Iec ts 62791 2015

4 Fig re F.2 – Plot of the data with blue data computed in the left rectan le in Fig re F.1 an red data computed in the rig t rectan le.. 4 Fig re F.3 – Plot of the data when the reflect

IEC TS 62791

Editio 1.0 2 15-0

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IEC TS 62791

Edit io 1.0 2 15-0

6.2.1 Phantoms for u e in the f eq en y ran e 2 MHz to 7 MHz 14

6.2.2 Phantoms for u e in the f eq en y ran e 7 MHz to 15 MHz in lu in

"micro-con ex" ar ay 1

4

6.2.3 Total internal- eflection s races 15

6.2.4 Sp tial y ran om distribution of low-ec o spheres 15

6.3 Ultrasonic pro erties of the tis ue-mimic in (TM) phantoms 15

7 Data ac uisition as umin a sp tial y ran om distribution of low-ec o spheres 16

7.1 Methodolog 16

7.2 Storage of digitized image data 17

7.3 Digital image f iles avai a le fom the s an er itself 18

8.3.1 Prelminaries 21

8.3.2 Computation of the L NR

n-values an L NR

m-value in a given de th

interval 21

n-value 21

An ex A (informative) Example of a phantom f or p r orman e testin in the 2 MHz to

7 MHz f eq en y ran e 2

An ex B (informative) Il u tration of the computation of LS NR

m-values as a fu ction

C.3 Phantom with 2 mm-diameter, low-ec o spheres an 8 spheres p r mi i tre 3

An ex D (inf ormative) Example of a phantom for p r orman e testin in the 7 MHz to

15 MHz f eq en y ran e 3

An ex E (informative) Determination of low-ec o sphere p sition to within D/8 in x, y

an z Cartesian co rdinates 3

E.1 Proced re 3

An ex F (informative) Test of total internal reflection prod ced by alumina an pl

ate-glas , plane reflectors 41

An ex G (inf ormative) Res lts of a test of re rod cibi ty of L NR

mvers s de th f or a

phantom with 4 mm-diameter low-ec o spheres an 2 spheres p r mi i tre 4

An ex H (inf ormative) Res lts for low-ec o sphere-con entration de en en e of

LS NR

mvers s de th f or phantoms with 4 mm-diameter spheres 5

An ex I (informative) Res lts for low-ec o sphere-con entration de en en e of

LS NR

m

vers s de th for phantoms with 3,2 mm-diameter spheres 5

An ex J (inf ormative) Comp rison of two dif ferent makes of s an er with simiar

tran d cers an con ole set in s 5

An ex K (informative) Sp cial con ideration for 3-D pro es 5

K.1 3-D pro es o eratin in 2-D imagin mode 5

K.2 2-D ar ay o eratin in 3-D imagin mode for determinin L NR

m-values as

a fu ction of de th for recon tru ted images 5

K.3 Mec anical y driven 3-D pro es o eratin in 3-D imagin mode 5

Biblogra h 6

Fig re 1 – Flow c art 17

Fig re 2 – Sc ematic of an image plane 2

Fig re A.1 – En view of the phantom a pl ca le f or 2 MHz to 7 MHz s owin the

sp tial y ran om distribution of 4-mm diameter low-ec o spheres 2

Fig re A.2 – To view of phantom with 4 mm-diameter, low-ec o spheres 2

Fig re B.1 – Con ex-ar ay image of a prototyp 4 mm-diameter low-ec o sphere

phantom for u e in the 2 MHz to 7 MHz f req en y ran e 2

Fig re B.2 – Au i ary fig res relatin to Fig re B.1 2

Fig re B.3 – Res lts cor esp n in to Fig res B.1 an B.2, demon tratin

re rod cibi ty 2

Fig re B.4 – Res lts cor esp n in to Fig res B.1, B.2 an B.3 2

Fig re B.5 – One of 8 p ral el l near ar ay images of the phantom containin 4 mm

-diameter, low-ec o spheres, at 4 MHz with foc s at 3 cm 2

Fig re B.6 – Thre s c es ive images of the set of 8 , se arated by D/4 eq al to

1 mm 2

Fig re B.7 – Res lts f or the 4 cm-wide, 3 cm-f oc s, l ne r ar ay ad res ed in Fig res

B.5 an B.6 2

Fig re B.8 – Res lts f or the 4 cm-wide, 3 cm-f oc s, l ne r ar ay ad res ed in

Fig res B.5, B.6 an B.7, u in al 8 image f rames cor esp n in to Fig re B.7 2

Fig re C.1 – One image o tained f om a phantom containin 3,2 mm-diameter, l

ow-ec o spheres by u in a 4 MHz l ne r ar ay f oc sed at 3 cm 2

Fig re C.2 – Re rod cibi ty res lt for two in e en ent sets of 7 images with a me n

n mb r of low-ec o sphere centres that is a out 15 p r 5 mm-de th interval 3

Fig re C.3 – Res lts o tained by u in b th sets of 7 in e en ent images

cor esp n in to Fig re C.2 3

Fig re C.4 – Sector image (c rved ar ay) at 4,5 MHz with multiple foci at 4 cm, 8 cm

an 12 cm de th ; the low-ec o spheres are 3,2 mm in diameter 31

Fig re C.5 – Re rod cibi ty res lts f or a multiple-lateral-f oc s (4 cm, 8 cm and 12 cm)

case cor esp n in to Fig re C.4 31

Fig re C.6 – Re rod cibi ty res lts f or the case cor esp n in to Fig re C.5, ex e t

that there is a sin le f oc s at 10 cm de th 3

Fig re C.7 – Re rod cibi ty res lts f or the case cor esp n in to Fig re C.5, ex e t

Fig re C.8 – Image of the phantom containin 2 mm-diameter, low-ec o spheres,

made with a c rved ar ay havin 1,5 cm radiu of c rvature, with its f oc s at 3 cm 3

