Iec 60601 2 3 2016

Also k now n as th Inter natio al Electrotech ical Voca ulary IE o ln... Me ical electric l equipment – Part 2-3: Partic lar requirements for the ba ic s fety and es e tial performance

Medic l ele trical e uipme t –

Part 2-3: Particular re uireme ts for the basic safety a d e s ntial performa c

of s ort wa e therapy e uipme t

Partie 2-3: Exige c s particul ères pour la s c rité de ba e et le performa c s

e s ntiel es des apparei s de thérapie à ondes courtes

Co yrig t © 2 16 IEC, Ge e a, Switzerlan

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Me ical electric l equipment –

Part 2-3: Partic lar requirements for the ba ic s fety and es e tial performance

of short wav therapy equipment

Partie 2-3: Exigence partic lère pour la sé urité de bas et les performance

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Edition 3.1 2 16-0

Medic l ele trical e uipme t –

Part 2-3: Particular re uireme ts for the basic safety a d e s ntial performa c

of s ort wa e therapy e uipme t

Partie 2-3: Exige c s particul ères pour la s c rité de ba e et le performa c s

e s ntiel es des apparei s de thérapie à ondes courtes

2 1.1 Sc p , o je t an relate stan ard 7

2 1.2 Normativ refere c s 8

2 1.3 Terms an d finitio s 8

2 1.4 Ge eral re uireme ts 9

2 1.5 Ge eral re uireme ts for te tin of ME EQUIPME T 9

2 1.6 Clas ificatio of ME EQUIPME T an ME SYS EMS 9

2 1.7 ME EQUIPME T id ntificatio , markin an d c me ts 9

2 1.8 Prote tio again t ele trical H Z R S from ME EQUIPME T 1

2 1.9 Prote tio again t MECH NICAL H Z R S of ME EQUIPME T an ME SYS EMS 15 2 1.10 Prote tio again t u wante an e c s iv radiatio H Z R S 15 2 1.1 Prote tio again t e c s iv temp rature an oth r H Z R S 15 2 1.12 Ac urac of c ntrols an in trume ts an prote tio again t hazard u o tp ts 15 2 1.13 HA AR OU SIT A ION an fault c n itio s for MEEQUIPME T 16 2 1.14 PR G AMMA LE ELECTRICAL MEDICAL SYS EMS (P MS) 17 2 1.15 Co stru tio of ME EQUIPME T 17 2 1.16 ME SYS EMS 17 2 1.17 Ele tromag etic c mpatibi ty of ME EQUIPME T an ME SYS EMS 17 An e e 17 AN E C (informativ ) Guid to markin an lab l n re uireme ts for ME EQUIPME T an ME SYS EMS 18 An e AA (informativ ) Partic lar g idan e an ratio ale 19 In e of d fin d terms u e in this partic lar stan ard 21

Fig re 2 1.101 – Diele tric stre gth te t for capacitiv A PLICA O S 13

Fig re 2 1.10 – Te t pro e 14

Fig re 2 1.10 – Diele tric stre gth te t for in u tiv A PLICA O S 15

© IEC 2 16

Part 2-3: Particular requirements for the basic safety and essential

performance of short wave therapy equipment

FOREWORD

1) Th Intern tio al Electrotech ical Commis io (IEC) is a worldwid orga izatio for sta d rdizatio comprising

al n tio al electrotech ical commite s (IEC Natio al Commite s) Th o ject of IEC is to promote

intern tio al co-o eratio o al questio s co cerning sta d rdizatio in th electrical a d electro ic fields To

this e d a d in a ditio to oth r activities, IEC publsh s Intern tio al Sta d rds, Tech ical Sp cificatio s,

Tech ical Re orts, Publcly Av ia le Sp cificatio s (P S) a d Guid s (h re fer refere to as “IEC

Publcatio (s) Th ir pre aratio is e tru te to tech ical commite s; a y IEC Natio al Commite intereste

in th s bject d alt with may p rticip te in this pre aratory work Intern tio al go ernme tal a d n

n-go ernme tal orga izatio s laising with th IEC also p rticip te in this pre aratio IEC cola orates closely

with th Intern tio al Orga izatio for Sta d rdizatio (ISO) in ac ord nce with co ditio s d termin d by

agre me t b twe n th two orga izatio s

2) Th formald cisio s or agre me ts of IEC o tech ical maters expres , as n arlyasp s ible, a intern tio al

co se s s of o inio o th rele a t s bjects since e ch tech ical commite h s re rese tatio from al

intereste IEC Natio al Commite s

3) IEC Publcatio s h v th form of recomme d tio s for intern tio al u e a d are ac e te by IEC Natio al

Commite s in th t se se Whie al re so a le eforts are ma e to e s re th t th tech ical co te t of IEC

Publcatio s is ac urate, IEC ca n t b h ld resp nsible for th way in which th y are u e or for a y

misinterpretatio by a y e d u er

4) In ord r to promote intern tio al uniformity, IEC Natio al Commite s un erta e to a ply IEC Publcatio s

tra sp re tly to th maximum exte t p s ible in th ir n tio al a d regio al publcatio s Any div rge ce

b twe n a y IEC Publcatio a d th coresp n ing n tio al or regio al publcatio sh l b cle rly in icate in

th later

5) IEC itself d es n t pro id a y atestatio of co formity In e e d nt certificatio b dies pro id co formity

as es me t services a d, in some are s, ac es to IEC marks of co formity IEC is n t resp nsible for a y

servicescarie out by in e e d nt certificatio b dies

6) Al u ers sh uld e s re th t th y h v th latest e itio of this publcatio

7) No la i ty sh l atach to IEC or its directors, employe s, serv nts or age ts including in ividual exp rts a d

memb rs of its tech ical commite s a d IEC Natio al Commite s for a y p rso al injury, pro erty d mage or

oth r d mage of a y n ture wh tso v r, wh th r direct or in irect, or for costs (including legal fe s) a d

exp nses arising out of th publcatio , u e of, or rela ce up n, this IEC Publcatio or a y oth r IEC

Publcatio s

8) Ate tio is drawn to th Normativ refere ces cite in this publcatio Use of th refere ce publcatio s is

in isp nsa le for th corect a plcatio of this publcatio

9) Ate tio is drawn to th p s ibi ty th t some of th eleme ts of this IEC Publcatio may b th s bject of

p te t rights IEC sh l n t b h ld resp nsible for id ntifying a y or al s ch p te t rights

DISCLAIMER

This Co sol date v rsio is n t an of icial IEC Standard an ha be n pre are for

user co v nie ce Only th cur e t v rsio s of th stan ard an its ame dme t s)

are to be co sid re th of icial d cume ts

This Co sol date v rsio of IEC 6 6 1-2-3 bears th e itio n mb r 3.1 It co sists of

the third e itio (2 12-0 ) [docume ts 6 D/97 /FDIS and 6 D/9 3/RVD] an its

ame dme t 1 (2 16-0 ) [d cume ts 6 D/13 0/FDIS an 6 D/13 0/RVD] Th technic l

conte t is ide tic l to th ba e e itio an its ame dme t

In this Re l n v rsio , a v rtic l l ne in th margin shows where th technic l co te t

is modifie by ame dme t 1 Additions are in gre n te t, d letio s are in strik thro gh

