IS 14679: Neurosurgical implants - Implantable perpheral nerve stimulators

9 Pages·1999·1.1 MB·English

by  Bureau of Indian Standards

इंटरनेट मानक
Disclosure to Promote the Right To Information
Whereas the Parliament of India has set out to provide a practical regime of right to
information for citizens to secure access to information under the control of public authorities,
in order to promote transparency and accountability in the working of every public authority,
and whereas the attached publication of the Bureau of Indian Standards is of particular interest
to the public, particularly disadvantaged communities and those engaged in the pursuit of
education and knowledge, the attached public safety standard is made available to promote the
timely dissemination of this information in an accurate manner to the public.
“जान1 का अ+धकार, जी1 का अ+धकार” “प0रा1 को छोड न’ 5 तरफ”
Mazdoor Kisan Shakti Sangathan Jawaharlal Nehru
“The Right to Information, The Right to Live” “Step Out From the Old to the New”
IS 14679 (1999): Neurosurgical implants - Implantable
perpheral nerve stimulators [MHD 7: Neurosurgery
Instruments Implants and Accessories]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
““IInnvveenntt aa NNeeww IInnddiiaa UUssiinngg KKnnoowwlleeddggee””
“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
Bhartṛhari—Nītiśatakam
“Knowledge is such a treasure which cannot be stolen”

:
SI 97641 9991
i
I

Indian Standard
NEUROSURGICALIMPLANTS-IMPLANTABLE
PERIPHERALNERVESTIMULATORS
ICS 11.040.40

0 BTS 1999
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARC
NEW DELHI 110002
May 9991 Price Group 2
yregrusorueN stnemurtsnI lanoitceS ,eettimmoC MHD 7
DROWEROF
sihT naidnI dradnatS was adopted yb the uaeruB of naidnI ,sdradnatS after the draft dezilanif yb the yregrusorueN
stnemurtsnI lanoitceS eettimmoC had neeb devorppa yb the lacideM tnempiuqE dna latipsoH gninnalP noisiviD
.licnuoC
ehT evitcejbo of siht dradnats si ot edivorp gnillebal ,stnemeriuqer niatrec ytefas dna ecnamrofrep ,stnemeriuqer
dna ecnerefer test sdohtem that lliw pleh hsilbatse a elbanosaer level of ytefas ssenevitceffe.dna for elbatnalpmi
larehpirep evren srotalumits dednetni for esu ni the feiler of .niap
sihT dradnats stcelfer the suoitneicsnoc efforts of those yllaitnatsbus denrecnoc htiw sti scope dna snoisivorp ot
poleved a dradnats for those ecnamrofrep slevel that dluoc ylbanosaer eb deveihca tis siht .emit
sihT dradnats si desab no the naciremA lanoitaN dradnatS IMAAUSNA SN 151984 elbatnalpmI‘ larehpirep
evren ’srotalumits deussi yb the naciremA lanoitaN ,etutitsnI ,cnI New York.
roF the esoprup of gnidiced whether a ralucitrap tnemeriuqer of siht dradnats si deilpmoc ,htiw the lanif ,eulav
devresbo or ,detaluclac gnisserpxe the stluser of a test, llahs eb dednuor off ni ecnadrocca htiw SI :2 1960 seluR‘
for gnidnuor off laciremun seulav .‘)desiver( ehT rebmun of tnacifingis secalp deniater ni the dednuor off eulav
dluohs eb the emas as that of the deificeps eulav ni siht .dradnats
IS 14679 : 1999
Indian Standard
LACIGRUSORUEN STNALPMI - ELBATNALPMI
LAREHPIREP EVREN SROTALUMITS
1 SCOPE )a A tnemetats that the ecived si dednetni for
esu ni the feiler of ,cinorhc ereves ;niap
sihT dradnats sehsilbatse ytefas dna ecnamrofrep
b) A noitpircserp dnegel as deriuqer yb -uger
stnemeriuqer for elbatnalpmi larehpirep evren
;snoital
srotalumits dednetni for esu ni the feiler of ,cinorhc
ereves .niap ehT dradnats srevoc lla stnemele of the cl snoitcurtsnI for ylreporp gnikcapnu the tinu
larehpirep evren noitalumits ,metsys hcihw stsisnoc so as ot tneverp lacisyhp egamad dna ot -er
of na detnalpmi ,reviecer detcennoc sedortcele decalp niat the ytirgetni of the elirets gnigakcap
no or dnuora the ,evren dna na lanretxe rettimsnart fi( ;)elbacilppa
for gnittimsnart gnitalumits seslup across the s’tneitap 4 snoitcurtsnI for gnitnalpmi the ,reviecer -ni
niks ot the detnalpmi .rcviccer :gnidulc
1) noitamrofnI tuoba the proper dohtem
suoenatucsnarT cirtcele evren ,srotalumits lanips cord
of gnicalp the sedortcele no or dnuora
,srotalumits yllatot elbatnalpmi evren noitalumits
the ;evren
metsys (that ,si those htiw elbatnalpmi eslup
,)srotareneg dna evren srotalumits dednetni for other 2) snoitcurtsni for gnikam the proper -noc
,snoitacilppa hcus as cinerhp evren mgarhpaid gnicap snoitcen neewteb the edortcele sdael
are revewoh ton derevoc ni siht .dradnats dna the ;reviecer dna
3) a ,gninraw fi elbacilppa that the ffuc
2 ECNEREFER edortcele yam esuac noisserpmoc of the
evren fi ti si too ;llams
ehT naidnI dradnatS SI 13450 (Part 1) : 1994 lacideM‘
lacirtcele :tnempiuqe Part 1 lareneG stnemeriuqer for 4 snoitcurtsnI for proper noitazilirets of the
’ytefas sniatnoc noisivorp hcihw hguorht ecnerefer ni elbatnalpmi ,stnenopmoc or, fi the ecived
siht text, setutitsnoc noisivorp of siht .dradnats tA the si deilppus elirets yb the ,rerutcafunam the
emit of ,noitacilbup the noitide detacidni evoba was tol ,rebmun the date yb hcihw the ecived
.dilav ehT dradnats si tcejbus ot noisiver dna seitrap tsum eb ,desu dna a tsil of proper steps ot
ot stnemeerga desab no siht dradnats are degaruocne cb nekat ot erusne that ytilirets si ton -moc
ot etagitsevni the ytilibissop of gniylppa the tsom ;desimorp

