Iec 60601 2 37 2015

+AMD1:2 15 CSV  IEC 2 15 In this p rtic lar stan ard, safety req irements ad itional to those in the general stan ard are sp cified for ULTRASONIC DIAGNOS IC EQUIPMENT.. MEDICA L ELECTR

Medical elect rical equipment –

Part 2- 37: Part icular requirement s for t he basic safety and essent ial per ormance

ofult rasonic medical diagnost ic and monit oring equipment

Apparei s élect romédicaux –

Part ie 2- 37: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des apparei s de diagnost ic et de survei lance médicaux à ult rasons

THIS PUBLICATION IS COPYRIGHT PROTECTED

Copyr ight © 2 15 IEC, Ge e a, Switzer la d

Al rig ts r es r ve Unle s oth rwis s e ifi d, n p rt of this p blc tio ma b r epr od c d or uti z d in a y form

or b a y me n , ele tr onic or me h nic l in lu in p oto o yin a d microfim, with ut p rmis io in wr itin from

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c p r i ht or h v a e q ir y a o t o tainin a ditio al ri hts to this p blc tio , ple s c nta t th a dre s b low or

y ur lo al IEC memb r Natio al Commite for ur th r informatio

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ni uti s e s u q elq e forme q e c s it et p r a c n pro é é, éle troniq e o mé a iq e, y c mp s la p oto o ie

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le c ord n é s ci-a r ès o c nta te le Comité n tio al d l EC d v tr ep y d résid n e

Th Intern tio al Ele trote h ic l Commis io (IEC) is th le din glo al or ga iz tio th t pr ep res a d p bls e

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Abo t IEC p blc tio s

Th te h ic l c nte t of IEC p blc tio s is k pt u d r c n ta t r eview b th IEC Ple s ma e s re th t y u h v th

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Th st an -alo e a plc t io for c n ultin th e tire

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En ls a d Fre c e tra t ed fom t he Terms a d Definitio s

cla s of IEC p blc t io s is u d sin e 2 0 Some e t rie

h v e b e c le t ed fom e rler p blc tio s of IEC TC 3 ,

7 ,8 a d CISPR

IEC Cust omer Servic Cent re - webst ore.ec ch/ csc

If y ou wis to giv e u your fe d a k o t his p blc tio or

n e furt her a sista c , ple s c nta t t he Cu tomer Serv ic

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A pro os de l'IEC

L Commis io Ele trote h iq e Inter natio ale (IEC) e t la premièr e orga is tio mo diale q i éla or e et p ble d s

Norme internatio ale p ur to t c q i a trait à léle tri ité,à léle tr oniq e et a x te h olo ie a p r enté s

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L c nte u te h iq e d s p blc tio s IEC e t c n tamme t rev Ve i e v u a s r er q e v u p s é e lé itio la

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biblo ra hiq e s r le Norme intern t io ale ,

Sp cific t io s t ec niq e , R ap ort s te h iq e et a tre

d c me ts d l EC Dis o ible p ur P , Ma OS, t ablett es

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e uti s nt difére t s crit ère (n méro d référe c , t exte,

c mit é d’ét ud s,…) Ele d n e a s i d s informatio s s r le

projets et le p blc t io s remplac ée o retiré s

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a glais et e fa ç is, e traite d s art icle Terme et

Définit io s d s p blc tio s IEC p ru s d p is 2 0 Plu

c rt ain s e tré s a térie re e t rait es d s p blc tio s d s

CE 3 , 7 , 8 et CISPR d l EC

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Si vou d sire n u d n er d s c mme taire s r c tt e

p blc t io o si v ou av ez d s q e t io s c nt ac t ez-n u :

Medical elect rical equipment –

Part 2- 37: Part icular requirement s for t he basic safety and essent ial

per ormance

of ult rasonic medical diagnost ic and monit oring equipment

Apparei s élect romédicaux –

Part ie 2- 37: Exigences part icul ères pour la sécurit é de bas et les

W arnin ! Mak e s re th t y ou o tain d this publc t ion from a a t horize distributor

At te tion! V eui ez vou a s rer q e vou a ez o te u c t te publc t ion via u distribute r a ré

c olour

inside

IEC 60601 - 2- 37

Editio 2.1 2 15-0

Medical elect rical equipment –

Part 2- 37: Part icular requirement s for t he basic safety and essent ial per ormance

ofult rasonic medical diagnost ic and monit oring equipment

Apparei s élect romédicaux –

Part ie 2- 37: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des apparei s de diagnost ic et de survei lance médicaux à ult rasons

CONTENTS

FOREWORD 4

INTRODUCTION 7

INTRODUCTION TO AMENDMENT 1 7

2 1.1 Sco e, o ject an related stan ard 8

2 1.2 Normative referen es 9

2 1.3 Terminology Terms an definition 10 2 1.4 General req irements 15 2 1.5 General req irements for testin ME EQUIPMENT 16 2 1.6 Clas if i ation of ME EQUIPMENT an ME SYS EMS 16 2 1.7 ME EQUIPMENT identif i ation, markin an doc ments 17 2 1.8 Protection again t electrical H ZARDS f rom ME EQUIPMENT 2

2 1.9 Protection again t MEC A ICAL H ZARDS of ME EQUIPMENT an ME SYS EMS 2

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

2 1.1 Protection again t ex es ive temp ratures an other H ZARDS 2

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

2 1.13 Hazardou situation an f ault con ition 2

2 1.14 PR GRAMMABLE ELECTRIC L MEDIC L SYS EMS (PEMS) 2

2 1.15 Con tru tion of ME EQUIPMENT 2

2 1.16 ME SYS EMS 2

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

2 2.6 ELECTR MAGNE IC COMP TIBILITY 2

An ex AA (informative) Guidan e an rationale f or p rtic lar s bclau es 3

An ex BB (informative) Guidan e in clas ification ac ordin to CISPR 1 3

An ex CC (inf ormative) Guidan e to the MA UFA TURER on the interpretation of TI an MI to b u ed to inform the OPERATOR 3

An ex DD (inf ormative) Example set-up to me s re s rf ace temp rature of external y a pl ed TRA SD CER AS EMBLIE 4

An ex EE (informative) Acou tic output ta le inten ed f or 3rd p rties 4

Bibl ogra h 4

In ex of def i ed terms 51

Fig re DD.1 – Set-up of an example test o ject to me s re the s rf ace temp rature of external y a pl ed tran d cers 4

Ta le 2 1.101 – List of s mb ls 15 Ta le 2 1.10 – Distributed es ential p rf orman e req irements 16 Ta le 2 1.10 – Acou tic output re ortin ta le 2

Ta le 2 1.10 – Overview of the tests noted u der 2 1.1 1.3 2

Ta le CC.1 – Relative imp rtan e of maintainin low exp s re in ices in variou s an in situation 41

+AMD1:2 15 CSV  IEC 2 15

Ta le DD.1 – Acou tic an thermal pro erties of tis ues & materials 4

Ta le DD.2 – Weig t % pure comp nents 4

INTERNATIONAL ELECTROTECHNICAL COMMISSION

MEDICA L ELECTRICA L EQUIPMENT –

Part 2-37: Particular requirements f or the basic safety

and essential perf ormance of ultrasonic medical

diagnostic and monitoring equipment

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 (P S) a d Guid s (h re f ter ref ere 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 f or 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 f or 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 eff orts 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 f or 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 if ormity, 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 re 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 rtific tio b die pro id c nf ormity

a s s me t s rvic s a d, in s me are s, a c s to IEC mark of c nformity 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 for 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 f ee ) 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

This Con ol d te version is not a of f icial IEC Sta dard a d ha be n prepare for

us r conv nie c Only the c r e t v rsion of the sta dard a d its ame dme t(s)

are to be con idere the of f icial doc me ts

This Con ol d te version of IEC 6 6 1-2-3 be rs the e ition number 2.1 It consists of

the s cond e ition (2 0 -0 ) [doc me ts 6 B/6 4/CDV a d 6 B/6 7/RVC] a d its

ame dme t 1 (2 15-0 ) [doc me ts 6 B/9 8/FDIS a d 6 B/9 8/RVD] The te hnic l

conte t is ide tic l to th ba e e ition a d its ame dme t

In this Re l ne v rsion, a v rtic l l n in the margin s ows where th te h ic l conte t

is modif ie by ame dme t 1 Ad itions a d deletions are displa e in re , with

deletions being struc through A s parate Fin l v rsion with al c a ge a c pte is

a ai able in this publ c tion

+AMD1:2 15 CSV  IEC 2 15

International stan ard IEC 6 6 1-2-3 has b en pre ared by IEC s bcommite 6 B:

Diag ostic imagin eq ipment, of IEC tec nical commite 6 : Electrical eq ipment in medical

practice

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

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

– Req irements an definition : roman typ

– Test sp cific tions: itali ty e

– Inf ormativ material a p arin o tsid of ta le , s c a n te , e ample a d ref ere 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 GENERAL S A DARD, IN THIS P RTICULAR S A D RD 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 standard are preceded by the term “Clau e” f ol 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 any

combination of the con ition is true

The verb l f orms u ed in this stan ard conf orm to u age des rib d in An ex H of the ISO/IEC

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

– “s al ” me n that complan e with a req irement or a test is man atory for complan 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 f or compl an e with this stan ard;

– “may” is u ed to des rib a p rmis ible way to ac ieve compl an 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 ele tric l

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

The commite has decided that the contents of the b se publ cation an its amen ment wi

remain u c an ed unti 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 specific publ cation At this date, the

IMPORTANT – Th 'colour inside' logo on the cover pa e of this publ c tion indic te

that it contain colours whic are consid re to be us f ul f or th cor e t

und rsta din of its conte ts Us rs s ould theref ore print this doc me t usin a

colour printer

+AMD1:2 15 CSV  IEC 2 15

In this p rtic lar stan ard, safety req irements ad itional to those in the general stan ard are

sp cified for ULTRASONIC DIAGNOS IC EQUIPMENT

A general g idan e an rationale for the req irements of this p rtic lar stan ard are given in

