IS 12375-9: Implants for surgery - Partial and total hip joint prostheses, Part 9: Determination of resistance to torque of head fixation of stemmed femoral components PDF
Preview IS 12375-9: Implants for surgery - Partial and total hip joint prostheses, Part 9: Determination of resistance to torque of head fixation of stemmed femoral components
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 12375-9 (1998): Implants for surgery - Partial and total hip joint prostheses, Part 9: Determination of resistance to torque of head fixation of stemmed femoral components [MHD 2: Orthopaedic 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” IS12375(Part9):1998 IS0 7206-9 : 1994 Indian Standard STNALPMI ROF YREGRUS - LAITRAP AND LATOT PIH TNIOJ SESEHTSORP PART 9 DETERMINATION OF RESISTANCETOTORQUE OF HEAD FIXATION STEMMED FEMORAL COMPONENTS ‘ . Ics11.040.40 Q BIS 1998 BUREAU OF INDIAN STANDARDS MANAK BHAVAN, 9 BAHADUR SHAH ZAFAR MARG NEW DELHI 110002 November 1998 Price Group 2 cideapohtrO stnemurtsnI dna seirosseccA lanoitceS ,eettimmoC DHM 2 LANOITAN FOREWORD sihT naidnI dradnatS hcihw si lacitnedi htiw 0SI 9-6027 : 4991 stnalpmI‘ for yregrus - laitraP dna latot pih tnioj sesehtsorp - traP 9 : noitanimreteD of ecnatsiser ot euqrot of daeh noitaxif of demmets laromef ’stnenopmoc deussi yb eht lanoitanretnI noitazinagrO for noitazidradnatS )OSI( saw detpoda yb eht uaeruB of naidnI sdradnatS no eht snoitadnemmocer of cideapohtrO stnemurtsnI dna seirosseccA lanoitceS eettimmoC dna lavorppa of eht lacideM tnempiuqE dna latipsoH gninnalP noisiviD .licnuoC ehT txet of evoba denoitnem 0SI dradnats sah neeb devorppa sa elbatius for noitacilbup sa naidnI dradnatS tuohtiw .snoitaived niatreC snoitnevnoc ,era ,revewoh ton lacitnedi ot esoht desu ni naidnI .sdradnatS noitnettA si ylralucitrap nward ot eht :gniwollof )a reverehW eht sdrow lanoitanretnI‘ dradnatS raeppa gnirrefer ot siht ,dradnats yeht dluohs eb daer sa naidnI‘ .’dradnatS )b Comma ),( sah neeb desu sa a lamiced rekram elihw ni naidnI ,sdradnatS eht tnerruc ecitcarp si ot esu a tniop ).( sa eht lamiced .rekram nI siht detpoda ,dradnats ecnerefer sraeppa ot niatrec lanoitanretnI sdradnatS for hcihw naidnI sdradnatS osla .tsixe ehT gnidnopserroc naidnI sdradnatS hcihw era ot eb detutitsbus ni rieht ecalp era detsil woleb gnola htiw rieht eerged of ecnelaviuqe for snoitide detacidni : International Corresponding Indian Standard Degree of Standard Equivalence 3696 : 7891 SI 0701 : 2991 tnegaeR edarg retaw ( third revision ) yllacinhceT tnelaviuqe l-6027 : 5891 SI 57321 ( traP 1 ) : 7891 laitraP dna latot pih tnioj :sesehtsorp lacitnedI traP 1 : ,noitacifissalC noitangised of snoisnemid dna stnemeriuqer sihT dradnats sah neeb deussi ni 9 .strap rehtO strap of siht dradnats :era traP 1 ,noitacifissalC noitangised of snoisnemid dna stnemeriuqer traP 2 gniraeB secafrus edam of cillatem dna citsalp slairetam traP 3 noitanimreteD of ecnarudne seitreporp of demmets laromef stnenopmoc tuohtiw noitacilppa of noisrot traP 4 noitanimreteD of ecnarudne seitreporp of demmets laromef stnenopmoc htiw