© IEC 2 16

Ele trome ical e uipme t, of IEC te h ical c mmite 6 : Ele trical e uipme t in me ical

practic

This third e itio can els an re lac s th s c n e itio of IEC 6 6 1-2-3 p bl s e in 19 1

an its ame dme t 1 p bls e in 19 8 This e itio c n titute a te h ical re isio an has

b e alg e with IEC 6 6 1-1:2 0

This p bl catio has b e drafe in ac ordan e with th ISO/IEC Dire tiv s, Part 2

In this stan ard, th folowin print ty e are u e :

– Re uireme ts an d finitio s: roman ty e

– Te st sp ecific tio s: italc ty e

– Informativ material a p aring outsid of ta les, s ch as n tes, examples a d refere ces: in smaler typ

Normativ text of ta les is also in a smaler typ

– TERMS DE IN D IN CLA S 3 OF T E GE ERAL S A DAR , IN T IS P RTICULAR S A DAR O A

NOT D: SMAL CA IT LS

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

– “clau e” mean o e of th s v nte n n mb re divisio s within th table of c nte ts,

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

– “s b lau e” mean a n mb re s b ivisio of a clau e (e.g 7.1, 7.2 an 7.2.1 are al

s b lau e of Clau e 7)

Refere c s to clau e within this stan ard are pre e e b th term “Clau e” fol owe b th

clau e n mb r Refere c s to s b lau e within this partic lar stan ard are b n mb r o ly

In this stan ard, th c nju ctiv “or” is u e as an “in lu iv or” s a stateme t is tru if an

c mbinatio of th c n itio s is tru

Th v rbal forms u e in this stan ard c nform to u ag d s rib d in An e H of th ISO/IEC

Dire tiv s, Part 2 For th p rp s s of this stan ard, th au i ary v rb:

– “s al ” mean that c mplan e with a re uireme t or a te t is man atory for c mpl an e

with this stan ard;

– “s o ld” mean that c mpl an e with a re uireme t or a te t is re omme d d b t is n t

man atory for c mplan e with this stan ard;

– “may” is u e to d s rib a p rmis ible way to ac ie e c mplan e with a re uireme t or

te t

An asteris (*) as th first c aracter of a title or at th b gin in of a paragrap or table title

© IEC 2 16

Th c mmite has d cid d that th c nte ts of th bas p bl catio an its ame dme t wi

"htp:/we store.ie c " in th data relate to th s e ific p bl catio At this date, th

u d rstan in of its co te ts Users sh uld therefore print this d cume t usin a

colour printer

© IEC 2 16

Th minimum safety re uireme ts s e ifie in this partic lar stan ard are c n id re to

pro id for a practical d gre of safety in th o eratio of s ort wav th rap e uipme t

This partic lar stan ard ame d an s p leme ts IEC 6 6 1-1 ( hird e itio , 2 0 ): Medic l

ele tric l equ ipme nt – Part 1: G e neral requireme ts for safety a d e sse tial p rorma c ,

h reinafer refer e to as th g n ral stan ard (s e 2 1.1.4)

Th re uireme ts are fol owe b s e ificatio s for th rele ant te ts

A "partic lar g idan e an ratio ale" s ctio givin s me e planatory n te , wh re

ap ro riate, ab ut th more imp rtant re uireme ts is in lu e in An e AA

Clau e or s b lau e for whic th re are e planatory n te in an e AA are mark d with an

asteris (*)

It is c n id re that a k owle g of th reas n for th s re uireme ts wi n t o ly faci tate

th pro er ap lcatio of th stan ard b t wi , in d e c urs , e p dite an re isio

n c s itate b c an e in cl nical practic or as a re ult of d v lo me ts in te h olo y

Howe er, this an e d e n t form part of th re uireme ts of this stan ard

© IEC 2 16

Part 2-3: Particular requirements for the basic safety and essential

performance of short wave therapy equipment

2 1.1 Scope, obje t and related standards

Clau e 1 of th g n ral stan ard

1

ap le , e c pt as fol ows:

2 1.1.1 Sco e

Rep la eme t

This partic lar stan ard s e ifie th re uireme ts for th safety of S O T-WA E T ERA Y

EQUIPME T,h reafer refer e to as ME EQUIPME T, as d fin d in s b lau e 2 1.3.2 6

L W POWER EQUIPME T as d fin d in s b lau e 2 1.3.2 2 is e empte from c rtain

re uireme ts of this stan ard

2 1.1.2 Object

Rep la eme nt

Th o je t of this partic lar stan ard is to e tabl s partic lar B SIC S F TY an E S N IAL

P RFO MA CE re uireme ts for S ORT-WA ET ERA Y EQUIPME T as d fin d in 2 1.3.2 6

2 1.1.3 Col ateral stan ards

Ad itio :

This partic lar stan ard refers to th s ap lcable c l ateral stan ard that are l ste in

Clau e 2 of th g n ral stan ard

IEC 6 6 1-1-3 d e n t ap ly Al oth r p bl s e c lateral stan ard in th IEC 6 6 1-1

s rie ap ly as p bls e

2 1.1.4 Particular standards

Rep la eme nt

In th IEC 6 6 1 s rie , partic lar stan ard may mo ify, re lac or d lete re uireme ts

c ntain d in th g n ral stan ard an c l ateral stan ard as ap ro riate for th partic lar

ME EQUIPME T u d r c n id ratio , an may ad oth r B SIC S F TY an E S N IAL

P RFO MA CE re uireme ts

A re uireme t of a partic lar stan ard tak s priority o er th g n ral stan ard

For bre ity, IEC 6 6 1-1 is refer e to in this partic lar stan ard as th g n ral stan ard

Col ateral stan ard are refere to b th ir d c me t n mb r

© IEC 2 16

Th n mb rin of clau e an s b lau e of this partic lar stan ard c r e p n s to that of

th g n ral stan ard with th prefix “2 1” (e.g 2 1.1 in this stan ard ad re s s th c nte t

of Clau e 1 of th g n ral stan ard) or ap lcable c lateral stan ard with th prefix “2 x”

wh re x is th final digit s) of th c lateral stan ard d c me t n mb r (e.g 2 2.4 in this

partic lar stan ard ad re s s th c nte t of Clau e 4 of th IEC 6 6 1-1-2 c l ateral

stan ard, 2 3.4 in this partic lar stan ard ad re s s th c nte t of Clau e 4 of th

IEC 6 6 1-1-3 c lateral stan ard, etc.) Th c an e to th te t of th g n ral stan ard are

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

“Re lac me t mean that th clau e or s b lau e of th g n ral stan ard or ap l cable

c l ateral stan ard is re lac d c mpletely b th te t of this partic lar stan ard

“Ad itio ” mean that th te t of this partic lar stan ard is ad itio al to th re uireme ts of

th g n ral stan ard or ap lcable c l ateral stan ard

“Ame dme t mean that th clau e or s b lau e of th g n ral stan ard or ap lcable

c l ateral stan ard is ame d d as in icate b th te t of this partic lar stan ard

Su clau e , fig re or table whic are ad itio al to th s of th g n ral stan ard are

n mb re startin from 2 1.101 Howe er d e to th fact that d finitio s in th g n ral

stan ard are n mb re 3.1 thro g 3.13 , ad itio al d finitio s in this stan ard are

n mb re b gin in from 2 1.3.2 1 Ad itio al an e e are letere AA, BB, etc an

ad itio al items a ), b ), etc

Su clau e , fig re or table whic are ad itio al to th s of a c l ateral stan ard are

n mb re startin from 2 x, wh re “x” is th n mb r of th c l ateral stan ard, e.g 2 2 for