An ex AA

Knowled e of the re son for these req irements wi not only faci tate the pro er a pl cation

of this p rtic lar stan ard but wi , in d e course, exp dite an revision neces itated by

c an es in cl nical practice or as a res lt of develo ments in tec nolog

The a pro c an phi oso h u ed in draf tin this p rtic lar stan ard f or saf ety of

ULTRASONIC DIAGNOS IC EQUIPMENT are con istent with those in stan ard of the

IEC 6 6 1-2-x series that a ply to other diag ostic modal ties, s c as X- ay eq ipment an

mag etic resonan e s stems

In e c case, the saf ety stan ard is inten ed to req ire in re sin so histication of output

display in icators an /or controls with in re sing energ levels in the inter ogatin f ield of

diag osis Th s, for al s c diag ostic modal ties, it is the resp n ibi ty of the OPERATOR to

u derstan the ris of the output of the ULTRASONIC DIAGNOS IC EQUIPMENT, an to act

a pro riately in order to o tain the ne ded diag ostic information with the minimum ris to the

P TIENT

The secon edition of IEC 6 6 1-2-3 was publ s ed in 2 0 Sin e that publ cation, the

(IEC 6 6 1-1:2 0 /AMD1:2 12) and a con ol dated edition 3.1 (IEC 6 6 1-1:2 0 an

IEC 6 6 1-1:2 0 /AMD1:2 12) were publs ed This amen ment to IEC 6 6 1-2-3 :2 0

ad res es thre is ues:

1) tec nical c an es pro osed by National Commite s as a res lt of 4 ye rs of practical

u age,

IEC 6 6 1-1-x , an

3) tec nical c an es as a res lt of maintenan e to normative referen es

MEDICA L ELECTRICA L EQUIPMENT –

Part 2-37: Particular requirements f or the basic safety

and essential perf ormance of ultrasonic medical

diagnostic and monitoring equipment

The clau es an s bclau es of the general stan ard a ply ex e t as fol ows:

201.1 Scope, object and related standards

Clau e 1 of the general stan ard a ples, ex e t as fol ows:

2 1.1.1 *Scope

Add ition Re l ac me t:

This International Stan ard a ples to the BASIC SAF TY an E S NTIAL PERFO MA CE of

ULTRASONIC DIAGNOS IC EQUIPMENT as defined in 2 1.3.217, hereinafter ref er ed to as ME

EQUIPMENT

If a clau e or s bclau e is sp cif i al y inten ed to b a pl ca le to ME EQUIPMENT only, or to

ME 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 ME EQUIPMENT an to ME SYS EMS, as relevant

HAZARDS in erent in the inten ed ph siological fu ction of ME EQUIPMENT or ME SYS EMS

within the s o e of this stan ard are not covered by sp cific req irements in this stan ard

ex e t in 7.2.13 an 8.4.1 of this stan ard

NOT Se als s b la s 4.2 of this sta d rd

This p rtic lar stan ard do s not cover ultrasonic thera eutic eq ipment Eq ipment u ed for

the imagin or diag osis of b d stru tures by ultrasou d in conju ction with other medical

proced res is covered

2 1.1.2 Obje t

Re la eme t:

The o ject of this p rtic lar stan ard is to esta l s p rtic lar BASIC SAF TY an E S NTIAL

PERFOR A CE req irements f or ULTRASONIC DIAGNOS IC EQUIPMENT as def i ed in 2 1.3.217

2 1.1.4 Partic lar sta dards

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

contained in the general stan ard as a pro riate for the p rtic lar ME EQUIPMENT u der

con ideration, an may ad other BASIC SAF TY an E S NTIAL PERFORMA 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

+AMD1:2 15 CSV  IEC 2 15

The n mb rin of section , 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 p rtic lar 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 final digit s) of the col ateral stan ard doc ment n mb r

(e.g 2 2.6 in this p rtic lar stan ard ad res es the content of Clau e 6 of the 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

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

sp cified 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 plca 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 plca le

col ateral stan ard is amen ed as in icated by the text of this p rtic lar stan ard

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

n mb red startin fom 2 1.101, ad itional an exes are let ered AA, BB, etc an ad itional

items a ), b ), etc

Subclau es or f i ures whic are ad itional to those of a col ateral stan ard are n mb red

startin f rom 2 x, where “x” is the n mb r of the col ateral stan ard, e.g 2 2 for 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 plca le

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

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

section, 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 modification; where it is inten ed that an p rt

of the general stan ard or a pl ca le col ateral stan ard, althou h p s ibly relevant, is not to

b a pled, a statement to that ef fect is given in this p rtic lar stan ard

201.2 Normativ references

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

Add ition:

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

safety a d es e t ial p rorma c

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

1

IEC 6 6 1-2-18:2 0 , Med ic l el ectric l e uipme t – Part 2-18: Partic l ar re uireme ts for

th b sic safety a d es e tial p rorma c of e dosc pic e uipme t

IEC 6 12 -1:2 0 , U l traso ics – H ydro h n s – Part 1: Measureme t a d c ara terizat ion of

med ic l ultraso ic fiel ds u t o 4 MHz

IEC 6 3 9:2 10, Ultra o ic – Field c ara teriz tio – Te t methods for the determin tio of

thermal a d me h nic l ndic s related to med ic l d ia n stic ultra o ic fields

201.3 Terminology Terms a d def initions

For the purp ses of this doc ment, the terms an def i ition given in the general stan ard

an in IEC 6 3 9, as wel as the f ol owin ad ition a ply:

NOT 1 An in e of d fin d terms is giv n after th Biblo ra h

NOT 2 A lst of s mb ls u e in this p rtic lar sta d rd is fo n in Ta le 2 1.101

2 1.3.2 1

BONE THERMAL IN EX

TIB

THERMAL IN EX f or a pl cation s c as f oetal (secon an third trimester) or ne natal

ce hal c ( hrou h the f ontanel e) a pl cation , in whic the ultrasou d b am p s es throu h

sof t tis ue an there is b ne close to a f ocal region is in the immediate vicinity of b ne

Unit: None

NOT Se IEC 6 3 9 for meth d of d terminin th BON T ER AL IN E

[SOURCE: IEC 6 3 9:2 10, 3.17, modif ied – The def i ition no lon er ref ers to ne natal

ce hal c a pl cation , an the original notes have b en deleted]

2 1.3.2 2

COMBINED-OP RATING MODE

mode of o eration of ULTR SONIC DIAGNOS IC EQUIPMENT that combines more than one

DISC E E-OP R TING MODE

2 1.3.2 3

CR NIAL-BONE THER AL IN EX

TI C

THERMAL IN EX f or a pl cation , in whic the ultrasou d b am p s es throu h b ne ne r the

b am entran e into the b d , s c as p ediatric an ad lt cranial or ne natal ce halc

a pl cation

Unit: None

NOT Se IEC 6 3 9 for meth d of d terminin th C A IAL-BON T ER AL IN E

[SOURCE: IEC 6 3 9:2 10, 3.21, modif ied – The def i ition now in lu es a ref eren e to

ne natal ce hal c a pl cation , an the original notes have b en deleted

2 1.3.2 4

DE AUL S T ING

sp cif i state of control the ULTR SONIC DIAGNOS IC EQUIPMENT wi enter up n p wer up, new

PATIENT select, or c an e f rom non-f oetal to f oetal a pl cation

2 1.3.2 5

DISCRE E-OP R TING MODE

mode of o eration of ULTR SONIC DIAGNOS IC EQUIPMENT in whic the purp se of the ex itation

of the ULTR SONIC TRA SD CER or ULTRASONIC TR NSD CER element group is to uti se only

one diag ostic methodolog

2 1.3.2 6

FUL SOF WA E CONTR L OF ACOUS ICOUT UT

me n by whic the ULTRASONIC DIAGNOS IC EQUIPMENT manages the acou tic output

in e en ent of direct OP R TOR control

+AMD1:2 15 CSV  IEC 2 15

2 1.3.2 7

INVASIVE TR NSDU ER AS EMBLY

a tran d cer whic , in whole or in p rt, p netrates in ide the b d , either throu h a b d

MUL I-PURPOS UL R SONIC DIA NOS IC EQUIPMENT

ULTR SONIC DIAGNOS IC EQUIPMENT that is inten ed f or more than one cl nical a plcation

2 1.3.210

NON-SCANNING MODE

mode of o eration of ULTRASONIC DIAGNOS IC EQUIPMENT that in olves a seq en e of

ultrasonic pulses that give rise to ultrasonic s an lnes that f ol ow the same acou tic p th

2 1.3.21

PRUDENT US S AT MENT

af f irmation of the prin iple ad isin avoidan e of hig exp s re levels an lon exp s re

times whie ac uirin only inf ormation whic is cl nical y req ired that only neces ary cl nical

inf ormation s ould b ac uired an that hig exp s re levels an lon exp s re times s ould

[SOURCE: IEC 6 3 9:2 10, 3.4 , modif ied – The def i ition has b en reworded

2 1.3.212

SCANNING MODE

mode of o eration of ULTRASONIC DIAGNOS IC EQUIPMENT that in olves a seq en e of

ultrasonic pulses that give rise to s an lnes that do not f ol ow the same acou tic p th

NOT 1 Se IEC 6 3 9 for meth d of d termin tio of th SOFT-TIS U T ER AL IN E

NOT 2 For th p rp s s of this d c me t, “s ft tis u “ in lu e al b d tis u s a d f l id b t e clu e s eletal

ratio of AT ENU T D A OUS IC OUT UT POWER at a sp cif ied p int to the AT EN AT D A OUS IC

OUT UT POWER req ired to raise the temp rature at that p int in a sp cif i tis ue model

by 1 °C

Unit: None

[SOURCE: IEC 6 3 9:2 10, 3.5 , modif ied – The term "AT EN AT D A OUS IC POWER" has

b en re laced twice by the term "AT EN AT D OUT UT POWER", an the original note has b en

deleted

2 1.3.215

TRANSD CER AS EMBLY

the tran d cer hou in (pro e), an as ociated electronic circ itry, the active ultrasonic

tran d cer mod le, an an l q id contained in the hou in an the integral ca le that

con ects the tran d cer pro e to an ultrasou d con ole

those p rts of ULTR SONIC DIAGNOS IC EQUIPMENT comprisin the ULTR SONIC TRA SD CER

an /or ULTR SONIC TR NSD CER ELEMENT GROUP, together with an integral comp nents, s c

as an acou tic len or integral stan -of f

Note 1 to e try: Th TRA S UCER A S MBLY is u u ly s p ra lefom th ultra o n in trume t c n ole

