|A&. TEST METHOD FOR DETERMINING THE SELF-TAPPING PERFORMANCE OF SELE-TAPPING MEDICAL BONE sc ALL Signtieance and Use AML This test method is used to determine the axial ‘compression ka free) required engage the el tapping Teate of sel tapping medial Bone srew ito a stand mera Te esis ned in this et meth bear no diet ‘coreation to the ail free required to inser the abject tone Screw into Bumance animal bone. This test methods Wed aly to measure the uniformity of the product tested o to compare the performance of diferent yet sir sia. products. This test method i nt aplicable to “self dilig” oe “salting! selfapping” sles of modical bone sews. M42 Apparats A421 Testing Apparaus—A schematic fr the axils tapping force test apparatus i iusiatd in Fig. A‘. The apparatus shall provide s variable speed motor cable of ‘continuously diving a spindle. The sine stall be capable of {comin reaton as well a atl tansation tallow "arial force on the est specimen. The apparatus and pile Shall be suliiemly rigid Yo veiher dest nor deform unde the conditions of loading encountered during the test. The spparats sal incorporate 2 test Hook clamp for the purpose ‘Of ipiay ing ast blk. The apparatus stall be capable of ‘coatnuously monitoring and eecrding the fc, tore, and sil displacement of the specimen. The apparatus sll be ‘aliratedfor the range of forces, ores an linear dspace- ment used in he detereinaton, A422 Compression Load Cell—A trnsducer to tensa the appli axial fore in an elccl signal sable for ‘continous recording ax elite over the range of forces De encountred in nett mtd, sal be rove The load ‘call shoul have an accuracy of 0.5% of al scale output and ‘low measurement reoltion of =1.0 N. A423 Torque Tronsdacer—A transducer (0 taste the applied torque ito am electrical signal suitable for continuous ‘ecrding and albrted ove the range of torques, bath in ‘Clockwise nd countercckwise ration, 1 be encoxnered in the test method, shall be provided. The torque tansdocer) F543 17 mart Srasace ——] sam om [Tiere Ey] ew con Tae FG Att Schematic of Tat Apparat or Determination of Sef shouldhave an accurcy of0.5 of fll-sce output and allow ‘messtrement rsouton of 20.10 N-m. NewALL_Aconthatiog congas oa aed re tance ‘tte for the woplcatonpoied hear ase te ‘ime denint n hand ALD M24 Linear Diplacement Trandacer\ tanadacee 0 ‘amlac the anal dopliccnent ofthe tet apparati's spindle {ato ap ckcrcal signal table for conics reer and ‘aired over the range of displacement tobe encountered in {he test meliol shal be provided. The sisplaccncet vars ‘dacer shuld hve un accuracy of 1 of fll sale and allow {rmcssurmeat seokaion of 05 sm. AS Test Bleck Clanp—A.clamp cc bling device shall ‘be incorporated into the testing fixture. This holding devise ‘shall maintain the dled pothole inthe test block inline wih the est specimen. The holding device shall be sufcinly rid to wether deflect no: deform under the coniions of loding ‘encourtered during the test and yt ot deform the test lock ‘during clamping of the test Hock or pefonmance of the es (84.26 Tet Block Thott Mock sal faba from ‘wiforms material hat conforms Specification P1830. The top ‘sed sto sural be la, scot, and pra within (04 sum) as required w enue tha Ue test lock will be sppored inthe Rate with the top surface at an angle of 9° to the centeine of he tet specinea. The eles of the est ‘lock shall be of such cameur oF squaceess ay eure (0 ‘ensure thatthe test block clamp shal old ke test block fie of ‘lative motion without deformation of the test block daring ‘lamping or esting. The test block thickness shal be aot ess than 25 am, ‘A427 Pilot Holes in Test BlockPilc ole shall be dled in be tstblock fr iserton and moval of the est specimen. ‘The dill size used shall be that specified by the serew ‘marufictre fo the size screw being tesed. The hoes shall be riled at 9° to the top surface ofthe tet Hock. The holes stall be died stright and tre fre of taper, bell mouth, or barrel shape. The hoes should te dled complcely throush the test Bock ané all particulate debris removed prior 1 inseting the es specimen, If there ae mule hoes in one test Hock the plot holes shal be spaced suficicnly far away fret Hock edssso that esting does not deform tes Block edges. Spacing should have «minimum distance «= scam ‘mended i A221 8. When the txt lock ie insted into the test fate (Fig. ALD. the plot hole. srew. and seewdtiver ‘ll he the sme xi ‘A428 Tes Specinen—The test specimen shall be «com platy fatricaed and finished bone screw ef suficientlengtt {allow completion ofthe test [A429 Reconler—The dats recorder shall be ssitible to record contiuausy, at a minimum rae of 10 Hz. atid ‘campression fore. tous. and ail spindle dsslacemest The ‘corde shall be capable of ceeding two ¥ axes smaliane- cust (fore and torque to ¥ Aris | and displacement to ¥ Axis 2) vers time (X ais), calibrated in unite of Newtons for force. Newton-netres fo terqe. and milimetres for dispace- ment The vale of force and terae should have a resoltion of (15% of fallscale output and sensitivity so a tence an cunts recording aay of = minim of LON ard 0.10 ‘Nim mspectnely. The alee of trguc hal have a eslation (of 05 of Fallscale cutut The linear deplcement sale ‘Should ave 2 nimi sensitiv 0 a ens an acre scoring sapabity fo 0S mm. ‘A420 Test Speed—The torsional force shall be applied a ‘constant rate of 30 min, The axial compression free stall be applied a a constant rte of approuimaely 2 Ns_ The torsional test speed has heen selected io represen the clinical Station cf hand-drven screws. The axe nad rat has teen selected to allow easy identhcation and reaction tthe unk se-iap evens onthe dita utput recorder. Othe test speeds fant loaf rates can be used povided they ae sified and reported, All comparive tests stall be performed a the same AAS Sampling [A431 Represertaive random samples may be taken from czch ft er processing quantity in accordance with Practice Ei. AA Procedare ASAI SelTupping Fowe—The pre-triled test block i sigily Sed inthe tet block carp Jerce shown in Fig AL ‘The appropiate siz screwdriver (Usver) is nse into the spindle and the alignneat ofthe pot bute wid he diver & ‘etifed. The sefsupping bore screw specimen is then pre asembled Cloaled") quo the diver The specimen(dnver ‘aSembly ister lowered Via the spindle into the plot ole and the axl displacement ofthe spinile adjusted to achieve a ‘macimum preload of L.0 8 to malntin screw-o-scewdrver engagement. ‘A4A2 The specimens then driven by the test apparatus a contnt rotational rit of 30 relation (in. The ‘sil force. tore. and displacement chaenes om the data4p Fes —17 recorder are monitored simultancousy while the axial force increased ot arate of approximately 2.0 Ns (= 1.0 Nis). The ‘2ual compression force shall continue 9 he mereased uni he scletpping features of the screw engage te tes Hock = dicta by s mah inccane in fogs snd exial pace mca a shows in Fig. A#2. ‘A445 This unique conbiaaton signifes the engagemest of the selFtapping Tears of the bone sew ino the test Intel and the onset of “selFtp” AU this moment, he Jncreane im asl fone should be eacontinued anf the Toad [evelat which sl apa it noted ratio hat "Toad fant old") while snwitanconly monitoring the specimen 19 ‘csi the continaed sfadvance ato the tet Block ae ted bby the cominually increasing tore and aval displacement. ‘Not that in some instances the axial force may decreas at he corset of sofia. as shown in Fig. A42, indicating sell ‘advarcement ofthe specimen into the test block without the ‘ned for continues, applied fore. hus, during ths phase of the tt the aval fore serves ony to mairtan diver to-srew cengagemen.) A444 A total of five complete revolutions should te achieved ater the onset of sell-tap to be censtered a vali Specimen. The matinum axial force achieved atthe enset of ‘Scletp shal te epatel asthe “sep force” Valu should bbe reputed ia Newtons. Os oceania, the specimen wil scl tap and then ceae nvancement ito the est block all” (or “ari within the fet Be revelations, ae indicated by a ‘il lose of torsional eictance and an unchanging Cla "IG. AA2 Type Test Method Ouput lined") atid dsplacemest. When a spscimen stalls, the sumption ofthe increase in axial force at a mate of 20 Nis (E10 Nas) is aceptale to once again achieve sep ‘worided: (1) the secondary, maximum axil force is repened the “sclFtap fore"; (2) the specimen complies Eve ‘evolion fcr the secondary sot and) theapecimes in Indicated ae “tlled” or “aripped” in tho Commenta seton of ‘hetest report Anyspacimen that xl more than cae stall be ‘considered invalid AAS Report ASL Repos the following information foreach specimen ‘esed (all standard unis fr eporang shall bein SL ua) ‘ASSLI Screw Ideniicaticn Reference any applicable ASTM oF 1SO specication that may apply 1 the specimen. IF Spcifiatiom do not ext provide head frm, dead fom, ims and minor ameter, thread pitch, overall ser lent, oad ad shank (umheeaded potioa of the nerew exclding the ead) Length, and typeof cre pint “AISI Screw chemical composition ‘MGS13 Ukinate tena stensth ‘AAS Solty force. ‘845.15 Comments regalingenique testing conditions or specimen occurences "ASSLT lnsenton lest speed if ouside the range specified. ASSIS Test Block Material Description Specification FIED grade (Note that Specficaton E39 ix itended to simalatesanvcllow bons However ol taping sree mast onstrate covial bone ae well Therefore, alternative mater (6) may he used io challenge the test specimens provided a ‘material choice jusificaton is inclded inthe test por.) For ‘materi tht does wt conform t Specification F830, provide: (Trade nave