IS 8409: Cardiovascular Surgery Instruments - Dilator, Valve, Tubb's Mitral Pattern

10 Pages·1991·1.1 MB·English

by  Bureau of Indian Standards

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IS 8409 (1991): Cardiovascular Surgery Instruments -
Dilator, Valve, Tubb's Mitral Pattern [MHD 6: Thoracic and
Cardiovascular Surgery Instruments]
“!ान $ एक न’ भारत का +नम-ण”
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“!ान एक ऐसा खजाना > जो कभी च0राया नहB जा सकता हहहहै””ै”
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“Knowledge is such a treasure which cannot be stolen”

IS 8409 : 1991

Indian Standard
CARDIOVASCULAR SURGERYINSTRUMENTS-
DILATOR,VALVE,TUBB'SMITRAL PATTERN-
SPECIFICATION
(F irst Revision )
UDC 615.472*5:616: 12-089.819.5

@ BIS 1991
BUREAU OF INDIAN STANDARDS
MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG
NEW DELHI I 10002
February 1991 Price Group 2
cicarohT and ralucsavoidraC yregruS stnemurtsnI lanoitceS ,eettimmoC DHM 6
FOREWORD
sihT naidnI dradnatS ( tsriF noisiveR ) was detpoaa yb eht uaeruB fo naidnI Standards, retfa eht tfard
dezilanif yb eht cicarohT and ralucsavoidraC yregruS stnemurtsnI lanoitceS eettimmoC had neeb
devorppa yb eht lacideM tnempiuqE and latipsoH gninnalP noisiviD .licnuoC
sihT standard was tsrif dehsilbup ni 1977. nI this ,noisiver secnarelot no suoirav snoisnemid evah neeb
deificeps and eht sesualc no ,hsinif gnikram and gnikcap evah neeb .deifidom ,sediseB a sampling plan
has neeb .dedda
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 ( .‘)desiver ehT rebmun fo -ingis
tnacif secalp deniater ni eht dednuor ffo eulav dluohs eb eht emas as that fo eht deificeps eulav ni
this standard.
IS 8409 : 1991
Indian Standard
CARDIOVASCULAR SURGERY INSTRUMENTS - ’
DILATOR, VALVE, TUBB’S MITRAL PATTERN -
SPECIFICATION
( First Revision )
1 SCOPE 5 SIZES, SHAPE AND DIMENSIONS
1.1 sihT standard sebircserp lanoisnemid and 5.1 ehT ,sezis epahs and snoisnemid fo eht
tnemurtsni shall eb as nwohs ni .giF 1.
rehto stnemeriuqer rof evlav ,rotalid s’bbuT
Mitral ,nrettap desu ni ralucsavoidrac .yregrus
5.1.1 ehT tnioj shall eb fo wercs epyt gnidrocca
ot eht sliated nevig ni SI 3642 ( traP 1 ) : 1990.
2 REFERENCES
5.2\Tolerances
2.1 ehT naidnI Standards detsil woleb era 5.2.1 ehT ecnarelot no raenil snoisnemid shall eb
yrassecen stcnujda ot this standard:
ni ecnadrocca htiw eht gniwollof :
f 0.05 mm no snoisnemid up ot O-2 ;mm
IS No. Title
1501 dohteM rof srekciV hardness = 0.1 mm no snoisnemid evoba 2.0 mm and
( traP 1 ) : 1984 tset rof cillatem slairetam : up ot O-5 ;mm
traP 1 VH 5 ot VH 100 ( second f 0.2 mm no snoisnemid evoba O-5 mm and
revision ) up ot O-02 ;mm
2771 draoberbiF sexob : traP 1 -roC f 0.5 mm no snoisnemid evoba 20.0 mm and
( traP )1 : 1977 detagur draoberbif sexob (fzrst up ot 50.0 ;mm
revision ) f 1.0 mm no snoisnemid evoba O-05 mm
and up ot O-001 ;mm and
3642 lacigruS stnemurtsni : traP 1
& 2.0 mm no snoisnemid evoba 100.0 .mm
( traP 1 ) : 1990 ,gnittuc-noN detalucitra epyt
stnemurtsni ( second revision ) 5.2.2 ehT lacitnedi snoisnemid fo owt sevlah fo
eht rotalid shall ton reffid and eht sevlah shall
4905 : 1968 sdohteM rof modnar sampling hctam htiw hcae rehto .yltcefrep
6603 : 1972 sselniatS leets bars and stalf 6 WORKMANSHIP AND FINISH
6.1 ehT gnikrow ecafrus fo eht rotalid gnidulcni
7531 : 1990 sdohteM rof gnitset fo noisorroc lanretni ecafrus and sevoorg shall eb dehsinif
ecnatsiser fo stainless leets
htooms and eerf morf ,srrub pits, ,skcarc ,selacs
lacigrus stnemurtsni tsrif( gnidnirg marks and rehto ecafrus .stcefed ehT
revision ) tnemurtsni shall eb eerf morf laudiser ,elacs
,dica ,esaerg gnidnirg and gnihsilop .slairetam
3 MATERIAL ecnailpmoC htiw eseht stnemeriuqer shall eb
dekcehc yb lausiv .noitcepsni
3.1 ehT tnemurtsni shall eb edam fo stainless
leets gnimrofnoc ot noitangiseD 20 Cr 13 ro 6.2 ehT ,rotalid tpecxe ,tfahs shall eb nevig a
30 Cr 13 fo SI 6603 : 1972. noitcelfer gnicuder ,hsinif rof ,elpmaxe satin
.hsinif ehT tfahs gnidulcni edalb noitrop fo eht
3.2 swercS shall eb fo eht stainless leets fo eht rotalid shall eb rorrim .dehsilop
emas snoitangised as desu rof rotalid .ydob
NOTES
1 ehT nitas hsinif yam eb deveihca gnisu na
4 HARDNESS etairporppa ,erudecorp rof elpmaxe .gnidnirg -hsurb
,gni gnihsiloportcele ,dna ni ,noitidda nitas gnihsinif
4.1 ehT hardness fo eht tnemurtsni shall eb 400 ( ssalg gnidaeb ro nitas gnihsurb 1. ehT hsinif llahs eb
ot 460 ,VH nehw detset ni ecnadrocca htiw SI mrofinu dna ,htooms dna ti dluohs ecuder .eralg
1501 traP( 1 ) : 1984. 2 stnemurtsnI fo rorrim hsinif llahs eb yletauqeda
dnuorg ot evomer all ecafrus snoitcefrepmi dna
4.2 Mating secafrus no eht emas ,tnemurtsni dehsilop ol evomer gnidnirg skram ni redro ot
eveihca a rorrim .hsinif sihT si deveihca yb gnisu na
hcus as etisoppo jaws and shanks, shall ton
etairporppa ,erudecorp rof elpmaxe ,gnihsilop -hsurb
yrav ni hardness yb erom than 40 .VH
,gni gnihsiloportcele dna rorrim .gniffub
1
U
A B C D E F G H J K _I
Size
lamS I 25 2'5 41 5'7 170 4 150 35 25 44 (0
muideM 35 2'5 50 6.2 175 6 155 37 35 60 X0
egraL 40 4'0 75 8'0 180 13 160 3s 42 70 P

