c as mo ie phones, TV remote

controls etc For that re son the ris s of these prod ct groups are comp ra le an

req irements of IEC 6 6 1 general an colateral stan ard are often u s ita le The

a pl cation of IEC 6 9 0-1, IEC 6 0 5, or in future IEC 6 3 8, wi in conju ction with this

doc ment cover the ris s a pro riately A CE SOR

is in man cases desig ed an / or

man factured by man facturers in the IT or au io / vide sector who are more ac u tomed to

these req irements This is in l ne with the a pro c of IEC 6 6 1-1-1

In contrast programmin interfaces or A CE SORIE in clnical a plcation are o erated by

HEA ING HEALTH-C RE PROF S ION LS in a cl nical en ironment an s ould therefore b

covered by the general stan ard

Cla s 2 1.1.3 – Col ateral sta dards

Regardin IEC 6 6 1-1-2 se the rationale to Clau e 2 1.17 in this an ex

IEC 6 6 1-1-9 has not b en a pled by the

HEA ING INS R ME

NT in u try in the p st

Comp red to the ME EQUIPMENT traditionaly in the s o e of IEC 6 6 1, HEA ING INS R MENT

have a very l mited en ironmental imp ct Sin e this s bject is covered by local legislation

s f f iciently an the en ironmental imp ct is not directly related to the s o e of b sic saf ety, it

was decided to not a ply this col ateral stan ard an han le the s bject outside of this

doc ment

Af ter a review of the IEC 6 6 1-1-1 req irements, it b came a p rent that

HEA ING

INS R MENT were not con idered in the cre tion of this g idel ne res ltin in a sig if i ant

n mb r of u s ita le req irements It was de med more f easible to con ider the a pl ca le

asp cts in the req irements of this p rtic lar stan ard rather than ado tin IEC 6 6 1-1-1 in

general

Subcla s 2 1.4.3 – E S NTIAL P RFOR AN E

he rin in truments do not have an es ential p rf orman e The fai ure of an f un tion do s

not present a ris an is a normal oc ur en e on e the b t ery is de leted Al other ris s of

he rin in truments are clas ifia le as b sic saf ety If a man facturer exten s the inten ed

u e to safety critical fun tional claims, the res ltin es ential p rforman e is not covered by

a pl cation of this p rtic lar stan ard

s mb ls for AP LIED PA T are u k own to HEA ING INS R MENT u ers an o erators A

markin is not ne ded, sin e HEA ING INS R MENT are alway neces ari y in tou h with the

PATIENT

Subcla s 2 1.7.8.1 – Colours of indic tor l g ts

L w p wer con umption is es ential in HEA ING INS R MENT tec nolog The PATIENT s ould

not b burdened with u ac e ta ly f req ent b tery c an e c cles or u re sona le prod ct

dimen ion d e to large b t eries At the state of tec nolog now an in f orese a le f uture

the u e of an other colours then red f or an in icator l g t (LED) is res ltin in an

u ac e ta le con umption of energ in a HEA ING INS RUMENT (b c groun : voltage an

c r ent con umption are in direct cor elation to the nature of the semi con u tor material in

u e an as a res lt in direct cor elation to the emited wavelen th / colour) For that re son,

in icator l g ts are generaly not req ired in this doc ment an if provided, the colour is not

man ated In icator l g ts are in u e, f or example in a pl cation where PATIENT may not

expres the los of f un tion d e to you g age or mental l mitation The colour red is

in icatin a critical situation only to p rson el in cl nical en ironment The typical HEA ING

INS R MENT u er is exp sed to red l g ts in home, of fice an other en ironments, whic

red ces the ne d of harmonization with the colour req irements of the general stan ard

Cla s 2 1.8 – Prote tion a ainst ele tric l HAZA DS from ME EQUIPMENT

There are no electrical hazard d e to an internal s p ly with low voltage an low energ

( ypical y 1,4 V an energ cle rly within the lmits of 2 1.16)

Con ection to external devices: Historicaly there are (re resentin the state of the art

con ection to a) con umer prod cts (au io input or b) medical prod cts (for programmin )

The RISK of a HEA ING INS R MENT is comp ra le to an au io he dphone Electrical in ulation

req irements of IEC 6 0 5 or IEC 6 9 0-1 (or other a pl ca le stan ard where relevant

cover this ris s f f iciently No in idents with HEA ING INS R MENT or au io he dphones have

b en re orted 2 1.7.9.2.5 Req ires an in tru tion to con ect HEA ING INS R MENT only to

stan ard compl ant prod cts

For these re son general y no in ulation is req ired in a HEA ING INS RUMENT Ex e t in case

of external con ection to non-medical prod cts, where an ad itional le kage c r ent test

b twe n sig al input an u er is req ired in 2 1.8.7

Ac es ible contacts at les than 1,6 V d.c of internal y s p l ed HEA ING INS R MENT were

not reg lated b fore publ cation of this doc ment an did not res lt in harm or injury