[SOURCE: IEC 6 12 -1:2 0 , 3.6 , modif ied – the original term "medical diag ostic

ultrasou d eq ipment" has b en re laced by "ULTR SONIC DIAGNOS IC EQUIPMENT" in the

defi ition

2 1.3.216

TRANSMIT PAT ERN

combination of a sp cif i set of tran d cer be m-formin c aracteristic (determined by the

tran mit a erture size, a odisation s a e, an relative timin /phase delay p t ern acros the

a erture, res ltin in a sp cif i f ocal len th an direction), an an electrical drive wavef orm of

a sp cif i f i ed s a e but varia le ampl tu e

[SOURCE: IEC 6 3 9:2 10, 3.5 ]

2 1.3.217

UL RASONIC DIA NOS IC EQUIPMENT

MEDIC L ELECTRIC L EQUIPMENT that is inten ed for ultrasonic medical examination

2 1.3.218

UL RASONIC TR NSD CER

device ca a le of con ertin electrical energ to mec anical energ an /or mec anical

energ to electrical energ , b th within the ultrasonic f req en y ran e

device ca a le of con ertin electrical energ to mec anical energ within the ultrasonic

f req en y ran e an /or reciprocal y of con ertin mec anical energ to electrical energ

aw f(

p

p ,

)10(

zf

zII

 is the A OUS IC AT EN ATION COE FICIENT as def i ed in IEC 6 3 9:2 10, def i ition 3.1;

z is the distan e f rom the EXT R AL TR NSD CER A ERTU E to the p int of interest;

f

wf

is the A OUS IC WORKING FREQUEN Y as def i ed in IEC 6 3 9:2 10, def i ition 3.4;

+AMD1:2 15 CSV  IEC 2 15

I

p

(z) is the PULS -A ERAGE INT NSITY me s red in water as def i ed in IEC 6 12 -1:2 0

an IEC 6 12 -1:2 0 /AMD1:2 13, defi ition 3.4

Unit: W m

–2

2 1.3.2 0

NUMB R OF PULS S P R ULTRASONIC SC N LINE

the n mb r of acou tic pulses travel n alon a p rtic lar UL RASONIC SCAN LINE

Note 1 to e try: Here ULTRA ONIC SCA LIN refers to th p th of a o stic p ls s o a p rtic lar B AM A IS in

SCA NING a d NON-SCA NING M D S

Note 2 to e try: This n mb r c n b u e in th c lc latio of a y ultra o n temp ral a era e v lu fom

H DR P ON me s reme ts

Note 3 to e try: Th folowin s ows a e ample of th N MB R OF P LS S P R ULTRA ONIC SCA LIN a d th

N MB R OF ULTRA ONIC SCA LIN S (;” in ic te th e d of a fame):

[SOURCE: IEC 61 5 : 2 0 /AMD1:2 13, 3.4 , modif ied – The f ourth example in the Note 3 to

entry has b en cor ected

medical in trument havin viewin me n , with or without o tic , introd ced into a b d cavity

throu h a natural or s rgical y cre ted b d o enin for examination, diag osis or thera y

Note 1 to e try: EN OSC P S ma b of rigid, f l xible or c p ule ty e, e c of whic ma h v difere t ima e

pic -u s stems (e.g via le s s or ele tro ic/ultra o ic s n ors) a d difere t ima e tra smis io s stems (e.g

o tic l (via le s s or fibre b n le ), or ele tric l/ele tro ic)

Note 2 to e try: Note 1 to e try difers fom NOT 1 of d finitio 3.1 in ISO 8 0 - in ord r to in lu e 'c p ule'

S ATIAL-P A T MPOR L-A ER GE INT NSITY f or NON-SC N ING MODE

comp nents, determined b yon the BREA -POINT DE TH, z

b, on the B AM-A IS

2 1.3.2 4

DE TH FOR P A AT ENUAT D PUL E-INT NSITY INT GRAL

z

pi 

NON-SC N ING MODE comp nents, determined b yon the BREA -POINT DE TH, z

b, on the B AM-

comp nents, determined b yon THE BREA -POINT DE TH, z

b, on the B AM-A IS

Unit: m

Note 1 to e try: B AM-A IS a d BRE K-POIN D P H ared fin d in IEC 6 3 9

Note 2 to e try: Th s b cript ‘si in ic te th s a inte sity inte ral (si) Th si for

SCA NING M D

c mp n nts at a p rtic lar p int is d termin d fom th s m o er a c mplete s a fame of th P LS -IN E SIT

IN EG ALS of th ULTRA ONIC SCA LIN S th t ma e u th s a nin c mp n nts of a c mbin d mo e No

-s a n d c mp n nts are e clu e fom th s m Se IEC 6 3 9 a d IEC 6 12 - for more d tais

2 1.3.2 6

DE TH FOR P A SUM OF AT ENUAT D PUL E-INT NSITY INT GRAL

z

si α

p sition of maximum AT EN AT D S ATIAL-P A T MPOR L-A ERAGE INT NSITY f or SC N ING

MODE comp nents, determined b yon the BREA -POINT DE TH, z

b, on THE B AM-A IS

Unit: m

Note 1 to e try: B AM-A IS a d BRE K-POIN D P H ared fin d in IEC 6 3 9

Note 2 to e try: Th s b cript “si” in ic te th “Sc n Inte sity Inte ral” th t is th s m at a p rtic lar p int of

th P LS -IN E SIT IN EG ALS of th ULTRA ONIC SCA LIN S c mprisin a SCA NING M D c mp n nt Se

IEC 6 3 9 a d IEC 6 12 - for a ditio al d tais

Unit: m

[SOURCE: IEC 6 3 9:2 10, 3.2 ]

201.4 General requirements

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

Add ition:

con idered an ULTRASOU D TRA SD CER an s al me t the req irements of this p rtic lar

stan ard

NOT Ex mple of s c ULTRA OU D TRA S UCERS in lu e tra s a in l tra s s p a e l (T E), re tal

la aro c pic a d oth r simiar intra-c vity pro e

An ULTRASOUN EN OSCOPE havin imagin me n in ad ition to ultrasou d s al also me t

the req irements of 2 1.1 6.5 of IEC 6 6 1-2-18:2 0

NOT Ex mple of s c a ditio al ima in me n in lu e o tic l a d CC

2 1.4.3 ES ENTIA L P RFOR A NCE

Add ition:

2 1.4.3.101 Additional E S NTIA L P RFORMA NCE re uireme ts

Ta le 2 1.10 l sts the p tential sources of u ac e ta le ris identified to c aracterize the

E S NTIAL PERFOR A CE of ULTRASONIC DIAGNOS IC EQUIPMENT an the s bclau es in whic

the req irements are f ou d

Table 2 1.10 – Distribute e s ntial perf orma c re uireme ts

Fre fom n is o a wa ef orm or artef acts or distortio in a ima e or eror of a dis la e

n meric l v lu whic c n ot b atrib te to a p y iolo ic l eff ect a d whic ma alter th

Fre fom th pro u tio of u inte d d or u c ntrole motio of TRA S UCER A S MBLIE

inte d d for intra-c rp re l u e

2 2.6.2.1.10

a

“in ore t in th s n e th t th dis la e v lu diff ers fom wh t is c lc late (h vin b e altere d rin d ta

tra sfer, or th c lc latio its lf is n t c re t

NOT In s me circ msta c s th n e for th re etitio of a ultra o n e amin tio s o ld b e alu te a a

p te tial h z rd, for e ample, intra-c rp re lin e tig tio a d stre s te tin for c rdio athic P TIE T

201.5 General requirements f or testing ME EQUIPMENT

Clau e 5 of the general stan ard a ples

201.6 Clas if ic tion of ME EQUIPMENT and ME SYS EMS

Clau e 6 of the general stan ard a ples

+AMD1:2 15 CSV  IEC 2 15

201.7 ME EQUIPMENT ide tif ic tion, marking a d documents

Clau e 7 of the general stan ard a ples, ex e t as f ol ows:

2 1.7.2.9 IP cla sific tion

Add ition:

If the sp cified IPX clas ification is a pl ca le for only p rt of the TRA SDU ER AS EMBLY, the

markin of the IPX code on the TRA SD CER AS EMBLY is not req ired

2 1.7.2.13 *Phy iologic l ef fe ts (s fety signs a d warning stateme ts)

For ULTRASONIC DIAGNOS IC EQUIPMENT ca a le of generatin output levels s bject to

2 1.12.4.2 an whic al ows the OPERATOR to directly vary the output levels, the ef fect of

adju tin the control whic varies the output level s al b cle r The markin s al b of the

nature of an active display

A display of THER AL INDEX an MECH NIC L IN EX s al b provided in ac ordan e with the

req irements of Clau e 2 1.12, together with the declaration of ac urac des rib d in 2 1.7.9

an Clau e 2 1.12

A display relevant to ultrasou d output levels (Clau e 2 1.12) s al b cle rly visible fom the

OPERATOR’S p sition, with the f ul name(s) or ab reviation(s) of the in ex (in ices) displayed

2 1.7.9.2.2 *Warning a d s fety notic s

Add ition:

For ULTRASONIC DIAGNOS IC EQUIPMENT ca a le of generatin output levels s bject to Clau e

2 1.12, inf ormation s al b provided to the OPERATOR on how to interpret the displayed

ultrasonic exp s re p rameters, THER AL IN E

X (TI ) an

MEC A IC L IN

EX (MI) ac ordin to

the g idan e given in An ex CC

The proced res neces ary for safe o eration s al b provided, drawin at ention to the

saf ety hazard that may oc ur as a res lt of an inadeq ate electrical in tal ation when the

