Iec 60601 2 33 2015

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15 MEDICA L ELECTRICA L EQUIPMENT – Part 2-33: Particular requirements f or the basic safety and essential perf ormance of magnetic resonance equipment f

Apparei s élect romédicaux –

Part ie 2- 33: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des apparei s à résonance magnét ique ut il sés pour le diagnost ic

THIS PUBLICATION IS COPYRIGHT PROTECTED

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

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

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

eith r IEC or IEC's memb r Natio al Commite in th c u tr y of th re u ste If y u h v a y q e tio s a o t IEC

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 dr es b low or

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

Dr oits d r eprod ctio ré er vé Sa f in ic tio c ntr aire, a c n p rtie d c te p blc tio n p ut êtr e repro uite

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

et le micr ofilms, s n la c rd é rit d l EC o d Comité n tio al d l EC d p y d d ma d ur Si v u a e d s

q e tio s s r le c p r i ht d l EC o si v u d sir ez o te ir d s droits s p léme tair es s r c te p blc tio , uti s z

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

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

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

Abo t IEC p blc tio s

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

late t e itio ,a c rr ig n a or a ame dme t mig t h v b e p bls e

IEC Cat alo ue - webst ore.e ch/ cat alo ue

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

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

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 P , Ma OS, A ndroid Ta let s a d

iPa

IEC p blc t i ns s arch - www ie ch/ se rch u

Th a v an e s arc e a le t o fin IEC p blc t io s b a

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

c mmitt e,…) It als gives informatio o projec t s, re la e

a d wit hdrawn p blc tio s

IEC Just P blshed - webst ore.e ch/ just pu lshed

St ay u to d te o al n w IEC p blc t io s Ju t Pu ls e

d t ais al n w p blc t io s rele s d A v aia le o ln a d

als o c a mo t h b emai

Ele t ro edia - www ele t ro edia.org

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

ele t ric l t erms c nt ainin more th n 3 0 0 terms a d

d finitio s in En ls a d Fre c , wit h e uiv ale t t erms in 15

a ditio al la g a e Als k nown a 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 ch/ glos ary

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

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

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

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

7 ,8 a d CISPR

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

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

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

Ce t re:c c@ie c

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

plu r éc nte, u c r rig n um o ame d me t p ut a oir été p blé

Cat alo ue IEC - webst ore.e ch/ cat alo ue

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

A ndroid et iPa

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,

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

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

IEC Just P blshed - webst ore.e ch/ just pu lshed

R este informé s r le n uvele p blc t io s IEC Ju t

Pu ls e d tai e le n uv ele p blc t io s p ru s

Dis o ible e lg e et a s i u e fois p r mois p r emai

Ele t ro edia - www.ele t ro edia.org

L premier dic t io n ire e lg e d terme éle t ro iq e et

éle triq e I c ntie t plu d 3 0 0 terme et d finit io s e

a glais et e fa ç is, ain i q e le terme é uiv ale t s d n

15 la g e a ditio n le Eg leme t a p lé Vo a ulaire

Elec trote h iq e Int ern t io al (IEV) e lg e

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

Plu d 6 0 0 e t ré s t ermin lo iq e élec t rot ec niq e , e

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

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

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

CE 3 , 7 , 8 et CISPR d l EC

Serv ic Clent s - w ebst ore.e c h/ cs

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

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

c c@iec c

Apparei s élect romédicaux –

Part ie 2- 33: Exigences part icul ères pour la sécurit é de bas et les

IEC 60601 - 2- 33

Editio 3.2 2 15-0

Apparei s élect romédicaux –

Part ie 2- 33: Ex igences part icul ères pour la sécurit é de base et les per ormances

essent iel es des apparei s à résonance magnét ique ut il sés pour le diagnost ic

FOREWORD 4

* INTRODUCTION 7

INTRODUCTION TO AMENDMENT 1 8

INTRODUCTION TO AMENDMENT 2 8

2 1.1 Sco e, o ject an related stan ard 9

2 1.2 Normative ref eren es 10 2 1.3 Terms an definition 1

2 1.4 General req irements 18 2 1.5 General req irements f or testin of ME EQUIPMENT 18 2 1.6 Clas if i ation of ME EQUIPMENT an ME SYS EMS 18 2 1.7 ME EQUIPMENT identif i ation, markin an doc ments 18 2 1.8 Protection again t electrical H ZARDS f rom ME EQUIPMENT 3

2 1.9 Protection again t mec anical H ZARDs of ME EQUIPMENT an ME SYS EMS 3

2 1.10 Protection again t u wanted an ex es ive radiation H ZARDS 3

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 f ault con ition 5

2 1.14 PR GRAMMABLE ELECTRIC L MEDIC L SYS EM (PEMS) 5

2 1.15 Con tru tion of ME EQUIPMENT 5

2 1.1 6 ME SYS EMS 5

* 2 1.17 Electromag etic comp tibi ty of ME EQUIPMENT an ME SYS EMS 5

* 2 2 Electromag etic comp tibi ty – Req irements an tests 5

An exes 5

An ex D (inf ormative) Symb ls on markin 5

An ex AA (informative) Partic lar g idan e an rationale 6

Biblogra h 1 9 In ex of defined terms u ed in this p rtic lar stan ard 131 Fig re 2 1.101 – Gradient waveform an E F CTIVE S IMULUS D RATION 12 Fig re 2 1.10 – Limits for cardiac an p ripheral nerve stimulation 3

Fig re 2 1.10 – Red ction of WHOLE BOD SAR l mits at hig temp ratures 4

Fig re 2 1.10 – Volume f or determinin the sp tial maximum of gradient output 4

Fig re 2 1.10 – Volume f or determinin the B 1 stray field 51

Fig re 2 1.D.101 – Sig s in icatin a tran mit only RF coi, tran mit / receive RF coi an a receive only coi

Fig re AA.1 – Static mag etic field : flow p tentials an retardation 8

Fig re AA.2 – Exp rimental data on PNS thres old of h man volu te rs in WHOLE

BOD MR EQUIPMENT 10

Fig re AA.3 – Double logarithmic plot of exp rimental thres old values for p ripheral

nerve stimulation 10

Fig re AA.4 – Resp n e value R(t) generated by con olution of a rectan ular

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

Fig re AA.5 – Gradient waveform G, stimulu wavef orm dB/dt an resp n e value R,

f or a tra ezoid EPI wavef orm startin at t = 0 1 0

Fig re AA.6 – Thres old values dB/dt for two gradient waveforms, plot ed again t

E F CTIVE S IMULUS D RATI

ON 1 0

Fig re AA.7 – Thres old value of dB/dt f or a sin soid gradient waveform, as fu ction

of the n mb r of half p riod in the wavef orm 1 1

Fig re AA.8 – SAR lmits for the exp sed mas of a P TIENT 1 4

Ta le 2 1.101 – List of s mb ls an a breviation 17

Ta le 2 1.10 – Rhe b se values p r typ of gradient s stem 3

Ta le 2 1.10 – Weig t factors for s mmation of the maximum output O i p r GRA IENT U IT 3

Ta le 2 1.10 – Temp rature lmits 3

Ta le 2 1.10 – SAR lmits f or volume tran mit coi s 4

Ta le 2 1.10 – SAR lmits f or local tran mit cois 41

Ta le 2 1.10 – FPO lmits a pl ca le f or c l n rical MR SYS EMS 5

Ta le 2 1.D.101 – Example of warnin sig s an prohibitive sig s MR SA FE Y SIGNS 5

Ta le 2 1.D.10 – RF coi s mb ls 6

Ta le 2 1.D.10 – MR con itional s mb ls 61

Ta le AA.1 – Static field oc up tional stan ard

Ta le AA.1 – Overview ph siological ef fects in h man , animals an model s stems, f or mag etic-f ield exp s res at field stren th relevant f or MRI The impl cation of the re orted ef fects are as es ed in the last column 7

INTERNATIONAL ELECTROTECHNICAL COMMISSION

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

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

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

this e d a d in a ditio to oth r a tivitie , IEC p bls e Intern tio al Sta d rd , Te h ic l Sp cif i atio 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 er e to a “IEC

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

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

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

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

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

2) Th f ormal 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 fom al

intere te IEC Natio al Commite s

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

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

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

misinterpretatio b a y e d u er

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

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

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

th later

5) IEC its lf d e n t pro id a y ate tatio of c nf ormity In e e d nt c rtific tio b die pro id c nf ormity

a s s me t s rvic s a d, in s me are s, a c s to IEC mark of c 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 rtif i atio b die

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

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

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

oth r d ma e of a y n ture wh ts e er, wh th r dire t or in ire t, or for 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

Pu lc tio s

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

in is e s ble for th c r e t a plc tio of this p blc tio

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

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

DISCLAIMER

This Con ol date 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 1-2-3 be rs the e ition number 3.2 It consists of

th third e ition (2 10-0 ) [doc me ts 6 B/7 7/FDIS a d 6 B/7 2/RVD], its ame dme t

1 (2 13-0 ) [doc me ts 6 B/8 4/CDV a d 6 B/9 4/RVC] a d its ame dme t 2 (2 15-0 )

[doc me ts 6 B/9 7/FDIS a d 6 B/9 7/RVD] The te hnic l conte t is ide tic l to th

ba e e ition a d its ame dme ts

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

is modif ie by ame dme ts 1 a d 2 Additions a d d letions are displa e in re , with

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

a ai able in this publ c tion

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

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

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

practice

This edition of IEC 6 6 1-2-3 is b sed on the secon amen ment to Edition 2 It has also

b en ada ted to the third edition of IEC 6 6 1-1 (2 0 ), with tec nical modification b in

introd ced where a pro riate

This publ cation 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: it al i typ

– 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)

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

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

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

combination of the con ition is true

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

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

– “s al ” me n that complan e with a req irement or a test is man atory for 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

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

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

A l st of al p rts of the IEC 6 6 1 series, publs ed u der the general title: Med ic l ele tric l

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

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

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

"htp:/ we store.iec.c " in the data related to the sp cif i publ cation At this date, the

The contents of the cor igen um of Marc 2 12 have b en in lu ed in this co y

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

th t it contains colours whic are considere to be us f ul f or the cor e t

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

colour printer

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

* INTRODUCTION

This p rtic lar stan ard is writ en at a moment in whic the tec nical evolution of

