Iec 60601 2 45 2015

In this Redl ne versio , a vertical l ne in the margin shows where the tec nical c ntent is modif ied by amendment 1... – Test sp cific tions: it al ic typ... Add itions: a HIG -V LTAGE

Edition 3.1 2 15-0

Medic l ele t rical e uipme t –

Part 2- 45: Part icular requirement s for t he ba ic safety and ess nt ial performanc

of mammographic X- ray e uipme t and mammographic st ereotact ic devices

Co yr ig t © 2 15 IEC, Geneva, Switz r lan

Al rig ts r eser ve Unles oth rwise sp cifie , n p rt of this p blc tio ma b r epro u e or uti ze in a y form

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

CH-121 Ge e a 2 info@ie c

Ab ut t he IEC

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

Internatio al Sta d r ds for al ele tri al ele tr onic a d relate te h olo ies

About IEC publc tion

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Th st an -alo e a plc t io for c nsult in t he e tire

biblo ra hic l informat io o IEC Intern tio al Sta d rds,

Te h ic l Sp cific tio s, Te h ic l R ep rts a d oth r

d c me ts A v aia le for PC, Ma OS, A ndroid Ta let s a d

iPa

IEC publc t ion s arc - www ie c / se rc pub

Th a v an e se rc e a les t o fin IEC p blc t io s b a

variety of crit eria (refere c n mb r, t ext, t ec nic l

c m itt e,…) It also gives informatio o projec t s, re la e

Ele t ro e ia - www ele t ro e ia.org

Th world's le din o ln dic t io ary of elec t ro ic a d

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a ditio al la g a es Also k nown as t he Int ern t io al

Elec t rot ec nic l Vo a ulary (IEV ) o ln

IEC Glos ar y - st d.e c / glos ary

More t ha 6 0 0 ele t rot ec nic l termin lo y e t ries in

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

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

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

7 , 8 a d CIS R

IEC Cu t omer Servic Ce t re - webst ore.ec c / cs

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

n e furt her as ista c , ple se c nta t t he Customer Serv ic

Ce t re:csc@ie c

Edit ion 3.1 2 15-0

Me ical elect ric l equipment –

Part 2- 45: Part ic lar re uireme t s for t he basic safety a d es e t ial performanc

of mammographic X - ra equipment and mammographic st ereotact ic device

Edition 3.1 2 15-0

Medic l ele t rical e uipme t –

Part 2- 45: Part icular requirement s for t he ba ic safety and ess nt ial performanc

of mammographic X- ray e uipme t and mammographic st ereotact ic devices

INTRODUCTION to Ame dme t 1 6

2 1.1 Sc p , o je t a d relate sta d rd 7

2 1.2 Normativ refere c s 9

2 1.3 Terms a d d finitio s 10 2 1.4 Ge eral re uireme ts 1

2 1.5 Ge eral re uireme ts f or te tin of ME EQUIPME T 12 2 1.6 Cla sific tio of ME EQUIPME T a d ME SYS EMS 13 2 1.7 ME EQUIPME T id ntif i atio , markin a d d c me ts 13 2 1.8 Prote tio a ain t ele tric l HAZA DS from ME EQUIPME T 17 2 1.9 Prote tio a ain t MECHANIC L HAZA DS of ME EQUIPME T a d ME SYS EMS 19 2 1.10 Prote tio a ain t u wa te a d e c s iv ra iatio HAZA DS 2

2 1.1 Prote tio a ain t e c s iv temp rature a d oth r HAZA DS 2

2 1.12 Ac ura y of c ntrols a d in trume ts a d prote tio a ain t h z rd u o tp ts 2

2 1.13 Ha ard u situ tio s a d f ault c n itio s for ME EQUIPME T 2

2 1.14 PR GR MMABLE ELECTRIC L MEDIC L SYS EMS (P MS) 2

2 1.15 Co stru tio of ME EQUIPME T 2

2 1.16 ME SYS EMS 2

2 1.17 Ele troma n tic c mp tibi ty of ME EQUIPME T a d ME SYS EMS 2

2 2 Ele troma n tic c mp tibi ty – Re uireme ts a d te ts 2

2 3 Ra iatio prote tio in dia n stic X-ra e uipme t 2

An e AA (informativ ) Partic lar g id n e a d ratio ale 4

Bibl o ra h 4

In e of d f i e terms u e in this p rtic lar sta d rd 5

Ta le 2 1.101 – Distrib te E S N IAL P RFO MANCE re uireme ts 1

Ta le 2 3.101 – Minimum v lu s of TOTAL FILTR TION a d f actors for d terminin th minimum AIR KERMA R T 3

Part 2-45: Particular requirements f or the basic saf ety and essential

perf ormance of mammographic X-ray equipment

and mammographic stereotactic devices

FOREWORD

1) Th Intern tio al Ele trote h ic l Commis io (IEC) is a worldwid org nizatio for sta d rdizatio 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 estio s c n ernin sta d rdizatio in th ele tric l a d ele tro ic fields To

this e d a d in a ditio to oth r a tivities, IEC p blsh s Intern tio al Sta d rds, Te h ic l Sp cif ic tio s,

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

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

in th su je 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 nizatio s laisin with th IEC also p rticip te in this pre aratio IEC c la orates closely

with th Intern tio al Org nizatio f or Sta d rdizatio (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 nizatio s

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

c nse sus of o inio o th rele a t su je ts sin e e c te h ic l c mmite h s re rese tatio f rom al

intereste IEC Natio al Commite s

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

Commite s in th t se se Whie al re so a le eff orts are ma e to e sure 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 resp nsible for th wa in whic th y are use or f or a y

misinterpretatio b a y e d user

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

tra sp re 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 resp n in n tio al or re io al p blc tio sh l b cle rly in ic te in

th later

5) IEC itself d es n t pro id a y atestatio of c nformity In e e d nt c rtif ic tio b dies pro id c nformity

as es me t servic s a d, in some are s, a c s to IEC marks of c nformity IEC is n t resp nsible for a y

servic sc rie o t b in e e d nt c rtif ic tio b dies

6) Al users sh uld e sure th t th y h v th latest e itio of this p blc tio

7) No la i ty sh l ata h to IEC or its dire tors, emplo e s, serv 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 rso al injury, pro erty d ma e or

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

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

Pu lc tio s

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

in isp nsa le for th c re t a plc tio of this p blc tio

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

p te t rig ts IEC sh l n t b h ld resp nsible f or id ntifyin a y or al su h p te t rig ts

DISCLAIMER

This Co sol dated versio is n t an of f icial IEC Standard an ha be n prepared f or

us r c nvenience Only the c r ent versio s of the stan ard an its amen ment(s)

are to be c nsidered the of f icial d c ments

T is Co sol dated version of IEC 6 6 1-2-4 be rs the editio n mber 3.1 It c nsists of

the third editio (2 1 -0 ) [do uments 6 B/817/FDIS and 6 B/8 1/RVD] an its

amen ment 1 (2 15-0 ) [do uments 6 B/917/CDV an 6 B/95 /RVC] T e tec nical

c ntent is identical to the ba e editio an its amen ment

In this Redl ne versio , a vertical l ne in the margin shows where the tec nical c ntent

is modif ied by amendment 1 Ad itio s an deletio s are displayed in red, with

deletio s being struc thro g A s parate Final versio with al c ange ac epted is

avai able in this p bl catio

+AMD1:2 15 CSV  IEC 2 15

Intern tio al sta d rd IEC 6 6 1-2-4 h s b e pre are b s b ommite 6 B: Dia n stic

ima in e uipme t, of IEC te h ic l c mmite 6 : Ele tric l e uipme t in me ic l pra tic

This third e itio c n els a d re la e th s c n e itio p bl s e in 2 01 This e itio

rd

e itio of

IEC 6 6 1-1 (2 0 ) a d to IEC 6 6 1-1-3 (2 10 2 0 ) Furth r mo if i atio s h v b e

ma e with re p ct to th c r e t te h olo y of MAMMOG AP IC X-R Y EQUIPME T

This p bl c tio h s b e draf te in a c rd n e with th ISO/IEC Dire tiv s, Part 2

In this sta d rd, th folowin print ty e are u e :

– Re uireme ts a d d finitio s: roma ty e

– Test sp cific tions: it al ic typ

– Inf ormativ material a p arin o tsid of ta les, su h as n tes, e amples a d ref ere c s: in smaler ty e

Normativ te t of ta les isalso in a smaler ty e

– TERMS DEFIN D IN CLAU E 3 OF T E GE ER L S AND R , IN T IS PA TICULA S AND R O AS

NOT D: SMAL C PITALS

In refer in to th stru ture of this sta d rd, th term

– “cla s ” me n o e of th s v nte n n mb re divisio s within th ta le of c nte ts,

in lu iv of al s b ivisio s (e.g Cla s 7 in lu e s b la s s 7.1, 7.2, etc.);

– “s b la s ” me n a n mb re s b ivisio of a cla s (e.g 7.1, 7.2 a d 7.2.1 are al

s b la s s of Cla s 7)

Ref ere c s to cla s s within this sta d rd are pre e e b th term “cla s ” fol owe b th

cla s n mb r Refere c s to s b la s s within this p rtic lar sta d rd are b n mb r o ly

In this sta d rd, th c nju ctiv “or” is u e a a “in lu iv or” , s a stateme t is tru if a y

c mbin tio of th c n itio s is tru

Th v rb l forms u e in this sta d rd c nform to u a e d s rib d in An e H of th ISO/IEC

Dire tiv s, Part 2 For th p rp s s of this sta d rd, th a xi ary v rb:

– “s al ” me n th t c mpl a c with a re uireme t or a te t is ma d tory f or c mpla c

