Iec 60601 2 8 2015

This p rtic lar stan ard esta l s es req irements to b compl ed with by the MA UFA TURERS in the desig an con tru tion of thera eutic X-RA EQUIPMENT.. MEDICAL ELECTRICA L EQUIPMENT – Par

Medical elect rical equipment –

Part 2- 8: Part icular requirement s for t he basic safety and essential per ormance

oft herapeut ic X- ray equipment operat ing in t he range 10 k V t o 1 MV

Apparei s élect romédicaux –

Part ie 2- 8: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des équipement s à rayonnement X de t hérapie fonct ionnant dans la

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

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

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

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

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

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

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A pro os de l'IEC

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

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

A pro os de p blc t i ns IEC

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

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Applc t io a t on me p ur c n ult er t ou le re s ig eme t s

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

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

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

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Recherche de p blc t i ns IEC - w ww ie ch/ se rch u

L re h rc e avan é p rmet d t ro ver d s p blc tio s IEC

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

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Medical elect rical equipment –

Part 2- 8: Part icular requirement s for t he basic safety and essential perormance

of t herapeut ic X - ray equipment operat ing in t he range 10 k V t o 1 MV

Apparei s élect romédicaux –

Part ie 2- 8: Ex igences part icul ères pour la sécurit é de ba e et les per ormances

essent iel es des équipement s à ray nnement X de t hérapie fonct ionnant dans la

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

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inside

IEC 60601 - 2- 8

Editio 2.1 2 15-0

Medical elect rical equipment –

Part 2- 8: Part icular requirement s for t he basic safety and essential per ormance

oft herapeut ic X- ray equipment operat ing in t he range 10 k V t o 1 MV

Apparei s élect romédicaux –

Part ie 2- 8: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des équipement s à rayonnement X de t hérapie fonct ionnant dans la

CONTENTS

FOREWORD 3

INTRODUCTION 5

INTRODUCTION TO THE AMENDMENT 5

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

2 1.2 Normative referen es 7

2 1.3 Terms an definition 8

2 1.4 General req irements 8

2 1.5 General req irements f or testin of ME EQUIPMENT 9

2 1.6 Clas if i ation of ME EQUIPMENT an ME SYS EMS 1

2 1.7 ME EQUIPMENT identification, markin an doc ments 1

2 1.8 Protection again t electrical H ZARDS f om ME EQUIPMENT 14 2 1.9 Protection again t MECH NIC L H ZARDS of ME EQUIPMENT an ME SYS EMS 15 2 1.10 Protection again t u wanted an ex es ive radiation H ZARDS 15 2 1.1 Protection again t ex es ive temp ratures an other H ZARDS 3

2 1.12 Ac urac of controls an in truments an protection again t hazardou outputs 3

2 1.13 HAZARDOUS SITU TIONS an fault con ition f or ME EQUIPMENT 3

2 1.14 PR GRAMMABLE ELECTRICAL MEDIC L SYS EMS (PEMS) 3

2 1.15 Con tru tion of ME EQUIPMENT 3

2 1.16 ME SYS EMS 31

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

Bibl ogra h 3

In ex of def i ed terms u ed in this p rtic lar stan ard 3

Ta le 2 1.101 – Data req ired in the tec nical des ription to s p ort Clau e 2 1.10 SIT an TY ET S compl an e 1

0 Ta le 2 1.10 – Permis ible LEA AGE RA IATION 16 Ta le 2 1.10 – Permis ible LEA AGE RA IATION fom X-RA TUB AS EMBLIE with B AM LIMITING DEVICE 18 Ta le 2 1.10 – Overview of me s rements 2

 IEC 2 15

MEDICA L ELECTRICA L EQUIPMENT –

Part 2-8: Particular requirements f or the basic safety and essential

perf ormance of therapeutic X-ray equipment operating

in the range 10 kV to 1 MV

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

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

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

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

Te h ic l Re orts, Pu lcly Av ia le Sp cif i atio s (P S) a d Guid s (h re fter ref ere to a “IEC

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

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

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

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

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

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

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

intere te IEC Natio al Commite s

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

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

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

misinterpretatio b a y e d u er

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

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

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

th later

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

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

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

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

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

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

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

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

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

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

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

This Consol date v rsion of IEC 6 6 1-2-8 be rs the e ition n mber 2.1 It consists of

the s cond e ition (2 10-1 ) [doc me ts 6 C/4 9/FDIS a d 6 C/5 5/RVD] a d its

ame dme t 1 (2 15-0 ) [doc me ts 6 C/5 3/CDV a d 6 C/619/RVC] The te h ic l

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

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

is modifie by ame dme t 1 Additions are in gre n te t, deletions are in strikethroug

re te t A s parate Final v rsion with al c a g s a c pte is a ai able in this

publ c tion

International Stan ard IEC 6 6 1-2-8 has b en pre ared by IEC s bcommit e 6 C:

Eq ipment for radiothera y, n cle r medicine an radiation dosimetry, of IEC tec nical

commit e 6 : Electrical eq ipment in medical practice

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

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

– Req irements an definition : roman typ

– Test sp cific tions: ital i ty e

– Inf ormativ material a p arin o tsid of ta le , s c a n te , e ample a d ref ere c s: in smaler ty e

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

– TER S DE INED IN CLA S 3 OF THE GENERAL S A D RD, IN THIS P RTIC LAR S A D RD OR AS

NOT D: SMAL C PITALS

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

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

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

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

s bclau es of Clau e 7)

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

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

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

combination of the con ition is true

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

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

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

with this stan ard;

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

man atory f or compl an e with this stan ard;

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

test

A lst of al p rts of the IEC 6 6 1 series, publ s ed u der the general title M E DICAL

E LE CTRICAL EQU IPM E N T, can b fou d on the IEC we site

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

remain u c an ed u ti the sta i ty date in icated on the IEC we site u der

"ht p:/ we store.iec.c " in the data related to the sp cific publ cation At this date, the

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

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

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

colour printer

 IEC 2 15

X-RA EQUIPMENT f or RA IOTHERA Y purp ses is u ed f or T LE HERA Y, where the RA IATION

SOURCE is far fom the tis ues to the tre ted (u ual y more than 5 cm), an also for

BRA H THERA Y, where the RA IATION SOURCE is p sitioned within or adjacent to the tis ue to

b tre ted This p rtic lar stan ard covers X-RA EQUIPMENT for b th T LE HERA Y an

BRA H THERA Y

The u e of X-RA EQUIPMENT for RA IOTHERA Y purp ses may exp se the P TIENT to dan er if

the eq ipment f ais to delver the req ired dose to the P TIENT, or if the eq ipment desig

do s not satisfy stan ard of electrical an mec anical safety The eq ipment may also cau e

dan er to p rson in the vicinity if the eq ipment itself fais to contain the radiation

adeq ately an /or if there are inadeq acies in the desig of the TREATMENT R OM

This p rtic lar stan ard esta l s es req irements to b compl ed with by the MA UFA TURERS

in the desig an con tru tion of thera eutic X-RA EQUIPMENT Subclau e 2 1.10.1 contain

l mits b yon whic INT RLOC S prevent, INT R U T or T R IN T IR A IATION in order to

avoid an u safe con ition

Subclau e 2 1.10.1 do s not at empt to define o timum p rf orman e req irements Its

purp se is to identify those f eatures of desig that are regarded, at the present time, as

es ential f or the saf e o eration of s c eq ipment It places l mits on the degradation of

eq ipment p rf orman e b yon whic it can b pres med that a f ault con ition exists, e.g a

comp nent fai ure, an where an INT RLOC then o erates to prevent contin ed o eration of

the eq ipment

It s ould b u dersto d that, b f ore in talation, a MA UFA TURER can provide a compl an e

certif i ate relatin only to TY E T S S: data avaia le fom SIT T S S s ould b in orp rated

in the A COMP NYING DOC MENT , in the f orm of a SIT T S re ort, by those who test the

eq ipment at in talation

MEDICAL ELECTRICA L EQUIPMENT –

Part 2-8: Particular requirements f or the basic safety and essential

perf ormance of therapeutic X-ray equipment operating

in the range 10 kV to 1 MV

201.1 Scope, obje t and relate standards

Clau e 1 of the general stan ard

1

a pl es, ex e t as fol ows:

2 1.1.1 Sco e

Re la eme t:

This international stan ard a pl es to the b sic saf ety an es ential p rf orman e of

thera eutic X-RA EQUIPMENT with NOMIN L X-RA TUB VOLTAGE in the ran e 10 kV to 1 MV

when con ected to alternatin c r ent SU PLY MAINS, here f ter refer ed to as ME EQUIPMENT

NOT This sta d rd c v rs T LE H RA Y a d BRACH T ERA Y

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

ME SYS EMS only, the title an content of that clau e or s bclau e wi say so If that is not the

case, the clau e or s bclau e a pl es b th to ME EQUIPME

The o ject of this p rtic lar stan ard is to establ s p rtic lar b sic saf ety an es ential

p r orman e req irements f or thera eutic X-RA EQUIPMENT It in lu es the req irements for

ac urac an re rod cibi ty of p rf orman e to the extent that these are related to radiation

q al ty an the q antity of ionizin radiation prod ced an th s mu t b con idered as

asp cts of safety

2 1.1.3 Col ateral sta d rds

Add ition:

This p rtic lar stan ard ref ers to those a pl ca le col ateral stan ard that are lsted in

Clau e 2 of the general stan ard an Clau e 2 1.2 of this p rtic lar stan ard

Th g n ral sta d rd is IEC 6 6 1 1:2 0 a d IEC6 6 1 1:2 0 /AMD1:2 12, Medical electrical equipm ent – Part 1:

G en ral requirem ents for ba s ic s afety a d e s ential p ro rm ance

2)

IEC 6 6 1 1 10, M edical el ectrical eq ipme t – Part 1-10: Ge eral req ireme t s for b sic s fet y a d e s nt ial

 IEC 2 15

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

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

ME EQUIPMENT u der con ideration, an may ad other b sic safety an es ential

p r orman e req irements

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

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

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

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

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

of Clau e 1 of the general stan ard) or a plca le colateral stan ard with the pref i “2 x”

where x is the final digit s) of the col ateral stan ard doc ment n mb r (e.g 20 4 in this

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

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

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

SPECIFIED by the u e of the f ol owin word :

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

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

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

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

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

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

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

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

stan ard are n mb red 3.1 throu h 3.13 , ad itional definition in this stan ard are

n mb red b gin in f om 2 1.3.2 1 Ad itional an exes are let ered AA, BB, etc an

ad itional items a ), b ), etc

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

n mb red startin fom 2 x, where “x” is the n mb r of the colateral stan ard, e.g 2 2 for

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

The term "this stan ard" is u ed to make referen e to the general stan ard, an a plca le

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

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

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

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

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

statement to that eff ect is given in this p rtic lar stan ard

201.2 Normativ referenc s

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

Add ition:

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

IEC 6 6 1-2-1:2 0 , Med ic l ele tric l e uipme t – P art 2-1: Part ic lar re uireme ts for t he

b sic safety a d es e tial p rorma c of ele tro a c lerators in t he ra g 1 MeV to 50 MeV

IEC 61217, Rad iothera y e uipme t – Co rd inates, moveme ts a d sc les

ISO/IEC Guide 9 -3:2 0 , Un ertainty of me sureme t – P art 3: Guid e to th e pres ion of

RA IOTHERA Y u in one or more RA IATION SOURCE with the RA IATION SOURCE/sources

in ide or close to the TARGE VOLUME

NOT B ACH T ERA Y te h iq e in lu e IN ERS ITIAL, IN RACA IT RY, S P RFICIAL or IN RALUMIN L

RA IOT ERA Y

2 1.3.2 2

INT RS ITIA L RA DIOTHERAPY

RA IOTHERA Y with RA IATION SOURCE in erted within the TARGE VOLUME

2 1.2.2 3

INTRA CA VITA RY RA DIOTHERA PY

RA IOTHERA Y in whic one or more RA IATION SOURCE , with or without SOURCE A PLICATORS,

are introd ced into a b d cavity throu h a natural or artificial o enin

2 1.3.2 4

INTRA LUMINA L RA DIOTHERA PY

RA IOTHERA Y in whic one or more RA IATION SOURCE , with or without SOURCE A PLICATORS,

are introd ced into a b d lumen s c as a blo d ves el, air way, or the gastrointestinal tract

2 1.3.2 5

SOURCE A PP ICA TOR

<BRA H THERA Y device to brin one or more RA IATION SOURCE into the inten ed p sition

NOT A SOUR E A PLICA O ma in lu e prote tiv s ieldin

2 1.3.2 6

T L RA DIOTHERA PY

T LE HERA Y

RA IOTHERA Y with a large RA IATION SOURCE TO SKIN DIS A CE, u ual y not les than 5 cm

201.4 Ge eral requirements

Clau e 4 of the general stan ard a ples, ex e t as f ol ows:

Add ition l su cl ause:

 IEC 2 15

2 1.4.101 Conv ntional me ning of ele tric l qu ntitie

In this p rtic lar stan ard, u les otherwise in icated, values of X-RA TUB VOLTAGE ref er to

p ak values

201.5 Ge eral requirements f or testing of ME EQUIPMENT

Clau e 5 of the general stan ard a ples, ex e t as f ol ows:

2 1.5.1 TYP T S S

Add ition:

2 1.5.1.101 Te t gra e

Thre grades of TY E T S an two of SIT T S proced res are SPECIFIED in 2 1.10 of this

p rtic lar standard; their req irements are as fol ows:

– TY E T S grade A: an analy is of ME EQUIPMENT desig , as related to the SPECIFIED

radiation safety provision , whic s al res lt in a statement in lu ed in the tec nical

des ription, regardin the workin prin iples or con tru tional me n by whic the

req irement is f ulfi ed;

– TY E T S /SIT T S grade B: vis al in p ction or f un tional test or me s rement of the

ME EQUIPMENT The test s al b in ac ordan e with the proced re SPECIFIED in this

p rtic lar stan ard an s al be b sed on o eratin states, in lu in fault con ition states,

whic are ac ieva le only without intereren e with the circ itry or con tru tion of the

ME EQUIPMENT;

– TY E T S /SIT T S grade C: fu ctional test or me s rement of the ME EQUIPMENT The

test s al b in ac ordan e with the prin iple SPECIFIED in this p rtic lar stan ard The SIT

T S proced re s al b in lu ed in the tec nical des ription When the proced re

in olves o eratin states that req ire intereren e with the circ itry or the con tru tion of

the ME EQUIPMENT, the test s ould b p rf ormed by, or u der the direct s p rvision o the

MA UFA TURER or the MA UFA TURER’S agent

Ta le 2 1.101 s mmarises the data req ired in the tec nical des ription to s p ort Clau e

2 1.10 SIT T S compl an e

2 1.5.4 Other con itions

Add ition:

a ) The A COMP NYING DOCUMENT s al in lu e

1) statements res ltin f rom TY E T S S: grade A;

2) detais of an res lts fom TY E T S S: grade B an grade C;

3) SPECIFIC proced res an test con ition f or SIT T S S grade C;

4) in tru tion on how to generate a des rib d fault con ition or, if not practica le, how

to generate a test sig al as close as practica le to the source of the sig al that

would have generated it, with a statement con rmin that the test sig al simulates

the one that would b prod ced in a p rtic lar fault con ition;

NOT In s me c s s, o e te t sig al ma simulate more th n o e f ault c n itio

5) in tru tion on how to reset the ME EQUIPMENT f or NORMAL US af ter the completion of

the SIT T S an how to verify this con ition

Compl ian e is c e k d b insp ct io of the ACC M PAN YING D CU M E N TS

with th AC O P N ING DO UME T ; in a ditio , th SIT T S re ort s o ld c ntain at le st th folowin : n me

a d a dre s of th RE PON IBLE O GA IZ TION site; M D L O T P REFERE CE of th e uipme t; n me, statu a d

emplo me t a dre s of al p rs n el ta in p rt in th te ts, a d d te of th ir p rticip tio ; e viro me tal a d

p wer s p ly c n itio s; th a tu l c n itio s, wh n te t c n itio s, pro e ure or d vic s diff er f rom th s giv n

b th MA UFACT RER, or wh re th informatio c n ot b d riv d f rom this p rtic lar sta d rd

Table 2 1.101 – Data re uire in the te h ic l d s ription to s pport

NOT Ŧ re uireme t of s b la s h vin n oth r id ntific tio

2 1.5.5 Supply volta e , type of c r e t, nature of s pply, fre u nc

Add ition:

a ) For al tests for the me s rement of AIR KERMA an AIR KERMA RAT in air for compl an e

with req irements on LEA AGE RA IATION an stray radiation it is as umed that the SU PLY

MAINS u ed f or the test is del verin its output at its nominal values

201.6 Clas if ic tion of ME EQUIPMENT a d ME SYS EMS

Clau e 6 of the general stan ard a ples

201.7 ME EQUIPMENT identif ication, marking and doc ments

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

2 1.7.2.2 Ide tific tion

Add ition:

X-RA TUB S an X-RA TUB HOUSING/as embl es s al b s p l ed to the RE PONSIBLE

OR A IZATION together with A COMP N ING DOC MENT

An inf ormation given on the X-RA TUB HOUSING s al not diff er f om that also given in the

A COMP N ING DOC MENT an s al in icate ac urately the data a plyin to the X-RA TUB

as embled in the X-RA TUB HOUSING It s al b the resp n ibi ty of the organization

as embl n the X-RA TUB into the X-RA TUB HOUSING to en ure that this inf ormation is

ac urate, an make s c c an es as may b neces ary in the event of X-RA TUB

re lacement Se also 2 1.10.1.2.10 8

X-RA TUB S s al car y the f olowin markin s (not a pl ca le to X-RA TUB AS EMBLIE

inten ed for BRA H THERA Y):

• name or trademark of the MA UFA TURER;

• MODEL OR TY E RE ERENCE;

• in ivid al identif i ation.