noitacilppa of noisrot traP 5 noitanimreteD of ecnatsiser ot citats daol of daeh dna kcen noiger of demmets laromef stnenopmoc traP 6 noitanimreteD of ecnarudne seitreporp of daeh dna kcen noiger of demmets laromef stnenopmoc traP 7 ecnarudnE ecnamrofrep of demmets laromef stnenopmoc tuohtiw noitacilppa of noisrot traP 8 ecnarudnE ecnamrofrep of demmets laromef stnenopmoc htiw noitacilppa of noisrot roF eht esoprup of gnidiced rehtehw a ralucitrap tnemeriuqer of siht dradnats si deilpmoc ,htiw eht lanif ,eulav devresbo ro ,detaluclac gnisserpxe eht tluser of a tset ro ,sisylana llahs eb dednuor off ni ecnadrocca htiw SI 2 : 0691 seluR‘ for gnidnuor off laciremun seulav ( revised )‘. ehT rebmun of tnacifingis secalp deniater ni eht dednuor off eulav dluohs eb eht emas sa taht of eht deificeps eulav ni siht .dradnats IS 12375 ( Part 9) : 1998 IS0 7208-9 : 1994 Indian Standard STNALPMI ROF YREGRUS - LAITRAP AND LATOT PIH TNIOJ SESEHTSORP PART 9 DETERMINATION OF RESISTANCE TOTORQUE OF HEAD FIXATION OF STEMMED FEMORAL COMPONENTS 1 Scope 0SI ,7891:6963 Water for analytical laboratory use - Specificaticn and test methods. sihT trap fo 0SI 6027 sebircsed a dohtem fo -reted gninim eht euqrot ,deriuqer rednu deificeps yrotarobal 0SI 7206-l:---“, implants for surgery - Partial and ,snoitidnoc ot nesool eht noitaxif fo eht daeh fo pih total hip joint prostheses - Part 7: Classification and tnioj sesehtsorp ni hcihw eht daeh si ton dednetni ot designation of dimensions. etator evitaler ot eht .kcen tI seilppa ot eht laromef tnenopmoc fo latot or laitrap pih tnioj stnemecalper ni hcihw eht daeh dna arm era deruces rehtegot yb a 3 Definitions gnikcol lacinoc repat or yna rehto snaem dna ni hcihw For eht sesoprup fo siht trap fo 0SI ,6027 eht -ifed eht daeh dna kcen era etarapes ,stnenopmoc dna snoitin nevig ni 0SI I-6027 .ylppa hcihw era made fo cillatem dna cillatem-non .slairetam sihT trap fo 0SI 6027 seod ton revoc sdohtem fo -xe gninima eht tset ;snemiceps eseht dluohs eb deerga 4 Principle neewteb eht tset yrotarobal dna eht ytrap gnittimbus eht nemiceps rof .tset gnitnuoM fo eht daeh no a ylmrif dexif kcen .tinu Im- noisrem fo eht ylbmessa ni diuqil ta a dellortnoc tem- .erutarep noitacilppA fo na laixa daol ot eht .ylbmessa noitacilppA fo a euqrot ot eht daeh dna eht -erusaem tnem fo eht euqrot deriuqer ot etaitini noitator fo eht 2 Normative references daeh no eht .kcen ehT gniwollof sdradnats niatnoc snoisivorp ,hcihw hguorht ecnerefer ni siht ,txet etutitsnoc snoisivorp 5 Reagent fo siht trap fo 0SI .6027 tA eht time fo ,noitacilbup eht snoitide detacidni erew .dilav llA sdradnats era tcejbus Fluid test medium, gnisirpmoc :rehtie ot ,noisiver dna seitrap ot stnemeerga desab no siht trap fo 0SI 6027 era degaruocne ot etagitsevni eht a) dellitsid or dezinoied retaw fo edarG 3 ni -drocca ytilibissop fo gniylppa eht most tnecer snoitide fo eht ecna htiw 0SI ;6963 or sdradnats detacidni .woleb Members fo CEI dna 0SI niatniam sretsiger fo yltnerruc dilav lanoitanretnI b) diuqil fo a noitisopmoc detats yb eht ytrap -bus .sdradnatS gnittim eht nemiceps