A PLIED P RT of the ULTRASONIC DIAGNOS IC EQUIPMENT is a TY E B A PLIED P RT

In tru tion on the saf e u e of TRA SDU ER AS EMBLIE s al b provided, an , in p rtic lar,

in tru tion to en ure that the ULTRASONIC DIAGNOS IC EQUIPMENT is of the cor ect typ f or its

inten ed a plcation; f or TRA SD CER AS EMBLIE intended for intra-corp re l u e, a warnin

in the in tru tion not to activate the TRA SD CER AS EMBLY outside the P TIENT’S b d if the

TRA SD CER AS EMBLY, when so activated, would not comply with electromag etic compl an e

req irements an may cau e harmful interf eren e with other eq ipment in the en ironment

The identification of intereren e with other eq ipment an mitigation tec niq es s al b

in lu ed in the A COMP N ING DOCUMENT if the MA UFA TURER claims a red ction in test

levels

A notice s al b provided if the ULTRASONIC DIAGNOS IC EQUIPMENT or p rts there f are

(HF) s rgical eq ipment If no s c me n are in orp rated, notice s al b given in the

A COMP N ING DOCUMENT an ad ice s al b given regardin the location an u e of the

TRA SD CER AS EMBLY to red ce the hazard of burn in the event of a defect in the HF

s rgical neutral electrode con ection

A PRU ENT US S AT MENT s al b provided f or ULTRASONIC DIAGNOS IC EQUIPMENT ca a le of

generatin output levels s bject to 2 1.12.4.2

Des ription s al b provided of an display or me n relevant to ultrasou d output by whic

the OPERATOR may modify the o eration of the ULTRASONIC DIAGNOS IC EQUIPMENT These

des ription s al b in a se arate section

A des ription of an display or me n by whic the OPERATOR may modify the o eration of the

ULTRASONIC DIAGNOS IC EQUIPMENT relevant to s rf ace temp rature for INV SIVE TRA SD CER

AS EMBLIE inten ed f or tran -o so hage l u e s al b provided

A des ription of those p rts of the TRA SD CER AS EMBLY that are p rmit ed to b immersed in

water or other l q id either f or NOR AL US or p r orman e as es ment purp ses s al b

provided

A recommen ation cal n the

OPERATOR’S at ention to the ne d for reg lar testin an

p riodic maintenan e in lu in in p ction of the TRA SD CER AS EMBLY for crac s that al ow

the in res of con u tive fluid s al b provided

In tru tion s al b provided regardin the avoidan e of u inten ed control setin s an

acou tic output levels

Output l mits selected ac ordin to 2 1.12.4.5.1 s al b declared in the A COMP N ING

DOCUMENT For MULTI-P RPOS ULTRASONIC DIAGNOS IC EQUIPMENT the output l mits s al b

declared f or e c a pl cation

defibri ator

The outer s rf ace of the p rtion of TRA SDU ER AS EMBLY whic is inten ed to b in erted

into a P TIENT s ould b c ec ed to en ure that there are no u inten ed rou h s r aces,

s arp ed es or protru ion whic may cau e harm

As the u e of ULTRASONIC DIAGNOS IC EQUIPMENT is in re sin in the home care are , sp cial

at ention s ould b p id to provide information to this typ of u er How this is ad res ed

s ould b doc mented in the RISK MA AGEMENT FILE Se IEC 6 6 1-1-1

2 1.7.9.2.10 Me s ge

Re la eme t of the first p ra ra h:

The in tru tion for u e s al lst al s stem mes ages, er or mes ages an fault mes ages

that are generated an are visible to the OPERATOR, u les these mes ages are self

explanatory

2 1.7.9.2.12 Cle ning, disinfe tion a d steri zation

Add ition:

Aft er first d ash d item, add :

NOT This lst of p rameters is n ith r e h u tiv n r ma d tory

+AMD1:2 15 CSV  IEC 2 15

After se o d d ash d item, ad d:

− a lst of the p rtinent p rts, comp nents an /or f un tion that s ould b c ec ed after

e c cle nin , disinfection or steri zation c cle, an method(s) of in p ction

NOT This lst of p rameters is n ith r e h u tiv n r ma d tory

2 1.7.9.3 Te hnic l d s ription

Add ition:

2 1.7.9.3.101 *Te hnic l data re arding a ou tic output le els (s e also Table 2 1.10 )

For e c mode, provide the maximum value of e c THER AL an MEC A IC L IN EX (as wel

as the as ociated p rameters l sted f or the o eratin con ition res ltin in the maximum

in ex value), for whic the o eratin mode in q estion is the largest (or sole) contributor

DOCUMENT

For a TRA SD CER AS EMBLY an ultrasou d in trument con ole that satisfies al of the

exemption con ition cited in 2 1.12.4.2 a) an b), information declared in the A COMP NYING

DOCUMENT s al state that the THER AL IN ICE an the MEC A IC L IN EX are b low 1,0 or

Table 2 1.10 – Acoustic output reporting table

NOT 1 Data s o ld o ly b e tere in o e of th c lumn relate to TIS

NOT 2 Inf ormatio n e n t b pro id d re ardin TIC f or a y TRA S UCER A S MBLY n t inte d d for tra s ra ial

NOT 1 Only o e o eratin c n itio p r in e

NOT 2 Data s o ld b e tere for “at s ra e” a d “b low s rf ac ” b th in th c lumn relate to TIS or TIB

NOT 3 Informatio n e n t b pro id d re ardin TIC for a y TRA S UCER A S MBLY n t inte d d for

tra s ra ial or n o atal c p alc u e

NOT 4 If th re uireme ts of 2 1.12.4.2 ) are met, it is n t re uire to e ter a y d ta in th c lumn relate

to TIS, TIB or TIC

NOT 5 If th re uireme ts of 2 1.12.4.2 ) are met, it is n t re uire to e ter a y d ta in th c lumn relate

to M I

NOT 6 “” in ic te c ls wh re a n meric l v lu s o ld b e tere Th e uipme t s tin relate to th

in e h s to b e tere in th o eratin c ntrol s ctio

201.8 Protection against electric l HAZARDS f rom ME EQUIPMENT

Clau e 8 of the general stan ard a ples ex e t as fol ows:

2 1.8.7.4.7 Me s reme t of th PA TIENT L A KA E C R ENT

Add ition, at the e d of t he first p ra ra h:

a d , for ul traso ic tra sd uc r as emblies o ly, where T

1

is

– 10 °C a ove the maximum al owa le temp rature sp cified in the A COMP N ING

DOC MENT f or cle nin , disinf ection, steri zation, normal u e or storage

2 1.8.10.4 Cord-conn cte HA ND-HE D parts a d cord-conne te foot o erate control

de ic s

Add ition:

This s bclau e do s not a ply to ULTRASONIC TRA SD CER AS EMBLIE

201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYST MS

Clau e 9 of the general stan ard a ples

201.10 Protection a ainst unwanted and exc ssive ra iation HAZARDS

Clau e 10 of the general stan ard a ples ex e t as fol ows:

Add ition l su cl ause:

2 1.10.101 *Ultra onic e ergy

The MA UFA TURER s al ad res the RISKS as ociated with ultrasonic energ in the RISK

MA AGEMENT PR CE S as des rib d in the text of this stan ard

+AMD1:2 15 CSV  IEC 2 15

Complian e is c e k d b insp ct io ofthe RISK M AN AGEM E NT FILE

Acou tic output s al b switc ed of f when the sig al ac uisition is sto p d (i.e the "f re ze"

f eature is ena led)

201.1 Protection a ainst e cessiv temperatures and other HAZARDS

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

2 1.1 1.2.2 *AP LIED PA T not inte d d to s pply h at to the PA TIENT

Add ition:

TRA SD CER AS EMBLIE a pl ed to the P TIENT s al have a P TIENT contact s rf ace

temp rature not ex e din 4 °C in NORMAL CON ITIONS when me s red u der test con ition

2 1.1 1.3.1.1

TRA SD CER AS EMBLIE a pl ed to the P TIENT s al have a P TIENT contact s rf ace

temp rature not ex e din 5 °C when me s red u der test con ition 2 1.1 1.3.1.2

Compl an e is c ec ed by o eration of the ULTRASONIC DIAGNOS IC EQUIPMENT an

temp rature tests as des rib d in 2 1.1 1.3

NOT P TIE T c nta t s ra e in lu e a y p rt of th A PLIE P RT, n t ju t th ra iatin s ra e, b t e clu in

remainin tex t ofth su cl ause with t he fo owin :

Compl ian e with t he re uireme ts of 1 1.1 a d 1 1.2 is c e k d b insp ctio of th RISK

M AN AGE M EN T FILE

2 1.1 1.3.1 Te t con itions

Th TRAN SDU CE R AS EM BLY sh l l b tested u der the fo owin c nd itions:

2 1.1 1.3.1.1 Simulate us

Th AP LIE D PART of t he TRAN SD CE R AS E M BLY sh ll b c u led a o st ic ly t o, a d b

initia y in thermal e uil ibrium with, a test o je t su h that th ultraso nd emitted fom t he

a tiv sura e of t he TRANSD CER AS E M BLY e ters t he test o jec

Th p sitioning, a d h ating or c ol ing of t he

TRAN SDU CE R AS

EM BLY sh l resemble t hose

c r esp nd ing to the intend ed a p c t io ofthat TRAN SDU CE R AS E M BLY This includ es using a

typic l amo nt of ultraso nd c u l ing med ium a pro riat e t o th int end ed a p c tio

Th t emp rat ure sh ll b me sured at t he p int o th AP LIE D PART of the U LTRASON IC

TRAN SDU CER AS E M BLY that c nta ts th PATIEN T d uring N RM AL U SE a d where the

temp rature is a ma imum

Th test o je t sh l h ve t hermal a d a o stic l pro erties mimicking those of a

a pro riate t is u In t he c se wh re the TRAN SDU CE AS EM BLY is intended for e tern l use

this test o ject sh l l a c u t for a sk in l ay r

For soft t is u , the material of t he test o ject sh l l h ve th fol lowing pro erties:

NOT 2 As h at d v lo s difere tly in tis u s ra e c ntainin s in, b n or s ft tis u , c ref ul c n id ratio

s o ld b giv n to th c oic of th mo el in relatio to th inte d d u e of th AP LIE PAR Ad itio al g id n e

c n b f ou d in An e D a d ref [3 ]

NOT 3 For th p rp s s of this te t, th rmal e ui brium ma b c n id re re c e wh n th rate of c a g of

temp rature of th A PLIE P RT is < 0,2 °C p r min te for thre c n e utiv min te

Th test o ject sh l l b design d (or ex ample, using a o stic a sorb rs) to red uc h at in

th sura e ofthe TRAN SDU CE AS E M BLY b minimizing ultraso nd refl ections

2 1.1 1.3.1.1.1 Te t methods

Test met hod a) or b) sp cified b l ow sh l l b sele ted

Test method a) s al b u ed where the ULTRASOU D DIAGNOS IC EQUIPMENT u es a closed

lo p temp rature monitorin s stem, as the u e of test method b) could res lt in ina pro riate

res lts

a) Test criteria b sed o test o ject n ar h ma t emp ratures

For TRAN SD CE R AS EM BLIE S intended for ex t ern l use, the initial temp rature of the

sura e of t he test o ject at the o je t-t ra sd uc r intera e sh l l b n t les t ha

3 °C a d the ambient temp rature sh l b 2 °C ± 3 °C

For IN VASIV TRAN SDU CE AS EM BLIES, th initial temp rature of t he sura e of th t est

o ject material at th o je t-tra sd uc r intera e sh l l b n t les t ha 37 °C a d the

ambient temp rature sh ll b 2 °C ± 3 °C

To me t th re uireme t s of this t es the temp rat ure of t he sura e of the AP LIED PART

sh l l n t ex ce d 4 °C

b) Test criteria b sed u o temp rature rise measureme ts

Th ambient temp rature sh l b 2 °C ± 3 °C For TRAN SDU CE AS EM BLIES int end ed for

ext ern l use, t he init ial temp rat ure of the sura e of t he test o ject at t he o

ject-tra sdu er intera e sh l l b b twee 2 °C a d 3 °C, a d the sura e t emp rature rise of

the AP LIE D PART sha n t ex ce d 10 °C For IN VASIV TRAN SDU CER AS E M BLIES, the initial

temp rature of t he sura e of the test o ject at the o ject -tra sd uc r intera e sh l l b

b twe n 2 °C a d 37°C, a d t he sura e temp rature rise sh ll n t ex ce d 6 °C

For TRAN SDU CE R AS E M BLIES intend ed for e tern l use, t he t emperature me sured u der th

test c nditio s of 2 1.1 1.3.1.1 sh l l b e u l to the sum of 3 °C pl us t he me sured

temp rature rise

1

Fig re in s u re bra k ts ref er to th Biblo ra h

+AMD1:2 15 CSV  IEC 2 15

For IN VASIV TRAN SDU CE R AS E MBLIES, th temp rat ure me sured u d er the t est c nd it ions of

2 1.1 1.3.1.1 sh ll b e u l to th sum of37 °C plus t he me sured temp rature rise

To me t the re uireme t s of this cla se, the c lc l at ed temp rature sh l n t ex ce d 4 °C

NOT Wh n f olowin this te t meth d, th temp rature ris is d f i e a th dif fere c b twe n th temp rature

of th TRA S UCER A S MBLY ju t b f ore th te t a d th ma imum temp rature of th TRA S UCER A S MBLY

d rin th te t a me s re a c rdin to 2 1.1 1.3.1.1

2 1.1 1.3.1.2 Sti air

Susp nd t he TRAN SDU CE AS E M BLY wit h a cl ea sura e (n c u l ing g l a p ed) in st ill air

or pl ac it in a statio ary p sitio in a e viro me tal c amb r with minimal airlow a ros

th AP LIE D PART oft he TRAN SDU CE R AS EM BLY

Test crit eria are b sed u o temp rature rise me sureme t s

Th ambient t emp rat ure sh ll b 2 °C ± 3 °C a d the initial t emp rat ure oft he AP LIE D PART

of th TRAN SDU CE AS E M BLY sh ll b the ambient temp rature During the test th

temp rature rise of the AP LIE D PART ofth TRAN SDU CE AS E M BLY sh l l n t ex ce d 27 °C

To me t the re uireme t s ofn t ex ce d ing a sura e temp rature of50 °C, th sum ofthe

sura e t emp rat ure rise o tained u der t hese test c nd itions a d 2 °C sh l b re ard ed as

th sura e t emp rat ure u d er test c nd itio s 2 1.1 1.3.1.2

NOT “In sti air” me n a e viro me t with ut air mo eme t (low) a d a air temp rature of 2 °C ± 3 °C

sta le within 0,5 °C Oth rwis it is re omme d d th t o e c r e ts f or temp rature drift

2 1.1 1.3.2 Operatin s t in s

Op rate t he U LTRASON IC DIAGN OS IC E QU IPM E NT at a set ting that giv s t he high st sura e

2 1.1 1.3.1.1 a d 2 1.1 1.3.1.2 sh l l b p rormed using id entic l tra smit p rameters

Th tra smit p rameters of the t est sh ll b re orded in the RISK M AN AGEMEN T FILE t est re ort

2 1.1 1.3.3 Te t duration

Th U LTRASON IC DIAGN OS IC E QU IPM E NT is c nt inu ly o erat ed for the duration of the tes

Th test a c rd ing to 2 1.1 1.3.1.1 sh ll b c ndu ted for 3 min

Th test a c rd ing to 2 1.1 1.3.1.2 sh ll b c ndu ted for the sh rter of:

a) 3 min; or

b) twic t he time p riod l imit ed b a a tomat ic o tput h l d or “ree e” fu ction in the c se

wh re th OPE RATOR is n t a l e to switc of that fu ct io

NOT If th ULTRA ONIC DIAGNOS IC EQUIPME T a tomatic ly “f re z s” or h lts its o tp t e rler th n th time

p rio giv n in this s b la s , th ULTRA ONIC DIAGNOS IC EQUIPME T s al b switc e o a ain imme iately

2 1.1 1.3.4 Temperature me s reme t

Th t emp rat ure of the TRANSDU CER AS E M BLY sh ul d b measured b a y a pro riat e me ns

su h as infa-red rad iometry or thermo o pl e methods

I f a t hermo o ple is used, t he thermo o pl e ju ction a d ad jac nt th rmo o ple lead wire

sh ul d b se urely h l d in g od t hermal c nt act with the sura e b ing me sured Th

th rmo o pl e sh ul d b p sit io ed a d se ured in su h a way th t it h s a n gl igible efe t

o the temp rature rise ofthe are b ing me sured

Th size of t he temp rature me sureme t are oft he se sor, or t he fo us size in c se of a

infa-red me sureme t system, sh uld b su h that a y avera ing efe t is minimized

Th temp rat ure sh l l b me sured o the sura e of the AP LIE D PART of the TRANSDU CER

AS

EM BLY in t hose are s th t give the high st sura e temp rature

Th me sureme t u c rt ainty sh ll b re orded in the RISK M AN AGE M E N T F ILE test re ort

NOT 1 As p rt of me s reme t u c rtainty d termin tio , th me s reme t s t-u c n b u e to ma e s rf ac

temp rature me s reme ts of ULTRA ONIC TRA S UCERS of k own ma imum s rf ac temp rature It is

re omme d d th t th me s reme t s t-u b v ld te

NOT 12 For th e timatio of u c rtaintie , th ISO Guid e t o t he ex pre sion of un ert aint y in me sureme t

s o ld b u e [17]

NOT 2 An me n to me s re th temp rature s o ld c n b a ty e th t is n t o erly s n itiv to dire t

ultra o ic h atin (or e ample, if a th rmo o ple is u e , it c n b a thin fim or fin wire th rmo o ple)

Ad itio al f actors, s c a eff ects of c n u tiv lo s s, ultra o ic h atin a d s atial a era in o th

me s reme t s n ors or its c n e tin c ble ” after “a era in ”, s o ld b c n id re are als rele a t wh n

a s s in th me s reme t u c rtainty

NOT 3 Ex mple me n f or me s rin s ra e temp rature of e tern ly a ple TRA S UCER A S MBLIE is

pro id d in An e D of this sta d rd

2 1.1 1.3.5 Te t criteria

Th TRANSD CE R AS E M BLY sh l l o erat e t hro g o t t he test as spe ified in 2 1.1 1.3.3

During t he tes the ma imum temp rature or th ma imum t emp rat ure rise sh ll n t ex ce d

th limits sp cified

Table 2 1.10 – Ov rview of th te ts note under 2 1.1 1.3

Te t to be ap led 

2 1.1 1.3.1.1

Simulate u e

te t

a) Temp rature Init ial l y t emp rat ure of t he sura e of

t he t est obje t at t he obj ect /

Init ial l y t he t emp rat ure at t he

obj ect -tra sd uc r int era e s a b

Init ial l y t het emp rat ure at t he

obj ect -tra sduc r int era e s a b

+AMD1:2 15 CSV  IEC 2 15

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

Add ition:

Th se p rts of the TRANSDU CE AS EM BLY sp cified b the M ANU FACTU E whic in N ORM AL

U SE are lkely to c me into c ntact with the OPE RATO or PATIE N T sh l me t the re uireme ts

of drip-pro f e uipme t (I PX1) Co n ctors of the TRAN SDU CE AS EM BLIES sh l l b exclud ed

fom t his re uireme t

NOT 1 For this cla s , NO MAL U E in lu e cle nin a d disinfe tio

Compl ian e is c e k d b the test prescribed for the se o d c ara terist ic, n meral 1 of

I EC 6 52 , with th TRAN SDU E R AS EM BLIES c nfig red as in NORMAL US , includ ing t he

c n e tion of a y c bl es, b t ex cl ud ing the c nd it io whe t he TRA SD CER AS EMBLY is

dis on ected f rom the ultrasou d con ole

Parts of the TRAN SDU CE AS EM BLIES sp cified b the M AN U FACTU RE as intended to b

immersed during NORM AL U SE, sh l l me t the re uireme ts of watert ight e uipme t (IPX7)