The a ove markin s may b given in the f orm of a combined desig ation explained in the

A COMP N ING DOCUMENT

X-RA TUB HOUSINGS s al car y the f ol owin markin s (not a plca le to X-RA TUB

AS EMBLIE inten ed f or BRA H THERA Y):

– name or trademark of MA UFA TURER or s p l er;

– typ an S RIAL N MB R of X-RA TUB HOUSING;

– maximum p rmis ible voltage of X-RA TUB HOUSING

X-RA TUB AS EMBLIE s al car y the f olowin markin s (not a plca le to X-RA TUB

AS EMBLIE inten ed f or BRA H THERA Y):

– name or trademark of MA UFA TURER or s p l er;

– typ an S RIAL N MB R of X-RA TUB ;

– maximum p rmis ible X-RA TUB VOLTAGE;

– nominal value of the p rmanent

FILTRATION of the X-RA TUB AS EMBLY in q al ty

eq ivalent FILTRATION;

– p sition of FOC L SPOT

X-RA TUB AS EMBLIE inten ed f or BRA H THERA Y s al car y the f ol owin markin s:

– typ an S RIAL N MB R of X-RA TUB AS EMBLY;

The A COMP N ING DOC MENT of X-RA TUB AS EMBLIE inten ed for BRA H THERA Y s al

– p sition of FOC L SPOT relative to the outside of the X-RA TUB AS EMBLY

NOT Sin e X-RA T B A S MBLIE inte d d f or BRACH T ERA Y are smal a d th X-RA T B a d th X-RA

T B HOU ING are of a inte ral d sig n t inte d d to b s rvic d in th f i ld it wo ld b impra tic l a d

u n c s ary to mark th tu e a d th h u in s p rately

The nominal value of the p rmanent FILTRATION in the SPECIFIED ran e of o eratin voltages

s al b in icated in the f orm of q al ty eq ivalent FILTRATION as fol ows:

– in thic nes of aluminium f or thera eutic X-RA TUB S f or o eration at voltages within the

ran e f rom 10 kV up to an in lu in 15 kV;

– ex e tional y, in thic nes of b ryl um or another s bstan e, e.g molybden m, for

thera eutic X-RA TUB S when the tub win ow is comp sed s bstantial y of b ryl um or

this other s bstan e;

– in thic nes of co p r f or thera eutic X-RA TUB S f or o eration at voltages within the

ran e f om 15 kV up to an in lu in 1 MV

Where there is a sig ificant variation in p rmanent FILTRATION of the X-RA TUB over the

entire ran e of voltages, this variation s ould b stated in the A COMP N ING DOC MENT

In cases where, for con enien e, p rmanent

FILTRATION is in icated in thic nes of other

material, e.g iron, the q alty eq ivalent FILTRATION of aluminium or co p r ac ordin to the

o eratin ran e of voltages s al also b given

2 1.7.2.6 Conne tion to the SUP LY MA INS

 IEC 2 15

For thera eutic X-RA EQUIPMENT that is SPECIFIED to b p rmanently in taled, the inf ormation

req ired in s bclau e 7.2.6 of the general stan ard ne d only b stated in the A COMP N ING

DOCUMENT

2 1.7.2.7 Ele tric l input power from the

SUP LY MA INS

Add ition:

For thera eutic X-RA EQUIPMENT that is SPECIFIED to b p rmanently in taled, the inf ormation

req ired in s bclau e 7.2.7 of the general stan ard ne d only b stated in the A COMP N ING

DOCUMENT

If compl an e with this stan ard is to b marked on the outside of the X-RA EQUIPMENT, s c

markin s al b made in combination with the MODEL OR TY E RE EREN E as fol ows:

MODELOR TY E RE ERENCE IEC 6 6 1-2-8:2 10

Markin in icatin compl an e of eq ipment, or s b s embly there f, with the req irements of

this stan ard s al b made only if compl an e of the ME EQUIPMENT or the s b s embly is

a) a mec anical s ale, or a n merical in ication, for e c avaia le movement;

b) a LIGHT FIELD in ication of the X- ay f ield, where an adju ta le B AM A PLIC TOR is

provided;

c) a mec anical s ale, or a n merical in ication, of the RA IATION SOURCE TO SKIN DIS A CE

The desig ation, direction of in re sin value an zero p sition of al movements s al comply

th s inof th P TIE T th pro isio s re uire b this s b la s are n t rele a t f or this ty e of d vic s

Compl ian e is c e k d b insp ctio

2 1.7.8.1 Colours of in ic tor l ghts

Add ition:

NOT Su cla s s 2 1.10.1.2.10 6 a d 2 1.10.1.2.1 1 of this p rtic lar sta d rd, a d 7.8 a d 15.4.4 of th

g n ral sta d rd, d al with in ic tors a d in ic tor lg ts

2 1.7.9 ACCOMPA NYING DOC MENT

2 1.7.9.1 Ge eral

Add ition:

The A COMP N ING DOC MENT s al cle rly state the identity of the thera eutic X-RA

EQUIPMENT, or s b s embly there f, to whic they ref er

The A COMP N ING DOC MENT s al state the lan uage(s) in whic they were original y

a proved by the

R an s al give a ref eren e identifyin at le st one original

version

NOT Ate tio is drawn to th fa t th t AC O P N ING DO UME T in a la g a e oth r th n th t in whic th y

are s p le a d a pro e b th MA UFACT RER of th ME EQUIPME T or s b s embly n e a c ref ul c e k b a

e p rt wh , wh re er p s ible, s o ld b a th riz d b th MA UFACT RER to a t in this c p city

2 1.7.9.3.1 Ge eral

Add ition:

The tec nical des ription s al contain ap ro riate in tru tion for the con ection of the

thera eutic X-RA EQUIPMENT to the SUP LY MAINS

The p sition of a referen e centre as the centre of a sphere of 10 mm radiu containin the

FOC L SPOT s al b des rib d in the A COMP NYING DOC MENT

NOT In this p rtic lar sta d rd th c ntre of th s h re is ref ere to a th refere c c ntre a d is u e o ly to

d s rib a plc ble dista c s f or th re uireme ts o LE K GE RA IA ION, s e 2 1.10.1.2.101

For BRA H THERA Y devices the MA UFA TURER s al des rib the p sition of the FOC L SPOT

an state the ac urac of this p sition in the A COMP NYING DOC MENT

Add ition l su cl ause:

2 1.7.9.101 Stateme t of compl a c

An statement of compl an e of a thera eutic X-RA EQUIPMENT with this stan ard s al b

made in the fol owin form:

Therap utic X-RA EQUIPMENT MODELOR TY E RE ERENCE IEC 6 6 1-2-8:2 10

201.8 Prote tion against electrical HAZARDS f rom ME EQUIPMENT

Clau e 8 of the general stan ard a ples, ex e t as f ol ows:

2 1.8.4.3 ME EQUIPMENT inte de to be conne te to a power sourc by a plug

Add ition:

Detac a le HIGH VOLTAGE C BLE CON ECTIONS s al b desig ed so that the u e of TOOLS is

req ired to dis on ect them

Provision s al b made to prevent the a p aran e of an u ac e ta ly HIGH VOLTAGE in the

MAINS P RT or in any other low voltage circ it as a res lt of a def ect or tran ient phenomenon

in the HIGH VOLTAGE circ it

NOT This c n b a hie e for e ample:

– b pro isio of a win in la er or a c n u tiv s re n c n e te to th PR T CTIV E RT T R IN L b twe n

HIGHVOLT GE a d low v lta e circ its;

– b pro isio of a v lta e lmitin d vic a ro s termin ls to whic e tern l d vic s are c n e te a d

b twe n whic a e c s iv v lta e mig t aris if th e tern l p th b c me dis o tin o s

Compl ian e sh ll b c ec ed b insp ction of d esign d ata a d c nstru t ion

 IEC 2 15

2 1.8.8.3 Diele tric stre gth

Add ition:

The dielectric stren th of the electrical in ulation of HIGH VOLTAGE circ its s al b s f ficient to

with tan the test voltages f or the d ration given in item a) of 2 1.8.8.3

The test s al b made without an X-RA TUB con ected an with a test voltage of 1,2 times

the NOMINAL X-RA TUB VOLTAGE of the thera eutic X-RA EQUIPMENT

If the thera eutic X-RA EQUIPMENT can b tested only with the X-RA TUB con ected an if

the X-RA

TUB

do s not al ow the thera eutic X-RA

EQUIPME

NT to b tested with a test

voltage of 1,2 times the NOMIN L X-RA TUB VOLTAGE, the test voltage may b lower but not

les than 1,1 times that voltage

I t em a)

Add ition:

The HIGH VOLTAGE circ its of thera eutic X-RA EQUIPMENT s al b tested by a plyin a test

voltage of 5 % of its f i al value ac ordin to 8.8.3 of the general stan ard, an in re sin it

d rin a time of 10 s to the final value, whic then s al b maintained for d ration of 15 min

2 1.8.10 Comp ne ts a d wiring

Add ition l su cl ause:

2 1.8.10.101 Ac e sible HIGH VOL A GE c ble

Ac es ible HIGH VOLTAGE ca les car yin X-RA TUB C R ENT s al in orp rate a flexible

con u tive s re n havin a maximum resistan e of 1 Ωm

–1

covered with a non-con u tive

material ca a le of protectin the s re n again t mec anical damage in NORMAL US

The s re n s al b con ected to the con u tive en los re of the HIGH VOLTAGE GENERATOR

an to that of the X-RA TUB AS EMBLY

Compl ian e sh l l b c e k d b visu l insp ction a d b me sureme t

The f lexible con u tive s re n is not to b recog ized as satisfyin a req irement f or a

protective e rth con ection b twe n the devices con ected by the ca le

201.9 Prote tion against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYST MS

Clau e 9 of the general stan ard a ples, ex e t as f ol ows:

2 1.9.4.1 Ge eral

Add ition:

The INS RUCTIONS FOR US s al in icate the maximum p rmit ed in l nation f or sta i ty an

the recommen ation to a ply whe l loc s or brakes d rin NOR AL US of the ME EQUIPMENT

201.10 Prote tion against unwante and excessive radiation HAZARDS

Clau e 10 of the general stan ard a pl es, ex e t as f ol ows:

2 1.10.1.2 ME EQUIPMENT inte de to produc dia nostic or th rape tic X-RA DIA TION

Add ition:

The req irements of this s bclau e a ply to thera eutic X-RA EQUIPMENT in NO MAL US

