IS 9165-1: Surgical instruments - Needles, suture, Part 1: Specification

9 Pages·1992·1.1 MB·English

by  Bureau of Indian Standards

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IS 9165-1 (1992): Surgical instruments - Needles, suture,
Part 1: Specification [MHD 1: Surgical Instruments]
“!ान $ एक न’ भारत का +नम-ण”
Satyanarayan Gangaram Pitroda
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“Knowledge is such a treasure which cannot be stolen”

--
: 2992
IS 9165 ( Part ‘I )

SURGICAL INSTRUMENTS - NEEDLES,
SUTURE
,PART 1 SPECIFICATION
First Revision
( >
UDC 615.472~2 : 616-089.84-7

Q BlS 1992
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARC3
NEW DELHI 110002
August 1992 Pike Group 1
lacigruS stnemurtsnI lanoitceS ,eettimmoC DHM 1
FOREWORD
sihT naidnI dradnatS ( traP 1 ) ( tsriF noisiveR ) was detpoda yb eht uaeruB fo naidnI
Standards, retfa eht tfard dezilanif yb eht lacigruS stnemurtsnI lanoitceS eettimmoC had neeb
devorppa yb eht lacideM tnempiuqE and latipsoH gninnalP noisiviD .licnuoC
sihT standard was tsrif dehsilbup ni 1979. tI has neeb desiver ot etaroprocni niatrec -acifidom
snoit desab no eht ecneirepxe deniag gnirud eht noitatnemelpmi fo this standard and align ti
htiw eht tsetal secitcarp gnieb dewollof ni eht ,dleif yllaicepse ni tcepser fo eht stnemeriuqer
fo ,lairetam dneb tset and ytilibixelf .tset ehT noisorroc ecnatsiser tset has neeb deifidom
ot align ti SI~htiw 7531 : 1990 sdohteM‘ rof gnitset fo noisorroc ecnatsiser fo stainless leets
lacigrus stnemurtsni (first revision )‘. A dednemmocer sampling naIp rof erutus seldeen has
osla neeb .dedulcni
ehT naidnI dradnatS rof erutus seldeen rof lareneg lacigrus sesoprup is gnieb issued ni tnereffid
parts. sihT trap ( traP 1 ) fo eht standard srevoc eht lareneg stnemeriuqer and stset elbacjlppa
ot all sepyt fo erutus ,seldeen thus gnivres as a latnoziroh standard rof erutus .seldeen ehT
shapes, sezis and snoisnemid fo erutus seldeen era dednetni ot eb derevoc ni tneuqesbus parts fo
this standard. traP 2 fo this standard srevoc eht shapes, sezis and snoisnemid fo deye erutus
.seldeen
roF eht esoprup fo gnidiced rehtehw a ralucitrap tnemeriuqer fo this standard is deilpmoc ,htiw
eht lanif ,eulav devresbo ro ,detaluclac gnisserpxe eht tluser fo a tset ro ,sisylana shall eb
dednuor ffo ni ecnadrocca htiw SI 2 : 1960 seluR‘ rof gnidnuor ffo laciremun seulav ( revised )‘.
ehT rebmun fo tnacifingis secalp deniater ni eht dednuor ffo eulav dluohs eb eht emas as that
fo eht deificeps eulav ni this standard.
IS 9165 ( Part 1) : 1992
Indian Standard
SURGICAL INSTRUMENTS - NEEDLES,
SUTURE
PART 1 SPECIFICATION
First Revision
( >
1 SCOPE 4 SIZES, SHAPES AND DIMENSIONS
-1.1 sihT standard seificeps eht stnemeriuqer rof 4.1 ehT ,sezis shapes and snoisnemid fo suoirav
erutus seldeen rof lareneg lacigrus .sesoprup sepyt fo erutus ,seldeen shall eb as nevig~ ni
evitcepser parts fo this standard.
2
REFERENCES
5 SSENDRAH
ehT gniwollof naidnI Standards era
2.1
yrassecen stcnujda ot this standard: 5.1 ssendraH fo eht erutus ,eldeen nehw detset
ni ecnadrocca htiw SI 1501 ( traP 3 ) : 1987,
IS No. Title shall eb 525 ot 625 .VH
1501 sdohteM rof srekciV hardness
traP( 3 ) : 1987 tset rof cillatem :slairetam 6 WORKMANSHIP AND FINISH
traP 3 sseL than VH 0.2
ehT ecafrus fo eht erutus eldeen shall eb
6.1
(
second revision ) htooms and shall eb eerf morf .gnittip
4905 : 1968 sdohteM fo modnar sampling 6.2 ehT eye fo eht eldeen shall eb naelc and
7531 : 1990 sdohteM rof gnitset fo noisorroc ylreporp demrof and shall eb htooms morf
ecnatsiser fo stainless leets edisni and .edistuo
lacigrus stnemurtsni tsrif(
6.3 ehT seldeen shall eb dehsinif htooms and
revision )
.thgirb
3
MATERIAL
6.4 ehT seldeen shall eb eerf morf gnidnirg
3.1 ehT _ erutus seldeen shall eb edam .__ morf . marks, gnihsilop trid ro rehto lairetam hcihw
stainless leets eriw fo rehtie fo eht gniwollof dluoc etatissecen gninaelc roirp ot noitazilirets