llA snoisnemid ni .sertemillim
FIG. 1 VALVED ILATOR,T UBB’S MITRAL PATTERN
gnikrow .dne ehT jaws shall nepo and esolc
6.3 Passivation and Final Treatment
ylhtooms and shall ton poleved yna yalp retfa
ehT stnemurtsni shall eb detavissap yb -ortcele
eht .tset
gnihsilop ro yb tnemtaert htiw 10 tnecrep
( v/v ) cirtin dica noitulos rof ton less than 30 7.2 Corrosion Resistance
setunim at a erutarepmet ton less than 10°C
and ton gnideecxe 60°C. ehT stnemurtsni shall The instruments shall be tested in ecnadrocca
neht eb desnir ni retaw and deird ni toh .ria htiw SI 7531 : 1990. yehT shall pass eht .tset
NOTE - fI eht tnioj si ,detacirbul eht tnacirbul llahs 8 MARKING AND PACKING
eb evisorroc-non dna elbatius rof lacidem noitacilppa
gnidrocca ot eht naidnI .aieopocamrahP 8.1 ehT stnemurtsni shall eb ylbigel and -iledni
ylb dekram htiw eht noitacidni fo eht ecruos fo
7 TESTS erutcafunam and eht sdrow ‘stainless ’leets r).t
eht srettel ‘ss’.
7.1 Performance
rotaliD shall eb desolc and denepo 1 000 semit 8.2 hcaE tnemurtsni shall eb depparw ni a
against a ecnatsiser ecrof fo 68.5 kN/m” at eht gninoihsuc lairetam ekil dedlof eussit .repap tI
2
SI 8409 : 1991
llahs neht eb tup ni a enelyhteylop gab or of the ecruos of ,erutcafunam dna the ;?drow
wrapped ni wax paper. ehT tnemurtsni llahs sselniats‘ .’leets
thereafter eb packed ni snotrac [ see SI 2771
9 GNILPMAS
( Part 1 ) : 1977 1.
9.1 ehT elacs of gnilpmas dna airetirc for
ytimrofnoc of the stnemurtsni ot the -eriuqer
stnem of siht noitacificeps llahs eb as nevig ni
.8.3 ehT packages llahs eb dekram htiw the
xennA .A
eman dna ezis of the ,tnemurtsni the noitacidni
ANNEX A
( Clause9 .1 )
GNILPMAS FO EVLAV ,ROTALID S’BBUT LARTIM NRETTAP
I-A TOL ssenmod of ,noitceles serudecorp nevig ni
SI 4905 : 1968 yam eb .dewollof
1.l-A nI yna ,tnemngisnoc lla the stnemurtsni 3-A REBMUN FO STSET DNA AIRETIRC
of the emas ezis dna shape, decudorp morf the ROF YTIMROFNOC
lacitnedi lairetam rednu ralimis snoitidnoc dna
gnivah the emas ecafrus hsinif llahs etutitsnoc 1.3-A llA the stnemurtsni detceles gnidrocca ot
a .tol co1 1 dna 2 of elbaT 1 llahs eb denimaxe for
,ezis shape dna ,snoisnemid pihsnamkrow dna
,hsinif dna tested for .ecnamrofrep nA -urtsni
Z-A ehT rebmun of stnemurtsni ot eb detceles
tnem ni the elpmas gniliaf ot teem yna of these
morf each tol llahs dneped nopu the ezis of the
stnemeriuqer llahs eb deredisnoc as .evitcefed
to! dna llahs eb ni ecnadrocca htiw co1 1 dna
ehT tol llahs eb deredisnoc as gnimrofnoc ot
2 of elbaT 1.
these ,stnemeriuqer fi on evitcefed si dnuof ni
the .elpmas
elbaT 1 elacS of gnilpmaS
2.3-A ehT tol gnivah neeb dnuof yrotcafsitas
( Clauses ,2-A 1.3-A dna 2.3-A ) gnidrocca ot 1.3-A llahs eb rehtruf tested for
other .stnemeriuqer roF siht ,esoprup a -bus
Lot Size Sample Size Sub-sample Size elpmas of ezis nevig ni co1 3 of elbaT 1 llahs eb
(1) (2) (3) .nekat esehT stnemurtsni ni the elpmas-bus yam
pu ot 1.5 1 eb detceles morf those ydaerla denimaxe
16 to50 3” gnidrocca ot .1.3-A Each tnemurtsni ni the
51 ot 051 5 : elpmas-bus llahs eb detcejbus ot ssendrah dna
151 dna evoba 8 3
noisorroc ecnatsiser tests. ehT tol llahs eb
deralced as gnimrofnoc ot the stnemeriuqer of