MR EQUIPMENT is in ra id progres an the s ientific fou dation of its saf e u e is sti

exp n in

This International Standard ad res es tec nical asp cts of the medical diag ostic MR SYS EM

an the MR EQUIPMENT therein related to the safety of P TIENT examined with this s stem, the

saf ety of the MR WORKER in olved with its o eration an the safety of the MR WORKER in olved

with the develo ment, man facturin , in tal ation, an servicin of the MR SYS EM Where

l mits of electromag etic f ield (EMF) exp s re of P TIENT an MR WORKERS are stated, these

l mits do not imply that s c levels of exp s re can b as umed to b ac e ta le for workers

in other profes ional setin s an f or the p pulation at large The l mits provide a sen ible

b lan e b twe n RISKS for the P TIENT an MR WORKERS an b nefits f or the P TIENT

Organizational asp cts of saf ety are the tas of the RE PONSIBLE OR A IZATION This tas

in lu es adeq ate trainin of staf f, rules of ac es to the MR SYS EM, q al fication of staf f or

decision that are related to safety, def i ition of medical resp n ibi ty an sp cific

req irements for p rson el f olowin f rom that resp n ibi ty when the P TIENT is in or ne r

the MR SYS EM

Examples of s c organizational asp cts are:

− o eration in FIRS LEVEL CONTR L ED OPERATING MODE;

− emergen y proced res for res s itation of the P TIENT who is in the MR SYS EM;

− emergen y proced res after a QUEN H of the s p rcon u tive mag et when present;

− set-up an maintenan e of a protocol f or s re nin the

P TIE

NT f or contrain ication or for

con ition that may af fect ac e ta le exp s re;

− rules f or ROUTINE MONITORING an for MEDIC L SU ERVISION of the P TIENT d rin the exam

− rules to minimize an to lmit the exp s re of MR WORKERS to EMF

Exten ive rationale is provided in An ex AA for some of the definition an req irements in

order to provide the u er of this stan ard with a re sona ly complete ac es to the source

material that was u ed in s p ort of the con ideration durin draf tin

The relation hip of this p rtic lar stan ard with IEC 6 6 1-1 an the col ateral stan ard is

explained in s bclau es 2 1.1.3 an 2 1.1.4

The introd ced EMF exp s re lmits req ired in this stan ard f or an MR WORKER wi never

ex e d those al owed for P TIENT Al exp s re l mits alowed f or a P TIENT an f or an MR

WORKER are exp cted to protect them again t negative he lth eff ects an u ac e ta le RISKS

For the exp s re to static mag etic field , s bjective s ort-term ph siological an sen ory

ef fects are exp cted These influen e the wel b in of the MR WORKER marginal y an only

d rin or s ortly af ter exp s re

For the exp s re to GRA IENT OUTP T an RF tran mit field , normaly no s ort-term

ph siological an sen ory ef fects are exp cted f or MR WORKERS

In ad ition no exp rimental or the retical b sis f or c mulative biological eff ects in h man ,

res ltin fom exp s re at the al owed levels has b en general y ac e ted

The req irements for acou tic noise exp s re are dif ferent f or P TIENT an MR WORKERS

INTRODUCTION TO AMENDMENT 1

This amen ment has b en publ s ed to ada t IEC 6 6 1-2-3 :2 10 to the tec nical

cor ection introd ced by Amen ment 1 (2 12) to IEC 6 6 1-1:2 0

INTRODUCTION TO AMENDMENT 2

This Amen ment 2 has b en develo ed to in re se the FIRS LEVEL CONTR L ED OPERATING

MODE l mit for the static field f om 4 T to 8 T takin into ac ou t FDA, ICNIRP an other p er

reviewed s ientific l terature In ad ition, a non-compulsory o tion, FIXED P RAME ER

OPTION:BASIC (FPO:B), is introd ced to l mit RF an gradient field outputs (p ak an RMS) for

s an in P TIENT with MR con itional implants Con eq ently, text is pro osed f or the

In tru tion for u e to g ide u ers in s an in P TIENT with MR con itional implants

Furthermore, ref eren es to newly publ s ed colateral stan ard have b en updated

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

MEDICA L ELECTRICA L EQUIPMENT –

Part 2-33: Particular requirements f or the basic safety and essential

perf ormance of magnetic resonance equipment for medical diagnosis

201.1 Scope, object and related standards

Clau e 1 of the general standard

1

a pl es, ex e t as f ol ows:

2 1.1.1 Sco e

Re la eme t:

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

MR EQUIPMENT an MR SYS EMS, here fter ref er ed to also as ME EQUIPMENT

This stan ard do s not cover the a pl cation of MR EQUIPMENT b yon the INT N ED US

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

The stan ard do s not f ormulate E S NTIAL PERFOR A CE req irements related to sp cific

req irements f or MR EQUIPMENT or MR SYS EMS u ed in INT RVENTION L MR EX MIN TIONS

2 1.1.2 Obje t

Re la eme t:

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

PERFO MA CE req irements f or MR EQUIPMENT to provide protection for the P TIENT an the MR

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

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

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 BASIC SAF TY an E S NTIAL

PERFO MA CE req irements

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

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

Colateral 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 prefix “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 col ateral stan ard with the prefix “2 x”

where x is the final digit s) of the col ateral stan ard doc ment n mb r (e.g 2 2.4 in this

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

2 3.4 in this p rtic lar stan ard ad res es the content of Clau e 4 of the 6 6 1-1-3 colateral

stan ard, etc.) The c an es to the text of the general stan ard are sp cif ied by the u e of

the fol owin word :

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

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

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

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

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

col ateral stan ard is amended 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 rom 2 1.101 However d e to the f act that def i ition in the general

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

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

ad itional items a ), b ), etc

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

n mb red startin f rom 2 x, where “x” is the n mb r of the colateral standard, e.g 2 2 f or

IEC 6 6 1-1-2, 2 3 for IEC 6 6 1-1-3, etc

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

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

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

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

relevant, a pl es without modification; where it is intended 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 references

NOT Informativ refere c s are lste in th biblo ra h b gin in o p g 1 9

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

Repla eme t:

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

IEC 6 6 1-1-2:2 0 2 14, Medic l electric l e uipme t – P art 1-2: Ge eral re uireme ts for

b sic s fety a d e s ntial p rorma c – Collateral sta dard : Electroma n tic c mp tibility

d isturb n e – Re uireme ts a d tests

IEC 6 6 1-1-6:2 10, Med ic l ele tric l e uipme t – P art 1-6: Ge eral re uireme ts for b sic

s fety a d e s ntial p rorma c – Collateral standard: U sa ility

IEC 6 6 1-1-6:2 10/AMD1:2 13

IEC 6 6 1-1-8:2 0 , Med ic l ele tric l e uipme t – P art 1-8: Ge eral re uireme ts for b sic

s fety a d e s ntial p rorma c – Collateral sta dard: Ge eral re uireme ts, tests a d

g ida c for alarm s stems in medic l electric l e uipme t a d med ic l electric l s stems

IEC 6 6 1-1-8:2 0 /AMD1:2 12

Ad ditio :

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

s fety a d e s ntial p rorma c

Amen ment 1:2 12

NEMA MS 4:2 0 2 10, Ac u tic n is me s reme t pro edure for d ia n stic ma n tic

re o a c ima in (MRI ) devic s

NEMA MS 8:2 0 , Ch ra teriz tio of the s e ific a s rption rate (SAR) for ma n tic

.d)((

x0

is the evaluation integration time, an is estimated at the RF tran mit

coi centre whic s al b an 10 s p riod over the d ration of the entire seq en e

Note 1 to e try: B

1

is d riv d fom th f lip a gle a era e o er a a ju tme t v lume, whic is ty ic ly

re re e te b th a ial c ntral sla wh rein M sig al is g n rate

2 1.3.2 2

CO P IAN E VOLUME

PATIENT ac es ible sp ce in whic compl an e of GRA IENT OUT UT is in p cted

In MR EQUIPMENT with a c l n rical WHOLE BOD MAGNE , the COMPLIA CE VOLUME is a c l n er

with its axis coin idin with the mag et axis an with a radiu of 0,2 m an with a len th

eq al to the gradient coi

In MR EQUIPMENT with a TR NSVERS FIELD MAGNE an a WHOLE BODY GR DIENT SYS EM, the

CO PLIA CE VOLUM

E is a c ln er al g ed with the p tient’s axis, of len th eq al to the

gradient coi diameter, an a diameter of 0,4 m or eq al to the distan e b twe n the p les of

the mag et, whic ever is les

In al other MR EQUIPMENT the COMPLIA CE VOLUME is the volume where an p rt of a PATIENT

b d can b pro erly located ac ordin to the

are arou d the MR SYS EM, to whic ac es is control ed f or saf ety re son to prevent H RM

f rom the mag etic field

Note 1 to e try: Th C N R L E AC E S ARE is n t id ntic l to th S ECIAL E VIR NME T or S ECIAL LO A ION

a d fin d in IEC 6 6 1 1 2:2 14

2 1.3.2 4

CO E T MP R TURE

me n temp rature of the b d core

NOT Ty ic ly e u l to th re tal s bln u l or tymp nic temp rature More rela le re re e tatio s of C RE

T MP RA URE are o s p a e l or arterial blo d temp rature Brain temp rature are C RE T MP RA URE

2 1.3.2 5

E F CTIVE S IMULUS D RATION

t

,ef

duration of an p riod of the monotonic in re sin or decre sin gradient, u ed to

des rib its l mits for cardiac or p ripheral nerve stimulation, defined as the ratio of the

pe k-to-pe k field variation an the maximum value of the time derivative of the gradient

Thre p rio s of mo oto ic c a g of th gra ie t G are s own in gra h a Th c re p n in G A IE T

OU P T dB/dt is s ownin gra hb a d th EF ECTIV S IMULU D RA ION t

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

* 2 1.3.2 7

EN IR NMENTA L T MP R TURE

temp rature [°C] of a u iform (isothermal) “blac ” en los re in whic an oc up nt would

ex han e the same amou t of he t by radiation an con ection as in the actual non-u iform

en ironment

NOT For th c lc latio of th E VIR NME T L T MP RA URE s e ratio ale in An e A

2 1.3.2 8

FIRS L VE CONTR L ED OP RA TING MODE

mode of o eration of the MR EQUIPMENT in whic one or more outputs re c a value that can

cau e ph siological stres to P TIENT whic ne d to b control ed by MEDICAL SU ERVISION

2 1.3.2 9

GRA DIENT OUT UT

p rameter c aracterizin the gradient p rorman e s c as rate of c an e of the mag itu e

of the mag etic f ield, or electric f ield in u ed by one or more GRA IENT U IT u der sp cified

con ition an at a sp cif ied p sition

2 1.3.210

GRA DIENT UNIT

al gradient coi s an ampl fiers that together generate a mag etic field gradient alon one of

the axes of the co rdinate s stem of the MR EQUIPMENT

INT RVENTIONA L MR EXAMINA TION

MR EX MIN TION a pl ed to g ide a medical (in lu ing in asive) proced re e.g bio s or the

treatment of a lesion

2 1.3.214

ISOCENTRE

in MR EQUIPMENT n l p int of the spatial y en odin gradients

NOT 1 Ty ic ly this als c re p n s to th re io of hig e t ma n t h mo e eity

[IEC 6 4 4-1:2 0 , def i ition 3.1.15]