Fig re C.9 – Re rod cibi ty res lts cor esp n in to Fig re C.8 3

Fig re C.10 – Res lts u in al 10 images in the image set that gave rise to

Fig re C.9 3

Fig re C.1 – Image of the phantom containin 2 mm-diameter, low-ec o spheres,

made with a hig -f req en y (15 MHz) l ne r ar ay, lateral y foc sed at 4 cm 3

Fig re C.12 – Re rod cibi ty res lts cor esp n in to Fig re C.1 3

Fig re C.13 – Res lts u in al 2 0 images in the image set that gave rise to Fig re

C.12 3

Fig re D.1 – En - an to -view diagrams of the phantom containin 2 mm-diameter,

low-ec o spheres for u e in the 7 MHz to 15 MHz f req en y ran e 3

Fig re D.2 – Image o tained by u in the phantom containin 2 mm-diameter, lo

w-ec o spheres an a p diatric tran d cer with a radiu of c rvature of a out 1,5 cm 3

Fig re F.1 – Average of 10 images o tained by u in a phased ar ay 4

Fig re F.2 – Plot of the data with blue data computed in the left rectan le in Fig re F.1

an red data computed in the rig t rectan le 4

Fig re F.3 – Plot of the data when the reflector is on the rig t side with blue computed

in the left rectan le an red computed in the rig t rectan le 4

Fig re F.4 – The p rcentage by whic the me n pixel values res ltin f om reflection

diff er fom the me n pixel values not in olvin ref lection 4

Fig re F.5 – Wide sector (15 °), 1 cm- adiu -of c rvature tran d cer with alumina

ref lector on the lef t 4

Fig re F.6 – Plot of the data with blue computed in the left rectan le in Fig re F.5 an

red computed in the rig t rectan le 4

Fig re F.7 – Plot of the data when the reflector is on the rig t side with blue computed

in the left rectan le an red computed in the rig t rectan le 4

Fig re F.8 – The p rcentage by whic the me n pixel values res ltin f om reflection

diff er fom the me n pixel values not in olvin reflection 4

Fig re G.1 – Example image of the phantom with a 4,2 MHz c rved ar ay an two l

ow-ec o spheres p r mi i tre 4

Fig re G.2 – Re rod cibi ty res lts cor esp n in to the image set, one of whic is

s own in Fig re G.1 4

Fig re H.1 – Example of an image fom the image set givin rise to the res lts in

Fig re H.2; the phantom contained an average of one 4 mm-diameter, low-ec o sphere

p r mi i tre 5

Fig re H.2 – Res lts cor esp n in to an image set, one of whic is s own in Fig re

H.1 51

Fig re H.3 – Example of an image fom the data set givin rise to the res lts in Fig re

H.4; the phantom contained an average of two 4 mm-diameter, low-ec o spheres p r

Fig re I 5 – Example of an image fom the 1 ml data set prod cin the res lts s own

in Fig re I 6 5

Fig re I 6 – Res lts f or the phantom containin one 3,2 mm-diameter, low-ec o sphere

p r mi i tre 5

Fig re J.1 – Res lts for Sy tem A s an er an 7CF2 3-D (swe t con ex ar ay)

tran d cer foc sed at 4 cm an o erated at 4,5 MHz in 2-D mode 5

Fig re J.2 – Res lts for Sy tem B s an er with a 4DC7-3 3-D (con ex ar ay)

tran d cer, o erated at 4 MHz in 2-D mode an foc sed at 4 cm The sector an le an

al other con ole set in s mimic ed those for the Sy tem A case (Fig re J.1) 5

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Tec nical Sp cification IEC TS 6 7 1 has b en pre ared by IEC tec nical commite 8

Ultrasonic

The text of this Tec nical Sp cification is b sed on the f ol owin doc ments:

Ful inf ormation on the votin for the a proval of this Tec nical Sp cif i ation can b f ou d in

the re ort on votin in icated in the a ove ta le

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Terms in bold in the text are defined in Clau e 3

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IMPORTANT – The 'colour inside' logo on the cov r pa e of this publ c tion in ic te

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

understa ding of its conte ts Us rs s ould theref ore print this doc me t using a

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A bi n ual version of this publ cation may b is ued at a later date

Ultrasonic pulse-ec o s an ers are widely u ed in medical practice to prod ce images of sof t

tis ue organ throu hout the h man b d Most ultrasonic pulse-ec o s an ers prod ce re l

-time images of tis ue in a s an plane by swe pin a nar ow, pulsed b am of ultrasou d

throu h the tis ue section of interest an detectin the ec o s generated by ref lection at

tis ue b u daries an by s at erin within tis ues General y, the swe p that generates an

image f rame is re e ted at le st 2 times p r secon , givin rise to the re l-time asp ct of

the displayed image The axes of the pulsed b ams general y l e in a plane that defines the

s an plane

Variou tran d cer typ s are employed to o erate in a tran mit receive mode to

generate/detect the ultrasonic sig als Line r ar ay , in whic the b am axes are al p ral el

to one another, res ltin in a rectan ular image, con ist of a l ne of h n red of p ralel

tran d cer elements with a s bset of adjacent elements prod cin one pulse at a time

Con ex ar ay are simiar to l ne r ar ay but the element ar an ements def i e p rt of the

s rf ace of a s ort rig t circ lar c l n er with the ar ay elements p ral el to the axis of the

c l n er The radiu of c rvature of the c l n er (an theref ore the ar ay) can have values

b twe n 0,5 cm an 7 cm The con ex ar ay generates a sector image sin e the b am axes

f an out over the s an plane A phased ar ay has a lne r ar an ement of elements, where al

elements act together to form a pulse an the direction an foc s of an emit ed pulse is

determined by the timin of ex itation of the elements The phased ar ay generates a sector

image Another typ of sector s an er is the mec anical sector s an er in whic a sin le

element tran d cer or an an ular ar ay tran d cer is rotated a out a f i ed axis d rin pulse

emis ion Al the foregoin tran d cer typ s commonly o erate within the feq en y range