An a teris (*) a th first c ara ter of a title or at th b gin in of a p ra ra h or ta le title

in ic te th t th re is g id n e or ratio ale relate to th t item in An e AA

A lst of al p rts of th IEC 6 6 1 s rie , p bls e u d r th g n ral title: Medic l electric l

e uipme t , c n b fo n o th IEC we site

NOT Th ate tio of Natio al Commite s is drawn to th fa t th t e uipme t MA UFA TURERS a d testin

org nizatio s ma n e a tra sitio al p rio folowin p blc tio of a n w, ame d d or re ise IEC p blc tio in

whic to ma e pro u ts in a c rd n e with th n w re uireme ts a d to e uip th mselv s for c n u tin n w or

re ise tests It is th re omme d tio of th c mmite th t th c nte t of this p blc tio b a o te f or

impleme tatio n tio aly n t e rler th n 3 y ars f rom th d te of p blc tio

IMPORTANT – T e 'c lo r inside' log o the c ver page of this p bl catio in icate

that it c ntains c lours whic are c nsidered to be us f ul f or the c r ect

u derstan in of its c ntents Us rs sh uld theref ore print this d c ment usin a

c lo r printer

+AMD1:2 15 CSV  IEC 2 15

Th third e itio of this p rtic lar sta d rd h s b e pre are to pro id a c mplete s t of

s f ety re uireme ts f or MAMMO R P IC X-R Y EQUIPME T, b s d o IEC 6 6 1-1:2 0 (3

rd

e itio ) a d its c l aterals This p rtic lar sta d rd a dre s s th s stem le el of

MAMMOG AP IC X-R Y EQUIPME T, whic c n ists of a c mbin tio of a X-R Y GE ER TOR,

a s ciate e uipme t a d A CE SORIE Comp n nts f un tio s are a dre s d a far a

n c s ary

Th minimum s fety re uireme ts s e ifie in this p rtic lar sta d rd are c n id re to

pro id f or a pra tic l d gre of s fety in th o eratio of MAMMO R P IC X-R Y EQUIPME T

Lik th pre io s e itio of this Part 2-4 , th pre e t third e itio in lu e re uireme ts o

HIGH-V LTA E GE ER TO S f or mammo ra h

+AMD1:2 15 CSV  IEC 2 15

Part 2-45: Particular requirements f or the basic safety and essential

perf ormance of mammographic X-ray equipment

and mammographic stereotactic devices

2 1.1 Scope, obje t and related standards

This intern tio al sta d rd a ple to th BASIC SAFE Y a d E S N IAL P RFO MANCE of

MAMMOG AP IC X-R Y EQUIPME T, in lu in e uipme t for MAMMO R P IC TOMOSYN H SIS, a d

MAMMOG AP IC S EREOTA TIC DEVICE , h re f ter als refer e to a ME EQUIPME T

NOT 1 This in lu es MAM O RA HIC X-RA EQUIPME T usin inte rate digital X-RA IMAGE RE E TO S or

inte rate stora e p osp or su systems

Ex lu e from th s o e of this d c me t are:

– dia n stic c n ole ;

– picture arc ivin a d c mmu ic tio s stems (PACS);

– n n-inte rate stora e p o p or re d rs;

– h rd c p c mera ;

– f ilms, s re n a d c s ete ;

– c mp ter aid d d te tio (CAD);

– d vic s for p rf ormin c re bio s a d oth r bio s in trume ts;

– mo e of o eratio inte d d to d mo strate lo al c ntra t me ium u ta e (c ntra t

e h n e digital mammo ra h );

If a cla s or s b la s is s e ific l y inte d d to b a plc ble to ME EQUIPME T o ly, or to

ME SYS EMS o ly, th title a d c nte t of th t cla s or s b la s wi s y s If th t is n t th

c s , th cla s or s b la s a ple b th to ME EQUIPME T a d to ME SYS EMS, a rele a t

NOT 2 IEC 6 6 1-2-7:19 8 a d IEC 6 6 1-2-3 are n t p rt of th 3

rd

e itio sc eme f or MAM O RA HIC X-RA

EQUIPME T a d MAM O RA HIC STEREOTA TIC D VIC S

Part 1: Ge eral re uireme t s for b sic s fet y a d e s nt ial p rorma c

+AMD1:2 15 CSV  IEC 2 15

S EREOTA TIC DEVICE , to e s re s fety, to s e ify meth d for d mo stratin c mpla c

with th s re uireme ts a d to pro id g id n e f or RISK MANA EME T

2 1.1.3 Col ateral stan ards

Add ition:

This p rtic lar sta d rd ref ers to th s a pl c ble c l ateral sta d rd th t are lste in

Cla s 2 of th g n ral sta d rd a d Cla s 2 1.2 of this p rtic lar sta d rd

IEC 6 6 1-1-2:2 0 2 14 a d IEC 6 6 1-1-3:2 0 a d IEC 6 6 1-1-3:2 0 /AMD1:2 13

In th IEC 6 6 1 s rie , p rtic lar sta d rd ma mo ify, re la e or d lete re uireme ts

c ntain d in th g n ral sta d rd a d c l ateral sta d rd a a pro riate f or th p rtic lar

ME EQUIPME T u d r c n id ratio , a d ma a d oth r BASIC SAFE Y a d E S N IAL

P RFO MANCE re uireme ts

A re uireme t of a p rtic lar sta d rd ta e priority o er th g n ral sta d rd or a c l ateral

sta d rd

For bre ity, IEC 6 6 1-1 is refer e to in this p rtic lar sta d rd a th g n ral sta d rd

Col ateral sta d rd are refer e to b th ir d c me t n mb r

Th n mb rin of cla s s a d s b la s s of this p rtic lar sta d rd c r e p n s to th t of

th g n ral sta d rd with th pre x “2 1” (e.g 2 1.1 in this sta d rd a dre s s th c nte t

of Cla s 1 of th g n ral sta d rd) or a plc ble c l ateral sta d rd with th prefix “2 x”

wh re x is th fin l digit s) of th c l ateral sta d rd d c me t n mb r (e.g 2 2.4 in this

p rtic lar sta d rd a dre s s th c nte t of Cla s 4 of th IEC 6 6 1-1-2 c l ateral

sta d rd, 2 3.4 in this p rtic lar sta d rd a dre s s th c nte t of Cla s 4 of th

IEC 6 6 1-1-3 c lateral sta d rd, etc.) Th c a g s to th te t of th g n ral sta d rd are

s e ifie b th u e of th folowin word :

"Re la eme t me n th t th cla s or s b la s of th g n ral sta d rd or a pl c ble

c l ateral sta d rd is re la e c mpletely b th te t of this p rtic lar sta d rd

"Ad itio " me n th t th te t of this p rtic lar sta d rd is a ditio al to th re uireme ts of

th g n ral sta d rd or a plc ble c l ateral sta d rd

"Ame dme t me n th t th cla s or s b la s of th g n ral sta d rd or a plc ble

c l ateral sta d rd is ame d d a in ic te b th te t of this p rtic lar sta d rd

_ _ _ _ _ _

2)

IEC 6 6 1-1-9:2 0 , M edic l el ect r al e uipme t – Part 1-9: Ge eral re uireme ts for b sic s fet y a d

e s nt ial p rorma c – Col l at eral St andard: Re uireme t s for e viro me t all y c n ciou desig

IEC 6 6 1-1-10:2 0 , M edical el ect r al e uipme t – Part 1-1 : Ge eral re uireme t s for b sic s fet y a d

e s nt ial p rorma c – Co at eral St andard : Re uireme ts for th dev l opme t of p y siol ogic clo ed-l oo

c nt roll ers IEC 6 6 1-1-1 :2 10, Medical ele t r al e uipme t – Part 1-1 : Ge eral re uireme t s for b sic

s fet y a d e s nt ial p rorma c – Co at eral St andard: Re uireme t s for med ical el ect ric l e uipme t a d

medical ele t r al s st ems u ed in t he h me h al th are e viro me t IEC 6 6 1-1-12:2 0 , M ed ical E l ect r al

+AMD1:2 15 CSV  IEC 2 15

Su cla s s, f i ure or ta le whic are a ditio al to th s of th g n ral sta d rd are

n mb re startin from 2 1.101 Howe er, d e to th fa t th t d f i itio s in th g n ral

sta d rd are n mb re 3.1 thro g 3.13 , a ditio al d finitio s in this sta d rd are

n mb re b gin in from 2 1.3.2 1 Ad itio al a n x s are letere AA, BB, etc a d

a ditio al items a ), b ), etc

Su cla s s, f i ure or ta le whic are a ditio al to th s of a c lateral sta d rd are

n mb re startin from 2 x, wh re “x” is th n mb r of th c lateral sta d rd, e.g 2 2 f or

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

Th term " his sta d rd" is u e to ma e refere c to th g n ral sta d rd, a y a pl c ble

c lateral sta d rd a d this p rtic lar sta d rd ta e to eth r

Wh re th re is n c r e p n in , cla s or s b la s in this p rtic lar sta d rd, th cla s

or s b la s of th g n ral sta d rd or a plc ble c l ateral sta d rd, alth u h p s ibly n t

rele a t, a pl e with ut mo if i atio ; wh re it is inte d d th t a y p rt of th g n ral

sta d rd or a plc ble c l ateral sta d rd, alth u h p s ibly rele a t, is n t to b a pl e , a

stateme t to th t ef fe t is giv n in this p rtic lar sta d rd

2 1.2 Normative referenc s

NOT Inf ormativ refere c sare lste in th biblo ra h b gin in o p g 4

Cla s 2 of th g n ral sta d rd a pl e , e c pt a f ol ows:

Re la eme t:

IEC 6 6 1-1-2:2 0 2 14, Med ic l el ectric l e uipme t – Part 1-2: Ge eral re uireme ts for

ba ic s fety and es e t ial p rormance – Col l ateral st and ard: El ectromag e c compatibil ity –

Re uireme ts and t ests

IEC 6 6 1-1-3:2 0 , Med ic l el ectric l e uipme t – Part 1-3: Ge eral re uireme ts for ba ic

s fety and es e t ial p rormance – Co ateral Stand ard: Rad iat ion prot ection in diag ostic

X-ray e uipme t

Add ition:

IEC 6 3 6:2 0 , Med ic l electric l e uipme t – X-ray tu e a semblies for medic l

d iag osis – Chara t eristics offoc l sp ts

IEC 6 613:2 10, Electric l and load ing chara terist ic of X-ray tu e a semblies for med ic l

d iag osis

IEC 6 7 8:2 0 , Med ic l el ectric l e uipme t – Gl os ary ofd efined terms

IEC 6 2 0-1-2:2 0 , Med ic l electric l e uipme t – Chara teristic ofd igital X-ray imaging

devices – Part 1-2: Determinat ion ofth d etective q antum eficiency – Detectors used in

mammo rap y

ISO 9 3 -3:19 9, Ph tograp y – Se sit ometry of s re n/il m syst ems for med ic l

rad iograp y – Part 3: Det ermination of se sitometric curv shap , sp ed and av rag

grad ient for mammo rap y

<X-ra mammo ra h > a era e a s rb d d s in th gla d lar tis u (e clu in s in) in a

u if ormly c mpre s d bre st of k own tis u c mp sitio , u in a s e ifie c lc latio

*MAMMOG A PHIC S EREOTA TIC DEVICE

d vic for thre -dime sio al lo al z tio of a p int within th bre st, a d f or me h nic ly

g id d pla eme t of a n e le or p sitio mark r for s c p rp s s a f i e-n e le a piratio ,

bre st a q ire at diff ere t k own a gle

NOT 1 Su h a d vic ma b a d dic te system or a A C S O Y f or MAM O RA HICX-RA EQUIPME T

2 1.3.2 7

MAMMOG A PHIC X-R Y EQUIPME T

X-R Y EQUIPME T wh re th IN E DED U E is bre st ima in

PIXEL v lu s re d dire tly af ter th a alo u -digital-c n ersio from th digital X-ra ima in

d vic or c u ts from p oto c u tin s stems with ut a y s f tware c r e tio s

[IEC 6 2 0-1-2:2 0 , d finitio 3.13]

2 1.4 General requirements

Cla s 4 of th g n ral sta d rd a pl e , e c pt a f ol ows:

2 1.4.3 ES E TIA L P RFO MA NCE

Add ition:

2 1.4.3.101 *Ad itio al E S N IA L P RFO MA NCE req irements

Ad itio al E S N IAL P RFORMANCE re uireme ts are fo n in th s b la s s l ste in

Lin arity of AIR K R A o er lmite interv ls of LOA ING FA TO S 2 3.6.3.1.2

Th re uire AP A E T RE IS ANCE OF S P LY MAIN a d oth r a pro riate S P LY MAIN

re uireme ts s al b pro id d in th A C MPANYINGD CUME T

MAMMOGR P IC X-R Y EQUIPME T is c n id re to c mply with th re uireme ts of this

sta d rd o ly if its s e ifie NOMINAL ele tric p wer c n b d mo strate at a AP A E T

RE IS ANCE OF S P LY MAIN h vin a v lu n t le s th n th t s e ifie b th MAN FA T RER

in th A C MPANYINGD CUME T

NOT If a NO IN L v lta e isclaime f or a mainsp wer su ply system, it is as ume th t th re is n v lta e of a

hig er v lu b twe n a y of th c n u tors of th system or b twe n a y of th se c n u tors a d e rth

An altern tin v lta e is c nsid re in pra tic to b sin soid l if a y insta ta e us v lu of th wa eform

c n ern d diff ers f rom th insta ta e us v lu of th id al wa eform at th same mome t b n more th n ± 2 %

of th p a v lu of th id al wa eform

Thre -p ase S P LY MAIN are c nsid re to h v a pra tic l symmetry if it d lv rs symmetric l v lta es a d

pro u es, wh n lo d d symmetric ly, symmetric l c re ts

Th re uireme ts of this sta d rd are b se u o th as umptio th t thre -p ase systems h v a symmetric l

c n g ratio of th MAIN VOL AGE with resp ct to e rth Sin le-p ase systems ma b d riv d f rom su h thre

-p ase systems.Wh re th su ply system is n t e rth d at th so rc , it is as ume th t a e u te me sures h v

b e pro id d to d te t, lmit a d reme y a y disturb n e of symmetry within a re so a ly sh rt time

Compl iance is ch ck d b insp cti n ofth AC OM PAN YING DOCU M E N TS

Add itional su cl ause:

2 1.4.101 Data rec rdin

Me n s al b in orp rate into th MEEQUIPME T to re ord th fol owin informatio with th

ima e wh n a q ire with a inte rate digital X-R Y IMA ERECE TOR,

Wh n tra sf er in a y of th a o e n te informatio a ima e d ta, it is re omme d d to

u e th o je ts id ntifie in th DICOM sta d rd (ISO 12 5 )

Th in tru tio s f or u e s al giv a pro riate g id n e to th OP R TO

Compl iance is ch ck d b insp ct i n

2 1.5 General requirements f or te ting of ME EQUIPME T

Cla s 5 of th g n ral sta d rd a pl e

+AMD1:2 15 CSV  IEC 2 15

2 1.6 Cla sif ic tion of ME EQUIPME T and ME SYS EMS

Cla s 6 of th g n ral sta d rd a ple , e c pt a fol ows:

2 1.6.2 Protectio against electrical sh c

2 1.7 ME EQUIPME T identif ic tion, marking and documents

Cla s 7 of th g n ral sta d rd a pl e , e c pt a f ol ows:

2 1.7.2 Markin o the o tside of ME EQUIPME T or ME EQUIPME T parts

2 1.7.2.6 Co nection to the S P LY MA IN

Add ition:

For MAMMO R P IC X-R Y EQUIPME T th t is s e ifie to b P RMAN N LY IN TAL ED, th

inf ormatio re uire in 7.2.6 of th g n ral sta d rd ma b state in th A C MPANYING

D CUME T o ly

2 1.7.2.7 Electrical inp t p wer f rom the S P LY MA IN

Add ition:

For MAMMOG AP IC X-R Y EQUIPME T th t is inte d d to b P RMAN N LY IN TAL ED, th

inf ormatio re uire in 7.2.7 of th g n ral sta d rd ma b state in th A C MPANYING

e) th c ara teristic of o er-c r e t rele s s re uire in th S P LY MAIN

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-7:19 8, su cla se 6.1j)

+AMD1:2 15 CSV  IEC 2 15

– th ma imum h at dis ip tio into th s ro n in air, giv n s p rately for e c

s b s embly th t dis ip te more th n 10 W a d mig t b s p rately lo ate o

in tal atio ;

– th ma imum h at dis ip tio into f orc d air c ol n d vic s, a d th c re p n in flow

rate a d temp rature ris of th forc d air stre m;

– th ma imum h at dis ip tio into a c ol n me ium uti ty a d th p rmis ible in ut

temp rature ra g , minimum f l w rate a d pre s re re uireme ts f or th uti ty

Add itional su cl ause:

– s rial d sig atio or in ivid al id ntific tio ;

– P RMAN N FILTR TION in terms of QUALITY EQUIV LE T FILTR TION

Th markin s o th B AM LIMITING DEVICE ma b hid e b c v rs in NO MAL U E In this

D CUME T

NOT Th B AM LIMITING D VIC is n t in th sc p of IEC 6 6 1-2-2 :2 10 Th refore th se re uireme ts h v

b e a a te f romIEC 6 6 1-2-2 :19 3 su cla se 6.1

2 1.7.8 Indicator l g ts and c ntrols

Add itional su cl auses:

2 1.7.8.101 In ication of X-ray related state

Th in ic tio of X-ra relate state s al b e clu e from 7.8 in th g n ral sta d rd

Th A C MPANYING D CUME T s al state th dime sio s a d lo atio s of al a ai a le

EF ECTIVE IMA E RECE TION A EAS

For MAMMOG AP IC X-R Y EQUIPME T th A C MPANYING D CUME T s al c ntain q al ty

RE PON IBLE O GANISATION Th s s al in lu e a c pta c criteria a d f re u n y f or th

te ts

+AMD1:2 15 CSV  IEC 2 15

Th p rf orma c of me n re uire to pre e t th ima e for dia n stic p rp s s al b

state in th A C MPANYING D CUME T

NOT Ex mples of su h me nsare ima e displa d vic s or h rd c p c meras

Ad itio al y f or MAMMOG AP IC X-R Y EQUIPME T pro id d with a inte rate digital X-R Y

IMA ERECE TO , th A C MPANYING D CUME T s al c ntain:

– a d s riptio of th f ile tra sfer f ormat of th ima e a q ire with this u it a d of a y

d ta a s ciate with th s ima e ;

– id ntific tio of th v rsio of ima e pro e sin a pl e to ORIGINAL D TA

Informatio dis la e o th u er interfa e ma b c n id re to s tisfy th s c n

re uireme t a o e

Th A C MPANYING D CUME T of a y MAMMO R P IC S EREOTA TIC DEVICE d sig e a a

A CE SOR for MAMMO R P IC X-R Y EQUIPME T s al c ntain:

– at le st o e MO EL OR TYP REFERE CE to MAMMO R P IC X-R Y EQUIPME T with whic it is

– DEFECTIVE DE ECTO ELEME T ,

– re la eme t of d ta origin tin f rom DEFECTIVE DE ECTOR ELEME T ,

NOT 10 Th v lu s state are o ly for c ara terisin th e uipme t.

f ) f or MAMMO R P IC X-R Y EQUIPME T in ic tin pre-c lc late or me s re CUR E T TIME

h) for MAMMO R P IC X-R Y EQUIPME T pro id d with AU OMATIC EXPOS RE C N R L

c ntrol n th LOA ING TIME, th s orte t LOA ING TIME a d/or th lowe t re ultin

CUR E T TIME PR DUCT;

i) if th X-R Y T B V LTA E or th X-R Y T B CUR E T in MAMMOG AP IC X-R Y EQUIPME T

is c ntrole b a AU OMATIC EXPOS RE C N R L, th ra g of th X-R Y T B V LTA E or

th X-R Y T B CUR E T d rin th IR A IATION s al b state in th in tru tio s f or u e;

j) if th s orte t LOA ING TIME d p n s u o LO DING FA TORS s c a X-R Y T B V LTA E

a d X-R Y T B CUR E T, th ra g s of th s LO DING FA TO S for whic th s orte t

LOA ING TIME is v ld s al b state

Th in tru tio s f or u e s al draw th ate tio of th RE PON IBLE O GANISATION to th n e

to re trict a c s to ME EQUIPME T in a c rd n e with lo al re ulatio s for R DIATION

