INTERNATIONAL STANDARD INTERNATIONAL ORGANISATION MEXflYHAPOaHAFI - Instruments articul&, Second edition 988-1 2-01 ORGANIZATION FOR STANDARDIZATION INTERNATIONALE DE NORMALISATION OPrAHM3A~MFi l-l0 CTAHflAPTM3A~MM Surgical instruments - Non-cutting, instruments - General requirements methods Instruments chirurgicaux et methodes d’essai ISO 71 51 articulated and test non tranchan ts - Spkifica tions g&Grales Reference number ISO 71 51 : 988 (E) ISO 71 51 : 988 (El Foreword ISO (the International Organization for Standardization) is a worldwide federation of national Standards bodies (ISO member bodies) The work of preparing International Standards is normally carried out through ISO technical committees Esch member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization Draft International Standards adopted by the technical committees are circulated to the member bodies for approval before their acceptance as International Standards by the ISO Council They are approved in accordance with ISO procedures requiring at least 75 % approval by the member bodies voting International Standard ISO 71 51 was prepared by Technical Committee ISO/TC 70, Surgical ins trumen ts This second edition cancels and replaces the first edition (ISO 71 51 : 983, of which it constitutes a minor revision International Printed in Switzerland Organkation for Standardkation, 988 I N TERN ATI ON AL Su rg i cal I SO 71 51 : 988 I E) STAN DARD i n stru m en ts - i n stru m en ts N on -cu tti n g , - G en eral arti cu l ated requ i rem en ts an d test m eth ods Scope Th i s I ntern ational corresponding arti cu l ated Standard test speci fi es m ethods i n stru m en ts for u sed general a general requ irem ents range of Req u i rem en ts and non-cu tting, i n su rg ery H eat Parts, treatm en t excl u di n g m an u factu red l foll owi n g reference were At val i d to text, the Al l agreements aged Standards i n th i s Standard sti tu te of Standards based of the m n tai n contain ti m e on i n vesti gate edi tion s th i s the reg i sters of 683-1 : 986, ti ng steel s - provi si on s l i sted of val i d th i s I n ternational revi si on , and Parti es are the M em bers to encou r- m ost of I nternational m ateri al g rad e com pon en t an d Parts M Vi ckers tes t 982, - M etal l i c I SO and free cu t- The 7: Part HV to HV H ardness - 6508 : RockweI l - test qu irem ents M etal l i c (scal es A - the of i n stru m en ts to and ensu re for sh al l be com pl i an ce the m ateri al heat-treated wi th the re- sh al l be used H ardness The Rockwel l test - test - the of hardn ess range a Vi ckers i n stru m en ts 40 hardn ess i n accordance of the to 48 H RC with range I SO of 6508 fi ni shed H RC 390 and i n stru m ents (approxi m atel y HV to 485 I SO H V) 6507-1 equ ivalent when tested respecti vel y 00 m ateri al s - of diti on s C - H ardness D - - E - F - G - su rfaces and sh an ks, the Rockwel l on sh al l the not sam e vary hardness i nstru m en t, in h ardness su ch by as opposite m ore than j aws u n i ts on scal e K) I SO 71 53-1 - 986, Parts su i tabl e M ati ng I SO treatm ent com ponent u nder with i n s teel s m a teri al s H eat recent I EC and Standards al l oysteel s t stai n l ess in di cated to 6507- : I SO Part 7: : 983, I n stru m ents Stai n l ess for su rgery - M etal l i cm ateri al s steel , The M ateri al The i nstru m en ts, least The stai n l ess table except steel for speci fied I n stru m ent com pon en t N on -cu tti n g , except i n serts, in I SO sh al l be made 71 53-1 in of the grade accordance H ardness Vi ckers arti cu l ated - Steel tungsten hardn ess 000 HV i n serts of the when of than 50 u n i ts Corrosi on on tu ngsten tested opposite m ore carbi de carbi de i n serts i n accordance bl ades the i n serts sh al l Vi ckers not HV with vary in sh al l I SO be at 6507-1 hardness hardn ess by scal e with Steel an d g rade l etter Parts in wi th - Reference accordan ce I SO The B bl ad e - body A, G eneral 71 53-1 i n stru m en ts, - in stru m en t qu irem ents B an d A sma” an d B - A, B, L, M, N, Two resi stan ce B l arg e screws sh al l g iven com pl y i n 2 wi th and one or both of the re- M N OTE an d resi stan ce grades retractors Retractors Rivets of Tabl e I for screws throu gh editi on s Standard steel s, Wrou gh of applyi ng below cu rren tl y 73 : to I nternati onal possi bi l i ty whi ch , the su bject H eat-treated Part provi si on s pu bl icati on , are Standards I SO of of h ard n ess an d Referen ces The H an d ri vets an d P test Wh en m eth ods pl aci n g state wh eth er both tests is carri ed ch oi ce to be i s l eft to th e tests ou t are an are If di screti on speci fi ed Order, to be th e of it is carried pu rch aser th e for determ i n i n g i n ten ded ou t or, does m an u factu rer th at if n ot corrosi on th e n ot, so pu rch aser wh i ch i n di cate, of th e th e ISO 71 51 : 988 (EI 4.2.2 Test for resistance to topper sulfate Except as specified below, there shall be no plating of topper on the instruments, when tested as specified in 5.1 Copper plating at the edges of the drops of the topper sulfate Solution, or at soldered or brazed junctions, or dulling of polished surfaces caused by the topper sulfate Solution, shall be disregarded A slight plating of topper in small areas of the joints, ratchets and serrations of the jaw shall be disregarded 4.2.3 Test for resistance NOTES The Satin finish should be achieved using an appropriate procedure, for example grinding, brushing, electropolishing and, in addition, Satin finishing (glass beading or Satin brushing) The finish should be uniform and smooth, and it should reduce glare Instruments of mirror finish should be