NOT 1 For this cla s , NO MAL U E in lu e cle nin a d disinfe tio

Compl ian e is c e k ed b t he test prescrib d in IEC 6 52 for IPX7, with the exce t ion of

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

2 1.12.1 Ac ura y of controls a d instrume ts

TRA SD CER AS EMBLIE inten ed f or tran -o so hage l u e s al b sp cified, in lu in an

display of s rf ace temp rature, if provided; se 2 1.7.9.2.2 an 2 1.12.4.2

NOT For th e timatio of u c rtaintie th ISO Guid e t o t he e pre sion of un ert aint y in me sureme t s o ld

b u e [17]

2 1.12.4.2 Indic tion of parameters rele a t to s fety

Add ition:

a) If the ULTRASONIC DIAGNOS IC EQUIPMENT is not ca a le of ex e din either a SOF TIS UE

THER AL INDEX of 1,0, a BONE THER AL IN EX of 1,0 or, f or ULTRASONIC DIAGNOS IC

IN EX of 1,0, in an mode of o eration, then no display of the THERMAL INDEX is req ired

(se also Annex AA con ernin 2 1.7.2.101)

NOT 1 ULTRA ONIC DIAGNOS IC EQUIPME T for whic th OU P T POWER divid d b th - 2 dB OU P T B AM

is n t e p cte to e c e a T ER AL IN E of ,0 if, for al o eratio c n itio s, b th fawf < 10,5 MHz,

a d A

a rt

< 1,2 cm

2

Co s q e tly, th re uireme t lste in Cla s 2 1.12.4.2a) is f ulfi e

b) If the ULTRASONIC DIAGNOS IC EQUIPMENT is not ca a le of ex e din a MECH NIC L IN EX

of 1,0 in an mode of o eration then no display of the MEC A IC L IN EX is req ired

NOT 2 ULTRA ONIC dia n stic EQUIPME T f or whic th p a -arefa tio al a o stic pre s re (p

r) is le s th n

1 MPa is n t c p ble of e c e in a MECH NICAL IN E of 1,0 if, f or al o eratio c n itio s, fawf > 1,0 MHz

Co s q e tly, th re uireme t lste in Cla s 2 1.12.4.2 b) is fulfi e

c) If the ULTRASONIC DIAGNOS IC EQUIPMENT is ca a le of ex e din either SOF TIS UE

THER AL INDEX, BONE THER AL INDEX of a value of 1,0 or, for ULTRASONIC DIAGNOS IC

EQUIPMENT inten ed f or tran cranial or ne natal ce hal c a pl cation , a CRA IAL THER AL

IN EX of 1,0, when an o erational mode is active, then the ca a i ty s al b avai a le

for the OPERATOR to display the SOF TIS UE THER AL IN EX (when ex e din a value of

0,4), the BONE THERMAL IN EX (when ex e din a value of 0,4) or a CRA IAL THER AL IN EX

(when ex e din a value of 0,4), but not neces ari y simultane u ly, in s c o erational

mode

d) If the ULTRASONIC DIAGNOS IC EQUIPMENT is inten ed solely for ad lt ce hal c a pl cation ,

then the THER AL IN EX display ne d only in lu e the CRA IAL-BONE THER AL IN EX when

eq al to or it ex e d a value of 0,4 an is ca a le of ex e din a value of 1,0

e) If the ULTRASONIC DIAGNOS IC EQUIPMENT is ca a le of ex e din a MEC A IC L IN EX of

1,0 in an mode of o eration, then the MECH NIC L IN EX s al b displayed when it eq als

or ex e d a value of 0,4 in s c an o erational mode

f) The ULTRASONIC DIAGNOS IC EQUIPMENT s al al ow the OPERATOR to display simultane u ly

b th a THERMAL IN EX (ac ordin to the req irements of a), c), an d) a ove) an the

MEC A IC L INDEX (ac ordin to the req irements of b) an e) a ove)

g) The in rements for the display of THERMAL IN ICE , if displayed (se a) – f) , s al b no

more than 0,2 over the entire ran e of display

h) The in rement f or the display of MEC A IC L INDEX, if displayed (se a) – f)] s al b no

more than 0,2 over the entire ran e of display

i) If an ULTRASONIC TRA SD CER inten ed for tran -o so hage l u e is ca a le of ex e din

a s race temp rature of 41 °C, then the s r ace temp rature s al b displayed or some

other in ication provided to the OPERATOR when the s rf ace temp rature eq als or

ex e d a value of 41 °C (se 2 1.1 1.3)

2 1.12.4.3 Ac ide tal s le tion of e c s ive output v lu s

Re la eme t:

a) For ULTRASONIC DIAGNOS IC EQUIPMENT in whic the desig al ows FUL SOF WARE CONTR L

OF A OUS IC OUTP T, the ULTRASONIC DIAGNOS IC EQUIPMENT s al switc to an a pro riate

DE A LT S T ING up n p wer up, entry of new P TIENT identification data or c an e fom a

non-o tal to a f oetal a pl cation These DE A LT S T ING levels s al b esta ls ed by

the MA UFA TURER but may b reconfig red by the OPERATOR

b) For MULTI-P RPOS ULTRASONIC DIAGNOS IC EQUIPMENT in whic the desig do s not al ow

FUL SOF WARE CONTR L OF A OUS IC OUTP T, the ULTRASONIC DIAGNOS IC EQUIPMENT s al

provide up n p wer up, entry of new P TIENT identification data or c an e f rom a non

-fo tal to a f oetal a pl cation, a remin er to the OPERATOR to c ec (an reset or c an e, if

a pro riate) the acou tic output an the MEC A IC L INDEX an /or THER AL IN EX

displayed

2 1.12.4.5.1 *Limits

Add ition:

+AMD1:2 15 CSV  IEC 2 15

Acou tic output s al b l mited b sed on RISK AS E SMENT an RISK MA AGEMENT folowin

ISO 14 71 u in the safety related p rameters sp cified in this stan ard an other relevant

information s c as clnical exp rien e

NOT F r g id n e o th rele a c of th s fety relate p rameters s e ifie in this sta d rd, s e An e C

201.13 Hazardous situations and f ault conditions

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

2 1.13.1.2 *Emis ions, d formation of ENCLOSURE or e c e ing ma imum temperature

Add ition at the e d of the t hird d ash:

As a exception, for TRA SD CER AS EMBLIE inten ed for external u e, the AP LIE D PART

temp rature ma ex ce d th value in 2 1.1 1.2.2 of t his stand ard b u to 5 °C during a

SIN GLE F AULT C N ITION, if a alarm or ind ic t ion is pro id ed to t he OPE RATOR, as d escribed in

12.3 of th g n ral stand ard , ind ic t in t hat a SIN GLE FAU LT C N DITION c using t he

temp rature rise h s o c red ;

NOT This e c ptio is v ld ONLY f or T AN D C R AS EM BLIE inte d d f or a plc tio to th s in s rf ac

201.14 PROGRAMMABL E ECTRICAL MEDICAL SYST MS (PEMS)

Clau e 14 of the general stan ard a ples

Clau e 16 of the general stan ard a ples

201.17 *Ele tromagnetic compatibi ity of ME EQUIPMENT and ME SYST MS

Clau e 17 of the general stan ard a ples ex e t as fol ows:

Add ition:

ULTRASONIC DIAGNOS IC EQUIPMENT s al comply with the req irements of IEC 6 6 1-1-2 as

modified in 2 2.6

202.6 EL CTROMAGNETIC COMPATIBILITY

Clau e 6 of IEC 6 6 1-1-2:2 0 a pl es, ex e t as fol ows:

2 2.6.1.1 Prote tion of ra io s rvic s

2 2.6.1.1.1 Re uireme ts

Re la eme t:

ULTRASONIC DIAGNOS IC EQUIPMENT s al b clas ified as Group 1 an clas A or clas B, in

– the disturb n e s al not prod ce noise on a waveform or artif acts or distortion in an

image or er or of a displayed n merical value whic may b atributed to a ph siological

eff ect an whic may alter the diag osis

– the disturb n e s al not produ e an er or in a display of in or ect n merical values

as ociated with the diag osis to b p rf ormed after 1

st

das

– the disturb n e s al not prod ce an er or in a displayed saf ety related in ication

– the disturb n e s al not prod ce u inten ed or ex es ive ultrasou d output

– the disturb n e s al not prod ce u inten ed or ex es ive TRA SD CER AS EMBLY s rf ace

c) *Ac ordin to the inten ed u e, the ULTRASONIC DIAGNOS IC EQUIPMENT s al b tested

u in a 2 Hz or 1 0 0 Hz mod lation feq en y (ph siological simulation f req en y),

whic ever re resents the worst case con ition The mod lation f eq en y ado ted s al

b dis losed in the test re ort

2 2.6.2.6 Conducte disturba c s, in uc d by RF f ields

2 2.6.2.6.2 Te ts

Re la eme t of item c)

C) PATIE NT-c u l ed c bles includ in the TRAN SD CE R AS E M BLY c ble sh l l b tested using a

c re t cl amp Al PATIE NT-c u led c bl es includ ing the TRAN SDU CE R AS E M BLY c ble ma

b tested simult an o sly using a singl e c re t cl amp

Th TRAN SD CER AS EM BLY of the U LTRASONIC DIAGN OS IC E QU IPM EN T sh ll b t erminated

during the test as sp cified b l ow In a c ses, n int ent io al de o pling devic sh l l be

used b twee t he inject ion p int a d th PATIEN T c u l i g p int

+AMD1:2 15 CSV  IEC 2 15

– For PATIEN T c u ling p ints th t h v c nd uct ive c ntact t o t he PATIEN T, terminal M of

th RC el eme t (se CISPR 16-1-2) sh l l b c n e ted d ire tly to the c ndu tiv

PATIEN T c n e tion, a d th ot her terminal of the RC eleme t sh ll b c n e ted t o

th gro nd refere c pla e If n rmal o eration of the U LTRASON IC DIAGN OS IC

E QU IPM EN T c n ot b v rified with terminal M of the artificial h nd c n e t ed t o the

c u li g p int, a PATIE N T simul at or ma b used b twe n terminal M of the art ificial

h nd a d t he PATIEN T c u l ing p int or p ints

– TRAN SDU CE AS E M BLY sh l l b terminat ed with th artificial h nd a d RC eleme t

sp cified in CISPR 16-1-2 Th metal fo of the art ificial h nd sh l l b sized a d

pla ed t o simulate the a prox imate are of PATIEN T a d OPE RATOR c u l ing in N ORM AL