The req irements s al b met f or e c SPECIFIE

D X-RA

TUB HOUSIN

G, whatever X-RA

TUB

SPECIFIED as s ita le it may contain, an f or al combination of comp nents an o erating

con ition SPECIFIED for the X-RA EQUIPMENT an relevant to the req irements

2 1.10.1.2.101 Limitation of L A KA GE RA DIATION from the X-R Y TU E A SS MBLY during

tre tme ts

The AIR KER A RAT f rom LEA AGE RA IATION f rom the X-RA TUB AS EMBLY, whic f or the

purp ses of this s bclau e s al b con idered to in lu e an

at a dista c of 5 mm f rom th s rf ac of th X-RA T B

A S MBLY

a

Se 2 1.10.1.2.10 a d f or e uipme t n t d sig e a d S ECIFIE to lo ate th TRE TME T C N R L P N L

o tsid th TRE TME T R O , s e 2 1.10.1.2.10

NOT 1 Prote tio of th OP RA O a ain t h z rd u ra iatio is th re p n ibi ty of th RE PON IBLE

O GA IZ TION

This s bclau e is not a plca le to X-RA TUB AS EMBLIE inten ed f or BRA H THERA Y

Compl ian e sh l l b c e k d u d er th foll owing c nd it ions:

– Th RADIATION APE RTU RE ofthe X-RAY TU BE H OU SIN sh l l b c vered so t hat th AIR KERM A

RATE o t he RADIATION BE AM axis is red uc d b a fa t or of at le st 10

6

Th d ime sio s

a d l oc tion of the a ert ure sh l l b stated in t he ACC M PAN YIN G D CU M EN TS Th c ver

sh l l n t ext end o tsid e t he RADIATION BEAM b more th n 5 mm

– Measurements of t he AIR KERM A RATE sh l l b made with the th ra e tic X-RAY E QU IPM E NT

o erat ed u d er c nditions that are p s ibl e wit hin the sp cific tions given in the

AC OM PAN YIN G D CU M E N TS a d are t he l east fa o ra le with re ard to c mplian e wit h t he

re uireme ts

NOT 2 Normaly th le st f av ura le c n itio s, th t is, c n itio s th t wo ld le d to ma imum LE K GE

RA IA ION, s al b d termin d b in p ctio of th S ECIFIE c n itio s of o eratio

– Measureme ts mad e at 1 m d ista c fom t he refere c c ntre (se n te in 2 1.7 9.3.1)

sh ll a era e the AIR KE RM A RATE o er a are of 10 cm

2

in the pla e of me sureme t

with n principal ine r d ime sion gre t er tha 2 cm

I n ord er to avera e t he AIR KE RM A RATE fom sma b ams of LE AKAGE RADIATION o er

th a pro riat e are , th RADIATION DE TECTOR ma h ve a e try wind ow with a are of

2

 IEC 2 15

– Measureme ts made at 50 mm d ista c fom th sura e of the X-RAY TU BE AS EM BLY

sh l l avera e the AIR KERM A RATE o er a are of 10 cm

2

, with n princip l line r

d ime sio gre ter tha 4 cm

Th RADIATION DETE TOR ma h ve a e try wind ow with a are of10 cm

2

– Measurements of AIR KE RM A RATE sh l l b made at the a p c bl e d istan es given in

Ta le 2 1.10 , u les t his is n t p ysic ly p s ibl e, in whic c se me surements ma b

mad e at a other d ist an e, as cl ose as p s ible to th re uired d istan e, a d refered to

th re uired d istan e

2 1.10.1.2.10 Limitation of L A KA GE R DIA TION a d unwa te ra iation from the X-R Y

TU E A SS MBLY at time oth r tha during tre tme ts

The req irements of this s bclau e are for al thera eutic X-RA EQUIPMENT, b th those in

whic the X-RA TUB can remain energized after a tre tment has b en terminated

intentional y, an those in whic the X-RA TUB is de-energized at the en of a tre tment

When me s rement is started at le st 5 s af ter an one o eration or event that sto s the

emis ion of the RA IATION B AM, the AIR KERMA RAT f rom LEA AGE RA IATION fom the X-RA

TUB AS EMBLY an fom radiation in the direction of the RA IATION B AM s al not ex e d a

at a distan e of 5 mm f rom the s rf ace of the X-RA TUB AS EMBLY

Compl ian e sh l l b c e k d u d er th following c nd it ions:

– Th thera e t ic X-RAY EQU IPM E N T sh ll b o erat ed u d er c nd itions of use th t are

p s ible within the sp cific tion giv n in the AC OM PAN YIN G D CU M E N TS, a d are the least

favoura l e wit h re ard t o this re uireme t , a d are S ECIF IE D as a p c ble for p rso s

ot her tha PATIEN TS to b n ar th X-RAY TU BE AS EM BLY wh n a tre tme t is n t b ing

c ried o t

– Measureme ts mad e at 1 m dist an e fom t he refere c c ntre sh l l a era e the AIR

KE RM A o er a are of 10 cm

2

in the pl an of me sureme t with n prin ipal line r

d ime sio gre ter th n 2 cm

– Measureme ts made at 50 mm fom th sura e of th X-RAY TU BE AS E M BLY sh ll a era e

th AIR KE RM A o er a are of 10 cm

2

with n principal line r dime sion gre ter tha 4 cm

– Measureme ts of AIR K RM A sh l l b mad e at t he a p c ble d istan es re uired in t his

su cl ause, u l es this is n t p ysic l l p s ibl e, in whic c se me sureme ts ma b

mad e at a other d istan e, as close as p s ibl e t o th re uired d ist an e, a d refered to

the re uired d ist an e

2 1.10.1.2.10 Limitation of u wa te ra iation f rom th X-RA Y TU E A SS MBLY with

BEAM LIMITING DEVICE or therape tic BEAM A PP ICA TORS

2 1.10.1.2.10 1 At a hme t of a c s orie

An B AM LIMITING DEVICE s p l ed or SPECIFIED s al b :

– an integral an p rmanent p rt of a remova le thera eutic B AMA PLIC TOR; or

– an integral an p rmanent p rt of a remova le adju ta le ac es ory B AM LIMITING

DEVICE; or

– p rmanently atac ed to the X-RA TUB HOUSING (se 2 1.10.1.2.101)

An remova le thera eutic B AM A PLIC TOR an an remova le adju ta le B AM LIMITING

DEVICE s al b so desig ed that the only man er in whic they can b at ac ed is directly

to the X-RA

TUB AS EMBL

Y

2 1.10.1.2.10 2 Limitation of ra iation to the PATIENT

X-RA TUB AS EMBLY, the AIR KERMA RAT S outside the RA IATION FIELD s al not ex e d the

p rcentages given in Ta le 2 1.10 of the AIR KER A RAT S on the RA IATION B AM axis

Table 2 1.10 – Permis ible L A KA E RA DIA TION f rom X-RA Y TU E A SS MBLIE

with BEAM LIMITING DEVICE

Lateral dimensio s of he le d block

Maximum AIR KER A R T at al pla e more than

Compl ian e sh ll b c ec ed u d er th following c nd it ions:

– All me sureme ts sh l l b mad e whe the X-RAY E QU IPM E NT is o erat ed at N OM IN AL X-RAY

TU BE V LTAG a d wit h the most att en ating FILTRATION S ECIF IE D

– Measurements sh l b mad e with fl at l ead bl ock s, or bl oc s of other at te u ting mat erial,

th t h v the same sh p as t he

RADIATION

FIELD a d the d ime sio s re uired in Ta le

2 1.10 Th bl oc s sh l l provid e suficient AT E NU ATION t o red uc t he AIR KERM A RATE o

th RADIATION BE AM a is b a fa t or of at l east 10

4

Curved rad io tra sluc nt d istal e ds of thera e tic BEAM AP LICATORS ma b removed for

th p rp se of me sureme ts

– Measureme ts sh l l b mad e at pl ac s more th n 2 mm fom t he ed ges of t he l ead blo k

in th plan of th d istal sura e of the BE AM LIM ITIN G DE VIC

– For ad just abl e BE AM LIM ITING DEVICE S, me sureme ts sh l b made at the minimum a d

ma imum fiel d sizes a ail able

– Measureme ts sh l avera e AIR KERM A RATE over a are ofn t more t ha 10 cm

AIR KER A RAT at an p sition 5 mm f rom the s rf ace of an p rt of the thera eutic

X-RA EQUIPMENT other than the X-RA TUB AS EMBLY s al not ex e d 0,0 mGy h

-

Compl ian e sh l l b c e k d u d er the foll owing c nd itions:

– Measureme ts sh l l b mad e with th X-RAY E QUIPM EN T o erated u d er c nd it ions of use

th t are p s ibl e wit hin the sp cific tions giv n in th AC OM PAN YIN D CU M E N TS a d are

th le st fa ou ra le with reg ard to this re u ireme t

– Measureme ts sh ll avera e the AIR KERM A RATE o er a are of 10 cm

2

, wit h n prin ipal

l i e r d ime sions gre ter t ha 4 cm

– Measureme ts sh ll b mad e at the a plc bl e d istan e

2 1.10.1.2.10 Control of IR A DIA TION

2 1.10.1.2.10 1 Tre tme t control pa el outside tre tme t room

Thera eutic X-RA EQUIPMENT not inten ed to b control ed in the vicinity of the P TIENT s al

b desig ed to b in tal ed so that the controls f or initiation of IR A IATION an the adju tment

s al b p s ible to re-energize the X-RA TUB only by an OPERATOR action fom the

TREATMENT CONTR L P NEL

2 1.10.1.2.10 2 Dista t in ic tion

Therap utic X-RA EQUIPMENT s al b provided with con ection f or an in icatin device

remote fom the TREATMENT CONTR L P NEL ar an ed so that s c a device can give an

in ication whi e its HIGH VOLTAGE GENERATOR is in a con ition cor esp n in to the emis ion of

a RA IATION B AM Tec nical detai s for the con ection of a s ita le device s al b given in

the A COMP NYING DOC MENT

2 1.10.1.2.10 3 Dista t control

Thera eutic X-RA EQUIPMENT s al b provided with con ection for a device that can b

p sitioned remote f om the TREATMENT CONTR L P NEL ar an ed so that s c a device can

cau e the X-RA

EQUIPME

NT to inter upt emitin a

RA IATION B AM

an can prevent the X-RA

EQUIPMENT f om startin to emit a RA IATION B AM Tec nical detai s f or the con ection of a

s ita le device s al b given in the A COMP N ING DOCUMENT

2 1.10.1.2.10 4 Inter uption

Thera eutic X-RA EQUIPMENT s al b provided with me n to al ow the emis ion of a

RA IATION B AM to b inter upted at an time at the TREATMENT CONTR L P NEL The control TO