NOT 2 Ty ic ly this c re p n s with th p sitio in th s stem targ te f or ima in

2 1.3.215

LOCA L RF TRA NSMIT COIL

RF tran mit coi other than a VOLUME RF TRA SMIT COIL

2 1.3.216

LOCA L SA R

SAR averaged over an 10 g of tis ue of the b d an over a sp cified time

MEDICAL ELECTRIC L EQUIPMENT whic is inten ed for in vivo MAGNE IC RE ON N E EX MIN TION

of a P TIENT comprisin al p rts in hardware an sof tware fom the SU PLY MAINS to the

en emble of MR EQUIPMENT, A CE SORIE in lu in me n f or display, control, energy

s p l es, an the CONTR L ED A CE S AREA, where provided

* 2 1.3.2 1

MA GNE IC RE ONA NCE WOR ER

MR WORKER

p rson that b cau e of his/her profes ion has to enter the CONTR L ED A CE S AREA or

eq ivalent of the MAGNE IC RE ON NCE SYS EM

NOT Oth r p rs n , s c a M v lu te rs a d P TIE T c rers, are n t c v re b this d f i itio Howe er,

OP RA O S a d staf are in lu e in this d f i itio (s e ratio ale)

2 1.3.2 2

MAXIMUM GRA DIENT S EWRA TE

the rate of c an e of the gradient o tained by switc in the GRA IENT U IT b twe n its

maximum sp cif ied gradient stren th G

+ma

−ma

in the s ortest p s ible ramp time

o taina le u der normal s an con ition

* 2 1.3.2 3

MEDICA L SUP RVISION

adeq ate medical management of P TIENT who can b at RISK f om some p rameters of

exp s re to the MR EQUIPMENT, either b cau e of the medical con ition of the P TIENT, the

levels of exp s re or a combination

2 1.3.2 4

NOR A L OP RA TING MODE

mode of o eration of the MR EQUIPMENT in whic none of the outputs have a value that can

cau e ph siological stres to P TIENT

tran ition of the electrical con u tivity of a coi that is car yin a c r ent f rom a s p r

con u tin state to normal con u tivity, res ltin in ra id b i -of f of f l id cryogen an decay

of the mag etic f ield

2 1.3.2 9

ROUTINE MONITORING

routine PATIENT monitorin , car ied out by resp n ible p rson el s c as the OP R TOR an

staf f of the MR EQUIPMENT an con istin of au io an /or vis al contact, as a pro riate with

S CON L VE CONTR L ED OP RATING MODE

mode of o eration of the MR EQUIPMENT in whic one or more outputs reac a value that

can prod ce sig ificant RISK for PATIENT , for whic expl cit ethical ap roval is req ired

(i.e a h man stu ies protocol a proved to local req irements)

2 1.3.2 2

S ECIAL PURPOS GR DIENT SYS EM

gradient s stem s ita le f or u e in MR EQUIPMENT f or a sp cial purp se

NOT An e ample of a S ECIAL P RPOS G A IE T S S EM is a gra ie t s stem th t c n b in orp rate in

rate of c an e of the mag etic fl x den ity with time (T/s)

Note 1 to e try: Th time rate of c a g of th ma n tic field dB/dt is a s me to b e alu te in a s ita ly low

fe u n y ra g (e.g  5 kHz) to disre ard ef fe ts of switc in amplf i r rip le

2 1.3.2 5

TRANSVERS FIE D MA NE

mag et for whic the f ield is at rig t an les to the axial direction of the PATIENT

2 1.3.2 6

VOLUME RF TRANSMIT COIL

RF tran mit coi s ita le f or u e in MR EQUIPMENT that prod ces a homogene u RF f ield over

an exten ed volume en omp s ed by the coi

NOT Th VOLUME RF TRA SMIT C IL c n b a WHOLE BOD RF TRA SMIT C IL, a H A RF TRA SMIT C IL or a RF

TRA SMIT C IL d sig e for h mo e e u e p s re of a s e if i p rt of th b d A sin le lo p c i e clo in th

b d or a p rt of th b d is c n id re to b a VOLUMERF TRA SMIT C IL (e ample:sin le lo pwrist c i)

2 1.3.2 7

WHOL BOD GRA DIENT SYS EM

gradient s stem s ita le f or u e in WHOLE BOD MR EQUIPMENT

WHOL BOD RF TRA NSMIT COIL

VOLUME RF TRA SMIT COIL of s f ficient size for whole b d examination of ad lt P TIENT

o tion within existin modes (i.e NOR AL OPERATING MODE or FIRS LEVEL CONTR L ED

OPERATING MODE), whic sp cifies a set of o erational lmit values for the al owa le RF field

“b sic” denotes a sp cific implementation of FPO, ex lu ively f or 1,5 T MR SYS EMS

Note 1 to e try: Th n te to e try in Fre c c n ernin th s urc of th a bre iatio “FPO:B” c n ern th Fre c

maximum time rate of c an e of the mag itu e of the mag etic field d rin the MR

EX MIN TION, evaluated at the location def i ed for FPO, i.e a s rf ace providin 5 cm cle ran e

tt

B

RMSB

t

F O



x

the mag etic f ield as ociated with the switc in gradients

RF ex itation where the two prin ip l electromag etic modes of the VOLUME RF TRA SMIT COIL

are driven with eq al ampl tu e an 9 ° phase dif f eren e

Note 1 to e try: This driv o eratio is d n te a “CP” o u er intera e a d in AC O P N ING DO UME T

Note 2 toe try: Circ larly p lariz d RF is als c mmo ly refere to a q a rature driv

Table 2 1.101 – List of s mbols a d abbre iations

201.4 Ge eral requirements

Clau e 4 of the general standard a pl es ex e t as f ol ows:

2 1.4.3 ES ENTIA L P RFOR A NCE

Add ition:

NOT 101 No E S N IAL P RFO MA CE re uireme ts h v b e id ntif i d for th M EQUIPME T within th s o e

of th sta d rd For th f un tio s of th M EQUIPME T c v re b this sta d rd n s e if i E S N IAL

P RFO MA CE re uireme ts h v b e id ntif i d Oth r fu ctio s of th M EQUIPME T ma c n titute E S N IAL

P RFO MA CE Se th g n ral sta d rd f or re uireme ts to th RIS MA AGEME T FILE of th MA UFACT RER to

c v r th a aly is of E S N IAL P RFO MA CE of th M EQUIPME T

201.5 Ge eral requirements f or testing of ME EQUIPMENT

Clau e 5 of the general standard a pl es ex e t as fol ows:

2 1.5.7 Humidity pre on itionin tre tme t

Add ition:

For those MR SYS EMS an MR EQUIPMENT that are to b u ed only in control ed en ironments,

as to b sp cif ied in the tec nical des ription, no h midity precon itionin is req ired

NOT A c ntrole e viro me t is n t th s me a C N R L E AC E SARE

201.6 Classif ication of ME EQUIPMENT and ME SYST MS

Clau e 6 of the general standard a pl es

201.7 ME EQUIPMENT ide tif ication, marking and doc ments

Clau e 7 of the general standard a pl es ex e t as f ol ows:

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

2 1.7.2.13 Phy iologic l eff ects (s f ety sig s a d warning stateme ts)

Add ition:

Ap lca le safety sig s ISO 7 10-W0 5 (se Ta le 2 1.D.101, safety sig 1) an ISO 7 1

0-W0 6 (se Ta le 2 1.D.101, safety sig 2) s al b placed at the entran e of the CONTR L ED

A CE S AREA The safety sig s may b ac omp nied by text explainin that the mag etic field

is alway on, but that EMF emis ion is restricted to the situation when the MR EQUIPMENT is

s an in

For MR EQUIPMENT that do s not req ire a CONTR L ED A CE S AREA, the ne d f or an location

of the saf ety sig s s al b des rib d in the RISK MA AGEMENT FILE by the MA UFA TURER

Information s al b provided in the in tru tion for u e con ernin sp cific ph siological

eff ects related to MR EQUIPMENT

OR A IZATION to ena le it to comply with the local reg lation an req irements f or exp s re

l mits a pro riate to the P TIENT an MR WORKER

2 1.7.9.2 Instru tions for us

2 1.7.9.2.10 Me s g s

Re la eme t:

The in tru tion for u e s al l st al s stem mes ages, er or mes ages, an f ault mes ages

that are generated related to safety con ern u les these mes ages are selfexplanatory

2 1.7.9.2.17 ME EQUIPMENT emit in ra iation

Add ition:

NOT Th in tru tio s f or u e in 2 1.7.9.2.101 a d th c mp tibi ty te h ic l s e if i atio s e t in th te h ic l

d s riptio in 2 1.7.9.3.101 pro id d taie inf ormatio c n ernin ele troma n tic field of th M EQUIPME T

Add ition:

* 2 1.7.9.2.101 Instruction for us f or MR EQUIPMENT

* a) Pre-s re nin of the P TIENT an the MR WORKER

In tru tion for u e s al provide cle r recommen ation to the RE PONSIBLE OR A IZATION

regardin pre-s re nin of P TIENT an MR WORKERS This specifical y a pl es to those

P TIENT an MR WORKERS who could b placed at RISK d e to their profes ional activity, p st

medical history, present medical state an /or the ph sical en ironment of the MR EQUIPMENT

These in tru tion s al in icate the ne d for a pre-s re nin programme to identify s c

P TIENT and MR WORKERS at RISK, an s al provide recommen ation to adeq ately

safeg ard these P TIENT an MR WORKERS f rom injury For the MR WORKER an the P TIENT

esp cial y the RISK d e to the p st prof es ional activity, whic could have cau ed ac idental

implantation of f er omag etic materials, s al b con idered

The fol owin sp cif i clas es of P TIENT s al b mentioned:

– clas es of P TIENT for whom MR EX MINATIONS are con idered to b contrain icated;

– clas es of P TIENT havin hig er than normal l kel ho d of ne din emergen y medical

tre tment, in e en ent of the ph sical en ironment of the MR EQUIPMENT;

– clas es of P TIENT havin a hig er than normal l kel ho d of ne din emergen y medical

treatment d e to the elevated values of the a pl ed field , when the MR EQUIPMENT is

ca a le of o eratin within the FIRS LEVEL CONTROL ED OPERATING MODE as des rib d in

s bclau e 2 1.12.4.101

* b) MEDICAL SU ERVISION OF P TIENT

In tru tion for u e s al provide cle r recommen ation to the RE PONSIBLE O GA IZATION to

esta l s a programme f or the s p rvision a pro riate to the clas es of P TIENT des rib d in