:noitisopmoc and .esu
Element Percentage 6.5 ehT tniop fo eht eldeen shall eb sharp
tpecxe erehw esiwrehto .deificeps
nobraC o-30 ot o-40
esenagnaM 1.00 Max 7
TESTS
surohpsohP 0.045 Max
seldeen shall eb eerf morf rehtaef
ruhpluS 0,045 Max 7.1 The
,segde srrub and ,skcin nehw denimaxe rednu
nociliS 00-l Max a noitacifingam fo 5X.
muimorhC 12.00 ot 14.00
lekciN 1.00 Max 7.2 noisorroC ecnatsiseR tseT
OR
ehT seldeen shall eb detset rof noisorroc
nobraC 0.60 ot 0.75 ecnatsiser ni ecnadrocca htiw SI 7531 : 1990.
esenagnaM 00.I Max yehT shall pass eht .tset
surohpsohP 0.040 Max
7.3 dneB tseT ( rof thgiartS seldeeN )
ruhpluS O-030 Max
nociliS 00-l Max Clamp eht eldeen at eht talf noitrop ni a eldeen
muimorhC 16.00 ot 18.00 redloh using a eceip fo tfos rehtael rof -orp
munedbyloM 57-O Max .noitcet sserP eht bmuht against eht eldeen
IS 9165 ( Part 1) : 1992
and dneb ti ot an elgna fo 90”. ehT eIdeen gnicreip ecnatsiser ni grams. ehT gnicreip
shall meed ot evah deliaf as gnieb oot ,drab fi ecnatsiser shall eb less than 25 g.
ti skaerb erofeb eht laitini dneb fo 90” is
.deveihca 8 MARKING AND PACKING
7.4 Flexibility Test ( for Curved Needles ) 8.1 ehT segakcap gniniatnoc eht deriuqer
rebmun fo seldsen shall eb dekram htiw eht
dloH eht eldeen neewteb eht bmuht and eht noitacidni fo eht ecruos fo ,erutcafunam ,epahs
regniferof and trexe erusserp inwards, os that ,ezis epyt fo eht eye and eht ytitnauq fo erutus
eht ladrohc ecnatsid neewteb eht eye and eht .seldeen
tniop is decuder ot 90 tnecrep fo eht lanigiro
eulav ni esac fo B/3 elcric seldeen and 80 -rep 8.2 ehT erutus seldeen shall eb dekcap as
tnec ni esac fo 2/l elcric ro B/5 elcric .seldeen deerga ot neewteb eht rerutcafunam and eht
taepeR eht tset ruof .semit erehT shall ton eb .resahcrup
yna tnenamrep tes ni eht eldeen retfa eht .tset
9 GNILPMAS
7.5 Sharpness Test (for All Needles, Except Blunt 9.1 ehT elacs fo sampling and airetirc rof
ytimrofnoc fo eht erutus seldeen ot eht -eriuqer
Point Needle )
stnem fo this noitacificeps shall eb as deerga
Push eht detniop sharp dne fo eht erutus eldeen ot neewteb eht resahcrup and eht .reilppus A
ylralucidneperp edisni eht dehcterts muinimula dednemmocer sampling plan is nevig ni
liof fo 520-O mm .ssenkciht erusaeM eht xennA A.
ANNEX A
( Clause 9.1 )
GNILPMAS NALP FOR ERUTUS SELDEEN
l-A TOL shall eb deredisnoc as gnivah deifsitas eseht
,stnemeriuqer fi ereht is on evitcefed ni eht
1.l-A nI yna ,tnemngisnoc all eht erutus seldeen
.elpmas
fo eht emas ,ezis epahs and snoisnemid and
decudorp morf eht emas lairetam rednu ralimis 2.2-A ehT tol gnivah deifsitas eht stnemeriuqer
snoitidnoc fo erutcafunam shall eb depuorg as nevig ni 1.2-A shah eb rehtruf detset rof -rus
rehtegot ot etutitsnoc a .tol ecaf stcefed ( 7.1 ,) hardness ( 5.1 ,) noisorroc
ecnatsiser ( 7.2 ,) dneb ( 7.3 ,) ytilibixelf ( 7.4 )
2.l-A roF gniniatrecsa eht ytimrofnoc fo eht and sharpness ( )5.7 as rep eht .noitacificeps roF
lairetam ot eht stnemeriuqer fo eht tnaveler this ,esoprup a sub elpmas as nevig ni nmuloc 4
,noitacificeps samples shall eb detset morf hcae fo elbaT 1 shall eb .detceles hcaE fo eht seldeen