INT R U T or T R IN T THE RA IATION an movements s al b hard wired

2 1.10.1.2.10 5 Initiation at the TREATMENT CONTR L PA NE

Re di y au ible an vis al sig als at the TREATMENT CONTR L P NEL s al in icate that the

X-RA TUB is energized

2 1.10.1.2.10 7 Tra sition period

The MA UFA TURER s al state in the A COMP N ING DOC MENT the time req ired to o tain

sta le o eratin con ition (X-RA TUB C RRENT an X-RA TUB VOLTAGE) If this time

ex e d 1 s, the MA UFA TURER s al provide s ff i ient information to ena le calc lation of

the maximum AB ORB D DOS to b exp cted in this p riod, at the start of an IR A IATION

2 1.10.1.2.10 8 X-RAY TUBE repla eme t

If at an time after original man facture the MA UFA TURER or an other p rson or

organization re laces or c an es the X-RA TUB in the X-RA TUB HOUSING, it is the

resp n ibi ty of that p rson or organization to en ure that al req irements of 2 1.10.1.2.101

to 2 1.10.1.2.10 are sti maintained by re ortin the relevant detai s of the c an e to the

RE PONSIBLE O GA IZATION an by recordin these detai s in the A COMP N ING DOC MENT

Compl ian e is c e k d b :

TYPE TEST grad e A – Stateme t : re ort re ard ing t he re lac me t of X-RAY TU BES

2 1.10.1.2.10 X-RAY TU E A SS MBLIE re uiring th OP RA TOR to be in the vicinity of

th PATIENT

Therap utic X-RA EQUIPMENT that req ires the OPERATOR to b in the vicinity of the P TIENT

may have the o tion of b in han held an s al :

– have a NOMINAL X-RA TUB VOLTAGE not gre ter than 7 kV;

– b so desig ed that the X-RA TUB AS EMBLY can b s p orted an held by mec anical

me n , as wel as b han held;

– provide a vis al sig al or an au ible in ication to the OPERATOR that the X-RA TUB is

energized;

– have the energization of the X-RA TUB at al times u der the control of the OPERATOR

A statement s al b in the A COMP N ING DOCUMENT ad isin that PR T CTIVE CLOTHING

mu t b worn by an

OPERATOR holdin an X-RA

BLY an by an other p rson

present in the TREATMENT R OM d rin emis ion of a RA IATION B AM

NOT A warnin remin in th OP RA O of this s o ld b dis la e o th X-RA T B A S MBLY

2 1.10.1.2.10 Marking of PROT CTIVE DEVICE

PR T CTIVE DEVICE , remova le or s bject to re lacement, s al b cle rly an p rmanently

marked with their AT ENU TION EQUIV LENT

2 1.10.1.2.10 1 Limitation of A BSORBED DOS

Thera eutic X-RA EQUIPMENT s al b provided with device(s) that can b preset to any value

in an a propriate ran e of a p rameter (IR A IATION time or DOS MONITOR U IT ) b arin a

predicta le relation hip to the AB ORB D DOS at a ref eren e p int in the TREATMENT VOLUME,

an whic automatical y T RMIN T S IR A IATION when the p rameter re c es the preset

value

Two in e en ent CONTR L ING TIMERS or two DOS MONITORING SYS EMS, of whic one is

mentioned a ove, s al b provided to monitor an control the AB ORB D DOS

For BRA H THERA Y devices a combination of CONTR L ING TIMER an DOS MONITORING

SYS EMS is al owed

Where IR A IATION time is u ed to control AB ORB D DOS there s al b an INT RLOC to

en ure sta le an ac urate kV an mA d rin IR A IATION, or there s al b a b c up

INT RLOCK b sed on f l en e

Compl ian e is c e k d b :

TYPE TEST grad e A – Stateme t : re ort re ard ing TE RM IN ATION OF IR ADIATION

SITE TE ST grad e C – P rinciple: v rific tion ofc r e t fu ctionin ofe c CON TR L ING TIM ER or

DOSE M ON ITORIN G SYS E M

OF IR ADIATION wit ho t h vin resele t ed the IR ADIATION t ime or D SE M ONITOR U N IT

2 1.10.1.2.10 3 DIS LA Y of pre ele te IRRA DIA TION time or DOS MONITOR UNIT

The preselected time or n mb r of DOS MONITOR U IT s al b displayed at the TREATMENT

SITE TEST grade B – P ro ed ure: sel ect a IR ADIATION time or a n mb r of D SE M ON ITOR

U N IT ; p rorm IR ADIATION a d v rify t hat t he presel ect ed t ime or D SE M ON ITOR U N IT remain

d ispl ay d u t il reset for t he n xt IR ADIA

The fol owin req irements s al b fulfi ed:

a) The desig s al en ure that the malfu ctionin of one s stem (CONTR L ING TIMER or

DOS MONITORING SYS EM) wi not af fect the cor ect f un tionin of the other

Compl ian e is c e k d b :

SITE TE ST grad e C – P rincipl e: v rific tio of c re t fu ctio ing of e c C N TR L IN G

TIM E R or D SE M ON ITORIN G SYS E M wit h g n rated or simul at ed mal fu ction oft he ot her

system

b) The desig s al en ure that the f aiure of an element common to b th s stems wi

T RMIN T IR A IATION

Compl ian e is c e k d b :

TYPE TEST grade A – Stateme t : re ort re ard ing whic eleme ts are c mmo to b t h

C N TR L IN G TIM ERS or D SE M ON ITO IN G SYS E M S a d to d emo strate h w failure of e c

of t hese el eme ts will TE RM IN ATE IR ADIATION

SITE TE ST grad e C – Principl e: v rific t ion of TE RMIN ATION OF IR ADIATION, b g n ration or

simul at ion of fa ure of e c c mmo eleme t

c) The desig s al en ure that fai ure of the p wer s p ly to either s stem wi T R INAT

IR A IATION

Compl ian e is c e k d b :

SITE TE ST grad e C – Principl e: v rific t ion of TE RMIN ATION OF IR ADIATION, b g n ration or

simul at ion of fa ure of th p wer su ply of the C N TR L IN G TIM E R or of the D SE

M ON ITO IN SYS EM power su ply

d) The two s stems (CONTROL ING TIMERS or DOS MONITORING SYS EMS) s al b ar an ed

either as a RED N A T COMBIN TION or as a PRIMARY/S COND RY COMBIN TION In the case

of a RED ND NT COMBINATION the p r orman e of b th s stems s al b stated by the

MA UFA TURER in the A COMP N ING DOC MENT In the case of a PRIMARY/S CON ARY

COMBIN TION the p rorman e of at le st the primary s stem s al b stated by the

MA UFA TURER

Complian e is c e k d b :

TYPE TE ST grad e A – Stateme t: re ort re ard ing systems of C N TR L IN G TIM E RS or D SE

M ON ITO IN SYS EM S

SITE TEST grade B – P ro ed ure: for a IR ADIATION time of 2 min or a c resp nd in

n mb r of DOSE M ON ITOR U N IT , c e k t he a c ra y of b th C NTR L IN G TIM ERS or DOSE

M ON ITO IN SYS EM S using a c l i rat ed st opwatch a d c mp re with the M AN U FACTU RER’S

sp cific t io s

2 1.10.1.2.10 5 Displa of ir a iation time or dos monitor units

The fol owin req irements s al b fulfi ed:

a) The DISPLA S f rom the CONTROL ING TIMERS or dose monitor s stems s al b of the same

desig They s al b placed s f ficiently close to the DISPLA of the preselected time or

DOS MONITOR U IT to p rmit con enient comp rison

Compl ian e is c e k d b :

SITE TEST grad e B – Pro ed ure: visu l l insp ct the

DIS LAYS

b) Af ter INT RRU TION or T R IN TION OF IR A IATION, the DISPLA S s al maintain their

re din s u les reset by the OPERATOR

Compl ian e is c e k d b :

SITE TEST grad e B – P ro ed ure: v rify t hat the DIS LAYS maintain their re d in s after

IN TE RRU PTION or TE RM IN ATION OF IR ADIATION

c) It s al b neces ary to reset the DISPLA S to zero after T RMIN TION OF IR A IATION

Compl ian e is c e k d b :

SITE TEST grad e B – P ro ed ure: att empt to initiat e IR ADIATION witho t h ving reset the

DIS LAYS to z ro;

d) In the event of f ai ure of the SU PLY MAINS, inf ormation displayed at the time of fai ure s al

b stored in a retrieva le f orm, at le st in one s stem

 IEC 2 15

SITE TEST grad e B – Pro ed ure: visu l l insp ct the DIS LAYS

2 1.10.1.2.10 6 Control of IR A DIA TION

The f olowin req irements s al b fulfi ed:

a) Eac of the two CONTR L ING TIMERS or DOS MONITO ING SYS EMS s al b ca able of

in e en ently T RMIN TING IR A IATION

Complian e is c e k d b :