2 MHz to 15 MHz, to whic this Tec nical Sp cification a pl es

A 2-dimen ional ar ay (2-D ar ay) is restricted to an ar ay of tran d cer elements distributed

over a s uare are or a spherical ca Su h an ar ay receives ec o s f rom a 3-D volume an

can prod ce images cor esp n in to an planar s rf ace in that volume A 3-D mec anical y

driven, con ex ar ay (3-D MD con ex ar ay) me n a con ex ar ay that ac uires images as it

is rotated mec anical y a out an axis lyin in its image plane or an exten ion of that plane

A 3-D mec anical y driven, l ne r ar ay (3-D MD l ne r ar ay) is simi ar to a 3-D MD con ex

ar ay, where the ar ay radiu of c rvature is infinite an the ar ay is either rotated a out an

axis or is tran lated p rp n ic larly to the s an plane of the l ne r ar ay For an overview of

c r ent 3-D an 4-D s stems, se section 1.5 an 10.2.2 of [1]

1

One me n for testin the imagin p rorman e of an ultrasou d pulse-ec o s an er is to

q antify the degre to whic a smal c st-l ke (low-ec o) o ject is distin uis ed f rom the

s r ou din sof t tis ue, i.e the degre to whic a smal c st-lke (low-ec o) o ject is

detecta le in the s r ou din sof t tis ue It is re sona le to as ume that the smal er the l

ow-e ho sphere that can b detected at some p sition, the b ter the resolution of the s an er,

i.e the b ter it wi del ne te the b u dary of an a normal o ject, s c as a tumour There

are thre comp nents of resolution defined in pulse-ec o ultrasou d:

– axial resolution (p ral el to the local pulse pro agation direction);

– lateral resolution (p rp n ic lar to the local pulse pro agation direction an p ral el to the

s an plane); an

– elevational resolution (p rp n ic lar to the local pulse pro agation direction an also to

the s an plane)

Axial resolution u ual y – but not alway – is b t er than lateral an elevational resolution

Th s, al thre comp nents s ould b given eq al weig t in me s rin dete tabi ity A

sphere has no pref er ed orientation an is therefore the b st s a e f or a c st-l ke o ject for

two re son First, al thre comp nents of resolution are weig ted eq al y no mater what the

b am’s in ident direction is Secon , the in ident b am’s pro agation direction wi vary

con idera ly in the case of con ex an phased ar ay de en in on where the o ject exists

in the imaged volume

It is imp rtant that the phantom al ows q antification of d te tabi ity to b car ied out over

the entire de th ran e imaged; th s, it is imp rtant that the low-ec o spheres exist up to the

entire s an in win ow A phantom lmited to a f lat s an in s rf ace is ac e ta le for a l ne r

ar ay, phased ar ay, or a f lat 2-D ar ay, but not for the remainin typ s of ar ay Eac of the

phantoms des rib d in this Tec nical Sp cification contain a ran om distribution of eq al

diameter [2] low-ec o spheres existin at al de th , in lu in the case of those desig ed for

testin con ex (c rved) ar ay

This Tec nical Sp cification s mmarizes the req irements f or a phantom to provide for

determination of dete tabi ity of low-ec o (c st-l ke) o jects f or any typ of pulse-ec o

tran d cer, ex e t (p rha s) a 2-D ar ay with a spherical-ca s rf ace

The International Electrotec nical Commis ion (IEC) draws at ention to the fact that it is

claimed that compl an e with this doc ment may in olve the u e of US Patents 5,5 4,212 an

8,8 7,5 2, con ernin an “Automated Sy tem an Method for Testin Resolution of

Ultrasou d Scan ers” an an “Ultrasou d Phantom Havin a Curved Surf ace”, resp ctively,

given in 8.2 an 8.3, an An exes A an D

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Wis on in Alumni Rese rc Fou dation,

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This Tec nical Sp cification def i es terms an sp cifies method for q antifyin the imagin

p rorman e of re l-time, ultrasou d B-mode s an ers The typ s of tran d cers u ed (se

section 7.6 an 10.7 of [1]) with these s an ers in lu e

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

are in isp n a le f or its a pl cation For dated ref eren es, only the edition cited a ples For

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

amen ments) a pl es

IEC 6 0 0-8 2, Intern tion l Ele trotec nic l Vo a ulary – U l traso ics (av aia le at :

ht t p:// ww w elect ro edia.org)

IEC 613 1-1, Ultraso ics – P ulse-e h sc n ers – Part 1: Te h iqu s for c libratin sp tial

me sureme t syst ems a d me sureme t ofsystem p int-spre d fu ct ion resp nse

IEC 613 1-2:2 10, Ultraso ics – Pulse-e h sc n ers – Part 2: Measureme t of ma imum

de th of p n trat io a d loc l dynamic ra g

3 Terms and def initions

For the purp ses of this doc ment, the terms an def i ition given in IEC 6 0 0-8 2,

IEC 613 1-1 an the fol owin a ply

3.1

a tiv are of a tra s uc r

are over whic tran d cer tran mit in an /or receivin elements are distributed

3.2

ba k c t er coef ficie t

intrinsic ba k c t er coef f icie t

BS C

intrin ic prop rty of a material at some f eq en y, eq al to the dif ferential s at erin cros

-section p r u it volume for a s aterin an le of 18 °

Note 1 to e try: Se [4], [5], [6]

[SOURCE: IEC 613 1-1:2 0 , 3.6, modified]

3.3

low-e ho sphere

spherical in lu ion in a phantom with ba k c t er coef f icie t mu h lower than that of the

b c grou d tis ue-mimic in material

Note 1 to e try: Al low-e h s h re in a p a tom h v th s mediameter with a tolera c of ±1 %

3.4

low-e ho sphere diameter

D

diameter of the low-ec o spherical in lu ion in a phantom

Note 1 to e try: It is g n raly a s me th t al low-e h sp ere in a p rtic lar p a tom h v th s me

diameter D.Th diameter tolera c is ±1 %

3.5

pix l

smal est sp tial u it or cel size of a digitized 2-dimen ional ar ay re resentation of an image