PR T CTION

2 1.7.9.3 Tec nical de criptio

Add itional su cl auses:

2 1.7.9.3.101 Specif icatio of X-RA Y SOUR E AS EMBLY and its positio

b) TA GE a gle(s) with re p ct to th s e ifie REFERE CEA IS;

c) p sitio with tolera c s of th FO AL S OT o th REFERE CE A IS;

+AMD1:2 15 CSV  IEC 2 15

f ) p sitio of th inters ctio of th REFERE CE A IS with th IMA E RECE TION A EA f or a

g) a gle of th REFERE CE A IS to th pla e of th IMA E RECE TION A EA a d, in

Add itional paragrap :

2 1.7.9.101 Ref eren e to A CC MPA NYING D CUME T

Th f ol owin s b la s s of this sta d rd c ntain a ditio al re uireme ts c n ernin th

2 3.1 101 Ad itio al re uireme ts for prote tio a ain t RE IDUAL R DIATION

2 1.8 Protection against electrical HAZARDS f rom ME EQUIPMEN

Cla s 8 of th g n ral sta d rd a pl e , e c pt a f ol ows:

2 1.8.4 Limitatio of v ltage, c r ent or energ

Add itional su cl auses:

2 1.8.4.101 HIGH-V L A E CA BL C N ECTION

Deta h ble HIGH-V LTA E C BLE C N ECTION s al eith r b d sig e s th t th u e of to ls

is re uire to dis o n ct th m or th y s al b pro id d with interlo k s th t at al time

wh n prote tiv c v rs or hig -v lta e c n e tio s are remo e :

– th ME EQUIPME T is dis o n cte from its p wer s p ly, a d

– c p cita c s in th hig -v lta e circ it are dis h rg d within th minimum time n c s ary

to g in a c s to th hig -v lta e circ it, a d

– th dis h rg d state is maintain d

Compl iance is ch ck d b insp cti n and b mea ureme t

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-7:19 8 su cla se 15 a )

2 1.8.4.10 Limitation of X-R Y T BE V L A GE

ME EQUIPME T s al b d sig e s a n t to d lv r in IN E DED U E, to a y c n e te X-R Y

T B AS EMBLY, a v lta e gre ter th n th NOMINAL X-R Y T B V LTA E f or th X-R Y T B

+AMD1:2 15 CSV  IEC 2 15

c n ern d or gre ter th n th NOMINAL X-R Y T B V LTA E th X-R Y T B AS EMBLY is

d sig e for, whic e er is th lower v lta e

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-7:19 8 su cla se 3.1

2 1.8.5 Separatio of parts

2 1.8.5.4 Working v ltage

Add ition:

2 1.8.5.4.101 Stator an stator circ it dielectric strength te tin

Th te t v lta e f or th diele tric stre gth te tin of stator a d stator circ it u e f or th

o eratio of th rotatin a o e of th X-R Y T B is to b ref er e to th v lta e e istin af ter

re u tio of th stator s p ly v lta e to its ste d state o eratin v lu

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-7:19 8 su cla se 2 4 l)

2 1.8.6 Protective e rthing, fun tional e rthin an p tential equal z tio of

Compl iance is ch ck d b visual insp ction and b mea ureme t

2 1.8.6.10 X-RA Y SOUR E A SS MBLY

In al c s s, th re s al b ele tric l c ntin ity b twe n th s re n of a fite hig -v lta e

c ble a d th a c s ible metal p rts of its re e ta le o th X-R Y SOUR E AS EMBLY

Th fle ible c n u tiv s re n is n t to b re o niz d a s tisfyin a re uireme t f or a

prote tiv e rth c n e tio b twe n th d vic s c n e te b th c ble

Compl iance is ch ck d b visual insp ction and b mea ureme t

2 1.8.7 LEA KA GE CUR E T and PATIE T auxi ary c r ents

A fix d a d P RMAN N LY IN TAL ED c ntral c n e tio p int ma b pro id d in id th o ter

E CLOS RE or c v r of th MAMMO R P IC X-R Y EQUIPME T If oth r s b s emble s c a

a X-R Y SOUR E AS EMBLY or a s ciate e uipme t are c n e te to th c ntral c n e tio

p int, th

EA T LEA A E CUR E T b twe n s c a c ntral c n e tio p int a d th e tern l

+AMD1:2 15 CSV  IEC 2 15

prote tiv s stem ma e c e th alowa le v lu s for a y o e of th sin le d vic s

c n e te

NOT 101 Th lmitatio of th E RTH LE K GE C R E TS within th e viro me t of MAM O RA HIC X-RA

EQUIPME T is inte d d to pre e t interere c in oth r ele tric l e uipme t Th pro isio of a c ntral c n e tio

p int is a c pta le, as for f i e a d P R A E T Y IN TAL E ME EQUIPME T th interu tio of th PR TE TIV

E RTH CON U TO is n t c nsid re to b a SINGLE FA L CON ITION Howe er, in su h c ses, a e u te

inf ormatio o th c mbin tio of su -as embles n e sto b pro id d

2 1.8.8 Insulation

2 1.8.8.3 Dielectric stren th

Ame dme t t o the compliance test for high-voltag circuit :

Th hig -v lt ag circu of M E E QU IPM E NT is test ed b ap lying n more than half t he test

v ltag , and th n th test v l t ag is gradual l raised o er a p riod of 10 s t o the full valu ,

which is maintain d for 3 min

Add ition to the test co ditions for high-vol tag circuit:

Th t est for t he high-voltag circuit shal l b made witho t an X-RAY TU BE co n ct ed and wit

a test voltag of1,2 t imes the N M IN AL X-RAY TU BE V LTAGE ofth M E EQU IPM EN T

I f t he

M E EQU IPM EN T c n b tested o ly wit h the X-RAY TU BE co n ct ed and ifthe X-RAY TU BE

do s n t all ow t he M E EQU IPM E NT to b tested wit h a test voltag of1,2 times the N OM IN AL

X-RAY TU BE V LTAGE, th t est voltag may b l ower b t n t les t han 1,1 times t hat volt ag

If d uring the d ielectric stre gth test th re is a RISK of o erh ating a transformer u d er tes it

is p rmitted to c ry o t the t est at a high r su ply fe u ncy

During t he d ielectric stre gt h tes t he t est volt ag in th hig -voltag circuit sh ul d b kept

a close a p s ibl e t o 10 %, and is n t to b o tside the ran e of10 % and 10 % ofthe

valu re uired

During the d iel ectric stre gth test, sl ight coro a d is harg s in t he high-voltag circuit are t o

b d isre arded if t he cea e wh n t he test v ltag is l owered to 1 0 % ofthe v ltag t o which

th t est co dit io is refered

Add itions:

a ) HIG -V LTAGE GEN E RATOR or su a semblies th re f, that are int egrated with an X-RAY

TU BE AS EM BLY are t o b tested with an ap ro riately l oad ed X-RAY TU BE

b ) Ifsuch H IG -V LTAGE GEN E RATOR do n t have se arate ad justme t of the X-RAY TU BE

CU RRE NT, the d urati n ofthe d iel ectric stre gt h test is to b reduced to such an ex tent that

the al l wabl e X-RAY TU BE l oad at the increa ed X-RAY TU BE V LTAGE will n t b ex ce ded

c )If the high-v l tag circuit is n t a ces ibl e for the mea ureme t of the test vol tag

ap l i d , ap ro riate mea ures sh ul d to b tak en to e sure that t he value is k pt a close

a p s ibl e to 10 %, and is n t to b o tsid e t he ran e of 10 % and 10 %, ofthe valu

re uired

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-7:19 8 su cla se 2 4

2 1.9 Protection against MECHANICAL HAZA DS of ME EQUIPME T and ME SYS EMS

Cla s 9 of th g n ral sta d rd a pl e , e c pt a f ol ows:

+AMD1:2 15 CSV  IEC 2 15

2 1.9.1 MECHA NICA L HAZA RDS of ME EQUIPME T

Add ition:

Su cla s 2 3.8.5.4.10 BREAS C MPRE SION DEVICE of this p rtic lar sta d rd a ple

2 1.9.2.1 General

Add ition:

Th mo eme t of ME EQUIPME T or ME EQUIPME T p rts whic c uld c u e p y ic l injury to

th PATIE T in NORMAL U E s al re uire th c ntin o s a tiv tio b th OP R TO e c pt in

c s s wh n MAMMO R P IC X-R Y EQUIPME T is d sig e for a s e ifie cl nic l a plc tio

(e.g pre o itio in , stere ta tic ima in ) th t ju tif i s inte tio al motio of a c s ible

mo in p rts d rin IN E DED U E Th HAZA DS of th mo in p rts s al b tre te b th

RISK MANA EME T PR CE S S of th MAN FA T RER

If in NO MAL U E a p wer-driv n ME EQUIPME T p rt is inte d d or l k ly to c nta t th

PATIE T, a d wh n a pro riate f or th d sig e a plc tio , me n s al b pro id d to d te t

PATIE T c nta t a d sto th motio if th c nta t c uld c u e p y ic l injury to th PATIE T

Me n s al b pro id d or warnin s giv n in th A C MPANYING D CUME T , to pre e t

injurie th t c uld re ult f rom c l sio of p wer-driv n ME EQUIPME T p rts with oth r mo in

or statio ary items lk ly to b in pro imity

Compl iance is ch ck d b fu ct i nal test and b insp ction of t he instructions for use

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-3 su cla se 2 4.1

with ut e d n erin th PATIE T

+AMD1:2 15 CSV  IEC 2 15

Al p wer-driv n motio s whic c uld c u e p y ic l injury s al b pro id d with a

emerg n y sto c ntrol In th e e t of a emerg n y sto , me n s al b pro id d f or

PATIE T a c s a d remo al whie ME EQUIPME T is dis ble

Compliance is ch ck d b fu cti nal test and b insp ction of the instructions for use

NOT Th se re uireme ts are a a te f rom IEC 6 6 1-2-3 su cla se 2 4.1

Add itional su cl auses:

2 1.9.2.101.1 Positionin of X-R Y SOUR E A SS MBLY f or stereotactic imagin

In stere ta tic ima in , d fin d a g lar p sitio s s al b pro id d for th X-R Y SOUR E

AS EMBLY Th X-R Y SOUR E AS EMBLY s al b c p ble of b in rigidly fix d in a y of th s

p sitio s On e fix d in a y s c p sitio , s b e u nt mo eme t of th X-R Y SOUR E

AS EMBLY s al re uire OP R TO c ntrol

Compl iance is ch ck d b mea ureme t a cord ing to t he test in 2 1.9.2.101.3

2 1.9.2.101.2 Motio of A PP IED PA RT durin bio sy or marker placement

Un er c n ta t c mpre sio f orc , th re s al b n dis la eme t in a y dire tio b twe n

th PATIE T S P O T a d th c mpre sio plate of more th n ± 0,5 mm a d ± 0,5° relativ to

e c oth r, a d th ir dis la eme t relativ to th PATIE T s al n t e c e ± 2 mm a d ± 2° in

a y dire tio

Th mo eme t of th n e le h ld r or c re bio s g n h ld r with a n e le in erte in it s al

re uire c ntin o s a tu tio a d c ntrol b th OP R TO

Compl iance is ch ck d b mea ureme t a cord ing to the test in 2 1.9.2.101.3

is re uired for t he test It co sists of a mo n n pl at e that is p rorated so t hat it c n serve a

a l oc t or for th test n edles At l ea t thre ste l n ed les ofd ifere t l en ths are t o b fix d

in t he mo nting pl ate, t he o ter parts p rp nd icular to its sura e and p inting in th s me

d irecti n

Th st eel n ed les are t est n ed les; th ir tips serv a test o jects Th y shal l b placed in a

pattern so that t he sp cified stere ta t ic bio sy volume c n b covered I t shal l b p s ibl e to

l oc te o e of th m within ± 5 mm of t he ce tre of that v lume, and t wo of the oth r t est

n ed le t ips also insid e th sp cified stere t actic biopsy v lume and within 10 mm of the

extreme x , y, z p ints that are intend ed to b reco struct ed wit h t he M AM M OGRAPH IC

+AMD1:2 15 CSV  IEC 2 15

b) Test procedure

Mea ure t he biopsy n ed le l en th and compare the resu e h r to the N OMINAL biopsy n ed l e

l en th or to t he biopsy n ed le l en th val ue stored or pro rammed in the M AM M OGRAPH IC

S E REOTAC IC DE VIC Th mea ured le gth shal agre with t he NOM IN AL l en th to within

± 0,3 mm Pl ace the TE ST DEVIC o t he PATIE N T SU PPOR of t he M AM M OGRAPH IC S EREOTAC IC

the sp cified st ere tactic biopsy v l ume and t wo ofthe other test n ed l e t ips are also loc ted

insid e the sp cified st ere tact ic biopsy v l ume and within 10 mm ofthe e t reme x , y, z p ints

that are inte ded t o b reco struct ed An at ten at ing, h mo e e us material , for e ample

2 mm Al, may b att ach d close to t he X-RAY SOUR E AS E M BLY

Sel ect a FOCAL S OT with which t he M AM M OGRAPH IC S E RE OTAC IC DEVIC is sp cified t o b

used

Posit io th M AM M OGRAPH IC X-RAY E QU IPM E N T t o a q ire a cranio-c ud al projection of t he

cl i ic l use F or ea h t est n ed le, p sition t he bio sy n ed le ti a cord in t o th p sition

c lcul at ed b the M AM M OGRAPH IC S E RE OTAC IC DEVIC Mea ure and record the d iffere ces in

x , y, z p sit ions b twe n ea h test n ed le t i and the biopsy n ed le t ip Re eat t he proced ure

with t he M AM M OGRAPH IC

X-RAY EQU IPM EN T rotat ed to t he e tremities in ea h d irect ion ofthe

ran e ofan ul ar d eviati n sp cified b t he M ANU F AC U RE for clinic l use ofan ular deviation

in ea h d irection and also to an intermed iate d eviat i ns of 9 ° or mul t iples th re f If t he

M AM M OGRAPH IC S EREOTAC IC DEVIC is d esig ed for more t han o e biopsy n ed le d irect ion

relat i e to the t est d evice, th n re eat t he procedure at a man d irect ions a p s ibl e u t o a

maximum ofsix within t he ran e sp cified b the M AN U FAC U RE R for clinic l use, incl ud ing at

lea t two d irect ions at e tremities of the sp cified ran e

c) I nterpretation of mea ured d at a

Compare t he differe ces in x, y, and z d irect i ns t o the re uireme t ab ve

2 1.10 Protection against unwanted and exc s ive radiation HAZAR S

Cla s 10 of th g n ral sta d rd a ple , e c pt a f olows:

2 1.10.1.2 ME EQUIPME T Inten ed to pro u e diag ostic or therapeutic X-radiation

Add ition:

MAMMOGR P IC X-R Y EQUIPME T s al c mply with th a plc ble re uireme ts of IEC 6 6 1

2 1.1 Protection against exc s ive temperature and other HAZA DS

Cla s 1 of th g n ral sta d rd a ple

2 1.12 Accura y of controls and instruments and prote tion against haz rdous

outputs

Cla s 12 of th g n ral sta d rd a pl e , e c pt a f olows:

+AMD1:2 15 CSV  IEC 2 15

X-RA

2 1.13 Ha ardous situations and f ault conditions f or ME EQUIPME T

Cla s 13 of th g n ral sta d rd a ple

2 1.14 PROGRAMMABLE ELECTRICAL MEDICAL SYS EMS (P MS)

Cla s 14 of th g n ral sta d rd a pl e

2 1.15 Construction of ME EQUIPME T

Cla s 15 of th g n ral sta d rd a ple , e c pt a f olows:

2 1.15.4 ME EQUIPME T c mp nents an general a s mbly

NOT An e ample of suita le me ns to c mply with this re uireme t is th pro isio of a k y-o erate switc

ara g d so th t p were mo eme ts a d th g n ratio of X-RA IATION are p s ible o ly wh n th k y is prese t,

b t b tery c argin is also p s ible in th a se c of th k y

2 1.16 ME SYS EMS

Cla s 16 of th g n ral sta d rd a ple

2 1.17 Ele tromagnetic compatibi ity of ME EQUIPMEN and ME SYS EMS

Cla s 17 of th g n ral sta d rd a ple

2 2 Ele tromagnetic compatibi ity – Requirements and tests

IEC 6 6 1-1-2:2 0 2 14 a ple , e c pt a fol ows:

+AMD1:2 15 CSV  IEC 2 15

Add ition:

2 2.101 Immu ity te tin of E S N IA L P RFO MA NCE

Th MAN FA T RER ma minimiz th te t re uireme ts of th a ditio al E S N IAL

P RFO MANCE lste in Ta le 2 1.101 to a pra tic l le el thro g th RISK MANA EME T

PR CE S

Wh n s le tin th re uireme ts to b te te , th MAN FA T RER n e s to ta e into a c u t

th s n itivity to th EMC e viro me t, pro a i ty of EMC c n itio a d s v rity, pro a i ty

a d c ntrib tio to u a c pta leRISK thro g th RISK MANA EME T PR CE S

Th a c ra y of th te t in trume ts u e to a s s th immu ity of th ME EQUIPME T s al

n t b aff ecte b th ele troma n tic c n itio s f or th te t

Th te t in trume t s al n t h v a influ n e o th immu ity of th ME EQUIPME T

Only n n-in a iv me s reme ts s al b p rf orme

ME EQUIPME T b in te te s al n t b mo if i d to p rf orm this immu ity te t

Compliance is ch ck d b insp cti n of th RISK M AN AGEM E NT FILE

2 3 Radiation protection in diagnostic X-ray equipment

2 3.4 General req irements

2 3.4.1 Statement of c mpl an e

Re la eme t:

For MAMMO R P IC X-R Y EQUIPME T, or a s b s embly, a y stateme t of c mpla c with th

re uireme ts of this sta d rd s al b giv n in th folowin form:

MAMMOGR P IC X-R Y EQUIPME T

+ )

IEC 6 6 1-2-4 :2 1 2 15

+ )

MODEL OR TYP REFERE CE

NOT This in lu es markin o th o tsid of ME EQUIPME T

Add itional su cl ause:

2 3.4.101 Qual fyin c n itio s f or defined terms

2 3.4.101.1 Electric p wer

Th ele tric p wer in th hig -v lta e circ it, me tio e in this p rtic lar sta d rd

in 2 1.7.9.2.1, g n ral items c), d), a d e) is c lc late a c rdin to th formula: P = fU I

P is th ele tric p wer

f is th f actor d p n in o th wa eform of th X-R Y T B V LTA E, s le te a b low

a d is

+AMD1:2 15 CSV  IEC 2 15

a) 0,9 f or ME EQUIPME T in lu in a six-p a HIGH-V LTA E GE ER TO , or

b) 1,0 f or ME EQUIPME T in lu in a twelv -p a HIGH-V LTA E GE ER TOR or a c n ta t

For M E EQU IPM E N T in which LOADING is co trol led b electro ic switching of th high voltag ,

usin a grid in an electro ic tub or in t he X-RAY TU BE, the LOADIN TIM E shal l b d et ermined

a the time interval b twee the inst ant wh n the timing device g n rates th signal t o st art

the IR ADIATION and the instant whe it g n rat es th signal to terminat e the IR ADIATION

For M E E QU IPM EN T in which LOADING is co trol l ed b simu an o s switchin in t he primaries of

b th th high-vol tag circuit and t he h ating su ply for th fil ame t of t he X-RAY TU BE, the

LOADING TIM E shal l b d etermin d a t he time interval b twe n the instant whe th X-RAY

TU BE CUR EN T first rises ab ve 2 % ofits maximum valu and t he instant wh n it final l fals

b l ow t he s me val ue

For oth r c s s, th wa th LO DING TIME is c ntrol e a d d termin d s al b d s rib d in

th RISK MANA EME T FILE

NOT 1 Se also d finitio 3.3 of IEC 6 6 1-1-3:2 0 a d IEC 6 6 1-1-3:2 0 /AMD1:2 13