adequately ground to remove all surface imperfections and polished to remove grinding marks in Order to achieve a mirror finish This should be achieved using an appropriate procedure, for example polishing, brushing, electropolishing and mirror buffing to boiling water Passivation When tested as specif ied in 5.2, there shall be no visible signs of corrosion 4.3 Workmanship The instruments shall be manufactured recognized Standards of workmanship in accordance with the Serrations shall mesh exactly in the fully closed Position of the instrument and final treatment The instruments shall, unless the metallurgical characteristics of the instrument (for example the presence of brazed or soldered joints) renders it inappropriate, be treated by a passivation process in accordance with good practice for these types of stainless steel NOTES Examples of-methods of passivation are by electropolishing or by treating with % ( V/ V) nitric acid Solution for not less than 30 at a temperature of not less than OC and not exceeding 60 OC The instruments should then be rinsed in water and dried in hot air If the joints are lubricated, the lubricant should be non-corrosive and suitable for medical application in accordance with the relevant national pharmacopoeia Teeth and prongs shall be appropriately sharp and equally shaped on both Parts of the instrument They shall mesh exactly and there shall be no resistance when the instrument is reopened 4.5 Elasticity Unless otherwise specified, there shall be no sharp edges Sharp edges around the sides of the jaws shall be removed The elasticity of the instruments shall be tested in accordance with 5.3 The instruments shall have joints which move smoothly and which shall be neither too loose nor too tight; it shall be possible to close and reopen the instrument easily with two fingers After the test, no distortion, Cracks or any other permanent modifications s hall be visible 4.6 Function of needle holders 4.4 Surface condition The function of needle holders shall be tested in accordance with 5.4 4.4.1 The fibre shal not Slip out, irrespective of whether the direc tion of the load is longitudinal or transverse General All sut-faces shall be free from pores, crevices and grinding marks The instruments shall be supplied free from residual scale, acid, grease, and grinding and polishing materials Compliance with these requirements shall be checked by inspection using normal Vision, corrected, if necessary Test methods 4.4.2 Surface finish 5.1 The surface finish shall be one of, or a combination following : of, the a) mirror polished; b) reflection-reducing, finish ; Cl an aPP Pu rposes for example Satin finish, matt black tface coating, for example for insulation 5.1 Copper sulfate test Test Solution CopperIll) sulfate pentahydrate (CuS04.5H20) Sulfuric acid [e(H2S04) = ,84 g/mll Distilled or de-ionized water 5.1 Apparatus Glass or ceramic beaker 49 log 90 ml ISO 71 51 : 988 (EI 5.1 Preparation of Sample Strub the instrument using soap and warm water, rinse thoroughly in distilled water, dip in 95 % (V/ V) ethanol and dry 5.1 Procedure Immerse the instrument in the test Solution contained in the beaker at room temperature for Remove the instrument and wash it with distilled water or water of equivalent quality, or wipe it with wet cotton wool Examine the instrument for evidente of topper deposits 5.2.4 Procedure Immerse the instrument in boiling water (5.2.1 ) in the beaker or vessel for at least 30 Subsequently, allow the instrument to cool for at least h in the water used for the test Then remove the instrument from the water and leave it exposed to the air for h Rub the instrument vigorously with a dry cloth and examine it for the presence of blemishes 5.3 Elasticity test for haemostatic needle holders forceps and 5.2 Boiling water test Place a test wire in accordance with table or as appropriate between the tips of the instrument jaws Fully close the instrument to the last ratchet Position Leave the instrument in this Position for h at room temperature Examine the instrument for the presence of Cracks and permanent deformation 5.2.1 5.4 Function Reagent Place a plastics fibre (e.g a suture filament) of maximum diameter 0,2 mm between the jaws of the instrument at a Point within the third of the length nearest the tip Fully close the instrument and apply a tensile forte of 20 N to the fibre Record whether the fibre is pulled out from the jaws Distilled or de-ionized water 5.2.2 Apparatus Glass or ceramic beaker or suitable corrosion-resistant s teel vessel 5.2.3 Preparation stainless Marking 6.1 The instruments shall be marked with at least the trademark of the manufacturer or the supplier of Sample Strub the instrument using soap and warm water, rinse thoroughly in water (5.2.1 ) and dry 6.2 Instruments having tungsten carbide inserts shall have gold-coloured handles Table - Test wire for haemostatic Test wire test of needle holders I Diameter of test wire Wire of stainless steel grade 1 in accordance with ISO 683-1 or other similar material forceps Dimensions in millimetres Nominal length (overall length) of haemostatic forceps l up to 30 over 30 to 50 over 50 to 200 over 200 Table - Test wire for needle holders Test wire Wire of stainless steel grade 1 in accordance with ISO 683-1 or other similar material Diameter of test wire Nominal Dimensions in millimetres length (Overall length) of needle holders W up to 60 over 60 This page intentionally leff blank This page intentionally leff blank I SO 71 51 : 988 U DC 61 472 Descriptors Pri ce based : m ed i cal on pag es eq u i pm en t, su rgi cal equ i pm en t, retractors (su rg i cal in stru m ents) , tests, speci fi cati on s