Note 1 to e try: Ea h pixel h s a a dre s c re p n in to its p sitio in th ara

Note 2 to e try: Pixel is a c ntra tio of ‘picture eleme t’

[SOURCE: IEC 613 1-1:2 0 , 3.2 , modified]

3.6

pix l v lu

integer value of a proces ed sig al level or integer values of proces ed colour levels,

provided to the display for a given pix l

Note 1 to e try: In a gra -s ale dis la th pix l v lu is c n erte to a lumin n e b s me, u u ly mo oto ic,

f un tio Th s t of inte er v lu s re re e tin th gra s ale ru s f rom 0 (bla k) to 2

me n of pix l value detected over an are A in a phantom image, where A is somewhat

smal er than the are of a circle of diameter D

Note 1 to e try: Th p ra e “s mewh t le s th n” is intro u e a p rtial c mp n atio f or th p rtial v lume

eff ect inth ele atio al dime sio [3]

Note 2 to e try: Th p rtial v lume ef fe t is a term c mmo in CT a d MR ima in , n mely if a o je t is smaler

th n th slc thic n s , th n th sig al wi in lu e th c ntrib tio of th t o je t a d th material aro n it For

e ample, if th o je t is a s h re, th n c ntrib tio to th sig al wi o c r fom material s ro n in th s h re

Note 1 to e try: Ex erie c d terminin LSNR -v lu s for n mero s c s s h s le to th c n lu io th t a 5 mm-

depth interval is a e u te for th p a toms c ntainin 3,2 mm-diameter a d 4 mm-diameter, low-e h s h re ,

a d a 2 mm-depth interval is a e u te f or th p a toms c ntainin 2 mm-diameter, low-e h s h re

Note 2 to e try: Th ma imum d pth (d pth of f i ld) is th s m of a s t of c ntig o s depth intervals; th s, if th

d pth of ield is 14 cm a d e c d pth interv l s a s 5 mm = 0,5 cm, th n th re are 14 cm/0,5 cm = 2 depth

intervals

Note 3 to e try: A re ta g lar s a are wi b s b ivid d into h riz ntal b n s; a s ctor s a are wi b

s b ivid d into a n lar rin s gme ts, th a g lar lmits b in d termin d b th s ctor a gle [s e Fig re B.2 d)]

Re ti n ar proje tio of th s are s gme ts in th ele atio al dire tio wi cre te v lume s gme ts a alo o s to

sla s a d p rtial c ln ric l s els with thic n s e u l to th depth interval, re p ctiv ly

Note 4 to e try: Depth interval is e pre s d in mi imetre (mm)

n merical value q antifyin the dete tabi ity of a macros o icaly u if orm, low-ec o sphere

in a macros o ical y u iform, s r ou din -b c grou d material an havin its centre in a

volume segment determined by a given depth interv l in the phantom

Note 1 to e try: L w-e h s h re with c ntre lo ate le s th n a dista c , 2D, fom a lateral ima e b u d ry

are e clu e

3.12

me n le ion sig al- o-nois ratio

me n value of le ion sig al- o-nois ratios for low-e ho sph re whose centres l e in a

volume segment determined by a given depth interv l in the phantom

Note 1 to e try: L w-e h s h re with c ntre lo ate le s th n a dista c , 2D, fom a lateral ima e b u d ry

elevational direction of the c bic ar ay, resp ctively

8.2

CMn) onto the image plane ne rest to z

CM

8.2

N total n mb r of detected low-ec o spheres with centres in the

volume segment determined by a de th interval (in lu in

al image f rames)

8.3.2

arbitrari y c osen 1 ml volume

CMn) onto the image plane ne rest to z

stan ard deviation of al MPVs with centres lyin within

volume segment, d, u in the entire image set

E.1

x

CMn, y

CMn, z

CMn

co rdinates of the centre of mas of the nth low-ec o sphere E.1

x

n, y

n

projection onto the ne rest image plane of the x- an y-

co rdinates of the centre of mas of the nth low-ec o sphere

(x

CMn, y

CMn)

NOT Ad itio al s mb ls u e o ly in relatio to Fig re F.4 are d f i e in th te t b low th t f i ure

5 General a d environmental conditions

The man facturer’s sp cif i ation s ould al ow comp rison with the res lts o tained fom the

tests des rib d in this Tec nical Sp cification

Al me s rements s ould b p r ormed within the f ol owin ambient con ition :

– temp rature, 2 °C ± 3 °C;

– relative h midity, 10 % to 9 %;

– atmospheric pres ure, 6 kPa to 10 kPa

Pro erties of ultrasou d phantoms, s c as sp ed of sou d an aten ation co ff i ient, can

vary with temp rature Con ult the sp cification publs ed by the phantom man facturer to

determine whether the exp cted acou tic pro erties are maintained u der the a ove

en ironmental con ition If not, the en ironmental con ition over whic exp cted an

re rod cible res lts can b o tained f rom the phantom or test o ject s ould b ado ted for

tests des rib d b low

6 Equipment re uired

The test proced res des rib d in this Tec nical Sp cif i ation s ould b car ied out u in

tis ue-mimic in phantoms with digitize ima e data ac uired fom the ultrasou d s an er

6.2 Pha tom geometrie

6.2.1 Pha toms f or u e in the fre ue c ra ge 2 MHz to 7 MHz

The phantom s ould al ow imagin to a de th of at le st 16 cm an provide f or display of the

entire B-s an image f ame L w-ec o spheres s ould b avai a le for dete tabi ity

as es ment over the entire image f ame an the diameter of these spheres s ould b

sp cified by the man f acturer within ±1 % The me n n mb r of spheres p r u it volume

s ould b at le st 1 p r mi i tre, but the volume f action con istin of spheres s ould not

ex e d 3,3 % Scan in win ows s ould provide f or contact of the entire emit in s r ace of

the tran d cer (a tiv are of a tra s u er), whi e al owin elevational tran lation of the

tran d cer over a s f ficient distan e that the most l kely n mb r of spheres traversed by the

s an plane at or ne r the focal distan e(s) is 2 or more in a 5-mm d pth interv l