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

Th term “ his stan ard” is u e to mak refere c to th g n ral stan ard, an ap lcable

c l ateral stan ard an this partic lar stan ard tak n to eth r

Wh re th re is n c r e p n in clau e or s b lau e in this partic lar stan ard, th clau e or

s b lau e of th g n ral stan ard or ap lcable c l ateral stan ard, alth u h p s ibly n t

rele ant, ap l e with ut mo ificatio ; wh re it is inte d d that an part of th g n ral

stan ard or ap lcable c l ateral stan ard, alth u h p s ibly rele ant, is n t to b ap le , a

stateme t to that efe t is giv n in this partic lar stan ard

2 1.2 Normative referenc s

Clau e 2 of th g n ral stan ard ap le

2 1.3 Terms and definitions

© IEC 2 16

2 1.3.2 3

MATCH D LOA

c mple load whic , wh n c n e te , re ults in th maximum p wer b in d l v re from th

S O T-WA E T ERA Y EQUIPME T into th load

2 1.3.2 4

OU P T CIR UIT

al c n u tiv parts u e to c u le radio- re u n y p wer from th g n rator to th

A PLICA O S, in lu in c n u tiv parts of th A PLICA O S an th ir c n e tin cable

2 1.3.2 5

* R T D OU P T POWER

valu of th maximum radio- re u n y p wer whic can b fe into a MA CH D LOAD

2 1.3.2 6

* S O T-WAV T ER P EQUIPMENT

ME EQUIPME T for th th rap utic treatme t of th P TIE T b e p s re to ele tric or mag etic

field pro u e in th fre u n y ran e of more than 13 MHz b t n t e c e in 4 MHz

2 1.4 General requirements

Clau e 4 of th g n ral stan ard ap le

2 1.5 General requirements for te ting of ME EQUIPME T

Clau e 5 of th g n ral stan ard ap le , e c pt as fol ows:

Ad itio al su b clause:

2 1.5.101 Ro tin tests

Th te tin d rin man facture s o ld in lu e:

a) Meas reme t of th o eratin fre u n y with th ME EQUIPME T o eratin u d r th

c n itio s s e ifie in item b) b low

b) Outp t p wer te t as s e ifie in s b lau e 2 1.12.1.101 b t o ly u d r th c n itio s

[A PLICA O (S), s acin (s), load re istan e] whic pro u e th maximum o tp t p wer

c) Meas reme t of th P TIE T LE K GE CUR E T u d r th c n itio s state in s b lau e

2 1.8.7.1 of this partic lar stan ard

2 1.6 Cla sification of ME EQUIPME T and ME S S EMS

Clau e 6 of th g n ral stan ard ap le

2 1.7 ME EQUIPME T identification, marking and doc ments

Clau e 7 of th g n ral stan ard ap le , e c pt as fol ows:

2 1.7.2 Markin o th o tsid of MEEQUIPMENT or ME EQUIPMENT parts

Ad itio al su b clause:

© IEC 2 16

• RA ED OU P T POWER in wats an th load imp dan e at whic this p wer is avai able;

• o eratin fre u n y in me ah rtz;

• s mb l n mb r 514 (n n-io izin ele tromag etic radiatio ) of IEC 6 8 8

Compla c is c e k d b y inspe ctio

2 1.7.3 Markin o th insid of MEEQUIPMENT or ME EQUIPMENT parts

Ad itio al su b clause:

2 1.7.3.101 * Markin for a ces

Symb ls n mb r 10 (cautio ) an n mb r 1 (o eratin in tru tio s) of T ble D.1 in

Ap e dix D of th g n ral stan ard s al b dis lay d o or n ar c mp n nts or o pan ls

givin ac e s to c mp n nts if adju tme t or re lac me t mig t cau e th ME EQUIPME T to

fai to c mply with IEC 6 6 1-1-2

Comp lia c is c e k d b y inspe ctio

2 1.7.4.2 * Control d vices

Ad itio :

Th o tp t c ntrol s al hav a s ale an /or an as o iate in icator re re e tin th radio

-fre u n y o tp t Th n meral “0” s al n t b u e u le s an p wer d lv re in this

p sitio is le s than 2 % of th RA ED OU P T POWER If th o tp t s ale or in icator

re re e ts wats of o tp t p wer, it s al b s mark d

Compla c is c e k d b y insp e ctio a d, if ap p ro riate, b y m easureme t ofth ou tpu t p owe r

(se 201.12.1.101)

2 1.7.9.2 Instructions for use

Ad itio al su b clause:

2 1.7.9.2.101 Ad itio al instructio s for use

Th in tru tio s for u e s al c ntain ad itio al y:

a) Informatio c n ernin th c mpatibi ty of A PLICA OR c n e tin cable in ord r to

pre e t th u e of u s itable cable

b) *Note o th ap lcatio of ME EQUIPME T drawin th OP RA O ’S ate tio to c rtain

pre autio s whic are n c s ary d rin treatme t

In partic lar, ad ic s al b giv n o :

© IEC 2 16

– Parts of th P TIE T’S b d c ntainin metal c implants ( or e ample a me ulary

nai) s o ld n rmaly b e clu e from th treatme t, u le s s e ial te h iq e

are u e

– Hearin aid s o ld b remo e

– Th P TIE T s o ld n t b alowe to c me into c ntact with c n u tiv parts

whic are earth d or whic hav an ap re iable capacitan e to earth an whic

may pro id u wante pathway for th radio- re u n y c r e t In partic lar, b d

or c airs havin metal frame s o ld n t b u e

– Th c n e tin cable as o iate with th A PLICA OR(S) s o ld b p sitio e in

cable for p s ible damag

Compla c is c e ke d b y insp ctio of th instructio s for use

– For S O T-WA E T ERA Y EQUIPME T with interc an eable A PLICA ORS, th te h ical

d s riptio s al state th maximum safe o tp t p wer that may b ap le to eac

A PLICA O

Compla c is c e ke d b y insp ctio of th te h ic l de scrip tio

2 1.8 Prote tion against electric l HAZARDS from ME EQUIPME T

Clau e 8 of th g n ral stan ard ap le e c pt as folows:

– with th s ort wav o tp t n t e ergiz d b t in s c a way that LE K GE CUR E T an

P TIE T A XILIAR CUR E T are n t afe te

2 1.8.8.3 * Dielectric stre gth

Ad itio :

AP LICA O S an th ir c n e tin cable s al with tan th maximum o tp t v ltag of th

S O TWA E T ERA Y EQUIPME T with ut break own b fore b in s bje te to th te t in 8.8.3

of th g n ral stan ard

© IEC 2 16

al oth r ob je ts with th e xc p tio ofth AP LIC ATOR arm of th ME EQUIPME T or simiar

sup p orting devic Th se o d AP LIC AT

R of th p ir is p sitio ed in th c nter ofa d

sp ace d ap p ro imately 10 mm ab ove a e rth d metal plate h ving a are a n les th n

900 cm2

Th ara geme t is sh wn in Figure 20 1.101

NOT It is es e tial th t th metal plate u e in this test h s a low Imp d nce to e rth at th o erating

fre ue c

Th S HOR T-WAV T ER APY EQUIPME T is op erated at R AT D MAINS VOLTAGE a d at th

R AT D OUTPU POWE sp ecified b y th MAN FAC TUR ER for th p articular p air of AP LICATOR S

u nder te st Th ou tp u t circu it is tune d to re so a c , re -p ositio ing th se o d AP LICATOR

as n ce ssary

Th te st is p erormed using a e arthe d metal p rob e of 8 mm diameter with a smo th a d

cle n h misp eric l e d, mou nte d into a insu lating rod to form a te st h ndle, as

i ustrated in Figure 2 1.102 Th h misp heric l e d of th p rob e sh l b e a p lied to th