tol .yletarapes ni eht elpmas-bus shall eb detcejbus ot eseht
.stset A tol shall eb deredisnoc as gnivah
3.l-A ehT rebmun fo snotrac ot ebA detceles
deifsitas eht stnemeriuqer fo eht ,noitacificeps
morf hcae tol shall dneped nopu eht ezis fo eht
fi ereht is on .eruliaf
tol and shall eb ni ecnadrocca htiw snmuloc 1
and 2 fo elbaT 1.
Table 1 Scale of Sampling
4.l-A ehT snotrac shall eb detceles at modnar ( Clauses ,3.1-A 1.2-A and A-2.2 )
morf eht .tol roF this ,esoprup ecnerefer yam
eb edam ot SI 4905 : 1968. .oN of Cartons No. of Cartons No. of Packets to
in a Lot to be Selected be Selected
2-A REBMUN FO STSET AND AIRETIRC elpmaS :buS
FOR YTIMROFNOC eziS elpmas
eziS
1.2-A morF hcae fo eht snotrac detceles as rep ’22‘ $, ’”5‘
2 %t
nmuloc 2 fo elbaT 1, a elbatius rebmun fo
stekcap ( as rep nmuloc 3 fo elbaT 1 ) shall eb ot9 15 3 13 5
ot
detceles at .modnar hcaE eldeen morf eseht 16 25 5 20 8
stekcap shall eb detcepsni rof ,sezis shapes and 26 ot 50 8 32 13
,snoisnemid pihsnamkrow and .hsinif A eldeen 51 ot 100 13 50 13
gniliaf ot teem eno ro erom fo eseht -eriuqer 101 ot 150 20 50 13
stnem shall eb deredisnoc as .evitcefed A tol 151 dna evoba 32 80 20
Standard kraM
ehT esu fo eht dradnatS Mark is denrevog yb eht snoisivorp fo eht Bureau of Indian
Standards Act, I986 and eht seluR and snoitalugeR edam .rednuereht ehT dradnatS Mark
no stcudorp derevoc yb an naidnI dradnatS syevnoc eht ecnarussa that yeht evah neeb
decudorp ot ylpmoc htiw eht stnemeriuqer fo that standard rednu a llew denifed metsys
fo ,noitcepsni gnitset and ytilauq lortnoc hcihw is desived and desivrepus yb SIB and
detarepo yb eht .recudorp dradnatS dekram stcudorp era osla ylsuounitnoc dekcehc yb
SIE rof ytimrofnoc ot that standard as a rehtruf .draugefas sliateD fo snoitidnoc rednu
hcihw a ecnecil rof eht esu fo eht dradnatS Mark yam eb detnarg ot srerutcafunam ro
srecudorp yam eb deniatbo morf eht uaeruB fo naidnI Standards.
Bureau of Indian Standards
SIB is a yrotutats noitutitsni dehsilbatse rednu eht Bureau of Indian Standards Act, 1986 to
etomorp suoinomrah tnempoleved fo eht seitivitca fo ,noitazidradnats gnikram and ytilauq
noitacifitrec fo sdoog and gnidnetta ot detcennoc srettam ni eht .yrtnuoc
Copyright
BIS has eht thgirypoc fo all its .snoitacilbup oN trap fo eseht snoitacilbup yam eb decudorper
ni yna mrof tuohtiw eht roirp noissimrep ni gnitirw fo .SIB sihT seod ton edulcerp eht eerf ,esu
ni eht esruoc fo gnitnemelpmi eht standard, fo yrassecen ,sliated hcus as slobmys and ,sezis epyt
ro edarg .noitangised seiriuqnE gnitaler ot thgirypoc eb desserdda ot eht rotceriD
( snoitacilbuP ,) .SIB
Revision of Indian Standards
naidnI Standards era deweiver yllacidoirep and ,desiver nehw yrassecen and ,stnemdnema fi
,yna era issued morf emit ot .emit sresU fo naidnI Standards dluohs niatrecsa that yeht era ni
noissessop fo eht tsetal stnemdnema ro .noitide stnemmoC no this naidnI dradnatS
may be
sent ot SIB gnivig eht gniwollof :ecnerefer
toD : .oN DHM 1 ( 2307 )
Amendments Issued Since Publication
dnemA .oN etaD fo eussI txeT detceffA
UAERUB FO NAIDNI SDRADNATS
:sretrauqdaeH

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