A low-e ho sphere diameter b twe n 3 mm an 4 mm is recommen ed for adeq ate

The phantom s ould al ow imagin to a de th of at le st 10 cm an provide f or display of the

entire B-s an image f rame L w-ec o spheres s ould b avai a le f or dete tabi ity

as es ment over the entire image f rame an the diameter of these spheres s ould b

sp cified by the man f acturer within ±1 % The me n n mb r of spheres p r u it volume

s ould b at le st 8 p r mi i tre, but the volume f raction con istin of s c spheres s ould

not ex e d 3,3 % Scan in win ows s ould provide f or contact of the entire emit in s rf ace

of the tran d cer whi e al owin elevational tran lation of the tran d cer over a s ff i ient

distan e that the most l kely n mb r of spheres traversed by the s an plane at or ne r the

f ocal distan e(s) is 2 or more in a 2 mm-depth interv l A low-e ho sphere diameter

b twe n 1 mm an 2 mm is recommen ed for adeq ate p rorman e as es ment in the

7 MHz to 15 MHz ran e

NOT On low-e h s h re c n s rv a two s c s h re if total intern l re e tio at a pla ar s ra e pro id s

a in e e d nt ima e Se Fig re D.1 for a e ample of g ometry

6.2.3 Total internal-ref le tion s rfa e

For phantoms with low-ec o spheres havin diameters of 3 mm to 4 mm, two p ral el, pl

ate-glas s races cau in total internal ref lection are ac e ta le in the phantom, as s own in

Fig res A.1 an A.2 For phantoms with low-ec o spheres havin diameters of 1 mm to 2 mm,

two p ralel, planar, alumina s r aces cau in total internal reflection are ac e ta le in the

phantom, as s own in Fig re D.1; a s rf ace rou h es of the alumina of 6 µm or les is

s ff i ient

6.2.4 Spatial y ra dom distribution of low-e ho sphere

Thou h the p sitioning of low-ec o spheres in the phantom may b precisely defined,

man f acturin costs wi l kely b mu h lower if the spheres are sp tial y ran omly distributed

The sp tial y ran om distribution of low-ec o spheres in a phantom is closely a proximated

by the Pois on pro a i ty distribution fu ction,

( )

!uve

uP

uv

−

=

(1)

where

v is the me n n mb r of low-ec o sphere centres p r mi i tre

For example, if v = 1 an P(u) is the pro a i ty of there b in u low-ec o sphere centres in an

arbitrari y c osen 1 ml volume, the stan ard deviation is σ = v

1/2

= 1

6.3 Ultra onic propertie of the tis ue-mimic ing (TM) pha toms

For an phantom, the fol owin ultrasonic pro erty ran es are sp cif ied to a ply at 2 °C

NOT Pro erty v lu s a d tolera c s s e ifie h re are g n raly simiar, b t n t id ntic l to th s s e ifie in

the low-ec o sphere material, no higher than − 0 dB relative to the b c grou d material

L n -term sta i ty: With ap ro riate atention, a phantom s ould maintain its original values

of ba k c t er coef ficie t within ± dB, aten ation co ff i ient feq en y within ± %,

pro agation sp ed ±1 % an den ity ± % f or at le st 5 ye rs For water b sed tis u

e-mimic in materials this req irement can b as ured via p riodic monitorin of the phantom

weig t as sp cified by the man facturer When the weig t has decre sed by a sp cified

amou t, the phantom can b returned to the man f acturer for tran fu ion with s ff i ient

aq e u solution to return the phantom to its weig t (an pres ma ly ultrasonic pro erties) at

the time of man facture

7 Data acquisition as uming a spatial y random distribution of low-e ho

spheres

7.1 Methodology

The b sic u it for data ac uisition f or tran d cer typ s a) throu h d) of Clau e 1 is a digitized

gray-s ale image in lu in the entire selected field of view Typical y, at le st 8 bits

(2 6 levels) of distin t gray levels are re l zed F r tran d cer typ s e) an f) of Clau e 1,

NOT 1 It is c stomary th t s ftware a d h rdware wi b ma e a aia le th t simplfy a q isitio , re ordin a d

lo g-term stora e of th s d ta

Fig re 1 s ows a flow c art of the methodolog

The me s rement protocol in olves ac uirin images whie the tran d cer u der test is

tran lated in the elevational direction over a section of the sp cified phantom For those

s stems in whic the b am axes cor esp n in to the image f rame le in a plane (definin the

"s an plane"), the tran d cer s ould b held in contact with a section of the s an in win ow

(with adeq ate coupl n gel) by an a p ratu whic also al ows tran lation in the elevational

direction, there y alowin ac uisition of image f rames with s an planes p ral el to one

another [7]

NOT 2 Eith r th tra s u er or th p a tom c n b tra slate

The maximum tran lational in rement b twe n ac uired f rames is a f un tion of the low-ec o

sphere diameter an al ows the plane of s mmetry (s an plane) of at le st one f ame to l e

within 1/8 of the sphere diameter f rom the centre of a detected sphere; i.e the maximum

in rement s ould b eq al to 1/4 of the sphere diameter

NOT 3 If a altern tiv meth d for d termin tio of low-e h s h re c ntre were s own in a p er re iewe

p blc tio to b at le st a a c rate a th meth d in Cla s 7 a d An e E, a d altern tiv s f tware were als

ma e a aia le f or c mp tin LS NR -v lu s a a f un tio of d pth, whic a re with v lu s o tain d in refere c

[7], th n emplo me t of s c a altern tiv meth d wo ld n t b in c n ict with this Te h ic l Sp cif i atio

Figure 1 – Flow c art

7.2 Stora e of digitize imag data

Image data in a DICOM (Digital Imagin an Commu ication in Medicine [8]) format are

avai a le on most s an ers Software ca a le of tran f er in an o enin DICOM- ormat ed