U SE

– For U LTRASON IC DIAGNOS IC E QU IPM EN T that h v mult iple PATIEN T c u ling p ints

int end ed to b c n e t ed to a single PATIEN T, e c artificial h nd sh l l b tied to a

singl e c mmo c n e tion a d t his c mmo c n e tion sh ll b c n e t ed to termin l

M of the RC eleme t, as sp cified in CISPR 16-2

Re la eme t of it em f)

f) *Ac ord ing to the int ended use t he U LTRASON IC DIAGNOS IC EQU IPM E N T sh l l b tested

usin a 2 Hz or 1 0 0 H z mod ul ation fe u n y whic e er re rese ts the worst -c se

c nd ition The modulation fe u n y ad opted sh l l b d isclosed in the test re ort

2 2.6.2.7 Volta e dips, s ort inter uptions a d volta e v riations on power s pply

input l ne

2 2.6.2.7.1 Re uireme ts

Re la eme t of it em a)

a) ULTRASONIC DIAGNOS IC EQUIPMENT

s al comply with the req irements of 6.2.1.10 of

IEC 6 6 1-1-2 as modif ied by clau e 2 2.6.2.1.10 of this stan ard at the IMMU ITY T S

LEVELS sp cified in Ta le 10 of IEC 6 6 1-1-2 Deviation f rom the req irements of

6.2.1.10 of IEC 6 6 1-1-2 is alowed at the IMMUNITY T S LEVELS sp cified in Ta le 10 of

IEC 6 6 1-1-2, provided the

ULTRASONIC DIAGNOS IC EQUIPMENT

remain safe, exp rien es

no comp nent faiures an is restora le to the pre-test state with OPERATOR intervention

Determination of compl an e is b sed up n p rorman e of the ULTRASONIC DIAGNOS IC

EQUIPMENT d rin an af ter a pl cation of the test seq en e ULTRASONIC DIAGNOS IC

EQUIPMENT f or whic the RAT D input c r ent ex e d 16 A p r phase are exempt f rom the

testin sp cif ied in Ta le 10 of IEC 6 6 1-1-2

The an exes of the general stan ard a ply

A nnex AA

(inf ormativ )

Guidance and rationale f or particular subclauses

Conc rning 2 1.1.1 Scope

The content of this p rtic lar stan ard has largely b en determined to cover ultrasonic

medical diag ostic an monitorin eq ipment in lu in ultrasonic ec o ran in devices (b th

man al an automatic s an in ), Do pler ec o ULTRASONIC DIAGNOS IC EQUIPMENT an

combination there f

The s o e has b en ke t general to en omp s as mu h of the wide ran e of (non-

thera eutic) medical ULTRASONIC DIAGNOS IC EQUIPMENT as p s ible For example, some

ULTRASONIC DIAGNOS IC EQUIPMENT is ca able of b in u ed with n merou dif ferent typ s,

p wer ratin s an f req en ies of TRANSD CER AS EM BLIES to cover a wide variety of

a pl cation This has be n taken into ac ou t in draf tin this p rtic lar stan ard

It is anticip ted that later edition of this p rtic lar stan ard may wel sp cify dif ferent or

ad itional p rameters for sp cif i ation relative to saf ety, ref lectin the state of bio hy ical

u derstan in an me s rement tec nolog as wi develo in the f uture

Conc rning 2 1.7.2.13 Phy iologic l ef fe ts (s f ety signs a d warning stateme ts)

The tran e so hage l IN ASIVE TRA SD CER AS EMBLY is con idered a u iq e case req irin

sp cial con ideration d e to its ad itional u e in len th monitorin a plcation

Conc rning 2 1.7.2.101 Acoustic output

With certain ULTRASONIC DIAGNOS IC EQUIPMENT in some o eratin modes, ten or more

dif ferent controls can aff ect ultrasoun output levels Whi e smal c an es in output level are

not of con ern to the OPERATOR, inad ertent large in re ses are to b avoided in many cases,

as with MULTI-P RPOS ULTRASONIC DIAGNOS IC EQUIPMENT (Se 2 1.12.4.3 of this stan ard.)

On most ULTRASONIC DIAGNOS IC EQUIPMENT, there is general y provided a sin le control

me n f or c an in the ampl tu e of the acou tic output, whi e le vin other p rameters

(s c as pulse len th, d ty c cle, etc.) u c an ed Of ten, the OPERATOR mu t have some

u derstan in of the o eration of this control for ef fective u e of the device, aside fom

con ern with saf ety This req irement ad res es the ne d to ef fectively in icate to the

OPERATOR the control (or controls) whose primary f un tion is to af fect ultrasou d output

levels, an the action ne ded to in re se or decre se output by manipulatin this direct

control me n

An exemption for ULTRASONIC DIAGNOS IC EQUIPMENT not ca a le of generatin output levels

prod cin u ac e ta le ris at any p s ible output level has b en implemented in 2 1.12.4.2

Con erning 2 1.7.9.2

2 Warning a d s fety notic s

Writen in tru tion , as wel as pre-programmed a pl cation-sp cific default levels, are

a pro riate me n for inf ormin the OPERATO of a pro riate ultrasou d output levels for

dif ferent cl nical u es

+AMD1:2 15 CSV  IEC 2 15

Conc rning 2 1.7.9.3.101 Te hnic l data re arding a oustic output le els

Ma imum Inde Valu

For the THER AL IN EX: f ol owin 5.6.2 of IEC 6 3 9:2 10, in lu in Ta le 1:

For TIS an TIB, the Maximum In ex Value is the larger of the s m of the ‘at s rf ace’ In ex

Comp nent Values an the s m of the ‘b low-s race’ In ex Comp nent Values;

For TI C, the Maximum In ex Value is the s m of the ‘at-s r ace’ non-s an ed an s an ed

TI C In ex Comp nent Values

For MI, fol owin 5.6.3 of IEC 6 3 9:2 10, the Maximum In ex Value is the largest

MECH NIC L IN EX of al active TRA SMIT P T ERNS i.e the Maximum In ex Value is the

largest of the MI In ex Comp nent Values of the active DISCRE E-OPERATING MODE in a

COMBINED-OPERATING MODE

Conc rning 2 1.10.101 Ultra onic e ergy

This p rtic lar stan ard places the resp n ibi ty for esta l s in up er l mits of al owed levels

of acou tic output on the MA UFA TURER b sed on ris analy is

Con ern with p s ible ex es ive levels are ad res ed by req irin an interactive re l-time

display of acou tic output s c as the THER AL INDICE an MEC A IC L IN EX as in lu ed in

this stan ard

Con erning 2 1.1 1.2.2 AP LIED PA RT not inte de to s p ly h at to the PATIENT

Diag ostic TRA SD CER AS EMBLIE are not inten ed to s p ly he t but do so b cau e of

energ los within the TRA SD CER AS EMBLY an ultrasou d a sorption in the P TIENT

NOT Ge eral g id n e for th a o stic pro ertie of a pro riate tis u is a aia le inth lterature[2 ]

When car yin out a ris analy is for the ULTRASOU D DIAGNOS IC EQUIPMENT, the u er of this

stan ard mu t take into ac ou t that the temp rature l mit of 4 °C in the general stan ard is

only a pl ca le for lon -term (more than 10 min) contact with he lth s in of ad lts Sp cial

con ideration s ould b taken f or an a pl cation on c i dren The influen e of dru s an the

con ition of the p tient are factors that s ould b also con idered in the ris -b nefit analy is

With resp ct to further not f orese a le develo ments, the saf ety of a lon -term u e of

tran d cers (more than 41 °C) in ide the b d is c r ently not wel in estigated It is as umed

that the saf e u e of temp ratures hig er than 41 °C on c i dren, in ide the b d an on

p tients with p s ible ris y con ition s ould also b b sed on cl nical exp rien e

The al owa le maximum temp rature of 4 °C f or p rts havin contact with the P TIENT

for more than 10 min is con istent with the general stan ard This re resents a safety factor

of 2 relative to the thres old for thermal y in u ed c ronic damage to the kid ey, one of the

most sen itive mammal an tis ues [3 ]

Net tis ue temp rature rise res lts f om the fol owin mec anisms:

– he t con u tion f rom the tran d cer;

– a sorption of ultrasou d in the tis ue;

– co l n by he t con u tion to other p rts of the tis ue;

– co l n by he t tran p rt d e to blo d p rf usion

Al TRA SD CER AS EMBLIE req ire test con ition an criteria a pro riate to the u iq e

clnical s an in en ironment en ou tered by the device

As ultrasoun diag ostic devices general y are u ed in temp rature control ed location , the

ambient temp rature of 2 °C ± 3 °C has b en c osen for the en ironment d rin the

me s rement of tran d cer s r ace temp rature

In NOR AL US , a tran -o so hage l or other IN ASIVE TRA SD CER AS EMBLY o erates

s r ou ded by tis ue, s c that the ambient temp rature is the p tient’s internal b dy

temp rature Unlke the con ition en ou tered when o eratin the TRA SD CER AS EMBLY in

sti air, b th ultrasou d energ an he t f rom the TRA SDU ER AS EMBLY are ef ficiently

tran f er ed into the adjoinin tis ue Both the he t directly con u ted f rom the TRA SD CER

AS EMBLY, as wel as the he t res ltin f rom ultrasou d a sorption within the tis ue, are

car ied of by tran p rt ef fects s c as blo d p rf usion, con u tion an radiation

In NOR AL US , typical y han -held pro es do not o erate whi e s r ou ded by tis ue; the

b d of the pro e as embly is in contact with ambient air temp rature, whi e only the smal

p rtion of the pro e inten ed to contact the p tient wi b exp sed to an ambient temp rature

determined by p tient’s core b d temp rature

Con erning 2 1.1 1.3 Me s reme ts

In the sti -air test of 1 1.3 of the general stan ard, es ential y al of the electrical energy

would b con erted into he t within a TRA SDU ER AS EMBLY, sin e ultrasou d radiation into

air (u l ke that into the b d ) is hig ly ineff i ient Due to the u e of coupln gel an the

u ual y low he t cap city of the ULTRASONIC TRA SD CER s rf ace layer, it can b exp cted

that, fom the f re -air situation into the normal u e situation, the s rf ace temp rature would

dro q ic ly The modification of 2 1.1 1.3 to al ow for a 5 °C l mit in the sti -air test is

a pro riate to en ure that in normal u e con ition the temp rature can dro to 4 °C within 1

min (Se 1 1.1, Ta le 2 of the general stan ard.)