NOT 2 Th se re uireme ts are a a te f rom IEC 6 6 1-2-7:19 8 su cla se 2.101.4

2 3.5 ME EQUIPME T identif icatio , markin and do uments

For MAMMO R P IC X-R Y EQUIPME T, th X-R DIATION d s to th PATIE T s al b d s rib d

u in b th th e tra c AIR KERMA a d th A ER GE GLANDULA D S , d termin d a c rdin to

th meth d s e ifie b th MAN FA T RER

2 3.6 RA DIATION management

2 3.6.2 Initiation an terminatio of the IR A DIATION

2 3.6.2.1 Normal initiatio and terminatio of the IR A DIATION

Add ition:

+AMD1:2 15 CSV  IEC 2 15

2 3.6.2.1.101 Co nectio s of external interlo ks

MAMMOGR P IC X-R Y EQUIPME T, e c pt MOBILE MAMMOG AP IC X-R Y EQUIPME T, s al b

pro id d with c n e tio s f or at le st o e e tern l ele tric l d vic s p rate f rom th

MAMMOG AP IC X-R Y EQUIPME T th t c n pre e t th X-R Y GE ER TO f rom startin to emit

X-R DIATION

MAMMOGR P IC X-R Y EQUIPME T, e c pt MOBILE MAMMOG AP IC X-R Y EQUIPME T, s al b

pro id d with c n e tio s f or at le st o e e tern l ele tric l d vic s p rate f rom th

MAMMOG AP IC X-R Y EQUIPME T th t c n c u e th X-R Y GE ER TO to sto emitin

X-R DIATION

If th state of th sig als from th s e tern l ele tric l d vic s is n t dis la e o th

C N R L PAN L, th A C MPANYING D CUME T s al c ntain informatio to th RE PON IBLE

O G NISATION th t this state s o ld b dis la e b vis al me n in th in tal atio

2 3.6.2.2 Saf ety me sure against f ai ure of n rmal terminatio of the IR A DIA TION

th c ntrol b whic th pre io s IR A IATION wa initiate

c) Me n s al b pro id d for th OP R TOR to termin te e c IR A IATION at a y time

f ) If th n rmal termin tio d p n s u o a o -g in X-R DIATION me s reme t,

– th s f ety me s re s al c mpris me n for termin tio of IR A IATION in th e e t of

a fai ure of th n rmal termin tio ;

– th CUR E T TIME PR DUCT s al b l mite to n more th n 8 0 mAs p r IR A IATION

u le s s e ifie a d ju tif i d b th MAN FA T RER;

– th s stem f or n rmal termin tio of IR A IATION a d th s stem u e f or th s f ety

me s re s al b s p rate s th t a faiure in o e s stem d e n t aff ect termin tio

g) For MAMMO R P IC X-R Y EQUIPME T pro id d with AU OMATIC EXPOS RE C N R L a

meth d b whic th OP R TO c n v rify th f un tio in of th AU OMATIC EXPOS RE

C N R L s al b pro id d a d th in tru tio s f or u e s al c ntain th d s riptio of th t

meth d

Compliance is ch ck d b insp ct i n and b th ap ro riat e fu ctional test s

2 3.6.3 RA DIATION d s an RA DIATION QUA LITY

Re la eme t:

+AMD1:2 15 CSV  IEC 2 15

2 3.6.3.1 Adjustment of RA DIATION d s an R DIA TION QUA LITY

2 3.6.3.1.1 General requirements f or the adjustment of RA DIA TION d s and RA DIATION

QUA LITY

It s al b p s ible to a ju t th R DIATION QUALITY a d th q a tity of X-R DIATION to matc

th ra g of bre st thic n s a d c mp sitio c re p n in to th IN E DED U E of th

MAMMOG AP IC X-R Y EQUIPME T

Wh n th a ju tme t of th q a tity of X-RA IATION c ntrib tin to th ima e is ma e thro g

a ma u l s le tio amo g dis rete v lu s of LOA ING FA TORS h vin a e s ntialy

pro ortio al relatio to th q a tity of X-R DIATION pro u e , p rtic larly v lu s for X-R Y

T B CUR E T, LOA ING TIME or CUR E T TIME PR DUCT, th s v lu s s al b c o e f rom th

An e B

NOT Usin v lu s a c rdin to this g ometric pro res io h lps th OP RATO in a justin th q a tity of

X-RA IATION b amo nts th t are just sig ific nt, b th in terms of X-RA IATION d se to th P TIE T a d ima e

q alty

Compl iance is ch ck d b insp cti n

2 3.6.3.1.2 Line rity of A IR KERMA o er l mited intervals of LOA DING FA TORS

Th v riatio of th MEAS RED V LU S of AIR KERMA s al l n arly f ol ow th c a g of th

s le te CUR E T TIME PR DUCT o er th wh le ra g of CUR E T TIME PR DUCT s le tio s

a aia le, with a a c ra y e u l or b ter th n 0,2

Compl iance is ch ck d b t he followin fu ct i nal test:

Th l inearity test shal l b p rormed at 3 kV or at th n arest X-RAY TUB V LTAGE setting

avail able For the tes pairs of X-RAY TU BE CU RREN T TIM E P ODUC settings shal l b selected

a fol l ows:

– Th l ower val ue of th first pair shal l coresp nd to the l owest availabl e CUR E NT TIM E

P ODUC setting F or M AM M OGRAPH IC TOM OSYN THESIS this l ower val ue sha b t he l owest

– Th rat io oft he val ues of the sel ected CUR EN T TIM E P ODU CT settings in ea h pair shal l

b a cl ose a p s ible t o 2, b t n t ex ce d ing 2

– Th hig er valu of th CU RREN T TIM E P ODU CT sett in s in ea h pair to b mea ured shal l

b used a the lower value of t he n xt pair ofCU RRE NT TIM E P ODU CT settings

– Th high r valu oft he last pair shal l coresp nd t o the high st avail abl e CU RR N T TIM E

P ODUC setting and t he l ower val ue shal l b hal f or n x t of hal f of th valu

coresp nd ing t o t he high st avail able CU RRE NT TIM E P ODU CT setting

N OT An ex ampl e of t his s le t ion rule is th fol l owing: If th a ail abl e C R E T TIME PR D C s t t ing are 1 ,

1 , 16, 2 , 25, 3 , 4 , 50, 63, 8 , 1 0 a d 1 5 mAs, t he p irs t o b t est ed are: 1 a d 2 mAs, 2 a d 4 mAs, 4

a d 8 mAs a d 63 a d 1 5 mAs

Th wh l e series of mea ureme ts re uired for th test shal l b p rormed witho t lo g

pauses and preferably within a p riod ofo e h ur

P erorm ten LOADIN S for ea h sel ected X-RAY TU BE CUR EN T TIM E P ODUC setting and

mea ure t he AIR KE RM A at a fixed l oc ti n 4 mm ab v t he PATIE NT SUP OR Calculate t he

av rag of the M EASU RE VALU E S ofAIR KERM A for ea h series often mea ureme ts

Calculate th linearity in relation t o ea h pair ofsett in s a cord in to the fo owin formula

Th q o e ts oft he av rag s divid ed b the resp ct i e select ed X-RAY TU BE CUR E NT TIM E

S shal l n t d ifer b more t han 0,2 t imes the mean valu ofth foll owing q otients:

+AMD1:2 15 CSV  IEC 2 15

22,0

|

|

22

11

22

11

QK

QK

QK

QK

K are the av rag s of the MEASU RED VALU E S of AIR KE RM A and

Q

1, Q

MEAS RED V LU S of AIR KERMA s al b n t gre ter th n

0,0 f or a y c mbin tio of LO DING FA TORS o er th ra g for IN E DED U E

Compl iance is ch ck d b t he followin fu ct i nal test:

Select a set of

OR combinat i ns for th re roducibility t ests, incl uding at lea t

th foll owing combinati ns:

– hig est avail abl e X-RAY TU BE V LTAGE with the l owest available X-RAY TU BE CUR EN T for

that X-RAY TU BE V LTAGE

– l owest avail able X-RAY TU BE V LTAGE wit h the high st avail able X-RAY TUB CU RRE N T for

that X-RAY TU BE V LTAGE

– a combinat ion of X-RAY TU BE V LTAGE and X-RAY TU BE CUR EN T for t he high st electric l

p wer

– a combinat ion of X-RAY TU BE V LTAGE and X-RAY TU BE CU RREN T for the l owest el ectric l

p wer

Th series of mea ureme ts re uired for t he test shal b p rormed witho t l on pauses,

preferably wit hin a p riod of o e h ur

Perorm ten LOADIN GS for ea h oft he combinat ions ofLOADIN FAC OR sel ected and mea ure

th AIR KE RM A at a fixed l oc t i n 4 mm ab ve the PATIEN T SU PPOR

Calculate t he co ficient ofvariat ion for ea h series of M E ASU RED VALU E S ofAIR KERM A

nKK

K

K

n+++

=

21

K

1, K

2, K

nare t he M EASURE D VALU ES ofAIR KE RM A

Kn

KKK

KKK

cv

n

1

22

22

1

−

−++

−+

−

=

Compliance is ch ck d b insp cti n.