AP LIC ATOR u nder te st a d m oved slowly b u t c ntinuously ove r th surfa e of th

AP LIC ATOR a d th fu ll le gth of its c n e ting c b le a d sh l n t b e alowed to re st at

a y p oint Du ring th te st evide nc of flash-over or b re kdown c nstitu tes faiure

Th test is the n re p eate d with th APPLIC ATOR S c a ging pla e s

b b ) Compla c for a inductive AP LIC ATOR a d its c n e ting c b le is c e ck d as folows:

Th AP LIC ATOR u nder te st is p ositio e d in th c nte r ofa d sp ace d a p ro imately 10 mm

ab ove a e rthe d metal p late h ving a are a n le ss th n 90 0 cm

Th S HOR T-WAV T ER APY EQUIPME T is op erate d at R AT D MAINS V LTAGE a d at th R AT D

OUTPU POWE spe cified b y th MAN FAC TUR ER for th p rticu lar AP LIC ATOR u nder test

Th ou tput circu it is tune d to reso a c , re-p sitio ing th AP LIC ATOR as n ce ssary

Th test is pe rformed using a e arthe d metal p rob e of 8 mm diame te r with a smo th a d

cle n h misp eric l e d, mou nted into a insu lating rod to form a te st h ndle, as

i ustrated in Figu re 20 1.10 Th he misp he ric l e d ofth p rob e sh l b e ap pled to th

AP LIC ATOR a d moved slowly b u t c ntinuously over th surfa e ofth AP LICATOR a d th

full le gth of its c n e cting c b le a d sh l n t b e alowed to re st at a y p int D uring th

te st evide nc offlash-over or b re akdown c nstitute s faiure

© IEC 2 16

10 m

> 0,5 m1

Metal plate con ected to e rth

AP LIC TOR b in tested

4

5

AP LIC TOR s p oSecon A PPLICA TOR

6Test pro e con ected to e r th

K ey

Figure 2 1.101 – Dielectric stre gth test for c pa itiv AP LIC TO S

IEC 44/12

© IEC 2 16

12

1

2

3

Ha dle ma e of insulatin mate al

8 mm diameter metal r od with h misp e c l e d

L w imp d n e c n e tio to e r th3

K ey

Fig re 2 1.10 – Test pro e

IEC 4 /2

© IEC 2 16

10 mm1

Metal plate con ected to e rth

AP LIC TOR b in tested

4

5

A PPLICA TOR s p o

Test pr ob con ected to e rth

Fig re 2 1.10 – Dielectric stre gth test for in uctiv AP LIC TORS

ME S S EMS

Clau e 9 of th g n ral stan ard ap le

2 1.10 Prote tion against unwanted and e ce sive radiation HAZA DS

Clau e 10 of th g n ral stan ard ap l e

2 1.1 Prote tion against ex es iv temperature and other HAZAR S

Clau e 1 of th g n ral stan ard ap l e

2 1.12 Ac urac of controls and instruments and protection a ainst

hazardous outputs

Clau e 12 of th g n ral stan ard ap l e , e c pt as folows:

2 1.12.1 Ac ura y of co trols an instrume ts

IEC 4 /2

© IEC 2 16

2 1.12.1.101 * Ac ura y of o tp t co trol set ing

Th maximum o tp t p wer of th S O T-WA E T ERA Y EQUIPME T wh n meas re as

d s rib d b low s al n t d viate from th RA ED OU P T POWER b more than ± 2 %

Comp lia c is c e k d b y me sureme t of th ou tp u t p owe r using th MATC HE LOAD

sp ecified b y th ma u fa turer

For LOW POWE E UIPME T, ma e th me asure me t as sp e cifie d b y th ma ufa turer

Th p ower me suring devic is sele cted so th t th e rror is within ± 5 % of th re ding whe n

c e k d using low fe qu e ncies (i.e 5 Hz to 6 Hz a.c.) or d.c a d th a cura y of th

me suring de vic at th working fequ en y sh l b e valdated

Du ring al th tests of this sub clause artificial c olng of th MATC HE LOAD is p ermited

provided it doe s n t afe t th m easu re d re su lt

2 1.12.4 Protectio against ha ard us o tp t

Ad itio al sub clauses:

2 1.12.4.101 * Maximum al owe o tput p wer

Th maximum o tp t p wer of th S O T-WA E T ERA Y EQUIPME T s al n t e c e 5 0 W

Compla c is c e k d b y insp e ctio of th resu lts ob tain d in th c mp lia c te st p e rform ed

in a c rda c with 2 1.12.1.101

2 1.12.4.10 Outp t re uctio means

T-WA

E T ERA Y EQUIPME

T s al in orp rate mean (an o tp t c ntrol) to re u e th

o tp t p wer to le s than 10 W or 5 % of th RA ED OU P T POWER, whic e er is th lower,

oth r than b d tu in of th OU P T CIR UIT

Comp lia c is c e ck d b y insp ectio a d fu n ctio al te st

2 1.12.4.10 * En rgizing th o tp t

S O T-WA E T ERA Y EQUIPME T s al b s d sig e that th OU P T CIR UIT can ot b

e ergiz d u le s th o tp t c ntrol is first s t to th minimum p sitio

This re uireme t s al als b met afer th interu tio an re toratio of th main s p ly

Compla c is c e ke d b y a functio al test

© IEC 2 16

Clau e 14 of th g n ral stan ard ap l e

2 1.15 Construction of ME EQUIPME T

Clau e 15 of th g n ral stan ard ap l e

2 1.16 ME S S EMS

Clau e 16 of th g n ral stan ard ap l e

2 1.17 Ele troma netic compatibi ity of ME EQUIPME T and ME S S EMS

Clau e 17 of th g n ral stan ard ap l e :

Annexes

Th an e e of th g n ral stan ard ap ly e c pt as folows:

© IEC 2 16

Annex C

(informative)

Guide to marking and label ing requirements

for ME EQUIPMENT and ME S ST MS

2 1.C.1 Marking on the outside of ME EQUIPME T, ME S S EMS or their parts

Ad itio al re uireme ts for markin o th o tsid of S O T-WA E T ERA Y EQUIPME T are

© IEC 2 16

Annex AA

(informative)