tnecer noitide of the .dradnats lf snoitcurtsnI for the ylbmessa dna noitarepo
of lanretxe ,stnenopmoc :gnidulcni
3 STNEMERIUQER
1) A noitpircsed of the noitcnuf of the -noc
slort for ,egatlov eslup ,noitarud eslup
3.1 Labelling Requirements
,ycneuqerf dna other tuptuo ;sretemarap
nI noitidda ot the other yrautats ,stnemeriuqer gnillebal
2) A noitpircsed of the snaem yb hcihw
no or gniynapmocca elbatnalpmi larehpirep evren
the yrettab nac eb ;detset
srotalumits llahs ylpmoc htiw stnemeriuqer of siht
3) A noitpircsed of how the cannctna -ta
.noitces
tach ot the rettimsnart dna of the proper
3.1.1 Device Markings tnemecalp of lanrctxc stnenopmoc revo
the detnalpmi ;rcvicccr dna
ehT ecived llahs eb dellebal as na clbatnalpmi
larchpircp evren .rotalumits ehT rettimsnart dna 4) snoitcurtsnI for gnitset the metsys ot
yfirev that ti si gninoitcnuf ;yltcerroc
reviecer llahs yalpsid the s’rerutcafunam ,eman the
ledom ,rebmun dna the laires .rebmun )6 yranoituaC ,noitamrofni :gnidulcni
)1 A tnemetats that noitalumits -arap
3.1.2 Irzformation MunuuWu~kuge Inset?
sretem tsum cb dcnimrctcd rednu the
A naicisyhp noitamrofni launam or package tresni dna noisivrepus of a ;naicisyhp
a tneitap noitamrofni launam hcihw yam cb denibmoc )2 A tnemetats that noitalumits at hgih
htiw the naicisyhp launam llahs eb deilppus htiw each stuptuo yam esuac tnasaelpnu -asnes
ecived dna llahs niatnoc at tsael the :gniwollof
snoit or rotom ;secnabrutsid dna