TYPE

TEST grad e A – St ateme t : re ort re arding the c p bil ity of e c C NTROL IN G TIM ER

or D SE M ONITORIN G SYS EM ind ep nde tly TO TE RM IN ATE IRRADIATION

SITE TE ST grad e C – P rincipl e: v rific tio of c re t fu ctio ing of e c C N TR L IN G

TIM E R or D SE M ONITORING SYS E M

b) The primary s stem, or b th s stems in the case of a RED ND NT COMBIN TION, s al

T RMIN T IR A IATION when the preselected time or n mb r of DOS MONITOR U IT has

b en re c ed The secondary s stem in a PRIMARY/S CON ARY COMBINATION s al

T RMIN T IR A IATION when the preselected time or n mb r of DOS MONITOR U IT has

b en ex e ded, either by not more than 10 % if a p rcentage margin is u ed, or by not

more than 0,1 min (or the eq ivalent of 0,1 Gy AB ORB D DOS at the NOR AL TREATMENT

DIS A CE) if a fixed margin is u ed

Compl ian e is c e k d b :

SITE

TE ST grad e C – P rincipl e: v rific tio of c re t fu ctio ing of e c C N TR L IN G

TIM E R or D SE M ON ITORIN G SYS EM wit h g n rated or simul at ed mal fu ction oft he ot her

C N TR L IN G TIM E R or DOSE M ON ITO IN G SYS E M

c) INT RLOC S s al b provided to en ure that the s stem whic has not terminated

IR A IATION is tested b f ore the next ir adiation to verify its ca a i ty of T R IN TING

IR A IATION

Compl ian e is c e k d b :

TYPE TE ST grad e A – Stateme t: re ort re ard ing th verific tion b t we n IR ADIATION S of

th c p bil ity ofth IN TE LOC TO TERM IN ATE IR ADIATION

SITE TEST grad e C – P rincipl e: verific tion of c rect fu ctioning of IN TE LOC S

2 1.10.1.2.10 7 Control of ir a iation in moving be m ra iotherapy

Where in MOVING B AM RA IOTHERA Y the sp ed of movement is automatical y adju ted to the

preselected time of IR A IATION or n mb r of DOS MONITOR U IT an if the o eration of a

switc T R IN T S IR A IATION when the selected final p sition is re c ed, the primary

s stem s al T R IN T IR A IATION when the preselected time or n mb r of DOS MONITOR

UNIT has b en ex e ded, either by not more than 10 % if a p rcentage margin is u ed, or by

not more than 0,1 min (or the eq ivalent of 0,1 Gy AB ORB D DOS at the NORMAL TREATMENT

DIS A CE) if a fixed margin is u ed

Compl ian e is c e k d b :

TYPE TE ST grad e A – St ateme t: re ort re ard in th c p bil ity of e c C N TR L IN TIM ER or

DOSE M ON ITORIN G SYS E M inde e d ent ly TO TERM INATE IR ADIATIO

SITE TE ST grad e C – P rinciple: v rific t ion of c re t TE M INATIO OF IR ADIATION b

g n ration or simulation of the S E CIFIED fa l t c nd ition

2 1.10.1.2.1 0 Sin le f ault con ition

2 1.10.1.2.1 0.1 List of spe if ic single fa lt conditions

Thera eutic X-RA EQUIPMENT s al b so desig ed an con tru ted that protection is

provided again t HAZARDS fom u wanted or ex es ive radiation when the X-RA EQUIPMENT is

in NORMAL US whi e in an one of the f ol owin SINGLE FA LT CON ITIONS (e c is de lt with in

– fai ure of the device(s) for preventin the emis ion of a RA IATION B AM whi e the X-RA

TUB is energized (se 2 1.10.1.2.1 0.4);

– combination of set values f or X-RA TUB VOLTAGE, X-RA TUB C R ENT an A DED FILT R

that has not b en selected by the OPERATOR (se 2 1.10.1.2.1 0.5), or that is not

SPECIFIED in the A COMP N ING DOCUMENT (se 2 1.10.1.2.1 0.6);

– in or ect orientation an /or location of an A DED FILT R in the X-RA TUB AS EMBLY (se

2 1.10.1.2.1 0.5 an 2 1.10.1.2.1 0.6);

– selection car ied out at the TREATMENT CONTROL P NEL dif ferent f rom a selection car ied

out in the TREATMENT R OM (se 2 1.10.1.2.1 0.3 an 2 1.10.1.2.1 0.5);

– fai ure to have the s stem at the preset X-RA TUB VOLTAGE an X-RA TUB CUR ENT;

– f ai ure of actual X-RA TUB VOLTAGE or X-RA TUB C R ENT to matc preset con ition

2 1.10.1.2.1 0.2 Prote tion a ainst f ai ure of termination

2 1.10.1.2.1 0.2.1 Limitation of ra iation output

The RA IATION B AM s al b so control ed that in the event of an fai ure of the device

req ired by 2 1.10.1.2.10 1 to fu ction normal y the IR A IATION is automatical y terminated

b fore the p rameter refer ed to in 2 1.10.1.2.10 1 has re c ed a value that is in ex es of

the pre-set value by more than 15 %

2 1.10.1.2.1 0.2.2 Cor e tion prior to f urther IR A DIA TION

Subseq ent to any fai ure of the device req ired by 2 1.10.1.2.10 to f un tion normal y it

s al not b p s ible to initiate emis ion of a RA IATION B AM

only by pre-set in (se

2 1.10.1.2.10 ) an p rf ormin the o eration at the TREATMENT CONTR L P NEL ref er ed to in

item e) of 2 1.10.1.2.105.5 An ad itional p sitive action at the TREATMENT CONTR L P NEL

s al b req ired b f ore an further emis ion of a RA IATION B AM is p s ible

NOT This lo k-o t of fu ctio s b e u nt to f aiure of th d vic re uire b 2 1.10.1.2.10 is to pro id a

o p rtu ity to in e tig te a d c re t th malf un tio prior to furth r IR A IA ION

2 1.10.1.2.1 0.2.3 Ch c on cor e t f unction

The device neces ary to comply with the req irements of 2 1.10.1.2.1 0.1 s al b so

desig ed an con tru ted that it s al not b p s ible to initiate the emis ion of a RA IATION

B AM u les a verification of the cor ect fu ctionin of the device has b en made s bseq ent

to e c oc asion on whic the emis ion of the RA IATION B AM has b en sto p d by the

device req ired by 2 1.10.1.2.10

2 1.10.1.2.1 0.3 Prote tion a ainst f ai ure of mov me t

2 1.10.1.2.1 0.3.1 Ge eral

On thera eutic X-RA EQUIPMENT that is desig ed to car y out automatical y a pre-selected

movement of the X-RA TUB AS EMBLY relative to the P TIENT SUP ORT whi e a RA IATION

 IEC 2 15

B AM is b in emited, neither movement nor the emis ion of a RA IATION B AM s al b

p s ible u les a p sitive action has b en car ied out at the TREATMENT CONTR L P NEL to

select the movement (whic may b zero movement prior to e c initiation

2 1.10.1.2.1 0.3.2 Ide tity of s le tion

If a selection of movement has b en car ied out in the TREATMENT R OM the emis ion of a

RA IATION B AM s al b p s ible only when the selection agre s with the selection car ied out

at the TREATMENT CONTR L P NEL

preselected movement has b en completed

2 1.10.1.2.1 0.4 Sta d-by with e ergize X-RA Y TU E

Therap utic X-RA EQUIPMENT so SPECIFIED that the X-RA TUB remain energized when

emis ion of a RA IATION B AM has b en sto p d in NOR AL US s al b so desig ed an

con tru ted that:

– there is a device to a sorb radiation u ti emis ion is red ced to the level req ired by

2 1.10.1.2.10 when emis ion of the RA IATION B AM has b en sto p d; an

– fai ure of the device that a sorbs radiation whi e the X-RA TUB is energized s al res lt in

the X-RA TUB b in de-energized; an

– it s al not b p s ible to energize the X-RA TUB if the device that a sorbs radiation is

not fu ctionin cor ectly

2 1.10.1.2.1 0.5 Remov ble A DDED FIL ERS

Therap utic X-RA EQUIPMENT desig ed for u e with remova le A DED FILT RS (whic may b

Z R FILT RS) that are not p rmanently at ac ed to remova le B AM LIMITING DEVICE or

remova le thera eutic B AM A PLICATORS s al b provided with an INT RLOC s stem:

– to alow the OPE

RATOR to select, f rom

SPECIFIE

D combination of X-RA

,

X-RA TUB C RRENT an remova le A DED FILT R, a n mb r of s c combination to b the

only combination with whic emis ion of a RA IATION B AM is p s ible; an

– to prevent emis ion of a RA IATION B AM unles a combination of X-RA TUB VOLTAGE,

X-RA TUB CUR ENT an remova le A DED FILT R has b en selected an confirmed by

OPERATOR action at the TREATMENT CONTR LP NEL b fore e c IRRA IATION; an

– to prevent emis ion of a RA IATION B AM u les a remova le A DED FILT R is cor ectly

oriented an located in the X-RA TUB AS EMBLY; and

– to prevent emis ion of a RA IATION B AM u les the selection or confirmation of remova le

A DED FILT RS at the TREATMENT CONTR L P NEL agre s with an selection car ied out at a

p rt of the X-RA EQUIPMENT other than the TREATMENT CONTR L P NEL

2 1.10.1.2.1 0.6 Remov ble therape tic BEAM A PP ICATORS with fix d A DDED FIL ERS