rof .tset , 1) To be .dehsilbup noisiveR( fo 0SI 7206-I: I9 85) 1 IS 12375 ( Part 9 ) : 1998 IS0 72068 : 1994 6 Apparatus 4.6 Means of maintaining the temperature fo eht diulf tset medium ta 73 “C + 1 “C. eeS erugif 1 rof na elpmaxe fo tset .sutarappa 6.5 Means of continuously aerating the fluid test medium, e.g. a llams ria pmup fo eht epyt desu rof 1.6 Specimen holder, fo a tnatsiser-noisorroc ma- .airauqa ,lairet dna gnivah a noitcurtsnoc dna snoisnemid ot tius eht gnitset enihcam dna tset .nemiceps 6.6 Means of measuring the torque deilppa ot eht daeh fo eht ,ylbmessa htiw na ycarucca fo 1 .% 6.2 Testing machine, elbapac fo gniylppa na laixa daol hguorht eht sixa fo eht kcen/daeh ,ylbmessa htiw 7.6 Neck unit, gnisirpmoc a neck/stem fo eht epyt ycarucca fo 1 % fo lluf elacs ,gnidaer dna fo gniylppa ot hcihw eht daeh si ot eb dettif ni ,ecivres or a a euqrot ot eht daeh ni a enalp ta thgir selgna ot eht dummy kcen gnivah eht same snoisnemid dna gnieb laixa ,daol htiw na ycarucca fo 1 % fo lluf elacs -daer made fo eht same ,lairetam yb eht same -rutcafunam .gni gni ssecorp dna ot eht same .noitacificeps ETON 1 ehT esu fo a ymmud kcen is tneinevnoc dna 3.6 Means of transmitting the axial load, e.g. na lacimonoce derapmoc htiw ylluf dehsinif laromef -opmoc ralubateca puc fo thgiew-ralucelom-hgih-artlu -ylop :stnen revewoh ni sesac fo etupsid eht tset dluohs eb -rep .enelyhte demrof gnisu eht etelpmoc demmets laromef .tnenopmoc Torque-measuring telnI for fluid &__I -..:1___ -Neck unit (6.7) daeH Acetabular cup or similar (6.3) - Figure 1 - Example of equipment for determination of resistance PO torcp ef head,&eck assembly IS 12375 ( Part 9 ) : 1998 IS0 7208-9 : 4991 7 Procedure 6.7 evomeR eht kcen/daeh ylbmessa from eht gnitset enihcam dna nemiceps .redloh 7.1 fI eht daeh si ton ni ecalp no eht stem, tnuom eht daeh ot eb detset no eht kcen tinu )7.6( ni eht 7.7 enimaxE eht tset ,snemiceps gnisu eht -htem rennam recommended yb eht ,rerutcafunam dna sdo detseuqer yb eht ytrap taht dettimbus eht -iceps tnuom eht ylbmessa ni eht nemiceps redloh .)1.6( fI nem rof .gnitset eht daeh si ni ecalp no eht stem, tnuom eht ylbmessa ni eht nemiceps .redloh 8 Test report 2.7 tnuoM eht nemiceps redloh dna ylbmessa ni eht ehT tset troper llahs edulcni eht gniwollof :noitamrofni gnitset enihcam .)2.6( a) a ecnerefer ot siht trap fo 0SI ;6027 3.7 ylppA dna niatniam a daol fo 1 000 N yllaixa ot b) eht ytitnedi fo eht tset ,nemiceps sa detats yb eht eht daeh hguorht eht gnidaol ecived .)3.6( ytrap gnittimbus eht nemiceps rof ;tset 4.7 etalucriC detaeh diulf tset medium hguorht eht c) eht mumixam euqrot deilppa erofeb eht daeh nemiceps redloh litnu eht erutarepmet fo eht redloh commenced ot etator no eht ;kcen dna stnetnoc sezilibats ta 73 “C + 1 “C. niatniaM siht erutarepmet dna niatniam noitarea fo eht diulf tset d) eht euqrot noitacilppa ;etar medium 4.6( dna .)5.6 wollA lla cinortcele ,sreifilpma ,sredrocer .cte taht form trap fo eht tset tnempiuqe e) eht stluser fo eht noitanimaxe detseuqer yb eht ot hcaer a elbats gnitarepo .erutarepmet ytrap gnittimbus eht