I
SI 14679 : 1999
3) A tnemetats that the rotalumits dluohs 3.2.5 Dimensions of CqJ’Electrodes
ton eb denaol ot other slaudividni dna
roF edortcele smetsys dengised ot dnuorrus the ,evren
that ti dluohs eb kept tuo of the reach
the ffuc retemaid llahs eb at tsael eno dna a flah semit
of ;nerdlihc dna
the retemaid of the evren ot eb detalumits [see
)h ecnamrofreP ,snoitacificeps yllacificeps the also 3.1.2(d)(3)].
tuptuo stnerruc dna smrofevaw for lla -moc
snoitanib of elbaliava liad sgnittes for eslup 3.2.6 Materials
,htdiw ,ycneuqerf dna edutilpma otni a ehT tnaluspacne ro/dna gnitaoc of the detnalpmi
mho-005 .daol ,reviecer the lacirtcele noitalusni of the dael ,seriw
the edortcele pad, dna the edortcele llahs eb desopmoc
3.1.3 Registration
of slairetam nwohs ot cb .elbitapmocoib
ehT rerutcafunam llahs edivorp snaem yb hcihw each
detnalpmi ecived nac eb deretsiger htiw the -unam 4 STSET
.rerutcaf A card ot eb denruter ot the rerutcafunam
sihT noitces sedivorp referee test sdohtem that llahs
llahs raeb ledom ,rebmun dna laires rebmun of the
eb desu ot yfirev ecnailpmoc of the ecived htiw the
;ecived ti llahs osla edivorp space for the s’tneitap
gnillebal dna ecnamrofrep .stnemeriuqer
eman dna latipsoh ,rebmun the eman of the ,latipsoh
the date of ,noitatnalpmi the noitacifitnedi of the evren 4.1 Compliance with the Labelling Requirements
,detalumits a noitpircsed of the esuac of niap dna the
4.1.1 Device Markings
eman of the gnidnetta .naicisyhp
ecnailpmoC htiw the stnemeriuqer of 3.1.1 llahs eb
3.2 Performance Requirements denimreted yb lausiv .noitcepsni
3.2.1 Electrical Sufcty 4.1.2 hjhnation Manual/Package Insert
ehT ksir tnerruc morf the detlusni seriw llahs not ecnailpmoC htiw the stnemeriuqer of 3.1.2 llahs eb
exceed 10 serepntaorcim )AP( [see osla SI 13450 dehsilbatse yb lausiv ,noitcepsni except for the
traP{ .])I lacirtcele ecnamrofrep snoitacificeps deriuqer
3.2.2 Stimulation Parameters ni 3.1.2 (h). ehT test tiucric of .giF 1 llahs eb desu ot
erusaem the tuptuo scitsiretcarahc ot eb reported dna
ehT ecived llahs eb dengised ot ecudorp at the .deitircv
sedortcele a safe dna evitceffe tnerruc ot etalumits the
larehpirep .evren hguohtlA the tseb sretemarap for 4.1.3 Registration
each tneitap tonnac eb ,detciderp the safe segnar of ecnailpmoC htiw the stnemeriuqer of 3.1.3 llahs cb
noitalumits sretemarap evah neeb denimreted ni denimreted yb lausiv .noitcepsni