1.2-A esehT stnemurtsni llahs eb detceles morf the noitacificeps fi enon of the stnemurtsni ni

the tol at modnar dna ni order ot erusne -nar the elpmas-bus sliaf ni yna of these tests.
dradnatS Mark
ehT esu of the dradnatS Mark si denrevog yb the snoisivorp of the uae~rB Q/” Ztuliurl
Stmtlurtls Act, lY86 dna the seluR dna snoitalugeR edam .rednuereht ehT dradnatS Mark no
stcudorp derevoc yb na naidnI dradnatS syevnoc the ecnarussa that yeht evah neeb decudorp
ot ylpmoc htiw the stnemeriuqer of that dradnats rednu a llew denifed metsys of ,noitcepsni
gnitset dna ytilauq lortnoc hcihw si desived dna desivrepus yb SIR dna operated yb the
.recudorp dradnatS dekram stcudorp are osla ylsuounitnoc checked yb SIB for ytimrofnoc
ot that dradnats as a rehtruf .draugefas sliateD of snoitidnoc rednu hcihw a ecnecil for the
esu of the dradnatS Mark yam eb detnarg ot srerutcafunam or srecudorp yam eb deniatbo
morf the uaeruB of naidnI .sdradnatS
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issued from time to time. Users of Indian Standards should ascertain that they are in possession of the
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1
Dot: No. MHD 6 ( 2191 )
Amendments Issued Since Publication
Amend No. Date of Issue Text Affected
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