2 1.7.9.2.101 a) an to the control ed modes of o eration of the

– in lu e the recommen ation that al P TIENT s ould receive at le st R UTINE MONITORING;

– if the MR EQUIPMENT is ca a le of o eratin within the FIRS LEVEL CONTR L ED OPERATING

MODE: give recommen ation that proced res s ould b esta l s ed to en ure that MEDICAL

SU ERVISION is provided when enterin the FIRS LEVEL CONTR L ED OPERATING MODE;

– if the MR EQUIPMENT is provided with a S COND LEVEL CONTR L ED OPERATING MODE: in lu e

notif i ation that o eration in the S CON LEVEL CONTR L ED OPERATING MODE req ires

a proval of in estigational h man stu ies protocol ac ordin to local req irements (e.g

ethic commite , in estigational review b ard, etc.) In ad ition it s al b stated that the

local a proval s ould sp cifical y state l mits f or GRA IENT OUTP T, SAR an static f ield

stren th

* c) Emergen y medical proced res

In tru tion for u e s al give cle r recommen ation to the RE PONSIBLE OR A IZATION to

define an implement sp cif i emergen y medical proced res that a ply to the P TIENT an

that take into ac ou t the presen e of the mag etic f ield, so that if d rin MR EX MINATION the

P TIENT fe ls i or is injured by external cau es, medical tre tment can b given as so n as

p s ible

These in tru tion s al in lu e recommen ation to esta l s a proced re f or removin

P TIENT ra idly f om the mag et's in uen e, if neces ary, by u in the EMERGEN Y FIELD

SH T DOWN U IT

* d) Exp s re of the P TIENT an MR WORKER to ex es ive acou tic noise

The in tru tion f or u e:

– s al draw atention to the p s ibi ty that ana sthetised P TIENT can have les than

normal protection again t hig sou d pres ure, so that e r protection for these P TIENT

s ould not b omited even at moderate sou d levels;

– s al draw at ention to the f act that in some cou tries legislation may exist coverin the

exp s re of p rson el to noise;

– s al state that f or tas s in the CONTR L ED A CE S AREA d rin s an in , the MR WORKER

s al we r adeq ate he rin protection to re c complan e with the rules for protection of

For MR EQUIPMENT that is ca a le of prod cin more than an A-weig ted r.m.s

sou d pres ure level (L

e , 1 h) of 9 dB(A), the in tru tion for u e:

– s al state that the A-weig ted r.m.s sou d pres ure level is me s red ac ordin to NEMA

MS 4:2 0 2 10;

– s al state that he rin protection s al b u ed f or the safety of the P TIENT an that this

he rin protection s al b s ff i ient to red ce the A-weig ted r.m.s sou d pres ure level

b low 9 dB(A);

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

– s al state that sp cial at ention an sp cial trainin f or the OPERATOR is req ired for

pro er p sitionin of the he rin protection, especial y when stan ard e r muf f s can ot b

a pl ed, or no protection at al can b a pl ed, as for ne nates an premature inf ants;

– s al draw at ention to a warnin that d e to in re sed an iety, ac e ted sou d pres ure

levels can sti b of con ern to preg ant women an the fo tu , to new-b rn , inf ants an

you g c i dren an to the elderly;

NOT 1 A s ita le warnin sig is s e ifie in ISO 7 10:2 0 , Ame dme t 3 (2 0 ) An a plc ble s fety

sig is ISO 7 10-M0 3 (2 1 ) (s e Ta le 2 1.D.101, s f ety sig 6)

* e) CONTR L ED A CE S AREA

When the in tal ation of a CONTR L ED A CE S AREA is req ired f or the MR EQUIPMENT (se

2 1.7.9.3.101 a) an 2 2), the in tru tion for u e

– s al state, that it is the resp n ibi ty of the RE PONSIBLE ORGA IZATION to f olow local

statutory req irements with resp ct to ac es to the CONTR L ED A CE S AREA;

– s al sp cify, prefera ly ac omp nied by a s aled diagram, the size an s a e of the

CONTR L ED A CE S AREA;

– s al in icate the ne d to esta l s adeq ate rules f or control n ac es to the

CONTR L ED A CE S AREA in terms of the p tential RISK to P TIENT an MR WORKERS within

the CONTR L ED A CE S AREA f rom the at raction of o jects containin iron or other

mag etical y active materials or f rom torq e on s c metal c materials an the p tential

RISK to p rson inad ertently enterin the are who can b af fected by the p s ible

d sf un tion of their medical implants s c as p cemakers;

NOT 2 For ma n tic f i ld stre gth le s th n 0,5 mT n a ministrativ c ntrols are re uire

– s al l st EQUIPMENT an to ls sp cified or recommen ed by the MA UFA TURER for u e in

the CONTROL ED A CE S AREA For al EQUIPMENT, A CE SORIE or to ls lsted, a des ription

s ould b given of sp cial me s res that are ne ded, if an , f or their in talation as wel as

sp cial precaution , if an , for their u e;

– s al state that p ripheral eq ipment, in lu in P TIENT monitorin , l f e s p ortin devices

an emergen y care eq ipment, whic is not sp cified or recommen ed for u e in the

CONTR L ED A CE S AREA, can b disturb d by the radio feq en y f ield, the switc ed

gradients or the mag etic f in e field of the MR EQUIPMENT an that this p ripheral

eq ipment can also disturb the pro er f un tionin of the MR EQUIPMENT;

– s al explain the me nin of device la el n f or MR safe, MR con itional an MR u safe

* f) Liq id an gase u cryogen

For MR EQUIPMENT eq ip ed with s p rcon u tin mag ets, in tru tion f or u e s al , in order

to prevent ac idents an QUEN H:

– req ire adeq ate provision f or s p ly of l q id cryogen;

– recommen that cryogen ref il n b p rf ormed by trained an exp rien ed p rson el only;

– provide inf ormation on maintenan e an in p ction of the mag et in lu in the lq id

cryogen level(s);

– provide inf ormation on the minimum cryogen level(s) req ired for normal o eration;

– req ire that f eq ent c ec s of cryogen level(s) b car ied out by the RE PONSIBLE

ORGA IZATION;

– give cle r inf ormation on p tential H ZARDs of the u e of l q id cryogen as wel as

information on pro er han l n of these l q id This s al in lu e information con ernin :

• the we rin of protective clothin to prevent f rostbite;

NOT Ap lc ble s fety sig s ISO 7 10-M0 4 (s e Ta le 2 1.D.101, s fety sig 7) a d ISO 7 10-M0 9 (s e

Ta le 2 1.D.101, s fety sig 8) are a pro riate for pla eme t n ar th lo atio wh re th cry g n refi is

p rorme

• proced res to b p r ormed af ter gas rele se;

• precaution again t lac of ox gen;

• the u e of non-mag etic containers f or the cryogen that are b in s p led;

• proced res to b fol owed if flamma le materials are fou d ne r the cryogen container

NOT 3 Liq id o y e c n a c mulate, or th g s o s o y e c n e tratio c n b c me hig in th vicinity

of th cry g n

* g) Op ratin modes

In tru tion f or u e s al provide information con ernin the me nin an b c grou d of e c

mode of o eration: NORMAL OPERATING MODE, FIRS LEVEL CONTR L ED OPERATING MODE, an

S CON LEVEL CONTR L ED OPERATING MODE, as they are defined in 2 1.12.4.101 The

in tru tion f or u e s al also give the explanation that the static mag etic f ield, GRA IENT

OUTP T an SAR levels f or P TIENT are b sed on c r ent s ientif i l terature related to saf ety,

an that the level of exp s re, the decision of le vin the NORMAL OPERATING MODE an the

p s ible ne d for ph siological monitorin of the P TIENT s al b a medical ju gement as to

the P TIENT ’ p tential RISK vers s b nefit

In tru tion f or u e s al explain the req irements of e c o eratin mode:

– For MR EQUIPMENT o eratin within the NOR AL OPERATING MODE, no sp cif i in ication or

me s re is req ired to b displayed

– For MR EQUIPMENT ca a le of o eration in FIRS LEVEL CONTR L ED OPERATING MODE, the

pro erties of the MR EQUIPMENT with resp ct to displayed in ication b fore enterin this

mode an to del b rate action when enterin this mode, as req ired in 2 1.12.4.101.4 s al

b des rib d Also, MEDIC L SU ERVISION s al b recommen ed as req ired in

2 1.7.9.2.101 b)

– For MR EQUIPMENT ca a le of o eratin within the S COND LEVEL CONTR L ED OPERATING

MODE, specific sec rity me s res s al b provided as req ired in 201.12.4.101.5 to

prevent unauthorised o eration in the S CON LEVEL CONTROL ED OPERATING MODE

Op ration in the S CON LEVEL CONTROL ED OPERATING MODE is only p rmit ed u der a

human studies protocol a proved ac ording to local req irements as req ired in

201.7.9.2.101 b)

In tru tion f or u e s al recommen that at ention s ould b p id to the saf ety of P TIENT in

terms of the del b rate action an MEDIC L SU ERVISION whic is req ired for enterin the

FIRS LEVEL CONTR L ED OPERATING MODE, or in terms of the sp cific sec rity me s res an

a proval of in estigational h man stu ies protocol ac ordin to local req irements req ired

for enterin the S CON LEVEL CONTR L EDOPERATING MODE

* h) Exp s re of the P TIENT an MR WORKER to the static mag etic field

For MR EQUIPMENT that is ca a le of o eration in the FIRS LEVEL CONTR L ED OPERATING MODE

or the S CON LEVEL CONTROL ED OPERATING MODE for static mag etic field, the in tru tion f or

u e s al :

– explain the p s ible ef fects that P TIENT an MR WO KERS can exp rien e when the main

static mag etic field is a ove the level of the NOR AL OPERATING MODE, p yin p rtic lar

at ention to the eff ects that can b exp rien ed if the P TIENT’s or the MR WORKER’S he d

is moved ra idly whie in ide or close to the MR EQUIPMENT, in lu in vertigo, nau e an

a metal c taste in the mouth;

– recommen that the P TIENT remain sti whi e in the region of hig static mag etic field;

– provide information on the values of B

0

whic the MR EQUIPMENT is ca a le of;

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

– explain that when the main static magnetic field is hig er than 3 T an not ex e din 4

8 T, the MR SYS EM is contin ou ly o eratin in the FIRS LEVEL CONTROL ED OPERATING

MODE an theref ore en ure that MEDIC L SUPERVISION is provided for al P TIENT ;

– explain that adeq ate trainin s al b given to MR WORKERS

to minimise ad erse he lth

eff ects arisin f rom the hig static mag etic f ield;

– explain the he lth ef fects related to the in re sed static mag etic field;

– explain the p s ible c an es in the MR comp tibi ty of the to ls an ac es ories u ed by

the

MR WORKER

as a fu ction of the value of the static mag etic field;