Thera eutic X-RA EQUIPMENT desig ed for u e with fixed A DED FILT RS that are p rmanently

at ac ed to remova le thera eutic B AM A PLICATORS s al b provided with an INT RLOC

s stem to prevent emis ion of a RA IATION B AM u les :

– a remova le thera eutic B AM A PLIC TO is cor ectly oriented an located in the X-RA

TUB AS EMBLY;

– the X-RA TUB VOLTAGE selected is one that is SPECIFIED f or u e with the selected

remova le thera eutic

B AM A PLIC

TOR

If several thera eutic B AM A PLIC TORS with diff erent fixed A DED FILT RS are SPECIFIED or

s p l ed f or the same FOCAL SPOT TO SKIN DIS A CE an f or the same RA IATION FIELD, they

s al b regarded as remova le A DED FILT RS an s al comply with 2 1.10.1.2.1 0.5

2 1.10.1.2.1 0.7 Indic tions of

2 1.10.1.2.1 0.7.1 Indic tion of a tomatic termin tions that are not pre-s t

Therap utic X-RA EQUIPMENT s al b provided with a visible in ication on the TREATMENT

CONTR L P NEL in icatin :

– when the emis ion of a RA IATION B AM has b en automatical y sto p d by me n

other than the device for pre-set termination req ired by 2 1.10.1.2.10 1, in p rtic lar

by an of the con ition s bject to the req irements of 2 1.10.1.2.10 3, an of

2 1.10.1.2.1 0.2 an 2 1.10.1.2.1 0.3;

– when the X-RA TUB has b en de-energized by a device neces ary to comply with the

req irements of 2 1.10.1.2.1 0.4

2 1.10.1.2.1 0.7.2 Indic tion of un atisfie INT RLOCKS

Thera eutic X-RA EQUIPMENT s al b provided with me n to in icate vis al y when initiation

of a RA IATION B AM has b en prevented by any of the con ition s bject to the req irements

of 2 1.10.1.2.10 3, an of 2 1.10.1.2.1 0.2, 2 1.10.1.2.1 0.3, 2 1.10.1.2.1 0.5 an

2 1.10.1.2.1 0.6

2 1.10.1.2.1 1 Indic tion of X-RA DIATION output

NOT X-RA IA ION o tp t d p n s o s v ral p rameters whic h v dif fere t DIS LA re uireme ts

2 1.10.1.2.1 1.1 Inf ormation on X-RA DIA TION output

Adeq ate inf ormation s al b provided in the A COMP N ING DOCUMENT a out fixed, semi

-p rmanently preselected, preselected or otherwise u ed p rameters or modes of o eration to

ena le the OPERATOR to preselect a pro riate con ition f or the IR A IATION an to o tain

data neces ary for the estimation of the AIR KERMA or WAT R KER A b in delvered, with

detai ed inf ormation a out radiation q al ty; se also 201.10.1.2.1 2.4

2 1.10.1.2.1 1.2 Indic tions of RA DIATION FIE D

Al devices s p led that modify the RA IATION B AM, ex e t those s p l ed for

BRA H THERA Y, s al have an outside s a e an /or markin s that alow recog ition of the

direction an extent of the RA IATION B AM, an

– for e c thera eutic B AM A PLICATOR b th the nominal dimen ion of the RA IATION FIELD

at the distal en an the nominal distan e f rom the FOCAL SPOT to the distal en s al b

cle rly an p rmanently marked on the thera eutic B AM A PLIC TOR; an

– f or e c adju ta le B AM LIMITING DEVICE me n s al b provided b th for in icatin the

nominal dimen ion of the RA IATION FIELD an for in icatin the nominal FOCAL SPOT TO

SKIN DIS A CE; an

– a statement s al b in lu ed in the A COMP N ING DOC MENT to remin the OPERATOR

that me s red values of the distan es an dimen ion ref er ed to in this s bclau e s ould

b u ed in a pro riate circ mstan es in te d of the nominal values

2 1.10.1.2.1 1.3 Indic tion of remov ble A DDED FIL ERS

Eac remova le A DED FILT R s p l ed with thera eutic X-RA EQUIPMENT s al b cle rly an

p rmanently marked to al ow it to b identif ied

– when the remova le A DED FILT R is atac ed to the X-RA TUB AS EMBLY, an

– when the remova le A DED FILT R is in a storage location

 IEC 2 15

2 1.10.1.2.1 1.4 DIS LA Y of conf irmation at the TREA TMENT CONTROL PA NE

Where a thera eutic X-RA EQUIPME

NT is so desig ed an con tru ted that the

TREATMENT

CONTR L P NEL can b located outside the TREATMENT RO M an a selection of a remova le

A DED FILT R (se 2 1.10.1.2.1 0.5) or movement (se 2 1.10.1.2.1 0.3) can b car ied out

at a p rt of the X-RA EQUIPMENT other than the TREATMENT CONTR L P NEL, the nature of the

selection s al not b displayed on the

TREATMENT CONTROL P NE

L u ti the relevant selection

or con rmin o eration at the TREATMENT CONTR L P NEL has b en cor ectly completed

2 1.10.1.2.1 1.5 Indic tion of X-ra tube volta e a d X-ra tube c r e t

There s al b cle r in ication on the TREATMENT CONTR L P NEL of the set values of X-RA

TUB VOLTAGE an X-RA TUB C R ENT, whether these are selected by the OPERATOR or f i ed;

se also 2 1.10.1.2.1 2.4

2 1.10.1.2.1 1.6 Indic tion of operational state

On the TREATMENT CONTR L P NEL of the thera eutic X-RA EQUIPMENT there s al b the

fol owin in icator l g ts (coloured and ar an ed to comply with 7.8 of the general stan ard):

– a yel ow in icator l g t when con ition of the HIGH VOLTAGE GENERATOR cor esp n in to

the emis ion of a RA IATION B AM exist, an

– a gre n in icator lg t in the REA Y S AT when only one o eration is req ired b f ore a

RA IATION B AM is emit ed

There s al also b an in icator l g t (neither red, nor yel ow or gre n), or another in ication,

that is visible when p wer is present at the X-RA EQUIPMENT

2 1.10.1.2.1 1.7 Dete tion a d DIS LA Y of ra iation output rate

the TREATMENT CONTR L P NEL of a s aled me s re of the relative AIR KER A RAT to al ow the

radiation output rate to b monitored u les :

– the distan e f rom the FOC L SPOT to the most distal p rt of the mou tin f or thera eutic

B AM A PLIC TORS on the X-RA TUB AS EMBLY is les than 8 cm, an

– the X-RA EQUIPMENT is desig ed for u e only with thera eutic B AM A PLIC TORS that

provide a nominal

FOC L SPOT TO SKIN DIS A CE

not gre ter than 4 cm

NOT In g n ral for d e RA IOT ERA Y th d te tio a d DIS LA of a iatio o tp t rate is re uire - For s me

clnic l p rp s s at s orter FO AL S OT TO S IN DIS A CE th imp rta c is le s a d th te h ic l dif fic lty of

impleme tatio gre ter Th dista c 4 cm h s b e c o e a th b u d ry

2 1.10.1.2.1 2 Agre me t betwe n in ic te v lu s a d eff ectiv v lue

NOT Th re uireme ts rele a t to th d gre of a re me t b twe n in ic te v lu s a d eff ectiv v lu s are

giv n in 2 1.10.1.2.1 2.1, 2 1.10.1.2.1 2.2 a d 2 1.10.1.2.1 2.3, a d c mpla c c n itio s are giv n in

2 1.10.1.2.1 3, 2 1.10.1.2.1 4, 2 1.10.1.2.1 5 a d 2 1.10.1.2.1 6

2 1.10.1.2.1 2.1 Reprod cibi ty of inte rate ra iation output

The co f ficients of variation of the values of the AIR KER A me s red in the RA IATION FIELD

f om any SPECIFIED B AM LIMITING DEVICE as des rib d in 2 1.10.1.2.1 3, 2 1.10.1.2.1 4,

2 1.10.1.2.1 5 an 2 1.10.1.2.1 6, s al not ex e d:

– 3 % for thera eutic X-RA EQUIPMENT desig ed to o erate at a NOMIN L X-RA TUB

VOLTAGE a ove 15 kV; or

– 5 % for thera eutic X-RA EQUIPMENT desig ed to o erate at a NOMIN L X-RA TUB

VOLTAGE not gre ter than 15 kV

2 1.10.1.2.1 2.2 Line rity of inte rate ra iation output

The average values of

AIR KERMA me s red in a

RA IATION FIE

LD s al cor esp n to the

f ol owin formula:

22

11

22

11

0 5,0

QK

QK

QK

QK

For the set values of SPECIFIED combination of X-RA TUB VOLTAGE an total FILTRATION

tested, se 2 1.10.1.2.10 1, the co f ficients of variation of the ratios of AIR KER A s al not

ex e d the value of 2 % when the ratios are me s red ac ordin to 2 1.10.1.2.1 3,

2 1.10.1.2.1 4, 2 1.10.1.2.1 5 an 2 1.10.1.2.1 6

NOT This re uireme t is for ra iatio q alty in of ar a it af fe ts p rc nta e d pth d s , a d for tra sie ts at

th initiatio o th e d of, a d d rin th emis io of th RA IA ION B AM

2 1.10.1.2.1 2.4 Ac ura y of ra iation qual ty

In this p rtic lar stan ard, no req irement for the ac urac of the in ication of X-RA TUB

VOLTAGE an X-RA TUB CUR ENT is imp sed

2 1.10.1.2.1 3 Ge eral te t conditions

2 1.10.1.2.1 3.1 Thermal conditions

The X-RA EQUIPMENT s al have re c ed a thermal con ition simi ar to that existin af ter

0,5 h of o eration at b twe n 6 % an 10 % of the SPECIFIED maximum contin ou p wer