4 Determinin c ordin te of c ntre of al d te ta le

low-e h s h re in v lume s gme ts d termin d

b depth intervals – 8.3.1

5 Determinin me n a d sta d rd d viatio s of

b c gro n sig al le els in v lume s gme ts

d termin d b depth intervals – 8.3.1

6 Comp tatio of me n pix l v lu s (MPV

n) after re-

c nterin s u re are s A at c ntre of low-e h

s h re proje te o n are t ima e pla e – 8.2

7 Comp tatio of th LSNR

n-v lu s in a giv n

depth interval – 8.3.2

8 Comp tatin th LS NR

m-v lu s in a giv n

depth interval – 8.3.1

9 Plotin of LSNR

m-v lu s a d n mb rs of

low-e h s h re a fu ctio s of

d pthin th p a tom – An e B

10 Interpretatio of plots of LSNR

m-v lu s a d

n mb rs of low-e h s h re a

f un tio s of d pth – An e J

images is avai a le When bitma images are avai a le f rom the s an er, those also can b

u ed Factors des rib d in 6.4 of IEC 613 1-2:2 10 a ply

7.3 Digital ima e fi e a ai able f rom the s a ner its lf

This method is u ed by most s an er man f acturers for in-hou e q al ty-control testin an

image-proces in develo ment Ca a i ties exist to exten the method for u e by clnical

p rson el u in , f or example, fi e-tran fer protocol (ftp) resources Alternatively, man

s an ers provide image fi es on remova le media, s c as USB th mb drives, mag

eto-o tical dis s, zip dis s, or CD-ROM, an these are a pro riate sources of digital image data

as wel Ful -s re n ca ture is avai a le on man s stems

7.4 Ima e arc iving s stems

Man imagin centres u e commercial y avai a le Picture Arc ivin an Commu ication

Sy tems (PACS) f or viewin an storin ultrasou d image data Man f acturers of PACS

s stems u ual y provide me n to ac uire images in an u compres ed format, s c as a 'tiff '

(Tag ed Image Fi e Format or a DICOM (Digital Imagin and Commu ication in Medicine [8])

f ormat, by work tation that have ac es rig ts to the image data

8 Automated data analysis f or quantifying low-e ho sphere dete tabi ity

Usin the image data o tained as des rib d in Clau e 7 an as umin neglgible gradients in

b c grou d MPVs, the h man-o server related dete tabi ity eq als the me n le ion sig al

-to-nois ratio (L NR

m) in e c one of contig ou volume segments determined by the d pth

intervals sp n in the entire de th ran e avai a le [3] [7]

Recal f rom Clau e 3.1 that the le ion signal- o-nois ratio for the nth low-e ho sphere

(LS NR

n) is a n merical value q antifyin the dete tabi ty of a macros o ical y u iform, low-

ec o sphere in a macros o ical y u iform, s r ou din -b c grou d material, with its centre

lyin in a volume segment determined by a given depth interv l L w-ec o spheres an

b c grou d material have intrinsic ba k c t er coef ficie ts, namely, BS C

o j

b g,

resp ctively For a spherical in lu ion, LS NR

n

has b en def i ed an dis u sed exten ively [9]

NOT Th "o je t c ntra t" in d cib ls e u ls 10 lo

10 [B C

o j/BS C

bk], a d this v lu is − 0 dB or lower f or th

low-e h s h re in c mp ris n to b c gro n material in th s e ific tio s a o e Su s ripts L (L sio ”) a d B

(Be d ”) are s e ial c s s of s b cripts “o j” a d “b g”, re p ctiv ly

8.2 Computation of me n pix l v lue (MP Vs)

MPV, as def i ed in 3.8, is the me n of pixel values detected over an are A in a phantom

image, where A is somewhat smal er than the are of a circle of diameter D; this def i ition

al ows f or p rtial comp n ation f or the p rtial volume eff ect in the elevational dimen ion [3]

In this Tec nical Sp cif i ation A is a s uare with side 2D/3 [3] For e c image o tained

ac ordin to 7.1, a set of MPVs is computed over are s A, ste p d in a raster p tern in the

image plane, with centres comprisin a simple, s uare ar ay an ne rest neig b ur sp cin

of D/4 Th s, for al images o tained by tran latin the tran d cer u der test in the elevational

direction in s c es ive ste s of D/4, e c MPV in a set is as ociated with one of the sites in a

simple c bic ar ay

Define (MPV)

ik

to b the MPV at the ik-site, where i, j an k are integers an (D/4) is the

x-co rdinate value, (D/4) is the y-co rdinate value, an (D/4)k is the z-co rdinate value of the

site Also, i an j cor esp n to rows an column , an k to the elevational direction,

resp ctively, of the c bic ar ay

Next, the co rdinates (x

CM, y

CMn, z

CMn) of the centres of low-ec o spheres s ould b

determined (se first p ragra h in 8.3.1 an E.1) Then, for e c n, the me n pix l value in

the image plane ne rest to the nth low-e ho sph re centres for the site havin x- an

y-co rdinates eq al to those of the centre (x

CMn

CMn) is computed, givin rise to a new set

of MPV-values (MPV

n, also desig ated as the sig al S

L); in general, these x

MPV

n, the only sig ificant pix ls l e within the in er circle s own in Fig re 2; therefore the

cros -hatc in , whic otherwise denotes an ex lu ion zone, do s not a ply to computation

of MPV

n Se also Formula (2) regardin the role of S

L

Fig re 2 is a s hematic of an image plane s owin the sp cial case of an in-plane, low-ec o

sphere centre (), con entric circles of radi defined in 8.3, an examples of ste pin s uare

are s A, del ne ted for computin me n pix l v lue (MPV)

ik

that are as ig ed to the ar ay

sites (■) centred in e c s uare

In Fig re 2 MPVs at image-plane sites in the central cros -hatc ed are

are ex lu ed fom calc lation of the b c grou d me n an stan ard

deviation , whi e MPVs at image-plane sites in the diagonal y hatc ed

an ulu are in lu ed, u les they are within a sphere of radiu 3D/4

con entric with a diff erent low-ec o sphere centre (e.g at lower rig t or

are within l mits (das ed l nes) adjacent to a l ne r ar ay or sector s an

image b u dary (vertical or o l q e, ful l nes, resp ctively) – 8.3.1

Key

 (MPV)-ara site (i,j,k ) in th ima e pla e with grid-s a in D/4 – Cla s 7

 nth low-e h sp ere c ntre, whic is als in th ima e pla e in this s e ial c s :