Particular guidance and rationale

AA.1 General guidanc

This ap e dix pro id s a c n is ratio ale for th imp rtant re uireme ts of this partic lar

stan ard an is inte d d for th s wh are fami ar with th s bje t of th stan ard b t wh

hav n t participate in its d v lo me t An u d rstan in of th reas n for th main

re uireme ts is c n id re to b e s ntial for th pro er ap l catio of th stan ard

Furth rmore, as clnical practic an te h olo y c an e, it is b le e that a ratio ale for th

pre e t re uireme ts wi faci tate an re isio of th stan ard n c s itate b th s

d v lo me ts

AA.2 Rationale for particular cla s s and s bcla se

Th folowin are ratio ale for s e ific clau e an s b lau e in this partic lar stan ard,

with clau e an s b lau e n mb rs paralel to th s in th b d of th d c me t

Definitio 2 1.3.2 5 – R T D OU P T POWER

Sele tio of th p wer meas reme t e uipme t an te h iq e wi d p n o wh th r th

o tp t is c ntin o s or p ls d

Definitio 2 1.3.2 6 – S ORT-WAV T ER P EQUIPMENT

Th first e itio ’s d finitio was c an e to mo e th minimum fre u n y u to 13 MHz

b cau e CISPR 1 l mits th amo nt of e erg that may b radiate b low 13 MHz

CISPR 1 d e p rmit u lmite radiate p wer at 13,5 MHz, 2 ,12 MHz, an 4 ,6 MHz s

c an in th fre u n y ran e in this stan ard to 13 MHz – 4 MHz s lv s that is u

Su clause 2 1.7.3.101 – Markin for a ces

Th re uire markin s h lp inform S RVICE P RSON EL that adju tin or re lacin c mp n nts

may d grad th S ORT-WA E T ERA Y EQUIPME T’S abi ty to s p re s interfere c

Su clause 2 1.7.4.2 – Control d vices

As th p wer d l v re d p n s o th load p sitio of th A PLICA O S relativ to th

P TIE T, a grad atio in relativ u its is c n id re to b ad q ate If th n meral "0" is

© IEC 2 16

Su clause 2 1.7.9.3.1 – Ge eral

As th c n itio s for th meas reme t of th RA ED OU P T POWER can vary, th

MA U ACT RER n e s to pro id informatio o h w it s o ld b meas re

Su clause 2 1.8.7.1 – Ge eral re uireme ts

As a smal LE K GE CUR E T can ot easi y b meas re in th pre e c of hig radio

-fre u n y c re ts, th te ts h re are p rforme with th radio- re u n y g n rator disable

Su clause 2 1.8.8.3 – Dielectric stre gth

Th re uireme ts an te ts of this s b lau e tak into ac o nt th fact that th in ulatio of

th OU P T CIR UIT is stre s d difere tly b radio- re u n y v ltag s Th in ulatin

materials als n e to b s itable for th hig e t temp rature o c r in in NORMAL U E

Su clause 2 1.12.1.101 Ac ura y of o tp t co trol set ing

An ac urac of ± 2 % is ad q ate for this kin of ME EQUIPME T

Su clause 2 1.12.4.101 – Maximum al owe output p wer

RIS S te d to in reas with th o tp t p wer A p wer of 5 0 W me ts th maximum

re uireme ts of n rmal treatme t (e c pt p s ibly wh le-b d h atin )

Su clause 2 1.12.4.10 – En rgizin th o tp t

En rgizatio of th g n rator o ly at th minimum s tin of th o tp t c ntrol pre e ts a

P TIE T from b in treate inad erte tly at an e c s iv ly hig s tin of this c ntrol

Su clause 2 1.12.4.10 – Adjustable timer

Sh rt wav th rap is ofe p rforme with ut c ntin o s s p rvisio Th refore a timer for

switc in of is d sirable

MEDICAL ELECTRICAL EQUIPME T (ME EQUIPME T) IEC 6 6 1-1:2 0 , 3.6

MEDICAL ELECTRICAL SYS EM (ME SYS EM) IEC 6 6 1-1:2 0 , 3.6

2 1.5 Exig n e g n rale relativ s au e sais d s A P REILS EM 2

2 1.6 Clas ificatio d s A P REI

LS EM et d s

EM 2

2 1.7 Id ntificatio , marq ag et d c me tatio d s A P REILS EM 3

2 1.8 Prote tio c ntre le DA GERS d'origin éle triq e pro e ant d s

A P REILS EM 31

2 1.9 Prote tio c ntre le DA GERS MECA IQU S d s A P REILS EM et SYS EME EM 3

2 1.10 Prote tio c ntre le DA GERS d s au ray n eme ts in olo taire et

e c s ifs 3

2 1.1 Prote tio c ntre le temp rature e c s iv s et le autre DA GERS 3

2 1.12 Pré isio d s c mman e , d s in trume ts et prote tio c ntre le

caractéristiq e d s rtie pré e tant d s DA GERS 3

2 1.13 SIT A ION DA GERE S S et c n itio s d d faut p ur le A P REILS EM 3

An e e AA (informativ ) Guid partic ler et ju tificatio s 4

In e d s terme d finis uti s s dan la pré e te n rme partic l ère 4

Fig re 2 1.101 – Es ai d te sio d te u d s A PLICA E RS capacitifs 3

Fig re 2 1.10 – So d d’e sai 3

Fig re 2 1.10 – Es ai d te sio d te u d s A PLICA E RS in u tifs 3

© IEC 2 16

Partie 2-3: Exigences particul ères pour la sécurité de base et

les performances essentiel es des apparei s de thérapie à ondes courtes

1) L Commis io Electrotech ique Intern tio ale (IEC) est un orga isatio mo diale d n rmalsatio

comp sé d le semble d s comités électrotech iques n tio au (Comités n tio au d l EC) L’EC a p ur

o jet d fa oriser la co p ratio intern tio ale p ur toutes les questio s d n rmalsatio d ns les d main s

d lélectricité et d lélectro ique A cet efet, l EC – e tre autres activités – puble d s Normes

intern tio ales, d s Sp cificatio s tech iques, d s Ra p rts tech iques, d s Sp cificatio s ac es ibles au

publc (P S) et d s Guid s (ci-a rès d n mmés "Publcatio (s) d l EC" L ur éla oratio est co fié à d s

comités d'étud s, au tra au d squels tout Comité n tio al intéres é p r le s jet traité p ut p rticip r L s

orga isatio s intern tio ales, gouv rn me tales et n n gouv rn me tales, e laiso a ec l EC, p rticip nt

égaleme t au tra au L’EC cola ore étroiteme t a ec lOrga isatio Intern tio ale d Normalsatio (ISO),

selo d s co ditio s fixé s p r ac ord e tre les d u orga isatio s

2) L s d cisio s ou ac ords oficiels d l EC co cern nt les questio s tech iques re rése te t, d ns la mes re

du p s ible, un ac ord intern tio al s r les s jets étudiés, éta t d n é que les Comités n tio au d l EC

intéres és so t re rése tés d ns ch que comité d’étud s

3) L s Publcatio s d l EC se prése te t sou la forme d recomma d tio s intern tio ales et so t agré es

comme teles p r les Comités n tio au d l EC Tou les eforts raiso n bles so t e tre ris afin que l EC

s'as ure d lexactitud du co te u tech ique d ses publcatio s; l EC n p ut p s être te ue resp nsa le d

lé e tuele mauv ise uti satio ou interprétatio qui e est faite p r un quelco que uti sateur fin l

4) Da s le but d'e courager luniformité intern tio ale, les Comités n tio au d l EC s'e gage t, d ns toute la

mes re p s ible, à a plquer d faço tra sp re te les Publcatio s d l EC d ns leurs publcatio s n tio ales

et régio ales Toutes div rge ces e tre toutes Publcatio s d l EC et toutes publcatio s n tio ales ou

régio alescoresp n a tes d iv nt être in iqué s e termes clairs d nsces d rnières

5) L’EC ele-même n fournit au un atestatio d co formité Des orga ismes d certificatio in é e d nts

fournis e t d s services d'é aluatio d co formité et, d ns certains secteurs, ac è e t au marques d

co formité d l EC L’EC n'est resp nsa le d'au un d s services efectués p r les orga ismes d certificatio

in é e d nts

6) Tou les uti sateurs d iv nt s'as urer qu' s so t e p s es io d la d rnière é itio d cete publcatio