– explain that when the main static mag etic field is hig er than 4 8 T, the MR SYS EM is

contin ou ly o eratin in the S COND LEVEL CONTR L ED OPERATING MODE an therefore

en ure that MEDICAL SU ERVISION is provided for al P TIENT Explain that in this situation

MR WORKERS s al not b al owed to ac es the MR EQUIPMENT without sp cial

authorization

i) Exp s re of the

P TIE

NT to time varyin mag etic field

For MR EQUIPMENT that is ca a le of o eration at levels of GRA IENT OUTP T a ove the NOR AL

OPERATING MODE the in tru tion f or u e s al:

– explain the p s ible ef fects on the P TIENT of the level of GRA IENT OUTP T in e c of the

o eratin modes with whic the MR EQUIPMENT is provided, p yin p rtic lar atention to

p s ible ef fects on the p ripheral nervou s stem an on the he rt;

– provide inf ormation on the GRA IENT OUTP T of whic the MR EQUIPMENT is ca a le in e c

o eratin mode;

– explain that the MR EQUIPMENT wi display an in ication of the a pro riate o eratin mode

when the value of GRA IENT OUTP T ex e d the l mits of the NORMAL OPERATING MODE;

– des rib the gradient s stem as either a WHOLE BODY GRA IENT SYS EM or as a SPECIAL

P RPOS GRA IENT SYS EM an des rib the volume in whic the G A IENT OUTP T is in

complan e

j) Exp s re of the P TIENT to radio f req en y mag etic f ield

The in tru tion for u e s al draw at ention to RISK factors, whic can in re se the p tential

f or local ex es ive RF he tin of the P TIENT an they s al des rib way for the OPERATOR

to mitigate these RISK factors These f actors in lu e:

– the presen e of con u tive (metal c) o jects or implants within the sen itivity region of

the RF tran mit coi Al clothin containin metal c thre d or comp nents an al other

metal c o jects s c as watc es, coin , etc s al b removed fom the P TIENT;

– the u e of medicinal prod cts in tran dermal p tc es whic can cau e burn to the

u derlyin s in;

– the fact that s in-to-s in contact can form a con u tive lo p throu h p rt of the b dy, e.g

in er thig -to-thig , calfto-calf , han -to-han , han -to-b d , an le-to-an le contact;

– the presen e of damp clothin ;

– the placement of the b d or extremities again t the RF tran mit coi s race;

– the contact b twe n P TIEN

T an RF receive coi ca le an the routin of the RF coi ca le

in proximity to RF tran mit coi ;

– the formation of lo ps with RF receive coi ca les and ECG le d ;

– the u e of MR con itional ECG electrodes an le d Inf orm the OPERATO to re d an

careful y folow the in tru tion for u e Inform the OPERATOR to alway u e electrodes

– the s an in of sedated or u con ciou P TIENT , or P TIENT with los of f eel n in an

b d p rt, e.g p raly is of arms or leg , an who would theref ore not b a le to alert the

OPERATOR as to ex es ive he tin an as ociated tis ue damage;

– the presen e of u con ected receive cois or electric ca les that remain in the RF tran mit

coi d rin the examination

For MR EQUIPMENT that is ca a le of op ration at SAR levels a ove the NOR AL OPERATING

MODE, the in tru tion f or u e s al :

– explain the p s ible eff ects of elevated values of the diff erent typ s of

modes provided by the MR EQUIPMENT, p yin p rtic lar at ention to the safety of

P TIENT who can have red ced thermal reg latory ca a i ties an in re sed

sen itivity to raised b d temp rature (e.g f ebri e an cardiac decomp n ated

P TIENT , those with compromised a i ty to p rspire, an preg ant women) In

ad ition, information des ribin the imp rtan e of en ironmental controls an the

eff ect of EN IRONMENTAL T MPERATURE on P TIENT CORE T MPERATURE rise s al b

provided, alon with recommen ation for en ironmental con ition f or the P TIENT;

– provide inf ormation on the values of e c typ of SAR the MR EQUIPMENT is ca a le

of;

– explain that the l mits f or the o eratin modes f or WHOLE BOD SAR given in

2 1.12.4.10 as ume that the ENVIR NMENTAL T MPERATURE is not more than 2 °C

In ad ition, the in tru tion for u e s al explain how the SAR is control ed outside

these environmental specification This explanation s al

• sp cify that the MR EQUIPMENT s al not b u ed when the EN IR NMENTAL

T MPERATURE is gre ter than 2 °C, or

• explain that the l mit of the FIRS LEVEL CONTR L ED OPERATING MODE f or SAR s al

b red ced ac ordin to 2 1.12.4.10 2 (only f or MR EQUIPMENT that has the

ca a i ty to me s re the EN IR NMENTAL T MPERATURE);

– draw atention to me n to red ce the RISK f rom hig SAR s an in , s c as the ne d

for bre k for the P TIENT to co l down, l g t clothin f or the P TIENT an adeq ate

venti ation of the P TIENT sp ce;

– explain that the value of the B

1+RMS displayed on the CONTR L P NEL for e c

seq en e is an in ication of the RF mag etic field inten ity It can b of u e to

determine the RISK of s an in a p tient with an active or p s ive implant

* k) Oc up tional exp s re to EMF

The in tru tion for u e s al draw atention to the f act that MR WORKERS can b exp sed to

the electromag etic field (EMF) emited by the MR EQUIPMENT It s al provide s f ficient

information relatin to the RISKS f rom these exp s res to ena le saf e workin proced res f or

the MR WORKER The relevant req irements of 2 1.7.9.2.101 i) an j) f or the P TIENT s al also

a ply for the MR WORKER This inf ormation s al also in lu e

– sp cification of are s to whic ac es by the MR WORKER is restricted, if any;

– information on the maximum levels of the exp s re in are s ac es ible to the MR WO KER,

expres ed in pro er u its for the static mag etic f ield (se s bclau e 2 1.7.9.2.101 h) an

2 1.12.4.10 ), the GRA IENT OUTP T (se s bclau e 2 1.7.9.2.101.i) an 2 1.12.4.10 )

an the RF tran mit f ield (se s bclau e 2 1.7.9.2.101 j) an 2 1.12.4.10 ) generated by

the MR EQUIPMENT;

– in tru tion that the MR WORKER s al b informed an trained s f ficiently so that they can

p rorm al their tas s safely in a way that minimizes their exp s re to EMF emit ed by the

MR EQUIPMENT;

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

– a statement that there is a p s ibi ty that mid Peripheral Nerve Stimulation (PNS) can b

in u ed in the P TIENT an MR WORKER when exp sed to the gradients in the FIRS LEVEL

CONTR L ED OPERATING MODE;

The RISK f actors as ociated with the exp cted exp s re levels f or the MR WORKER s al b

explained A des ription of way for the MR WO KER to mitigate these RISK f actors s al b

given

Known f actors to draw atention to are:

– the p s ible ph siological eff ect of exp s re to RF radiation is he tin Exp s re to RF

radiation can b minimized by ke pin s ff i ient distan e away f om the tran mit RF coi

or by red cin time of exp s re d rin s an in ;

– the p s ible ph siological eff ect of exp s re to the GRA IENT OUTP T is p ripheral nerve

stimulation for the p rson exp sed Esp cial y MR WORKERS p r ormin INT RVENTION L

MR EX MIN TIONS, s al b informed an trained that, althou h p ripheral nerve stimulation

is not exp cted, the

SAF

TY of

P TIENT

s al not b compromised d rin interventional

proced res d e to p ripheral nerve stimulation Exp s re to GRA IENT OUTP T can b

minimized by ke pin s ff i ient distan e away f om the gradient coi s d rin s an in

– the p s ible ph siological ef fects of exp s re to static mag etic field are diz ines ,

vertigo, an a metal c taste in the mouth of the p rson exp sed Exp s re to the static

mag etic f ield can b minimized by stayin away f rom the magnet (not ju t d rin

s an in but al the time) an by avoidin ra id movements of the he d whi e in the static

mag etic field

The INS RU TIONS FOR US may state that it is general y ac e ted that no publ s ed eviden e

s p ortin the oc ur en e of c mulative an /or lon -term eff ects after exp s re to EMF

NOT 4 L c l re ulatio s mig t a ply

The in tru tion for u e s al state that the l mits for MR WORKERS may not b ap l ca le when

an MR WORKER is preg ant It mig t b req ired in some cou tries that the ‘memb r of the

publ c’ lmit b a pl ed to the f oetu , whic impl es that the preg ant MR WORKER is not

al owed to b present in the examination ro m d rin s an in

The in tru tion for u e s al state that in some cou tries legislation mig t exist coverin

oc up tional l mits f or exp s re to EMF, that are lower than the l mits for MR WORKER given in

this stan ard

* l) Au i ary EQUIPMENT

The RE PONSIBLE OR A IZATION s al b made aware that an a pl cation of phy iological

monitorin an sen in devices to the P TIENT s ould b made u der the RE PONSIBLE

OR A IZATION’S direction an is the RE PONSIBLE OR A IZATION’S resp n ibi ty

The in tru tion for u e s al warn the RE PONSIBLE O GA IZATION an the OPERATOR that the

u e of au i ary eq ipment, s c as ph siological monitorin an gatin eq ipment an RF

tran mit coi s, whic has not b en sp cif i al y tested an a proved for u e in the en ironment

of the MR EQUIPMENT mig t res lt in burn or other injuries to the P TIENT In tru tion f or u e

s al further warn the RE PONSIBLE ORGA IZATION an the OPERATO that even au i ary

devices la el ed as MR saf e or MR con itional with MR EQUIPMENT or MR SYS EMS mig t b

m) EMER ENC FIELD SH T DOWN U IT

The in tru tion for u e s al in icate when an how the EMER EN Y FIELD SHUT DOWN UNIT

s ould b o erated in the event of an emergen y Examples of situation whic would req ire

emergen y field s ut down s al b provided

NOT 5 Perma e t ma n ts c n ot b d -e ergiz d in c s of emerg n y

n) Fire precaution

The in tru tion f or u e s al recommen to the RE PONSIBLE OR A IZATION that fire

precaution s ould b dis u sed with the local fire de artment, that emergen y proced res

s ould b esta l s ed an that it is the RE PONSIBLE OR A IZATION’s resp n ibi ty to take the

neces ary initiatives

o) Artef acts

The in tru tion f or u e s al alert the OPERATOR to the f act that image artefacts can oc ur as

a res lt of tec nological an ph siological factors (e.g mag et homogeneity, gradient

l ne rity, trun ation, al asin , motion, flow, c emical s ift, s s e tibi ty variation , etc.) The

eff ects of these f actors (e.g image non-u iformity, ge metric distortion, g osts, wra arou d

etc.) on the image s al b des rib d Method of cor ectin or mitigatin s c eff ects (e.g

c an in b n width, gradient moment n l n , pre-saturation, etc.) s al also b dis u sed

p) Recommen ed trainin

The in tru tion for u e s al recommen that trainin is ne ded f or the MR WORKER to

o erate the MR EQUIPMENT safely an ef fectively This trainin s al in lu e emergen y

proced res, in lu in those for the is ues des rib d in this s bclau e u der

– c) Emergen y medical proced res

The in tru tion for u e s al des rib the q al ty as uran e proced res recommen ed f or the