(x = x

CMn,y = y

CMn, z = z

CMn

; in g n ral (x ≠ x

CMn,y ≠ y

CMn,z ≠z

CMn

Th in er circle is a low-e h sp ere b u d ry (p y ic l), h vin (s e ial-c s ) ra iu D/2 at its inters ctio with

th ima e pla e; in g n ral th inters ctio ra iu is ≤D/2 – s e 3.4

Th mid le circle (math matic l) in th ima e pla e h s (s e ial-c s ) ra iu 3D/4; in g n ral th inters ctio

v lu s th t are a sig e to th ar a site (■) at th c ntre of th s s u re – s e 8.2; wh n

circle inters ct s c s u re , s ftware ma e c oic s to in lu e or e clu e s me pix ls (cro s-h tc in in ic te

a e clu io z n ) – s e 8.3

Th d s e -ln s u re (to ) d n te th pre io s, ste p d are A in th ima e pla e for c mp tin (MPV)

ijk–

h tc in are not a plc ble) – s e 8.3.2

Th circ lar cro s-h tc e are (lower rig t) h s ra iu ≤ D/4 a d d n te th inters cte are of th ima e pla e

with th “mid le circle (math matic l)” s ro n in a oth r, o t-of -pla e, low-e h s h re, h vin its c ntre at z ≠

z

CMn

– s e 8.3.1

1 Vertic l ful ln a d p ralel d s e ln d n te th lateral b u d ry of a ln arara ima e a d th b u d ry

of th e clu io z n of bre dth D/3 id ntif i d b cro s s (X)

2 Oblq e, ful ln a d p ralel d s e ln d n te th lateral b u d ry of a s ctors a ima e a d th b u d ry

of th e clu io z n of bre dth 2

1/2

D/3 id ntif i d b cro s s (X); th c o e bre dth of th e clu io z n is

d p n e t o th s ctor a gle a d th s e if i bre dth for a 9 ° s ctor is s own

Als X d n te a s u re ara site t hat d e n t h ve a a s ciat ed (MPV) a d th refore d e n t c ntrib te t o c lc latio s

IEC 1

2

1/2

D/3

8.3 Determination of the LSNR

m-v lu for a giv n depth interv l

8.3.1 Prel minarie

Firstly, the Cartesian co rdinates of the centres of al detecta le low-ec o spheres in the

volume segment determined by the depth interv l s ould b determined A pref er ed method

f or ac ompls in this is des rib d in Clau e 7 an An ex E, an this is also the method u ed

in determinin L NR

m-values as a f un tion of de th in other an exes

Secon ly, al MPVs that mig t b sig ificantly influen ed by the presen e of a neig b urin

low-ec o sphere s ould b el minated for c mp t ation of b ck gro nd me ns a d standard

deviat ions in s bclau e 8.3.2; that is, for this computation, do not u e an MPV

ik

at c bic

ar ay sites that l e within a radiu eq al to 3D/4 of a y low-ec o sphere centre, the

co rdinates of whic were determined ac ordin to the last p ragra h a ove

8.3.2 Computation of th LSNR

n

m-value in a giv n d pth interv l

The LS NR

nfor the nth low-ec o sphere is def i ed by

n

nn

n

SS

L NR

B

mBL

image plane closest to z

CMn

S

mBn

is the me n of al MPVs in the sp cified image plane whose centres are within the

an ulu defined by radi eq al to 3D/4 an 2D an centred at the co rdinates of S

The L NR

m-value f or the volume segment determined by the depth interv l is then

∑

=

=N

1

(3)

where

N is the total n mb r of detected low-ec o spheres with centres in the volume segment

determined by the de th interval (in lu in al image f rames) but ex lu in those lyin

within 2D of a phantom b u dary (se 3.1 )

8.3.3 Sta dard er or cor e pondin to e c LS NR

n-v lue

The stan ard er or cor esp n in to e c L NR

n-value is given by N

−1/2

times the stan ard

deviation of the L NR

n-values cor esp ndin to the depth interv l in olved

Annex A

(inf or mative)

Example of a phantom f or perf ormance testing

in the 2 MHz to 7 MHz frequency range

Fig res A.1 an A.2 b low i u trate a phantom containin low-ec o spheres that me ts the

sp cification in this Tec nical Sp cif i ation Fig re B.1 s ows an image of a prototyp

phantom havin ne rly the same dimen ion as are de icted in Fig res A.1 an A.2 A flat

alumina ref lector exists in place of one of the plate glas ref lectors The alumina reflector has

4 6 cm ×1 cm flat s a nin win ow

5 plate-gla s refle tor

6 1 cm thic a rylc plate

a d o e 4 mm diameter, a e h ic s h re p r mi i tre

Figure A.1 – End view of the pha tom ap l c ble f or 2 MHz to 7 MHz s owing the

In Fig re A.1 the en s of a conical s an in win ow are de icted at the to of the phantom

The f lat, s an in win ow ac ommodates lne r ar ay , phased ar ay an flat 2-D ar ay [2]

The p ralel plate-glas rectan les provide − via total internal ref lection − for exten ion of the

image outside of the volume oc upied by tis ue-mimic in material

Key

1 a e h ic s h re

2 6 cm × 1 cm flat s a nin win ow

3 1 cm thic a rylc plate

4 plate-gla s refle tor

a d o e 4 mm diameter, a e h ic s h re p r mi i tre

Figure A.2 – Top view of pha tom with 4 mm-diameter, low-e ho sphere

Annex B

(inf or mative)