2 3.6.4.2.10 Remote in icatio of REA DY S AT in mammograp y

Me n s al b pro id d f or a c n e tio to e a le th REA Y S AT to b in ic te remotely

from th C N R L PAN L This re uireme t d e n t a ply to MOBILE MAMMO R P IC X-R Y

NOT Su cla ses 2 3.6.4.3.10 a d 2 3.6.4.3.10 c ntain re uireme ts o o eratin d ta f or MAM O RA HIC

X-RA EQUIPME T, as p rt of X-RA GE ERATO S th t are c nsid re es e tial f or prote tio a ainst in ore t o tp t

Th re uireme ts of this s b la s a ply to th a c ra y of al v lu s of LO DING FA TO S,

wh th r in ic te , fix d or pre ele te wh n c mp re with MEAS RED V LU S of th s me

LO DING FA TOR

Compl iance is determined b t ests a cording to 2 3.6.4.3.10 10

2 3.6.4.3.10 2 Ac urac an repro u ibi ity of X-RA Y

This s b la s is a pl c ble o ly if th LO DING TIME is e u l to th IR A IATION TIME of th

EF ECTIVE IMA E RECE TION A EA at e c p int or eleme t of th X-R Y IMA E RECE TO

NOT An e ample for MAM O RA HIC X-RA EQUIPME T wh re this su cla se is n t a plc ble are slot sc n in

systems

2 3.6.4.3.10 5 Ac urac of CUR E T TIME PR DUCT

In a y s e ifie c mbin tio of MAMMOG AP IC X-R Y EQUIPME T with s b-a s mble , th

er or o th v lu of th X-R Y T B CUR E T TIME PR DUCT s al n t b gre ter th n

2 3.6.4.3.10 Te t c n itio s f or the ac urac of loadin factors

2 3.6.4.3.10 1 Ac urac an repro u ibi ity of X-RA Y T BE V L A GE

and high st selectabl e valu s of th X-RAY TU BE V LTAGE and at the l owest, med ium and

hig est selectabl e val ues of

CUR E NT TIM E P ODUC

+AMD1:2 15 CSV  IEC 2 15

Complete ea h set oft en mea ureme ts for ea h combinati n of X-RAY TU BE V LTAGE and

CU RRE N T TIM E P ODU CT preferably within a t ime p riod of o e h ur

series of mea ureme t to v rify compl iance

2 3.6.4.3.10 2 Ac urac of X-RA Y T BE CUR E T

On mea ureme t shal l b mad e for t he l owest IN DICATE D VALU E of X-RAY TU BE CU RRE N T with

the hig est IN DICATE D VALU E of X-RAY TU BE V LTAGE and t he sh rtest IN DICATE D VALU E of

LOADING TIM E

On mea ureme t shal b mad e for the lowest IN DICATED VALU E ofX-RAY TU BE CU RRE N T wit h

th high st INDICATE D VALU E of X-RAY TU BE V LTAGE and a LOADINGTIM E of ap ro imately 1 s

On mea ureme t shal l b mad e for the hig est IN DICATED VALU E of X-RAY TU BE CUR EN T with

th high st availabl e X-RAY TU BE V LTAGE and a LOADINGTIM E of ap ro imat ely 1 s

2 3.6.4.3.10 3 Ac urac of LOA DING TIME

On mea ureme t shal b mad e for t he lowest IN DICAT D VALU E of LOADIN G TIM E wit h t he

hig est INDICATED VALU E of X-RAY TU BE V LTAGE and an IN DICATED VALU E of X-RAY TU BE

CU RREN T

On mea ureme t shall b mad e for th l owest INDICATE D VALU E of LOADIN G TIM E and t he

hig est availabl e electric p wer, P

2 3.6.4.3.10 4 Ac urac of CUR E T TIME PR DUCT

On mea ureme t sha b mad e for th lowest INDICATE D VALU E ofCU RRE NT TIM E P ODU CT

and t he high st avail able X-RAY TU BE V LTAGE

On mea ureme t sha b made for t he high st IN DICATED VALU E of CU RRE NT TIM E P ODU CT

and t he lowest availabl e X-RAY TU BE V LTAGE

2 3.6.4.3.104 Indication of A DDED FIL ERS

If X-R Y EQUIPME T h s pro isio s to s le t A DED FILT RS b remote c ntrol or a tomatic

s stems, th s le te A DED FILT R s al b in ic te o th C N R L PAN L In c s s wh re

th FILT R c a g is a tomatic, this in ic tio ma b dis la e afer th termin tio of

IR A IATION

Compl iance is ch ck d b insp cti n and b the ap ro riate fu ct ional t ests

2 3.6.4.4 In ication of automatic mode

Add ition:

For MAM O R P IC X-R Y EQUIPME T in whic c ntrol of e p s re c n itio s is a hie e b

a tomatic v riatio of o e or more LOA ING FA TO S, A DED FILT RS or TA GE , inf ormatio

a o t th ra g a d interelatio of th s LO DING FA TORS s al b giv n in th in tru tio s

f or u e

Compl iance is ch ck d b insp cti n and b the ap ro riate fu ctional tests

2 3.6.4.5 Dosimetric In ications

Add ition:

+AMD1:2 15 CSV  IEC 2 15

For MAMMOG AP IC X-R Y EQUIPME T with a inte rate digital X-R Y IMA E RECE TOR th

A ER GE GLANDULA D S s al b in ic te f or e c a q ire ima e

2 3.6.5 AU OMA TIC C N R L SYS EM

Re la eme t:

2 3.6.5.1 General AEC req irements f or MAMMOG A PHIC X-R Y EQUIPME T

MAMMOGR P IC X-R Y EQUIPME T s al b pro id d with AU OMATIC EXPOS RE C N R L

NOT Th in lusio of a ma u l mo e o tio is n t in c ntra ictio to th se re uireme ts a d ma b useful in

sp cial c ses

Th p rforma c re uire f or th IN E DED U E of AU OMATIC EXPOS RE C N R LS s al b

d termin d in th RISK MANA EME T PR CE S a d b v rifie b a pro riate te ts

Compl iance is ch ck d b insp ct i n and b th ap ro riat e fu ct ional t ests

NOT Within this su cla se a stora e p osp or re d r, in lu e with th origin l MAM O RA HIC X-RA

EQUIPME T, or in ic te as c mp tible with its INTE D D U E, is c nsid re as a inte rate digital X-RA IMAGE

RE E TO Th ty e test f or a c mbin tio of MAM O RA HIC X-RA EQUIPME T with ut a inte rate X-RA IMAGE

RE E TO with a stora e p osp or plate a d/or re d r or oth r digital d te tor is th resp nsibi ty of th system

inte rator a d ma b c rie o t a c rdin to 2 3.6.5.3

MAMMOG AP IC X-R Y EQUIPME T with ut a inte rate X-R Y IMA E RECE TO o ly re uire th

u e of fim for te tin th AEC p rforma c For MAMMOG AP IC X-R Y EQUIPME T with ut a

inte rate X-R Y IMA E RECE TOR, th A C MPANYING D CUME T s al c ntain n c s ary

informatio or l mitatio s o th c ara teristic of th X-R Y IMA E RECE TO th t c n b u e

in ord r to me t th re uire p rforma c

MAMMOGR P IC X-R Y EQUIPME T inte d d to b u e with c rtain n n-inte rate digital X-R Y

IMA E RECE TO S o ly ma b te te with s c digital X-R Y IMA E RECE TORS a c rdin to

2 3.6.5.3

In oth r c s s th AEC fu ctio s al maintain f ilm o tic l d n ity within a a pro riate ra g

wh n th thic n s of a bre st e uiv le t material is v rie o er a a pro riate ra g a d th

X-R Y T B V LTA E is v rie a pro riately for s c thic n s o er th ra g re omme d d

b th MAN FA T RER f or cl nic l u e Th a pro riate c mbin tio of X-R Y T B V LTA E

a d thic n s of th o je t is to b state b th MAN FA T RER Th AEC s al b o era le

in al c mbin tio s of cl nic l y rele a t c n g ratio s of th MAMMO R P IC X-R Y

EQUIPME T, e.g grid, n grid, ma nific tio a d (if a plc ble) stere ta tic mo e , a d with

v rio s TA GE /FILT R c mbin tio s

a) Test method

Mea ure the o tic l density of rad iograms of PH AN TOM S mad e of brea t tis u e uival ent

material , prod uced with th AU TOM ATIC E XPOSUR CON TROL in o eration Determine the

variat i ns in d ensit for d ifere t PH ANTOM thicknes and for d iffere t X-RAY TU BE V LTAGE S

b) Test aran eme t

U se a t est aran eme t with the foll owing chara t erist ic :

1) A DIR C F OCAL DIS AN CE, remainin u chan ed for a t ests in a series

+AMD1:2 15 CSV  IEC 2 15

2) Sel ect t he X-RAY TU BE V LTAGE, TARGET, and FILT ATION to reflect the PH ANTOM

thicknes Sel ect the de sity co trol t o the val ue that is typic l l used cl i icaly

3) An 18 cm  2 cm rad iograp ic c s ett e for mammo rap y, t he s me c s ette b ing

used for al l tests in a series Ift he M AM M OGRAPH IC X-RAY E QU IPM E N T incl ud es more

than o e PATIEN T SU PPOR the the AEC shal l also b tested usin these

aran eme ts

4) Test th thick es ran e fom 2 mm to 70 mm in steps of10 mm Th size oft he

PH AN TOM S sha provid e suficient co erag of the AEC detector, for e ample

10 cm  15 cm or a semicircle wit h a rad ius of10 mm A l arg r size is recomme d ed

to g n rate cl i ic lly relevant d istribut ions of S AT E RED RADIATION Th PHAN TOM shall

ext end 10 mm b yond t he ch st wal edge of th PATIE NT SU PPOR and at l ea t 10 mm

b yond the edg of the AEC detector

5) I f the grid c n b removed , or PATIEN T SU PPOR witho t a grid is provid ed, th AEC

fu ction shal l also b tested for these co fig rations

6) P rovision for a curate and re roducible film proces in and for mea uring the o t ic l

density of proces ed fil ms Th fil m proces or stabil ity d urin the AEC test shal l

re ul arly b test ed and d emo strated wit h a se sit ometer tes at l ea t at th

b ginning, half way t hro g the test and at th e d It is n t ap ro riate t o d ivid e the

test int o d iffere t parts, and it is also imp s i ble to make this t est if t he proces or is

n t stabl e I f there is a sma drift in proces or p rormance d urin t he t est p riod, t his

drift must b t ak n int o co sid erat i n whe making th e aluation

c) Rad io rap ic fil m and intensifyin s re n

Use t he s me combination ofrad iograp ic fil m, intensifyin s re n and rad iograp ic c s ette

a cord ing t o the informat ion given in t he instruct i ns for use If a d iffere t intensifyin s re n

is recomme ded for sp cial proced ures, i.e stere t axy or mag ific ti n, th AEC shal l also

b tested using this aran eme t

d) Setting the AU TOM ATIC E XPOSU RE CON TROL

– Posit io the PH AN TOM o the PATIE NT SU PPOR and e sure that it overl aps th area of

th AEC se sor

– For settings fo ow t he instruct i ns for use

e) Compl iance crit eria

M EASU RE D VALU ES of o tic l d ensit shal l b within 0,3 for 2 mm to 70 mm of t is u