RE PONSIBLE OR A IZATION, in lu in a des ription of al of the phantoms to b u ed

r) Maintenan e

The in tru tion f or u e s al in lu e the recommen ed maintenan e s hed les f or the

MR EQUIPMENT Items that s ould b p rf ormed by service p rson el s al b identified

* s) Emergen y action in case of a QUEN H

The in tru tion for u e s al in lu e in tru tion on how to identify a QUEN H an how to act

in the event of a QUEN H, esp cial y when the ventin s stem of the s p rcon u tin mag et

s stem f ais

* t Scan in of P TIENT with active or p s ive implants

The in tru tion f or u e s al declare that MR s an in is contra-in icated for P TIENT with

implants, the ex e tion b in P TIENT with k own MR safe or MR con itional implants that

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

can b s an ed ac ordin to the con ition sp cif ied in the implant la el n The in tru tion

f or u e s al des rib the sig ificant RISKS as ociated with the s an in of P TIENT with

active or p s ive implants containin metal or other mag etic an /or electrical y con u tive

materials

− the electromag etic f ield mig t exert stron f orces on the metal c s c implants;

− or the electromag etic field mig t interf ere with the o eration of active devices;

− They the implants mig t cau e sig if i ant artef acts in the MR image;

− an MR s an in when an implant is present mig t cau e ad erse he lth ef fects H R s c

as internal he tin that res lts in tis ue damage, los of ph siologic fu ction an seriou

injury

When the implant device is la eled as MR safe or MR con itional, the OPERATOR is then

informed via the in tru tion for u e of the implant a out the saf ety an p s ible con ition to

b taken into ac ou t d rin s an in The in tru tion for u e s al explain that further

information is des rib d in the A COMP NYING DOC MENT of the implant MA UFA TURER

The in tru tion for u e s al also ad res the fol owin related to MR s an in of P TIENT

with MR con itional implants:

− the MR s an s ould only b con u ted b sed on the res lt of a ris vers s b nef it

as es ment by the RE PONSIBLE OR A IZATION;

− the MR OPERATOR s al ad ere to the con ition of u e defined in the MR con itional implant

− the in tru tion for u e s al in lu e a statement to explain the roles an resp n ibi ties of

the MR MA UFA TURER, the implant MA UFA TURER an the MR OPERATOR in s an in of

P TIENT with MR con itional implants

NOT 8 Sample te t is pro id d in An e A

* u) Scan in of preg ant P TIENT

The in tru tion f or u e s al des rib that s an in of preg ant P TIENT with the WHOLE

BOD RF TRA SMIT COIL s ould b l mited to the NOR AL OPERATING MODE with resp ct to the

SAR level

Atention s al b drawn to the fact that the fetu is con idered as p rt of the general publc,

an that it is esp cial y sen itive to p tential thermal events d rin the first trimester The

RE PONSIBLE OR A IZATION s ould b ad ised to avoid s an in p tients in the first trimester

or with u k own preg an y statu

NOT Pre n n y statu is p rt of th RIS informatio It is re omme d d th t fe d a k via th u er interf ac b

pro id d to th OP RA O d rin e amin tio s tu to v ld te th pre n n y statu Th M EQUIPME T ma

e f orc s a nin in NO MAL OP RA ING M D u le s th pre n n y statu is NO

v) Scan in of P TIENT with elevated b d CORE T MPERATURE

The in tru tion f or u e s al des rib that the MR EQUIPMENT s al lmit the b d CORE

T MPERATURE rise to avoid u d e he t stres and prevent local tis ue damage in the b d of

the P TIENT to values given in Ta le 2 1.10 The practical con eq en e of this l mitation is

that P TIENT with a CORE T MPERATURE hig er than 3 ,5 °C can ot b s an ed an P TIENT

with a CORE T MPERATURE hig er than 3 ,0 °C can only b s an ed in NOR AL OPERATING

MODE

The in tru tion for u e s al des rib that the MR EQUIPMENT provides the o eratin modes to

ena le the OPERATOR to lmit the b dy CORE T MPERATURE rise of the P TIENT to avoid u d e

he t stres an prevent local tis ue damage in the b d of the P TIENT Ap lca le l mit values

w) Ab ut f un tion

The in tru tion for u e s al sp cify where in the u er interf ace the a out fu ction of the

s an er can b fou d The a out fu ction s al sp cify the hardware an sof tware

sp cification of the s stem, whic together with the data given in the

A COMP NYING

DOCUMENT can b u ed to determine the sp cif i ation of the static mag etic field, the

gradients an the RF More sp cifical y the folowin information s al be given:

– Nominal B

0value

– Maximum SP TIAL FIELD GRA IENT of the static mag etic field [T/m] outside the FIXED

mag et covers

NOT Historic l la eln pra tic f or MR c n itio al d vic s u e G/cm wh re 1 T/m is e uiv le t to 10

G/cm Pro idin th c n ersio fa tor a d/or th q a titie in b th u its ma b a pro riate

– Maximum sp tial en odin gradient ampl tu e [mT/m] an maximum slew rate [T/m/s]

b th sp cified on a p r axis b sis

– Nominal f req en y ran e p r n clei

– Maximum combined GRA IENT OUTP T [T/s] on a c l n er with a diameter of 0,2 m, 0,4 m

an b re-diameter min s 0,1 m

NOT 6 For TRA S ERS FIELD MAGN T ty e th c ln er a is (ie P TIE T a is) is p rp n ic lar to th

ma n t a is Th term P TIE T b re is to b re la e b ma n t g p b twe n p le s o s: th term ma n t

le gth is to b re la e b p le s o diameter

x) FPO (FIXED P RAME ER OPTION)

If the s stem has FPO ca a i ties, the f olowin inf ormation s al be given:

a statement that FPO l mits the gradient an RF output in terms of dB/dt an B

1+

;

a statement that FPO req ires OPERATOR activation;

in tru tion on how to activate FPO;

a statement that FPO lmits may b p rt of MR con itional medical device la el n an that

other s an in l mits an /or P TIENT pre aration may b req ired in ad ition to FPO to ful y

comply with the implant device MR con itional la el n ;

a statement that FPO do s not alter previou ly esta ls ed o eratin modes, i.e FPO can work

in NOR ALOPERATING MODE an FIRS LEVEL CONTR L ED OPERATING MODE;

a statement in icatin that FPO is f or u e with devices that have MR con itional la el n that

sp cifies FPO an the u e of FPO when s an in P TIENT with medical devices that do not

have FPO la el ng is p tential y hazardou an may cau e seriou injury or de th

2 1.7.9.3 Te h ic l de cription

2 1.7.9.3.1 General

Re la eme t oft he eig th d ash d item of t he first p ra ra h a d Note 2:

information p rtainin to an neces ary rec r ent BASIC SAFE Y testin in lu in detai s of the

me n , method an recommen ed f req en y

Add ition:

2 1.7.9.3.101 Te h ic l de cription of MR EQUIPMENT

a) CONTR L ED A CE S AREA an SPECIAL EN IRONMENT

For

M

R

EQUIPM

ENT that generates a stray field ex eedin 0,5 mT outside its p rmanently

at ac ed FIXED mag et cover, an /or an electromag etic interf eren e level that do s not

comply with IEC 6 6 1-1-2, the tec nical des ription

1) the mag etic frin e field stren th s al not ex e d 0,5 mT, an

2) the electromag etic interf eren e level comples with IEC 6 6 1-1-2:2 0 ;

– s al give cle r recommen ation as to how this CONTROL ED A CE S A EA s al b

delmited, e.g by markin s on the f lo r, b r iers an /or other me n to al ow the

RE PONSIBLE ORGA IZATION

to adeq ately control ac es to this are by u authorised

p rson ;

– s al state that the

CONTROL ED A CE S A EA

s ould b la el ed at al entries by

a pro riate warnin sig s, in lu in an in ication of the presen e of static mag etic f ield

an their at ractive f orce or the torq e on f er omag etic materials (se An ex AA f or

examples of warnin sig s an prohibitive sig s)

en ure compl an e with IEC 6 6 1-1-2:2 14, the tec nical des ription s al des rib the ne d

f or adeq ate RF s ieldin , in lu in the presen e of an RF do r switc an interloc

mec anism preventin u d e RF emis ion an immu ity

NOT 5 Se als 2 2.5.2.2.2

When the MR EQUIPMENT is desig ed f or in tal ation in a ro m in whic au iovis al contact

with the PATIENT is l kely to b l mited, the tec nical des ription s al sp cif y provision in the

desig of the ro m an in the EQUIPMENT to ena le au io an vis al contact with the PATIENT

d rin the MR EX MIN TION The au io vis al contact s al b s f f icient to al ow ROUTINE

MONITORING an MEDIC L SUP R ISION of the PATIENT

* b) Comp tibi ty tec nical sp cif i ation s e t

In ad ition to the in tru tion f or u e f or MR EQUIPMENT a comp tibi ty tec nical sp cifi ation

s e t s al b provided with s f f icient inf ormation to ena le testin the pro er o eration of

p ripheral eq ipment an to provide information to the RE PONSIBLE ORGA IZATION The

comp tibi ty tec nical sp cif i ation s e t (prod ct data s e t s al des rib a n mb r of

p rameters whic c aracterise the MR EQUIPMENT The p rameter l st in lu es:

– Mag et: typ , f ield stren th, b re dimen ion, cryogen typ s an b i -of f rates, sp tial

distribution of s r ou din f ield in plots relatin to a typical in talation of the

MR EQUIPMENT:

 The plots s al re resent thre s ita le orthogonal planes throu h the mag et centre

to i u trate maximum sp tial extent of iso-mag etic contours

 Eac plot s al contain at le st the iso-mag etic contours with values of 0,5 mT,

1 mT, 3 mT, 5 mT, 10 mT, 2 mT, 4 mT, an 2 0 mT as wel as a distan e s ale

an a s p rimp sed outl ne of the mag et

 The p sition in location outside the FIXED mag et covers where S ATIAL FIELD

GR DIENT (S G) of the main mag etic f ield is a maximum, an the values of B

0

an the

sp tial gradient of B

0

S G at that location At this location the force on a saturated

f er omag etic o ject res ltin f rom the sp tial gradient of the main mag etic f ield is

maximum

 The p sition in location outside the FIXED mag et covers where the prod ct of the

mag itu e of the static mag etic f ield B

location, the f orce on a diamag etic or p ramag etic o ject, or a f er omag etic

material b low its mag etic saturation p int, is a maximum

 A plot re resentin the 0,5 T, 1 T, 1,5 T, 2 T, 3 T an the 4 T iso-mag etic contours of

the static mag etic f ield at p sition ac es ible to an relevant f or the MR WOR ER