Me s rement res lts in worst case situation b twe n contacts res lted in actual d.c c r ents

cle rly b low 10 µA A l mit f or p tient au i ary circ its was introd ced in 2 1.8.4.2 of this

doc ment

Cla s 2 1.9 – Prote tion a ainst MECHANICAL HAZA DS of ME EQUIPMENT a d ME SYS EMS

Mec anical hazard of HEA ING INS R MENT are lmited to the fol owin items that are

covered in this clau e:

– s arp ed es to b avoided (also after dro test ;

– req irements to avoid p rts from remainin in the e r ( he 3 N req irement in 2 1.9.10 is

derived from the extraction force of an in trument ;

– mec anical req irements an in tru tion to avoid smal c i dren f rom swal owin p rts

where a pl ca le

Subcla s 2 1.9.6 – Acoustic e ergy (in lu in infra- an ultrasou d) an vibration

The rationale f or c o sin 13 dB as a critical level derives f rom Directive 2 0 /10/EC, an

2 CFR 1910.9 OSHA, whic state that a noise a ove 14 dB is not al owed regardles of

d ration Con iderin the intent to del ver elevated sou d to a p tient f or comp n ation of a

he rin imp irment, it was decided to fol ow e rl er EHIMA recommen ation (e.g Draf t

prEN 5 2 0), homologation practice (e.G NSH), FDA g idan e (21 CFR 8 1 4 0 He rin aid

devices) an esta l s ed practice in the commu ity by req irin p rtic lar me s res a ove a

13 dB level (se also la el n req irements in 2 1.7.9.2.2)

Cla s 2 1.1 – Prote tion a ainst e c s iv temperature a d other HAZA DS

Us al y there is no u ac e ta le ris of f ire, he t or ig ition d e to an internal s p ly with low

voltage an low energ Most req irements of the general stan ard are theref ore not

a pl ca le an temp rature me s rements are typical y not req ired

Subcla s 201.12.2 – USABILITY of ME EQUIPMENT

Comp red to the ME EQUIPMENT traditionaly in the s o e of IEC 6 6 1, HEA ING INS R MENT

have very l mited u a i ty asp cts Typical examples f or PRIMA Y OP RATING FU CTIONS are

A DOUS SITUATIONS

a d f ault conditions for

ME EQUIPME

NT

Due to the a sen e of electrical hazard , fire an he t hazard (se An ex AA clau e 2 1.8

an 2 1.1 ) man req irements of this clau e of the general stan ard are not a pl ca le

Cla s 2 1.14 – PROGR MMABL E ECTRICAL MEDICAL SYS EMS (P MS)

In l ne with the low ris s cau ed by HEA ING INS R MENT comp red to ME EQUIPMENT

traditional y in the s o e of IEC 6 6 1, the sof tware f or HEA ING INS RUMENT is rather

u critical an of lower complexity Historical y the HEA ING INS R ME

NT in u try has a pl ed

IEC 6 3 4 an not IEC 6 6 1-1-4 Sin e this a pro c is now esta ls ed an has proven

a pro riate, it is not de med neces ary to f ol ow the a pro c of the third edition of

IEC 6 6 1 to tai or an sp cif y the IEC 6 3 4 req irements

Cla s 2 1.15 – Construction of ME EQUIPMENT

Due to the a sen e of electrical hazard , f ire an he t hazard (se An ex AA, Clau es

2 1.8 an 2 1.11) man req irements of this clau e of the general stan ard are not

a pl ca le

Cla s 2 1.16 – MESYS EMS

This clau e of the general stan ard was de med to exten ive to b a pl ed to the f ew minor

s stem asp cts of HEA ING INS RUMENT SYS EMS Al s stem asp cts were ad res ed in the

in ivid al clau es of this p rtic lar stan ard in te d, s p ortin an e sier a plcation of this

doc ment

Cla s 2 1.17 – Ele troma n tic compatibi ty of ME EQUIPMENT a d ME SYS EMS

IEC TC 2 has prod ced IEC 6 1 8-13 as an EMC stan ard f or HEA ING INS R MENT That

stan ard is esta ls ed an more s ita le to the produ ts in the s o e of this doc ment than

IEC 6 6 1-1-2