7) Au un resp nsa i té n d it être imputé à l EC, à ses a ministrateurs, employés, au i aires ou

ma d taires, y compris ses exp rts p rtic lers et les membres d ses comités d'étud s et d s Comités

n tio au d l EC, p ur tout préjudice cau é e cas d d mmages corp rels et matériels, ou d tout autre

d mmage d quelque n ture que ce soit, directe ou in irecte, ou p ur s p orter les cỏts (y compris les frais

d ju tice) et les d p nses d coula t d la publcatio ou d luti satio d cete Publcatio d l EC ou d

toute autre Publcatio d l EC, ou au cré it qui lui est ac ord

8) L'ate tio est atiré s r les référe ces n rmativ s cité s d ns cete publcatio L'uti satio d publcatio s

référe cé s est o lgatoire p ur un a plcatio corecte d la prése te publcatio

9) L’ate tio est atiré s r le fait que certains d s éléme ts d la prése te Publcatio d l EC p uv nt faire

lo jet d droits d bre et L’EC n saurait être te ue p ur resp nsa le d n p s a oir id ntifié d tels droits

d bre ets et d n p sa oir sign lé leur existe ce

DÉGAGEMENT DE RESPONSABILIT

Cet e v rsion co sol d e n’est pa un Norme IEC of iciel e, el e a été pré aré par

commo ité p ur l uti is te r Se les les v rsio s courantes d cet e n rme et de

so (ses) ame d me t s) d iv nt être co sid ré s comme les docume ts of iciels

Cet e v rsio co sol dé d l EC 6 6 1-2-3 p rte le n méro d'é ition 3.1 El e

compre d la troisième é itio (2 12-0 ) [d cume ts 6 D/97 /FDIS et 6 D/9 3/RVD] et

son ame d me t 1 (2 16-0 ) [d cume ts 6 D/13 0/FDIS et 6 D/13 0/RVD] L co te u

techniqu est ide tiqu à celui d lé itio de ba e et à so ame d me t

© IEC 2 16

Dans cet e v rsio Re l ne, u e l gn v rtic le dans la marg indiqu o le co te u

techniqu est mo ifié par l ame d me t 1 L s ajo ts so t e v rt, les su pres io s

sont e ro ge, bar é s Une v rsio Finale av c toutes les mo ific tio s a ce té s est

dispo ible dans cet e p bl c tion

L Norme internatio ale IEC 6 6 1-2-3 a été établ e par le s u -c mité 6 D: Ap areis

éle tromé icau , d c mité d’étu e 6 d lIEC : Éq ip me ts éle triq e dan la pratiq e

mé icale

Cete troisième é itio an ule et remplac la d u ième é itio d lIEC 6 6 1-2-3 p bl é e

19 1 et s n ame d me t 1 p bl é e 19 8 Cete é itio c n titu u e ré isio te h iq e et

s’alg e av c l IEC 6 6 1-1:2 0

Cete p blcatio a été ré ig e s lo le Dire tiv s ISO/IEC, Partie 2

Dan la pré e te n rme, le caractère d'mprimerie s ivants s nt uti s s:

– Exig n e et d finitio s: caractère romain

– Modalté s d'e ssais: c ra tères italqu es

– In icatio s d n ture informativ a p rais a t h rs d s ta le u , comme les n tes, les exemples et les

référe ces: p tits caractères romains L texte n rmatif à l ntérieur d s ta le u est égaleme t e p tits

caractères

– TERME DE INIS A L’ARTICLE 3 DE LA NO ME GE ERALE, DA S LA PRE E T NORME

P RTICULIEREOU C MME NOT S:P TIT S MAJU CULE

Co c rnant la stru ture d la pré e te n rme, le terme

– “article” d sig e lu e d s dix-s pt s ctio s n méroté s dan la table d s matière , av c

to te s s s b ivisio s (par e emple, lArticle 7 in lut le paragrap e 7.1, 7.2, etc.);

– “paragrap e” d sig e u e s b ivisio n méroté d'u article (par e emple, 7.1, 7.2 et

7.2.1 s nt to s d s paragrap e ap arte ant à lArticle 7)

Dan la pré e te n rme, le référe c s à d s article s nt pré é é s d mot “Article” s ivi d

n méro d larticle c n ern Dan la pré e te n rme partic l ère, le référe c s au

paragrap e uti s nt u iq eme t le n méro d paragrap e c n ern

Dan la pré e te n rme, la c njo ctio "o " e t uti s e av c la vale r d'u "o in lu if , ain i

u é o c e t vrai si u e c mbinais n d s c n itio s q el e q 'ele s it e t vraie

lAn e e H d s Dire tiv s ISO/IEC, Partie 2 Po r le b s in d la pré e te n rme:

– “d v ir” mis au pré e t d l n icatif sig ifie q e la satisfactio à u e e ig n e o à u

e sai e t o l gatoire p ur la c nformité à la pré e te n rme;

© IEC 2 16

Le c mité a d cid q e le c nte u d la p blcatio d bas et d s n ame d me t n s ra

pas mo ifié avant la date d stabi té in iq é s r le site we d lIEC s u

"htp:/we store.ie c " dan le d n é s relativ s à la p blcatio re h rc é A c te date,

IMPORTANT – Le lo o "c o lour ins ide " q i se tro v sur la page d cou erture de cet e

p bl c tio indiq e qu'el e contie t d s co le rs q i so t co sid ré s comme uti es à

u e b nn compré e sio d so co te u Les uti s te rs de raie t, par co sé ue t,

imprimer cet e p bl c tio e uti s nt u e imprimante coule r

© IEC 2 16

Le e ig n e minimale d s c rité s é ifié s dan la pré e te n rme partic lère s nt

c n id ré s c mme as urant u d gré pratiq e d s c rité dan le fo ctio n me t d s

ap areis d th rapie à o d s c urte

Cete n rme partic l ère mo ifie et c mplète lIEC 6 6 1-1 ( roisième é itio , 2 0 ):

App areis éle tromé dic ux – Partie 1: Exigen es gé nérales p ur la sé cu rité de b ase et les

pe rforma ce s e sse tieles, d sig é ci-aprè s u le terme n rme g n rale (v ir le 2 1.1.4)

Le e ig n e s nt s ivie d s é ificatio s relativ s au e sais c r e p n ants

Un s ctio intitulé "g id partic l er et ju tificatio s" c nte ant, q an c la c n ie t, d s

n te e plcativ s c n ernant le e ig n e le plu imp rtante fig re e An e e AA

Le article et paragrap e c mp rtant d s n te e plcativ s e An e e AA s nt marq é

© IEC 2 16

Partie 2-3: Exigences particul ères pour la sécurité de base et

les performances essentiel es des apparei s de thérapie à ondes courtes

2 1.1 Domaine d'appl cation, objet et norme connex s

L'Article 1 d la n rme g n rale

1

s’ap lq e, av c le e c ptio s s ivante :

2 1.1.1 Domain d'ap l c tion

Remp la eme t :

L pré e te n rme partic l ère s é ifie le e ig n e d s c rité ap lcable au A P REILS

DE T ERA IE A ONDE C URT S, d sig é ci-aprè s u le terme d'A P REILS EM, c mme

d finis dan le paragrap e 2 1.3.2 6

Le A P REILS A B S E P IS A CE tels q e d finis dan le paragrap e 2 1.3.2 2 s nt

e empté d c rtain s e ig n e d la pré e te n rme

2 1.1.2 Objet

Rempla em ent :