lacinilc ,slairt dna the tuptuo of the ecived llahs

mrofnoc ot the gniwoliof retemarap :segnar 4.2 Compliance with the Performance
Requirements
a) esluP ycneuqerF : I ot 100 Hertz ;)zH(
)b esluP htdiW : 50 ot 2 000 sdnocesorcim ;)sp( 4.2.1 Electrical Safety
dna tseT sdohtem for gnihsilbatse ecnailpmoc llahs eb as
c) tuptuO tnerruC/egatloV : 0 ot 14 stlov (V) nevig ni SI 13450 (Part 1).
hguorht a mho-005 (30 .‘\im
4.2.2 Stimulation Parameters
3.2.3 CVavefi,rm
ehT test tiucric for lla retemarap stncmcrusaem llahs
ehT mrofevaw llahs tsisnoc of decnalab evitisop dna tsisnoc of a ,elpmis ,mho-OOS evitsiser ,daol as nwohs
evitagen phases, so that the ten charge hguorht the ni .giF 1. ehT reviecer tuptuo llahs eb tested at the
scdortcclc si .deziminim mumixam gnilpuoc ycneiciffe clbsvcihca ni the ydob
ertcmitnec-’flah( gnicaps necwtcb the lcttimsnart
3.2.4 s/o.,/l/u‘C
anirctna dna the .)rcviccer
hca!l ccivcd llahs evah na gnitimil-tuptuo lortnuc that
a) esluP ycneuqerF or noititcpeK Rate )R(I‘/( si
~:ac cb set yb cilt naicisyhp as lacinilc sgnidnif .etacidni
derusaem as the lacorpicer of the :avrcrlti
ehT gnitilnil-tuptlLo lortnoc llahs eb scparatc morf the
llccwtcb
’egatlov‘ lortnoc yb the ,tneitap so that the stuptuo TWO CO~ISXLI~IVC :IUISC OIISC~S i/’ i I.
LISC~ sscldragcr ‘lo ytiralop [ .sm .giF .])a(Z
set yb the tneitap tonnac exceed the mumixam set yb
the .naicisytlp 1)) esluP htdiW )rlcP( si dcrusacm tn the
tniopdim of’thc eslup at rhc
IXIXIII~UIII pulw
2
IS14679:1999
edutilpma [see .giF .])b(2 hgih hguone ,ytivitisnes the tnerruc noitubirtsid llahs
mrifnoc the noitca of the gnikcolb roticapac WS(
c) esluP edutilpmA )AP( si ,derusaem at a eslup
htdiw of 200 s, as the raenil etamitse of the .giF 3).
egareva eulav of the eslup thgieh morf the
4.2.4 Controls
start of the eslup tesno 1 [see giF 2(c)].
ecnailpmoC htiw the tnemeriuqer of 3.2.4 llahs cb
4.2.3 Waveform
denimreted yb lausiv .noitcepsni
ehT mrofevaw llahs eb devresbo yb snaem of the test
tiucric nwohs ni .giF 1. ehT reviecer tuptuo roticapac 4.2.5 Dimensions of Cufj Electrodes
dluohs kcolb the d.c. tnenopmoc of tnerruc otni the
ecnailpmoC htiw the tnemeriuqer of 3.2.5 llahs eb
daol gnipeek 0 tlov (V) level no the ,epocsollicso at
denimreted yb lausiv .noitcepsni
OSCILLOSCOPE
I
1 1
TRANSMITTER 1 = V/SO0 CI
-“won
TRANSMITTER RECEIVER -’
I
.GIF 1 TSET CIRCUITF ORV ERIFYINGP ERFORMANCSEP ECIFICATIONS
PW(at Atmar+h\rmcld-
2

l-----P, -1
(a)
.;cl~ 2 IN:IM:IIIJISA:~M ;10 ESLUP REPIITITIONR A IF. (a), PULSE WIDTH ,)b( AND PULSI: .AMIY.III UUE (c) .
Bureau of Indian Standards
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Bureau of Indian Standards Act,
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and gnidnetta ot detcennoc srettam ni eht .yrtnuoc
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use, in
gnitnemelpmi eht standard, fo yrassecen ,sliated hcus as slobmys and ,sezis epyt ro edarg .snoitangised
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Review of Indian Standards
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;yllacidoirep a standard gnola htiw stnemdnema is demriliaer nehw weiver setacidni that on segnahc era
such
;dedeen fi eht weiver setacidni that segnahc era ,dedeen ti is nekat up rof .noisiver sresU fo naidnI Standards
dluohs niatrecsa that yeht era ni noissessop fo eht tsetal stnemdnema ro noitide yb gnirrefer ot eht tsetal issue fo
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sihT naidnI dradnatS has neeb depoleved morf toD : .oN DHM 7 .)3952(
Amendments Issued Since Publication
dnemA .oN etaD fo eussI txeT detceffA
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