-e uivalent material

2 3.6.5.3 AEC req irements f or MA MMOG A PHIC X-RA Y EQUIPME T pro ided with an

integrated digital X-R Y IMAGE RECE TO

2 3.6.5.3.1 General requirements

NOT Within this su cla se a stora e p osp or re d r, in lu e with th origin l MAM O RA HIC X-RA

EQUIPME T, or in ic te as c mp tible with its INTE D D U E, is c nsid re as a inte rate digital X-RA IMAGE

RE E TO

Th p rforma c of th AEC s al b e alu te b jointly a s s in ima e q alty, a

PATIE T, a c ara teriz d b th A ER GE GLANDULA D S , a d c mp rin th m to th

s e ific tio s pro id d

Th a pro riate c mbin tio of X-R Y T B V LTA E a d thic n s of th o je t is to b state

b th MAN FA T RER Th AEC s al b o era le in al c mbin tio s of cl nic l y rele a t

c nfig ratio s of th MAMMOG AP IC X-R Y EQUIPME T, e.g grid, n grid, ma nif i atio (if

a pl c ble) tomo y th sis a d stere ta tic mo e , a d, wh n a plc ble, with th dif fere t

TA GE /FILT R c mbin tio s

+AMD1:2 15 CSV  IEC 2 15

Al c nfig ratio s of c mbin tio s of s tin s of th MAMMOG AP IC X-R Y EQUIPME T (e.g

ma nif i atio , tomo y th sis a d stere ta tic mo e ) th t u e AEC LO DINGS s al b

e alu te p r th s e ific tio s of th MAN FA T RER

NOT An e ample for th se testsc n b fo n in IEC 612 3-3-2:2 0 a d is in lu e in 2 3.6.5.3.3

2 3.6.5.3.2 AEC reprod cibi ty

Th re ro u ibi ty of th AEC s al b e alu te b re e te ly ima in a P AN OM u d r

s e ifie c n itio s, me s rin th v riatio s in X-R Y T B LOA ING (mAs), AIR KERMA or

a era e PIXEL v lu , a d c mp rin th re ults with th s e ific tio s a d s rib d in c)

Compl a c criteria, b low

a) Test method

Using clinic l l rel evant X-RAY TU BE V LTAGE and TARGET/FILTE R combinations, mea ure o e

of t he q antities

– X-RAY TU BE LOADIN G (mAs)

– AIR KERM A at a fix d p sit ion b twee t he X-RAY SOU RC AS E M BLY and t he X-RAY IM AGE

RE CE PTOR;

– av rag valu of l inearised PIXEL val ues in a re ion of i nt erest of t he imag of the

PH AN TOM;

for five ro ti e LOADIN GS with PH AN TOM S made ofbrea t tis u -e uivale t material, wat er or

Polymet hylmetha rylate (PM MA), d et ermin th variati n in th mea ured q antity for ea h

LOADING relati e t o the mean value for the LOADIN series

Add itional ly, ifan AEC ad justme t or corection co trol is pro ided, mea ure t he sel ected

q ant ity a listed in a) ab ve at ea h M ANU FAC URER sp cified co trol st ep using t he s me

X-RAY TU BE V LTAGE, TARGE /FILTE R, and PH AN TOM co fig rations and determine t he variation for

ea h resp ct ive LOADIN

b) Test aran eme t

U se a test aran eme t wit h the fol l owing chara terist ic :

1) a DIRECT F OCAL DIS ANC remainin u chan ed for al l t ests in a series;

2) dosimet ers or ot her mea ureme t instrume t ation sh uld b p sition d t o avoid

interere ce with AEC se sor

c) Compliance crit eria

Compliance is a hiev d ifn M E ASU RE VALU E of the select ed q ant ity d iffers b more t han

± 15 % fom the mean valu for the test LOADIN S or, a a pro riate, th MAN FA T RER’S

+AMD1:2 15 CSV  IEC 2 15

2 3.6.7 Imagin perf orman e

2 3.6.7.3 NOMINA L FO AL S OT VA LU

Add ition:

Th re uireme ts of th c lateral sta d rd are c n id re a met if th NOMINAL FOC L S OT

V LU of th X-R Y T B s e ifie to b u e in c nta t mo e is smal er th n or e u l to 0,4

a c rdin to IEC 6 3 6, a d if th NOMINAL FOC L S OT V LU s e ifie to b u e in

g ometric ma nif i atio c n itio s is smaler th n or e u l to 0,2 a c rdin to IEC 6 3 6

2 3.6.7.4 RA DIATION DE ECTO or X-RA Y IMA GERECE TOR

If a digital X-R Y IMA E RECE TOR is inte rate in th MAMMO R P IC X-R Y EQUIPME T, its

c ntrib tio to th metric of ima in p rforma c s al b s e if i d in th RISK MANA EME T

FILE in a c rd n e with IEC 6 2 0-1-2 This c ntrib tio s o ld e s re th ef ficie t u e of X

-R DIATION

Compl iance is ch ck d b insp ct i n of th RISK M AN AGEM E NT FILE

2 3.6.7.4.2.2 DEFECTIVE DE ECTOR E EME T

Th MAN FA T RER s al s e ify

– th ma imum a c pta le n mb r of is late DEFECTIVE DE ECTOR ELEME T in th e tire

IMA E RECE TION A EA a d th ma imum a c pta le n mb r in a y s b ivisio with th ir

distrib tio o er th IMA E RECE TIONA EA;

– th ma imum a c pta le siz a d n mb r of c n e tin DEFECTIVE DE ECTOR ELEME T

a d th ir distrib tio in th e tire IMA E RECE TION A EA a d th ma imum a c pta le

n mb r in a y s b ivisio a d distrib tio o er th IMA E RECE TION A EA of c n e tin

DEFECTIVE DE ECTOR ELEME T gro p d b to olo y ty e (e.g 2 a ja e t d te tor

eleme ts, 3 a ja e t d te tor eleme ts, 2  2 a ja e t d te tor eleme ts, etc.);

+AMD1:2 15 CSV  IEC 2 15

– th ma imum a c pta le n mb r of d f ectiv l n s, c lumn a d s gme ts, a d th

minimum a c pta le dista c b twe n d f ectiv l n s or c lumn with th ir width, le gth

a d distrib tio o er th e tire IMA E RECE TION A EA a d th ma imum a c pta le

n mb r in a y s b ivisio a d distrib tio o er th IMA E RECE TION A EA

Th s d f ects s al n t sig if i a tly d gra e th le el of ima e q al ty re uire f or th

IN E DED U E

Th MAN FA T RER s al d termin , d s rib , a d s e ify th a c pta le pro ertie ,

n mb rs, p sitio s a d ara g me ts of th DEFECTIVE DE ECTO ELEME T in th RISK

MANA EME T FILE

Me n s al b pro id d

– to d termin a d id ntify th DEFECTIVE DE ECTO ELEME T pre e t in th digital X-R Y

IMA E RECE TOR a c rdin to th c te orie a o e;

– to al ow th RE PON IBLE O G NISATION to d termin wh th r th digital X-R Y IMA E

RECE TO p rf orms a c rdin to its s e ific tio s, b fore d gra atio of th ima e q al ty

p rforma c re uire f or th IN E DED U E o c rs;

– to g n rate or u d te th d s riptio of th DEFECTIVE DE ECTOR ELEME T to b u e

d rin th re la eme t PR CE S s e ifie in 2 3.6.7.4.2.3, if re uire Me n ma b

pro id d to ma e this d s riptio a ai a le to th RE PON IBLE O GANISATION

Th in tru tio s f or u e s al c ntain in tru tio s o h w a d wh n to u e th pro id d

me n a a p rt of th q al ty c ntrol pro e ure , or of th mainte a c of ME EQUIPME T, to

b p rf orme b th RE PON IBLE O GANISATION or u d r its re p n ibi ty

Compl iance is ch ck ed b insp cti n of t he RISK M ANAGE M EN T FILE and the AC OM PAN YING

DOCU M EN TS

2 3.6.7.4.2.3 * Replacement of data originating from DEFECTIVE DE ECTOR E EME T

Me n s al b pro id d to re la e th R W D TA origin tin f rom th DEFECTIVE DE ECTO

ELEME T b a pro riate d ta, in s c a wa th t th c re p n in picture eleme ts d n t

s ow a sig ific nt vis al d gra atio c mp re to th d ta pro id d b th n n-d f ectiv

d te tor eleme t of a oth rwis e uiv le t digital X-R Y IMA E RECE TO

This re la eme t PR CE S s al matc th c r e t state of th digital X-R Y IMA E RECE TOR,

or th late t d s riptio of its DEFECTIVEDE ECTO ELEME T

Th re la eme t PR CE S s al b a ple to al ima e s e if i d for th IN E DED U E in

clnic l pra tic

Th RISK MANA EME T FILE s al in lu e

– th d s riptio of th re la eme t PR CE S,

– th s e if i atio of th p rforma c pro id d b th re la eme t PR CE S,

– th ju tific tio for its c p bi ty to f ulfi th n e

Me n s al b pro id d to inform th RE PON IBLE O GANISATION if th c r e tly a ple

re la eme t PR CE S d e or d e n t alow a hie eme t of th s e if i d p rforma c

Th s me n ma b a tomatic, or p rt of th q alty c ntrol pro e ure to b p rforme b

th RE PON IBLE O G NISATION Th in tru tio s for u e s al c ntain in tru tio s o h w a d

wh n to u e th s me n , to eth r with th d s riptio of th me s re to b ta e in c s s

of faiure

Compliance is ch ck ed b insp cti n of the RISK M ANAGE M EN T FILE and the AC OM PAN YING

DOCU M EN TS