L’o jet d la pré e te n rme partic l ère e t d’établr d s e ig n e partic l ère d S CURIT

DE B S et d P RFORMA CE E S N IEL E d s A P REILS DE T ERA IE A ONDE C URT S tels

Dan la s rie IEC 6 6 1, d s n rme partic l ère p u e t mo ifier, remplac r o s p rimer

le e ig n e d finie dan la n rme g n rale et dan le n rme c l atérale e fo ctio d

c q i e t ap ro rié à lA P REIL EM c n id ré, et ele p u e t ajo ter d’autre e ig n e d

S CURIT DE B S et d P RFO MA CE E S N IEL E

Un e ig n e d’u e n rme partic l ère pré aut s r le ig n e c re p n ante d la n rme

g n rale

© IEC 2 16

Par s u i d c n isio , lIEC 6 6 1-1 e t d sig é , dan la pré e te n rme partic l ère, par

le terme “n rme g n rale” Le n rme c l atérale s nt d sig é s par le r n méro d

d c me t

L n mérotatio d s article et d s paragrap e d la pré e te n rme partic l ère c r e p n

à c l e d la n rme g n rale av c le préfix “2 1” (par e emple 2 1.1 dan la pré e te n rme

ab rd le c nte u d lArticle 1 d la n rme g n rale) o d la n rme c latérale ap lcable

av c le préfix “2 x”, o x e t (s nt le (le ) d rnier(s) c ifre(s) d n méro d d c me t d la

n rme c l atérale (par e emple 2 2.4 dan la pré e te n rme partic lère ab rd le c nte u

d lArticle 4 d la n rme c l atérale IEC 6 6 1-1-2, 2 3.4 dan la pré e te n rme

partic lère ab rd le c nte u d l Article 4 d la n rme c l atérale IEC 6 6 1-1-3, etc.) Le

mo ificatio s ap orté s au te te d la n rme g n rale s nt pré is e e uti sant le terme

s ivants:

“Remplac me t sig ifie q e l article o le paragrap e d la n rme g n rale o d la n rme

c l atérale ap l cable e t remplac c mplèteme t par le te te d la pré e te n rme

partic lère

“Ad itio ” sig ifie q e le te te d la pré e te n rme partic lère vie t s’ajo ter au e ig n e

d la n rme g n rale o d la n rme c latérale ap l cable

“Ame d me t sig ifie q e larticle o le paragrap e d la n rme g n rale o d la n rme

c l atérale ap l cable e t mo ifié c mme in iq é dan la pré e te n rme partic l ère

Le paragrap e , fig re o tableau q i s nt ajo té à c u d la n rme g n rale s nt

n méroté à partir d 2 1.101 To tefois, e rais n d fait q e le d finitio s dan la n rme

g n rale s nt n méroté s 3.1 à 3.13 , le d finitio s c mpléme taire dan la pré e te

n rme s nt n méroté s à partir d 2 1.3.2 1 Le an e e c mpléme taire s nt n mmé s

AA, BB, etc et le p ints c mpléme taire a ), b ), etc

Le paragrap e , fig re o tableau q i s nt ajo té à u e n rme c l atérale s nt

n méroté à partir d 2 x, o “x” e t le c ifre d la n rme c latérale, par e emple 2 2 p ur

lIEC 6 6 1-1-2, 2 3 p ur l IEC 6 6 1-1-3, etc

L’e pre sio “la pré e te n rme” e t uti s e p ur s référer à la n rme g n rale, à to te le

n rme c latérale ap lcable et à la pré e te n rme partic l ère, c n id ré s e s mble

Lors u la pré e te n rme partic lère n c mpre d pas d’article o d paragrap e

c r e p n ant, l article o le paragrap e d la n rme g n rale o d la n rme c latérale

ap l cable, bie q ’ p is e être san o jet, s’ap lq e san mo ificatio ; lors u’ e t

d man é q ’u e partie q elc n u d la n rme g n rale o d la n rme c latérale

ap l cable, bie q e p te tieleme t p rtin nte, n s’ap lq e pas, c la e t e pre s me t

me tio n dan la pré e te n rme partic l ère

c arg c mple e q i, lors u'ele e t c n e té , d n e l e à la p is an e maximale d l vré

par lA P REIL DE T ERA IEAONDE C URT S dan la c arg

2 1.3.2 4

CIR UIT DE SO TIE

e s mble d s partie c n u tric s uti s e p ur tran metre au A PLICA E RS la p is an e

haute fré u n e fo rnie par le g n rate r, y c mpris le partie c n u tric s d s

A P REIL EM d traiteme t th rap utiq e d P TIE T par e p sitio d c lui-ci à d s c amp

éle triq e o mag étiq e pro uits dan la plag d fré u n e c mpris s e tre 13 MHz et

4 MHz

2 1.4 Exigenc s générale

L’Article 4 d la n rme g n rale s’ap l q e

2 1.5 Exigenc s générale relative aux e s is de AP AREILS EM

L'Article 5 d la n rme g n rale s'ap lq e av c le e c ptio s s ivante :

Paragrap he c mpléme ntaire :

2 1.5.101 Es ais in ivid els d série

Il c n ie t q e le e sais e c urs d fabricatio c mp rte t :

a) Le me urag d la fré u n e d fo ctio n me t d I' A P REIL EM fo ctio nant dan le

c n itio s s é ifié s au p int b) ci-d s o s

b) Un e sai d p is an e d s rtie tel q e s é ifié au paragrap e 2 1.12.1.101, mais

© IEC 2 16

2 1.7 Identific tion, marqua e et doc mentation de AP A EILS EM

L'Article 7 d la n rme g n rale s'ap lq e av c le e c ptio s s ivante :

2 1.7.2 Marq ag sur l e térie r d s AP A EIL EM o des parties d’AP A EIL EM

Paragrap he c mp léme taire :

2 1.7.2.101 Cara téristiqu s d sortie

L’A P REIL DE T ERA IE A ONDE C URT S d it c mp rter le informatio s s ivante :

• P IS A CE DE SO TIE A SIGN E e wats ain i q e l mp dan e d c arg c re p n ant à

c t e p is an e;

• fré u n e d fo ctio n me t e mé ah rtz;

• s mb le n méro 514 (ray n eme t éle tromag étiq e n n io isant d lIEC 6 8 8

L c nformité est vérifié p ar e ame n

2 1.7.3 Marq ag à l ntérie r des AP A EIL EM ou parties d’AP A EIL EM

Paragrap he c mpléme ntaire :

2 1.7.3.101 * Marq ag d’a cès

Le s mb le n méro 10 (av rtis eme t et n méro 1 (in tru tio s d fo ctio n me t d

T bleau D.1 d lAn e e D d la n rme g n rale d iv nt être plac s s r le c mp sants o

prè d c u -ci o e c re s r d s pan eau d n ant ac è au c mp sants, si le r ré lag

o le r remplac me t p ut e traîn r la n n-c nformité d l A P REIL EM par rap ort à

lIEC 6 6 1-1-2

L c nformité est vérifié p ar e ame n

2 1.7.4.2 * Disp sitifs d comman e

Ad itio :