2 1.10.1.2.1 3.2 Fre ue c

The f eq en y of the MAINS VOLTAGE u ed for the test s al b within ±1 % of the nominal

f eq en y

2 1.10.1.2.1 3.3 Depe de c upon te t in trume ts

The U CERTAINTY of test in truments an method s al not b in lu ed in the values of the

co ff i ients of variation or in the average values of AIR KER A

2 1.10.1.2.1 3.4 Ex lu ion of statistic l U CERTA INTY

The statistical UN ERTAINTY res ltin f om the l mited n mb r of me s rements s al not b

in lu ed in the values of the co f ficients of variation req ired in 2 1.10.1.2.1 2.1 an

 IEC 2 15

2 1.10.1.2.1 4 Set ing f or me s reme ts

2 1.10.1.2.1 4.1 X-ra tube volta e

Me s rements to test re rod cibi ty of integrated radiation output, l ne rity of integrated

radiation output, an re rod cibi ty of radiation q alty s al b car ied out:

– at the NOMINAL X-RA TUB VOLTAGE set in ;

– at a proximately 5 % of the NOMIN L X-RA TUB VOLTAGE setin , or the lowest SPECIFIED

X-RA TUB VOLTAGE set in , whic ever is the hig er

If only one X-RA TUB VOLTAGE setin is SPECIFIED, then me s rements s al b car ied out

at that set in

2 1.10.1.2.1 4.2 X-ra tube c r e t

Durin e c test the X-RA TUB C R ENT setin s al b the maximum SPECIFIED for that

2 1.10.1.2.1 4.3 Ir a iation time or dos monitor units

At e c combination of the MAINS VOLTAGE req ired in 2 1.10.1.2.1 5 an the X-RA TUB

VOLTAGE setin s req ired in 2 1.10.1.2.1 4.1, the device req ired in 2 1.10.1.2.10 1 s al

b pre-set to sto the emis ion of a RA IATION B AM at a proximately:

– 0,0 of the maximum value for two sets of f i e me s rements (a total of ten) an

– 0,2 of the maximum value f or two sets of five me s rements (a total of ten)

Two sets of f i e me s rements e c s al b made u der identical con ition (se b xes

marked A an B as wel as C an D in Ta le 201.10 )

2 1.10.1.2.1 5 Number of me s reme ts (in lude Table 2 1.10 )

Eac COE FICIENT OF V RIATION (se 2 1.10.1.2.1 2.1 an 2 1.10.1.2.1 2.3) or average value

of AIR KER A (se 2 1.10.1.2.1 2.2) s al b determined f rom a po ulation of 3 values

derived f om me s rements a proximately evenly distributed in time

Ten of the me s rements s al b made with a MAINS VOLTAGE u der lo d within ±1 % of the

rated MAINS VOLTAGE f or the X-RA EQUIPMENT Ten of the me s rements s al b made with

a MAINS VOLTAGE u der lo d b twe n 9 % an 9 % of the rated MAINS VOLTAGE f or the X-RA

EQUIPMENT Ten of the me s rements s al b made with a MAINS VOLTAGE u der lo d

b twe n 10 % an 1 0 % of the rated MAINS VOLTAGE for the X-RA EQUIPMENT

The me s rements can b re resented by the overview in Ta le 2 1.10

Table 2 1.10 – Ov rview of me s reme ts

2 1.10.1.2.1 6 Me s reme ts a d e aluation

2 1.10.1.2.1 6.1 Reprod cibi ty of inte rate X-RA DIATION output

Calc lation of the co f ficients of variation to test the re rod cibi ty of integrated radiation

output ac ordin to 2 1.10.1.2.1 2.1 s al b car ied out f or e c of the four rows of

me s rements s own in Ta le 2 1.10 (3 me s rements f or e c calc lation)

2 1.10.1.2.1 6.2 Line rity of inte rate ra iation output

Calc lation of average values of AIR KERMA to test the l ne rity of integrated radiation output

s al b calc lated for e c of the four rows of me s rements (3 me s rements for e c

calc lation) The satisfaction of the f ormula in 2 1.10.1.2.1 2.2 s al b tested b th with the

average values of AIR KERMA calc lated f or the NOMIN L X-RA TUB VOLTAGE setin an with

the average values of AIR KER A calc lated for the lower X-RA TUB VOLTAGE set in

2 1.10.1.2.1 6.3 Reprod cibi ty of ra iation qual ty

For e c IR A IATION, me s rements of total AIR KER A s al b made u der the con ition of

2 1.10.1.2.1 3, 2 1.10.1.2.1 4 an 2 1.10.1.2.1 5 at the sides proximal an distal to the

X-RA TUB of an a sorb r, whic s ould b water where practica le, with an AT ENU TION

EQUIV LENT to the half value layer SPECIFIED for the combination of X-RA TUB VOLTAGE an

total FILTRATION tested

For this me s rement the RA IATION B AM s al b lmited by a B AM LIMITING DEVICE, ju t

large enou h to cover the me s rin device(s)

Calc lation of the co ff i ients of variation to test the re rod cibi ty of radiation q alty

req ired in 2 1.10.1.2.1 2.3 s al b car ied out:

– u in the me s rements in the b xes marked A;

– u in the me s rements in the b xes marked B;

– u in the me s rements in the b xes marked C;

– u in the me s rements in the b xes marked D

together with the cor esp n in values determined f rom the me s rements at the distal side

of the a sorb r (3 me s rements f or e c calc lation)

The ratio of the AIR KER A at the distal side of the a sorb r to the AIR KER A at the proximal

side s al b taken

201.1 Prote tion against exc ssive temperatures a d other HAZARDS

Clau e 1 of the general stan ard a ples

201.12 A ccuracy of controls and instruments and protection against hazardous

outputs

Clau e 12 of the general stan ard a ples

201.13 HAZARDOUS SITUATIONS and f ault conditions f or ME EQUIPMENT

Clau e 13 of the general stan ard a ples

 IEC 2 15

201.14 PROGRAMMABL EL CTRICAL MEDICAL SYST MS (PEMS)

Clau e 14 of the general stan ard a ples

201.15 Construction of ME EQUIPMENT

Clau e 15 of the general stan ard a ples

201.16 ME SYST MS

Clau e 16 of the general stan ard a ples

201.17 Electromagnetic compatibi ity of ME EQUIPMENT and ME SYST MS

Clau e 17 of the general stan ard a ples

The an exes of the general stan ard a ply

Bibl ogr aphy

IEC 6 6 1-2-17:2 13, Med ic l el ectric l e uipme t – P art 2-17: P artic lar re uireme ts for

th b sic safety a d es e tial p rorma c of a tomatic l ly-c ntrol l ed bra h t hera y

afterload ing e uipme t

3

—————————

MA UFA TURER IEC 6 6 1-1:2 0 /AMD1:2 12, 3.5

MEDIC L ELECTRIC L EQUIPMENT (ME EQUIPMENT) IEC 6 6 1-1:2 0 , 3.6

PRIMARY/S COND RY (TIMER) COMBIN TION IEC TR 6 7 8:2 0 , rm-21-1

PR GRAMMABLE ELECTRIC L MEDIC L SYS EM (PEMS)… EC TR 6 7 8:2 0 , rm-8 -84

UN ERTAINTY (OF MEASUREMENT) ISO/IEC Guide 9 :2 0 , 2.2

 IEC 2 15

X-RA TUB HOUSING IEC TR 6 7 8:2 0 , rm-2 -0

X-RA TUB VOLTAGE IEC TR 6 7 8:2 0 , rm-3 -0

ZER FILT R IEC TR 6 7 8:2 0 , rm-3 -06

_ _

AVANT-PROPOS 3

INTRODUCTION 4

2 1.1 Domaine d'a pl cation, o jet et normes con exes 41

2 1.2 Référen es normatives 4

2 1.3 Termes et définition 4

2 1.4 Exigen es générales 4

2 1.5 Exigen es générales relatives au es ais des A P REILS EM 4

2 1.6 Clas if i ation des A P REILS EM et desSYS EME EM 4

2 1.7 Identif i ation, marq age et doc mentation des A P REILS EM 4

2 1.8 Protection contre les D NGERS d'origine électriq e provenant des A P REILS EM 5

2 1.9 Protection contre les D NGERS MEC NIQUE des A P REILS EM et SYS EME EM 51

2 1.10 Protection contre les D NGERS d s au rayon ements in olontaires ou

ex es if s 51

2 1.1 Protection contre les temp ratures ex es ives et les autres DA GERS 6

2 1.12 Précision des comman es, des in truments et protection contre les

caractéristiq es de sortie présentant des dan ers 6

2 1.13 SITU TIONS D NGEREUS S et con ition de défaut p ur les A P REILS EM 6

2 1.14 SYS EME ELECTROMEDIC U PRO RAMMABLE (S MP) 6

2 1.15 Con tru tion de l A P REIL EM 6

2 1.16 SYS EME EM 6

2 1.17 Comp tibi té électromag étiq e des A P REILS EM et des SYS EME EM 6

Bibl ogra hie 6

In ex des termes définis uti sés dan la présente norme p rtic l ère 7

Ta le u 2 1.101 – Don é s néces aires dan la des ription tec niq e p ur étayer la

conformité à L’E SAI SUR SIT E DE TY E de 2 1.10 4

Ta le u 2 1.10 – RA ON EMENT DE FUIT admis ible 5

Ta le u 2 1.10 – RA ON EMENT DE FUIT admis ible des GAINE EQUIPE S à

DISPOSITIF DE LIMITATION D FAISCEA 5

Ta le u 2 1.10 – Vue d’en emble des mes rages 6