– Gradient s stem: typ , maximum ampl tu e, fastest rise time, maximum slew rate an

sp tial distribution of the maximum mag itu e values of the vector s m of the field

comp nents generated by e c of the thre GRA IENT UNIT :

• Sp tial distribution of the maximum mag itu e values of the vector s m of the field

comp nents generated by e c of the thre GRA IENT UNIT simultane u ly at the

p sition ac es ible to an relevant for the MR WORKER d rin s an in as des rib d

in s bclau e 2 1.12.4.10 2.3

• Sp tial distribution of the maximum mag itu e values of the vector s m of the field

comp nents generated by e c of the thre GRA IENT U IT simultane u ly at

p sition on virtual c l n ers co xial with the p tient axis with diameters of 0,2 m, 0,4

m an 0,1 m les than the nar owest a erture of the P TIENT ac es ible sp ce The

virtual c l n ers have the same len th as the gradient coi In the c l n er axis

direction the p ints s al have a se aration of not more than 0,0 0,0 m Detai ed

calc lation s al b p r ormed in a f as ion eq ivalent to the des ription given in

• the sp tial distribution of the maximum RF tran mit f ield for the u lo ded coi at the

p sition ac es ible to an relevant f or the MR WORKER d rin s an in as des rib d

in s bclau e 2 1.12.4.10 3.3

• the maximum RF tran mit field at the ISOCENTRE of the s stem when the u lo ded coi

is p sitioned for imagin at the ISOCENTRE, an the distan es fom the ISOCENTRE on

the coi axis (i.e normal y the z-direction) at whic the RF tran mit field is red ced by

3 dB an 10 dB f om the maximum f ield at the ISOCENTRE

NOT 2 Th s re uireme ts are f or

P TIE

T s f ety a d c n e u ntly difer fom th re uireme ts f or th

M

WO K RSa d f i e in s b la s 2 1.12.4.10 3.3

– Comp tibi ty protocols:

The MA UFA TURER of MR EQUIPMENT s al s g est protocols, whic can b ru

routinely on the MR EQUIPMENT, to ena le the MA UFA TURER of p ripheral eq ipment

to test the fu ctional ty of the p ripheral eq ipment in the field prod ced by the MR

EQUIPMENT The protocols are desig ed to ru the MR EQUIPMENT with hig tran mit

RF field or high gradient slew rates an ampl tu es so that the MAN FA TURER of

p ripheral eq ipment can investigate the influen e of the MR

EQUIPMENT

on its

p ripheral eq ipment The tests are not intended for estimation of the p s ible

ef ect of the p ripheral eq ipment on the res lting image q al ty of the

MR EQUIPMENT an are no g arante that the p ripheral equipment wi fu ction

pro erly

– PATIENT sp ce: size, ventiation, commu ication, an l g tin

– PATIENT SU PORT: dimen ion , p sitionin , ac urac an maximum lo d

* c) Saf ety provision in the event of a QUEN H

For MR EQUIPMENT eq ip ed with s p rcon u tin mag ets, the A COMP N ING DOC MENT

s al

– state the req irements for a ventin s stem for the s p rcon u tin mag et whic

con ects the cryostat of the mag et to the outside atmosphere an whic is desig ed to

with tan a QUEN H an to protect ne rby p rson in the event of a QUEN H;

– provide g idel nes for the con tru tion (dimen ion , p sition, as embly an material to b

a pl ed) of the ventin s stem for the s p rcon u tin mag et in ide an outside the

examination ro m;

– recommen a preventive maintenan e program, whic states that reg lar c ec s of the

adeq atenes of the f un tion of the ventin s stem for the s p rcon u tin mag et are to

b made;

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

– state req irements for the desig of the examination ro m to en ure safety of the P TIENT

an other p rson in ide an outside the examination ro m in the event of f ai ure of the

ventin s stem d rin a QUEN H The s g ested desig s al ad res the is ues of

red cin pres ure bui d-up, temp rature decre se an ox gen de letion d rin a QUEN H

A n mb r of ac e ta le solution f or s c provision , demon trated to b ef fective by

simulation or test, s al b l sted, so that even when the ventin s stem of the

s p rcon u tin mag et f ais to work adeq ately, the c an e of a H ZARD for the P TIENT

or other p rson in ide as wel as outside the examination ro m, as cau ed by pres ure

bui d-up, temp ratures decre se or ox gen de letion d rin the QUENC , is red ced

con idera ly;

– state the ne d for the RE PONSIBLE OR A IZATION to esta l s an emergen y plan for a

QUEN H, in lu in a situation in whic the ventin s stem for the s p rcon u tin mag et

f ai s to f un tion adeq ately;

– state the ne d f or p s ible extra control me s res f or the

P TIE

NT ventiation s stem in

order not to exp se the P TIENT to ad itional hel um tran p rted to the P TIENT via the

P TIENT venti ation s stem The P TIENT venti ation s stem s ould have its inlet o enin in

a safe place (s c as at a low level in the examination ro m or directly con ected to the

air con itionin of the examination ro m), or b con ected to a

QUENC

detector, so that

the P TIENT venti ation s stem can b automatical y control ed when a QUEN H oc urs an

wi not tran p rt hel um to the P TIENT in ide the s an er

NOT 3 Th v ntin s stem for th s p rc n u tin ma n t is c n id re to b th cry g nic v nt pip a d al

th e tra c mp n nts n c s ary to s fely a c mmo ate a QU NCH

NOT 4 Ex min tio ro m c nfig ratio s d mo strate b simulatio or te t th t are a c pta le in lu e:

– c n g ratio s in whic th RF d or o e s o tward or is a sldin RF d or;

– c n g ratio s in whic th RF d or o e s inward , if th s in lu e e tra pre a tio s to pre e t PRE S RE

b id u This c n b re lz d b o e of th f olowin

• a emerg n y e amin tio ro m air e tra tio s stem, whic c n b switc e o (p s ibly a tomatic ly

via a h rdwire o y e mo itor in th c i n of th e amin tio ro m to d te t th e c p of h lum g s)

to ma imum in th e e t of a QU NCH; or

• a o e in in th wal or c i n of th e amin tio ro m, v ntin toward a o e are ; or

• a p s ibi ty of o e in th o s rv tio win ow in th e amin tio ro m o tward or b sldin ; or

• a s c n in e e d nt v ntin s stem f or th s p rc n u tin ma n t th t remain o eratio al in c s th

re ular v ntin s stem for th s p rc n u tin ma n t is o stru te ; or

• e uiv le t meth d d mo strate to b eff ectiv b simulatio or te t

d) Decay c aracteristic of mag etic field

For MR EQUIPMENT with s p rcon u tin mag ets or resistive mag ets, the tec nical

des ription s al provide decay c aracteristic of the mag et in case of a

QUENC

or of an

emergen y field s ut down to ena le the RE PONSIBLE OR A IZATION to implement adeq ate

l f e s p ortin an other safety proced res These c aracteristic s al in icate the time fom

activation of the EMER EN Y FIELD SH T DOWN U IT to the moment at whic the f ield stren th in

the centre of the mag et has fal en to 2 mT

In the tec nical des ription, g idan e s al b given regardin where an how to in tal the

actuator of the EMER ENC FIELD SH T DOWN U IT

e) Typ of gradient s stem

The gradient s stem s al b la el ed in the tec nical des ription by the

MA UFA TURE

R either

as a WHOLE BOD GRA IENT SYS EM or as a SPECIAL P RPOS GRA IENT SYS EM

f) Safety site re dines c ec l st

Recommen the u age of a ‘saf ety site re dines c ec l st’, whic s ould l st al the saf ety

related asp cts for the in tal ation an s ould b ac nowled ed by the relevant p rties

201.8 Protection a ainst electrical HAZARDS f rom ME EQUIPMENT

Clau e 8 of the general standard a pl es ex e t as fol ows:

* 2 1.8.7.3 Al owable v lue

Repla eme t:

d) The al owa le values of the

EARTH LEA AGE C R ENT are 5 mA in NORMAL CON ITION an

10 mA in SINGLE FA LT CON ITION For p rmanently in tal ed MR EQUIPMENT the EARTH

LEA AGE C RRENT u der NORMAL CON ITION an SINGLE FA LT CON ITION s al not ex e d

e)a ) Limits for P TIENT LEA AGE CUR ENT an P TIENT A XILIARY CUR ENT u der normal

an sin le fault con ition do not a ply for f eq en ies a ove 1 MHz Hazard arisin f rom

hig f eq en y c r ents are ad res ed in 2 1.12.4.10 2

201.9 Protection a ainst mechanical HAZARDs of ME EQUIPMENT and ME SYS EMS

Clau e 9 of the general standard a pl es ex e t as f ol ows:

2 1.9.6 Acoustic e ergy (inclu ing infra- a d ultra ound) a d vibration

Re la eme t:

* 2 1.9.6.2.1 Audible a ou tic e ergy

The MR EQUIPMENT s al not prod ce noise havin an u weig ted p ak sou d pres ure level

(L ) hig er than 14 dB referen ed to 2 µPa in an ac es ible are

Compl ian e is c e k d b a plying NEMA MS 4

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

Addition:

2 1.9.7.101 Hel um v s els of MR EQUIPMENT

If the hel um ves el is desig ed as a pres ure ves el, then it s al b in compl an e with

s bclau e 9.7 of the general stan ard, or with national reg lation

NOT 1 Th ma s is a c lerate for 15 mm, a d th n d c lerate d rin c mpre sio of th 6 mm of f oam,

re ultin in a forc e uiv le t fom 2 to 3 time th S FE WO KING LOA

—————————

+AMD1:2 13 AMD2:2 15 CSV  IEC 2 15

Where mec anical analy is proves that the fol owin static lo d test is more severe than the

d namic lo d test sp cified in the general stan ard, it is p s ible to waive the d namic lo d

test b sed on RISK management

P rior t o p rormin t his t es a PATIE N T SU PPORT/susp nsio system is p sit ion d h rizo tall

in its most d isadvantag o s p sition in N ORM AL U SE wh re PATIE NT LOADIN G a d u lo d ing

takes pl ac

A mas whic results in a forc c lc l ated t o b gre ter t ha the dy amic l oad sh l l b pla ed

o th PATIEN T SU PPORT Th c nta t are of t his mas is e uiv lent to th t d efined in