I lustrations of the computation of LSNR

m-values

as a function of depth

Fig re B.1 – Conv x-ar a ima e of a prototype 4 mm-diameter

low-e ho sphere pha tom f or us in the 2 MHz to 7 MHz fre ue c ra ge

In Fig re B.1 one of the plane reflectors (on the left is alumina in te d of plate glas an a

vertical l ne of elevated ec o s oc urs at the sl g tly rou h s race of that alumina plate A

p ralel, 3 mm-thic , plate-glas reflector exists 10 cm to the rig t of the alumina plate The

maximum width of the sector image is 18,6 cm Rigorou testin f or the eff ectivenes of either

plate glas or alumina plates, regardin total internal ref lection an the ef fect of s rf ace

diff use s at erin , is presented in An ex F

Fig res B.2 throu h B.8 s ow au i ary images, an res lts of analy is, as des rib d in more

detai in the f i ure an s b-f i ure ca tion

IE C

a) Cro ped image f romFig re B.1 with the vertic l

lne of low-level, diff us e h e at the f lat, alumina

plate’s surf ac remo ed

b) Map in of MP Vs in gray-s ale

c) Sets of 7 site identif ied with a low-e h sp ere

c ntre in Fig re B.1

d) 5mm-depth intervals distin uished with

dif f erent gray levels

Figure B.2 – Auxi iary figure relating to Figure B.1

a) Me n L NR (LS NR

m)-value a a f unctio of

depth a determined with two in epen ent s ts of

2 image core p n in to Fig re B.1 an B.2

b) Number of low-e h sp ere c ntre dete ted

in e ch 5 mm-depth interval

In th n tatio a o te in 8.3.2, re d LS NR f or Me n LSNR at th ordin te la el of th left gra h

Figure B.3 – Re ults cor e pon ing to Figure B.1 a d B.2,

demon tratin reproducibi ity

In Fig re B.4 a) al 5 images are u ed in one set; s c u e is recommen ed Fig re B.4 b)

s ows that the n mb r of low-ec o spheres in the 5 mm-de th intervals in the focal ran e is

a out 2

a) Me n L NR (LS NR

m)-value a a f unctio of

depth usin al 5 image core p n in to th s

Figure B.5 – One of 8 paral el l ne r-ar a ima e of th pha tom

containing 4 mm-diameter, low-e ho sphere , at 4 MHz with f oc s at 3 cm

In Fig re B.6 the gre n x's identify the determined centres of the low-ec o spheres identif ied

with the resp ctive images Where there is no x, the low-ec o sphere centre was identified

with a ne rby image

In Fig re B.7 the image set 1 to 4 is in e en ent of the image set 41 to 8 The agre ment

f or the two sets of data plot ed in p nel a) is re sona le but s ould b b ter Panel b) s ows

the me n n mb r of low-e ho sphere in a de th interval is a out 7

Figure B.6 – Thre s cc s iv ima e of the s t of 8 , s parate by D/4 e ual to 1 mm

a) Me n L NR (L NR

m)-value a

In Fig re B.8 a) the c rve-it is mu h b t er for the doubl n of the n mb r of low-e ho

sphere p r centimetre de th interval Doubl n the n mb r of detected low-e ho sphere in

the 3 cm-f ocal zone would b t er define the minimum (most negative) value of the L NR

m, but

the lmited are of the win ow in this phantom preclu ed o tainin more than 8 images

a) Me n L NR (L NR

m)-value

in e en ent (non-overla pin ) parts of the phantom is as es ed.

C.2 Phantom with low-e ho sphere diameter 3,2 mm, having 2 spheres per

mi l l tre

The f irst example is f or a l ne r ar ay o eratin at 4 MHz with a f oc s at 3 cm The elevational

interval b twe n images is D/4 = 3,2 mm/4 = 0,8 mm An image is s own in Fig re C.1

Res lts for two cases in whic there is no overla b twe n imaged volumes are s own in

Fig re C.2 Both sets contain 7 images cor esp n in to a net elevational displacement of

7 × 0,8 mm = 5,6 cm Here the me n n mb r of low-ec o sphere centres p r 5 mm-depth

interval is a out 15, in te d of 2 , but re rod cibi ty is sti go d Fig re C.3 s ows the res lt

when the entire 14 images are u ed an the average n mb r of low-ec o sphere centres p r

volume segment determined by the depth interv l is a out 3 ; the c rve fit is ex el ent

in icatin ex el ent re rod cibi ty The net elevational displacement is 140 × 0,8 mm =

1 ,2 cm

Figure C.1 – On ima e obtaine from a pha tom containing 3,2 mm-diameter,

low-e ho sphere by using a 4 MHz l ne r ar a f oc s d at 3 cm

IE C

a) Me n L NR (LS NR

m)-value a

a f unctio of depth

b) Number of low-e h sp ere c ntre dete ted

in e ch 5mm-depth interval

In th n tatio a o te in 8.3.2, re d LSNR f or Me n LSNR at th ordin te la el of th left gra h

Fig re C.2 – Reproducibi ity re ult for two indepe de t s ts of 7 ima e with a me n

number of low-e ho sphere c ntre that is about 15 per 5 mm-depth interv l

In Fig re C.3 b) the n mb r low-ec o spheres p r 5 mm-de th interval at the f ocal de th is

a out 2 , cor esp n in to the recommen ed n mb r in 6.2.1, an the c rve-f it in a) is go d,

as exp cted

a) Me n L NR (LS NR

m)-value a

a f unctio of depth

b) Number of low-e h sp ere c ntre dete ted

in e ch 5mm-depth interval

In th n tatio a o te in 8.3.2, re d LSNR f or Me n LSNR at th ordin te la el of th left gra h

Figure C.3 – Re ults obtaine by using b th s ts of 7 indepe de t

ima e cor e pon ing to Figure C.2

The next re rod cibi ty stu y in olves a con ex ar ay o eratin at 4,5 MHz an i u trates the

a i ty to diff erentiate p rf orman e for diff erent f oc sin c oices Figure C.4 s ows an image

with multiple foci at 4 cm, 8 cm an 12 cm; Fig re C.5 s ows the cor esp n in

re rod cibi ty res lts Fig re C.6 s ows re rod cibi ty res lts cor esp n in to a sin le,