Le dis o itif d c mman e d p is an e d s rtie d it c mp rter u e é h le eto u

in icate r as o ié re ré e tant la p is an e d s rtie à radiofré u n e Le c ifre “0” n d it

pas être uti s , sauf si u e p is an e q elc n u d lvré dan c te p sitio e t inférie re à

2 % d la P IS A CE DE SO TIE A SIGN E Si l é h l e o l n icate r d p is an e d s rtie

re ré e te d s wats d p is an e d s rtie, u marq ag c r e p n ant d it l n iq er

L c nformité e st vérifié e p ar e ame et, le c s é ché ant, p ar de s me sures de la puis a c de

sortie (voir 20 1.12.1.10 1)

© IEC 2 16

En partic l er, i y a le d'at irer late tio s r le p ints ci-aprè :

1) Po r to s le A P REILSDE T ERA IE A ONDE C URT S:

– Le fo ctio n me t d c rtain dis o itifs éle triq e implanté , stimulate rs

cardiaq e par e emple, p ut être c mpromis lors d'u traiteme t par o d s

c urte En cas d d ute, i c n ie t d d man er c n ei au mé e in q i s it le

P TIE T

– L'uti satio d'u A P REIL DE T ERA IE A ONDE C URT S p ut c mprometre le b n

fo ctio n me t d'autre A P REILS EM rel é au P TIE T

2) Po r le s mble d s A P REILS DE T ERA IE A ONDE C URT S à le c ptio d s

A P REILS A B S E P IS A CE :

– Il c n ie t d n pas ap lq er le traiteme t par o d s c urte au P TIE T à

trav rs d s v teme ts Il c n ie t d’éloig er le matériau c n u te rs d la z n

à traiter De plu , i c n ie t d n pas lap lq er au P TIE T p rtant d s o jets

métal q e tels q e d s bio x o d s v teme ts c nte ant d s matériau

métal q e (par e emple, d s b uto s, agrafe o fis métal q e )

– Il c n ie t d n pas s umetre au traiteme t le partie d c rp d

P TIE T

c mp rtant d s implants métal q e (clo intramé ulaire par e emple), sauf e

cas d’uti satio d te h iq e s é iale

– Il c n ie t d’e le er le ap areis d c r e tio au itiv

– Il c n ie t q e le P TIE T n p is e pas v nir e c ntact av c d s partie

c n u tric s mis s à la tere o pré e tant par rap ort à la ter e u e capacité

ap ré iable s s e tible d pro urer d s c emin me ts in é irable p ur le

c urant haute fré u n e En partic l er, i c n ie t d n pas uti s r d s lts o

d s c ais s à armature métal q e

– Il c n ie t d dis o er le câble d c n e io d l A PLICA E R OU DE

A PLICA E RS d F Ç N à E IT R to t c ntact av c le P TIE T, av c d s o jets

c n u te rs o av c d s o jets ab orbant lé ergie

c) Un re omman atio à I'OP RA E R d v rifier p rio iq eme t l s latio d s

A PLICA E RS et d le rs câble , p ur e re h rc er le d fauts é e tu ls

L c nformité est vérifié e p ar e ame de s instructio s d'uti satio

– Po r le A P REILS DE T ERA IE A ONDE C URT S d té D’A PLICA E RS interc an eable ,

la d s riptio te h iq e d it in iq er la p is an e d s rtie e to te s c rité maximale

p u ant être ap lq é à c aq e A PLICA E R

L c nformité est vérifié e p ar e xame de la descriptio te h iqu e

2 1.8 Prote tion contre le DANGERS d'origine électrique prov nant des

AP AREILS EM

L’Article 8 d la n rme g n rale s’ap l q e c mme s it :

2 1.8.3 Cla sific tio des PA TIE AP LIQU E

Le A PLICA E RS et le rs câble d c n e io d iv nt s p orter la te sio d s rtie

maximale d s A P REILS DE T ERA IE A ONDE C URT S san s bir d claq ag , avant d’être

s umis à l e sai d 8.8.3 d la n rme g n rale

a ) L c nformité des AP LICAT UR S c p acitifs et de leurs c b les de c n e xio e st vérifié e de

la fa o su iva te :

Ch qu e p aire d'APPLIC AT UR S est sou mise à les ai e u ti sa t les c b les sp é cifié s p r le

FAB R ICAN L'AP LIC AT U soumis à les ai est susp end ou su p p orté de fa o à se

trouver à au moins 5 cm de tou t autre ob jet à le xce ptio d b ras de I'AP LIC AT U de I'

AP AR EIL EM ou de tou t au tre sup port simiaire L deuxièm e AP LIC AT U de la p aire est

pla é au c ntre et à e nviro 10 mm au-des us d’u ne plaque métal qu e mise à la tere

do t la surfa e e st infé rieure ou égale à 900 cm

p rticu lière d’AP LIC AT UR S e es ai L circuit de sortie est réglé à la ré so a c , e

dé pla a t le se o d AP LIC AT U selo le s b esoins

L'es ai est efe tué e u ti sa t u ne so de mise à la tere, c nstitu ée d'une b are

métal que de 8 mm de diamètre termin e p ar u ne e trémité h misp hérique ls e et p rop re

et introduite da s un ma c e e matiè re isola te p ur c nstitu e r une p oigné e d'e ssai, tel

qu'i ustré à la figure 201.10 L'e xtrémité h misp hériqu e de la so de doit être ap plquée à

l AP LIC AT U e n e ssai et dé pla é le teme nt m ais de fa o c ntinue sur la surfa e de I'

AP LIC AT U et sur tou te la lo gueur de so c b le de c n e io et i n doit lu i être

autorisé de re p os e aucun p int Au c urs de les ai, le c ntourn me t ou le claquage

c nstitue u ne défai a ce

L’es ai est e nsuite rép été e c a gea t le s AP LIC AT UR S de p la e

b b ) L c nformité d’u n AP LIC AT U inductif et de so c b le de c n e io e st vérifié c mme

su it :

L’AP LIC AT U e es ai e st pla é au ce ntre et à e nviro 10 mm au-de ssus d’une plaque

© IEC 2 16

lAP LIC AT U et dé la é le nteme t mais de fa o c ntinue sur la surfa e de

I'AP LICAT U et su r toute la lo gu e u r de so c b le de c n e io et i n doit lu i être

au torisé de re p os e aucu n p int Au c u rs de les ai, le c ntourn me nt ou le claquage

c nstitue u ne défai a ce

© IEC 2 16

10 m

> 0,5 m1

6Son e d’es ai r elé à la ter r e

K ey

Fig re 2 1.101 – Es ai d te sion d te u d s AP LIC T URS c pa itifs

IEC 44/2

© IEC 2 16

12

1

2

3

Poig é e matér uia isola t

Barr e métalq e d 8 m d diamètr e à extrémité h misp é q e

Liaiso à la ter r e d faible imp d n e3

K ey

Fig re 2 1.10 – So de d’es ai

IEC 45/2

© IEC 2 16

10 mm1

A PPA EIL EN E SAI

Plaq e métal q e r elé à la ter r e

A PPLIC T U en es ai

4

5Sup ort D’AP LIC T U

Son e d’es ai r elé à la terr e

Fig re 2 1.10 – Es ai de te sio d te u d s AP LIC T URSin uctifs

L’Article 9 d la n rme g n rale s’ap l q e

2 1.10 Prote tion contre le DANGERS dus aux rayonnements involontaire et

e c ssifs

L’Article 10 d la n rme g n rale s’ap lq e

IEC 46/2