Figure 3 ofth g n ral sta dard a d is a plied for at le st o e minut e An l os of fu ction

or stru t ural d ama e that c uld result in u a c pt abl e RISK c nstitutes a fa ure

NOT 2 Th fo m d s rib d in Fig re 3 is n t u e in this te t

2 1.9.8.3 Stre gth of PATIENT or OP R TOR s pp rt or s spe sion s stems

2 1.9.8.3.3 Dy amic forc s du to loa ing from person

Add ition:

Where it is determined that the d namic lo din test of the general stan ard a pl es, the

fol owin provides an alternative me n of compl an e

NOT 1 Th ma s is a c lerate for 15 mm, a d th n d c lerate d rin c mpre sio of th 6 mm of f oam,

re ultin in a forc e uiv le t fom 2 to 3 time th S FE WO KING LOA

Where mec anical analy is proves that the f ol owin static lo d test is more severe than the

d namic lo d test sp cified in the general stan ard, it is p s ible to waive the d namic lo d

test b sed on RISK MA AGEMENT

Compl ian e is c e k d b the fo owin test :

Prior to p rormin this tes a PATIE N T su p rt/susp nsion syst em is p sition d h rizo tal l in

its most d isadvant ag o s p sition in

NO MAL U SE WH ERE PA

TIEN T l oad ing a d u load ing tak es

pla e

A mas whic results in a forc c lc lated t o b gre ter tha the dynamic load sh l l b pla ed

o t he PATIE N T su p rt Th c ntact are of this mas is e uival ent to t hat d efined in

Figure 3 ofth g n ral standard a d is a pl ied for at le st o e minute An los of fu ct ion

or stru t ural d ama e that c uld resul t in u a c pt abl e RISK c nstitutes a fa ure

NOT 2 Th fo m d s rib d in Fig re 3 of th g n ral sta d rd is n t re uire for this te t

201.10 Protection a ainst unwanted and exc ssive ra iation HAZARDS

Clau e 10 of the general stan ard a pl es

201.1 Protection a ainst ex essiv temperatures and other

S

Clau e 1 of the general stan ard a pl es

201.12 Accura y of controls and instruments and prote tion against hazardous

outputs

* 2 1.12.4 Prote tion a ainst hazardous output

2 1.12.4.1 Inte tional e c e ing of s fety l mits

Add ition:

NOT Th s c n le el c ntrole o eratin mo e c v rs al rele a t re uireme ts f or M EQUIPME T

2 1.12.4.2 Indic tion rele a t to s fety

When d rin its o eration one or more of the outputs of the MR EQUIPMENT re c a level that

mig t cau e u d e phy iological stres to the P TIENT, the OPERATOR s al decide whether or

not this o eration is in the interest of the P TIENT In this s bclau e, req irements on the

desig of the MR EQUIPMENT are given that can help the OPERATOR to make that decision The

req irements in this s bclau e des rib thre levels of o eration of MR EQUIPMENT that are

sp cified with resp ct to the u er inter ace an information given to the OPERATOR

(2 1.12.4.101) an with resp ct to the values of output p rmit ed (2 1.12.4.10 –

2 1.12.4.10 )

The req irements of this s bclau e s al a ply se arately f or the o eratin modes regardin

the GRA IENT OUTP T, the SPECIFIC AB ORPTION RAT S (SAR) an the static mag etic f ield

Demon tration of compl an e with the req irements of this s bclau e relatin to o eratin

modes,( i.e the me n f or control, the delb rate action req ired an the information an

in ication provided) s al b c ec ed by in p ction The method of me s rement to

demon trate compl an e with the o eratin mode l mits contained in 2 1.12.4.10 an

2 1.12.4.10 are des rib d in 2 1.12.4.10

2 1.12.4.101

MR EQUIPMENT s al comply with the folowin req irements:

a) Me n (control) s al b provided in order to en ure, that the lmit s) of the (selected)

o eratin mode can ot b ex e ded This control s al b in e en ent of OPERATO input

(as to P TIENT size, mas or p sition) or s al b c ec ed by the MR EQUIPMENT in order to

detect an OPERATO input er or

b) A reset to the NOR AL OPERATING MODE with resp ct to SAR an dB/dt s al b p rormed

automatical y with c an e of the P TIENT

c) The MR EQUIPMENT s al display on the CONTR L P NEL up n req est the predicted value

f or the SAR The MR EQUIPMENT s al display on the CONTR L P NEL up n req est the

predicted value for the B

1+

R S averaged over any 10 s p riod of the s an The B

1+

R S

value s al only b displayed when a volume RF tran mit coi is a pl ed

d) The MR EQUIPMENT s al , on req est, display “CP” on the CONTR L P NEL if CIRC LARLY

POLARIZ D RF is u ed f or the s an For s stems ca a le of other typ s of drivin the

VOLUME RF TRA SMIT COIL, me n s al b provided to the MR OPERATOR to select

CIRCULARLY POLARIZ D RF If selected, CIRCULARLY POLARIZ D RF s al b active over the

entire examination

NOT It is a s me th t th ma imum G A IE T OU P T th s stem c n d lv r is k own a d a aia le in th

te h ic l d s riptio

NT that is not ca a le of o eration at levels a ove the

NOR AL OPERATING

MODE as sp cified in 2 1.12.4.10 and 201.12.4.10 , no sp cific in ication of the

o eratin mode is req ired to b displayed at the CONTROL P NEL

2 1.12.4.101.4 FIRS L VE CONTROL ED OP RA TING MODE

MR EQUIPMENT that al ows the o eration in the FIRS LEVEL CONTROL ED OPERATING MODE as

sp cified in 2 1.12.4.10 an 2 1.12.4.10 s al comply with the f ol owin req irements:

a) Before the start of e c s an, an in ication of the o eratin mode def i ed by the predicted

value of the GRA IENT OUTP T an SAR, to b a pl ed d rin the s an s al b displayed at

the CONTR L P NEL

b) If the value of the GRA IENT OUTP T or SAR that controls the s an is s c as to enter the

FIRS LEVEL CONTROL ED OPERATING MODE, the at ention of the OPERATOR s al b drawn to

this con ition by a cle r in ication on the CONTR L P NEL A record of the o eratin mode

or eq ivalent data s al b an integral p rt of the image data

c) A del b rate action of the OPERATOR s al b neces ary in order to enter the FIRS LEVEL

CONTR L ED OPERATING MODE

2 1.12.4.101.5 SECOND L VE CONTR L ED OP RA TING MODE

MR EQUIPMENT, whic al ows the o eration in the S CON LEVEL CONTR L ED OPERATING MODE

f or values of the GRA IENT OUTP T or SAR as sp cif ied in 2 1.12.4.10 an 2 1.12.4.10 , s al

comply with the fol owin req irements:

a) A sp cific sec rity me s re that prevents ac es to the S CON LEVEL CONTR L ED

OPERATING MODE s al b de ctivated b fore enterin the S CON LEVEL CONTR L ED

OPERATING MODE The sp cific sec rity me s re s al b desig ed so that the S CON

LEVEL CONTROL ED OPERATING MODE

can b ac es ed only u der the authorisation of the

medical y resp n ible p rson actin u der the authority of a h man stu ies protocol

a proved ac ordin to local req irements The sp cific sec rity me s re s al in olve a

key-loc , a combination loc , a software p s word, or other protective device

b) Before the start of e c s an, an in ication of the o eratin mode defined by the

maximum GRA IENT OUTP T an SAR value for the s an, an a statement of the SAR an

that controls the s an values an the eq ivalent

data s al b an integral p rt of the image data

d) An in ication to the OPERATOR s al b in lu ed that the o erating con ition are

p tential y hazardou and that these con ition s ould not b a pl ed for normal clnical

u e

e) The MR EQUIPMENT s al provide me n to set adju ta le l mits (in the S CON LEVEL

CONTR L ED OPERATING MODE) of GRA IENT OUTP T or diff erent types of SAR whic can ot

b adju ted by the OPERATOR, u les authorized

* 2 1.12.4.10 Prote tion a ainst e c s iv low fre u nc f ield v riations

produ e by the gra ie t s stem

2 1.12.4.10 1 Ge eral

In this stan ard, low feq en y field variation prod ced by the gradient s stem are the

variation whic mig t prod ce cardiac or p ripheral nerve stimulation (PNS) (i.e the

E F CTIVE S IMULUS D RATION > 0 µs an th s no tis ue he tin is con idered)

2 1.12.4.10 2 Obje tiv s for l mitation of PNS OUT UT

The MR EQUIPMENT s al b desig ed to automatical y control the gradient wavef orms so that

the oc ur en e of intolera le p ripheral nerve stimulation (PNS) in the P TIENT an in the MR

WORKER at an o eratin mode is minimized

NOT M EQUIPME T th t me ts th re uireme ts giv n in th folowin s b la s s are c n id re to s tisfy

th s o je tiv s wh n b la c d a ain t th ir dia n stic eff i a y

For this p rtic lar stan ard it is u dersto d that

– PNS is the sen ation of an activation of the nervou s stem d e to gradient switc in ;

– the on et of sen ation is the P S THRE HOLD LEVEL (se 2 1.3.2 7);

– u comf orta le PNS is the level tolera le to the P TIENT an the MR WORKER when pro erly

informed an motivated;

– intolera le PNS is the level at whic the P TIENT wi as the s an proced re to b

terminated immediately;

– cardiac stimulation is the in u tion of an ecto ic b at or other cardiac ar hythmia

The MR EQUIPMENT s al minimize the oc ur ren e of u comforta le PNS in the NO MAL OPERATING

MODE

2 1.12.4.10 3 Limits f or PNS OUT UT

2 1.12.4.10 3.1 Ge eral

In this s bclau e, l mits for the P TIENT an the MR WORKER are expres ed as a maximum

value for the P S OUTP T, either as the

electric field E in u ed in the P TIENT or the MR WORKER by the c an in mag etic field of the

gradients, or

dB/dt, the TIME RAT OF CH NGE OF THE MAGNE IC FIELD of the gradients

The l mits are a f un tion of the E F CTIVE S IMULUS D RATION t

s,ef f.The E F CTIVE S IMULUS

D RATION is i u trated in Fig re 2 1.101 f or some waveforms

Test con ition u ed to demon trate complan e to these l mits are defined in 2 1.12.4.10 2

NOT MR WO K R e p s re lmits are th s me a th ma imaly alowe lmits for th P TIE T Compla c

with th P S OU P T lmits f or P TIE T th ref ore a tomatic ly imple c mpla c f or th M WO K RS

2 1.12.4.10 3.2 Limits relate to pre e tion of c rdia stimulation

To protect again t cardiac stimulation in e c o erating mode, the GRA IENT OUTP T of al

GRA IENT U IT s al satisfy:

2

efs,

ex ptE

2

efs,

ex p

d/d

tt

B