This is also true f or IN ASIVE TRA SDU ER AS EMBLIE inten ed f or tran -o so hage l u e

Althou h contact with the internal s r ace of the o so hag s is prolon ed, the time in whic

the initial tran d cer temp rature is in contact with a single tis ue site is relatively s ort

Furthermore, the tran d cer are that is he ted is relatively smal , providin l tle he t

ca acity, an the res ltin he t is ra idly drawn away f rom the tran d cer as it p s es

throu h the mouth an into the o so hag s As a res lt, no tis ue en ou ters a temp rature

in ex es of the ste d -state temp rature for cl nical s an in for other than a brief moment

In the case of fo tal en ovaginal u e, whi e exp s re time play an imp rtant role [16]

b cau e of intervenin tis ue an fluid stru tures an the same tran ient contact dis u sed

f or tran -o so hage l a pl cation , the s rf ace temp rature of an en ovaginal tran d cer

do s not tran late directly to the temp rature ultimately af fectin the fo tu

Tis ue-mimic in material (TMM) with thermal an acou tical pro erties simi ar to h man

tis ue most a pro riate to the typical u e of the ULTRASONIC TRA SDU ER u der test s ould b

u ed The TMM is inten ed b th to in ibit co l n by con ection an to model the acou tic

pro erties of a sp cific tis ue The u e of thre diff erent typ s of models can b ju tif ied:

– a model with a b ne mimic close to the s rf ace;

– a model with a s in mimic at the s rf ace;

– a model con istin of a soft tis ue mimic

The test o ject s ould b desig ed s c that in re sin the size wi have a negl gible eff ect

on the s rf ace temp rature of the TRA SDU ER AS EMBLY

When the TRA SD CER AS EMBLY is inten ed f or intra-cavity u e, the TRA SD CER AS EMBLY

s ould b p t ed in a tis ue-mimic in material (TMM) to a de th s c that in re sin the

de th wi have a negl gible eff ect on the s r ace temp rature of the TRA SDU ER AS EMBLY

+AMD1:2 15 CSV  IEC 2 15

When the s r ace of the ULTRASONIC TRA SD CER is c rved, care s ould b taken to en ure

that the whole s rf ace is in contact with the model u ed to mimic the inten ed u e

Alternative materials may b u ed where the res lts can b s own to b comp ra le; most

sig ificantly, however, the material u ed s al ex ibit an ultrasonic a sorption co f ficient an

thermal pro erties a pro riate to the inten ed model

Conc rning 2 1.1 1.3.1.2 Sti l air

For some TRA SD CER AS EMBLIE s c as mec anical y roc ed 3D pro es, or sol d state

pro es with integrated multiplexin electronic , the temp rature of the A PLIED P RT (s r ace

temp ratures) may not sta i ze at an initial ste d -state temp rature eq al to the air ambient

temp rature when the acou tic p wer is ‘off ’ (i.e non-energized tran d cer elements)

Rather, a fixed off set temp rature may exist

In s c cases, the initial A PLIED P RT temp rature s al b the ambient temp rature plu a

ste d -state off set temp rature, an the f i al s rf ace temp rature s al b con idered as the

s m of the me s red A PLIED P RT temp rature rise o tained d rin the 3 min test plu the

of fset temp rature plu 2 °C

Conc rning 2 1.1 6.5 Ingre s of water a d partic late mat er into ME EQUIPMENT a d ME

SYS EMS

Al

TRA SDU ER AS EMBLIE

are as umed to req ire some contact with fluid d rin normal

o eration Some TRA SD CER AS EMBLIE are desig ed to b immersed in water b th

wherein the water b th provides a ln in the acou tic coupl n p th to the P TIENT whie other

TRA SD CER AS EMBLIE , employed for contact s an in , ne d only minimal contact with

some coupl n gel at the

TRA SDU ER AS EMBL

Y’

Sactive s race The

R is

exp cted to sp cify, throu h k owled e of the a plcation an TRA SD CER AS EMBLY desig ,

the p rts of the TRA SDU ER AS EMBLY that may b wet ed in NORMAL US , se 2 1.7.9.2.2

The req irement an test as sp cified are con idered s ita le for this ULTRASONIC DIAGNOS IC

EQUIPMENT an avoid con ict with the WAT RTIGHT req irements of the general stan ard The

tests sp cified are doc mented in IEC 6 5 9 The IPX1 code in icates protection of

eq ipment again t the in res of water with harmful eff ects by drip in ; the IPX7 code

in icates protection of eq ipment again t in res of water with harmf ul eff ects by temp rary

immersion

Con erning 2 1.12.4.5.1 Limits

Whi e this p rtic lar stan ard places no upp r l mits on p rmit ed levels of acou tic output, al

EQUIPMENT is l mited f or tec nical re son , compl an e with local reg latory req irements, or

re son res ltin f rom the MA UFA TURER’S RISK MA AGEMENT On the one han the

MA UFA TURERS s ould contin ou ly trac the s ientific dis u sion on saf ety of ultrasonic

field for diag ostic ultrasou d, on the other han the

OPERATORS

s ould k ow a out the –

p s ibly a pl cation-de en ent – l mits of their EQUIPMENT as selected by the MA UFA TURER

Compl an e with 2 1.12.4.5.1 may b c ec ed by in p ction of the relevant doc mentation of

the res lts of the RISK MA AGEMENT proces provided by the MA UFA TURER, in lu in

relevant information s c as clnical exp rien e

Conc rning 2 1.17 Ele troma netic compatibi ty of ME EQUIPMENT a d ME SYS EMS

ULTRASONIC DIAGNOS IC EQUIPMENT is categorised as clas A (u der 6 6 1-1-2) when the

en ironment f or the inten ed u e as defined by the MA UFA TURER is in a hospital or a simi ar

en ironment For the exten ion of the inten ed u e into a residential en ironment the

ULTRASONIC DIAGNOS IC EQUIPMENT has to b categorised as clas B For f urther detai s se

An ex BB

ULTRASONIC DIAGNOS IC EQUIPMENT, whic is the s bject of this p rtic lar stan ard, is

clas ified in Group 1 (u der 6 6 1-1-2), sin e the device mu t intentional y generate radio

f eq en y energ an tran mit it throu h a s ielded external ca le (up to 2 m or lon er in

len th) to a

TRA SD CER AS EM

BLY at the en of the ca le

For IN ASIVE TRA SDU ER AS EMBLIE , radiated an con u ted emis ion p r IEC 6 6 1-1-2

s ould b p r ormed b th with an without the tran d cer active to en ure compl an e when

the tran d cer is outside the b d an not activated, an secon ly, when the tran d cer is

in ide the b d an activated The con ition “in ide the b d an activated” s ould b

simulated u in a phantom havin the same aten ation as h man tis ue in the f req en y

p s b n of the tran d cer The phantom s ould only b u ed whi e makin radiated an /or

con u ted emis ion me s rements in the f eq en y p s b n of the tran d cer u les the

phantoms f req en y c aracteristic are k own over the entire feq en y ran e of 15 kHz to

1 0 0 MHz

Con erning 2 2.6.2.1.6 Variable gain

ULTRASONIC DIAGNOS IC EQUIPMENT that in orp rates a varia le gain s al b tested at the

typical u er gain This s ould b determined u in a tis ue mimic in an /or f low phantom

a pro riate f or the a pl cation to adju t the gain an other image en an ement adju tments

to re resent typical u er set in s The phantom s al b removed prior to

IMMU I

TY testin in

ac ordan e with 101.6.2 of IEC 6 6 1-1-2

If this req irement can b met with the normal software of the ULTRASONIC DIAGNOS IC

EQUIPMENT, the test s al b p rormed u in the normal software If this req irement can ot

b met u in the normal sof tware of the ULTRASONIC DIAGNOS IC EQUIPMENT, a method s al b

provided to implement this o erational mode The u e of sp cial software may b req ired If

sp cial sof tware is u ed, it s al not in ibit c an es in gain that may oc ur as a res lt of

testin

Conc rning 2 2.6.2.1.10 Compl a c criteria

There is common agre ment that it is not p s ible to req ire that nothin ha p n when an

electromag etic disturb n e is a pl ed to an ULTRASOU D DIAGNOS IC EQUIPMENT whic is

inten ed to ac uire sig als in the µV ran e by me n of a tran d cer whose ca le len th is

more than 2 m

The sen e of the req irement is that u der the test con ition sp cified in 6.2 of IEC 6 6 1-1

-2, the ULTRASONIC DIAGNOS IC EQUIPMENT s al b a le to provide the E S NTIAL PERFOR A CE

an remain safe

Examples of conf orman e to the compl an e criteria:

– ULTRASONIC DIAGNOS IC EQUIPMENT display an image that may have regular dots or

das es or l nes prod ced by the disturb n e, but in a way that is recog isa le as other

than ph siologic an that would not aff ect diag osis;

– ULTRASONIC DIAGNOS IC EQUIPMENT display an image that may have l nes on a Do pler

trace, but in a way that is recog isa le as other than ph siologic an that would not aff ect

diag osis;