nemiceps rof .tset 5.7 ylppA )2.6( na yllatnemercni gnisaercni euqrot ot 9 Disposal of test specimens eht daeh litnu eht daeh snigeb ot etator no eht ,kcen ylsuounitnoc gnidrocer eht euqrot .deilppa etoN eht oN trap fo eht sisehtsorp llahs eb desu rof lacinilc mumixam euqrot deilppa erofeb noitator commences. sesoprup retfa .gnitset droceR or etaluclac from eht gnidrocer eht etar fo -pa This tset yllamron stluser ni eht refsnart fo lairetam noitacilp fo .euqrot from eno tnenopmoc ot eht rehto dna segnahc eht fI noitaxif si deveihca yb eht esu fo a wercs daerht eht erutan fo htob gnitam .secafrus Care dluohs eb -rexe euqrot dluohs eb deilppa ni eht gninesool .noitcerid desic ni eht esu fo eht nemiceps rof rehtruf -nahcem laci stset esuaceb eht gnidaol regime may evah NOTE 2 gnidnepeD no eht snaem desu rof gnippirg eht deretla eht lacinahcem .seitreporp nI ,ralucitrap ti si ,daeh ti yam eb yrassecen ot dnirg llams staif no eht ecafrus recommended taht rehtien eht neck/stem compo- fo eht ,daeh yllaicepse ni eht esac fo drah slairetam such stnen ron eht daeh era desu rof rehtruf gnitset yb eht sa .scimarec dohtem nevig ni siht trap fo 0SI .6027 3 Bureau of Indian Standards SIB. is a yrotutats institution dehsilbatse rednu eht Bureau ofIndian Standards Act, 1986 ot etomorp suoinomrah tnempoleved fo eht seitivitca fo .noitazidradnats gnikram and ytilauq noitacifitrec fo sdoog and gnidnetta ot detcennoc srettam ni eht .yrtnuoc Copyright SIB 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 .snoitangised seiriuqnE gnitaler ot thgirypoc eb desserdda ot eht rotceriD ,)snoitacilbuP( .SIB Review of Indian Standards stnemdnemA era issued ot standards as eht deen sesira no eht basis fo .stnemmoc era’sdradnatS osla deweiver ;yllacidoirep a standard gnola htiw stnemdnema is demriffaer nehw hcus weiver setacidni that on segnahc era ;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 ’SIB‘ ’koobdnaH and sdradnatS‘ : ylhtnoM .’snoitiddA sihT naidnI dradnatS has neeb depoleved morf toD : .oN DHM 2 ( 2709 .) Amendments Issued Since Publication dnemA .oN etaD fo eussI txeT detceffA RUREAU OF .INDIAN STANDARDS :sretrauqdaeH Manak ,navahB 9 rudahaB Shah rafaZ Marg, weN ihleD 110002 :smargeleT Manaksanstha senohpeleT : 323 01 31,323 94 02, 323 33 75 ( nommoC ot all seciffo ) lanoigeR :seciffO enohpeleT lartneC : Manak ,navahB 9 rudahaB Shah rafaZ Marg 323 76 17. WEN IHLED 110002 323 3841 nretsaE : 41/l C. .I .T emehcS IIV M, V. .I .P ,daoR alotkinaM 337 84 99, 337 85 61 ATTUCLAC 700054 337 86 26,337 86 62 nrehtroN : SC0 ,633-533 rotceS ,A-43 HRAGIDNAHC 160022 I 60 38 43 60 20 25 nrehtuoS : C. .I .T Campus, VI ssorC ,daoR IANNEHC 600113 I 235 02 16,235 04 42 235 15 19,235 23 15 nretseW : ,ayalakanaM 9E MIDC, ,loraM irehdnA )tsaE( 832 238‘,59.29 78 ;85 MUMBAI 400093 I 8327891,8327892, sehcnarB : ,DMEADAMHA .ERGLAGNAB .LAPOHB .RAWHSENABUHB EROT&$BMIOC .DABADIRAP .DABAIZAHG .ITAHAWUG .DABAREDYH JAIPUR. .@LPNAK .WQNKCUL .RUPG,AN ANTAP .ENUP .MARUPAHTNANAVURIHT Print&l ta Ned india F’hting hcss, ,ajruhK aidnI
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