© ISO 2016 Implants for surgery — Metallic materials — Part 7 Forgeable and cold formed cobalt chromium nickel molybdenum iron alloy Implants chirurgicaux — Produits à base de métaux — Partie 7 Alliag[.]
INTERNATIONAL STANDARD ISO 83 -7 Third edition 2016-11-15 Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobaltchromium-nickel-molybdenum-iron alloy Implants chirurgicaux — Produits base de métaux — Partie 7: Alliage forger mis en forme froid base de cobalt, de chrome, de nickel, de molybdène et de fer Reference number ISO 5832-7:2016(E) I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n © ISO 2016 ISO 83 -7: 01 6(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise specified, no part o f this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission Permission can be requested from either ISO at the address below or ISO’s member body in the country o f the requester ISO copyright o ffice Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 83 -7: 01 6(E) Contents Page iv Introduction v Scope Normative references Terms and definitions Chemical composition Microstructure 5.1 Grain size 5.2 Inclusion content Mechanical properties Test methods Foreword © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n iii ISO 83 -7: 01 6(E) Foreword I SO (the I nternational O rganiz ation for Standardiz ation) is a worldwide federation of national s tandards bodies (ISO member bodies) The work o f preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has b een es tablished has the right to b e represented on that committee I nternational organi zation s , governmental and non- governmental, in liaison with I SO, al so take p ar t in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f elec trotechnical s tandardi z ation T he procedures used to develop this cument and those intended for its fur ther maintenance are describ ed in the I SO/I E C D irec tives , Par t I n p ar ticu lar the different approval criteria needed for the di fferent types o f ISO documents should be noted This document was dra fted in accordance with the editorial ru les of the I SO/I E C D irec tives , Par t (see www iso org/direc tives) Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights ISO shall not be held responsible for identi fying any or all such patent rights Details o f any patent rights identified during the development o f the document will be in the Introduction and/or on the I SO l is t of p atent declarations received (see www iso org/p atents) Any trade name used in this document is in formation given for the convenience o f users and does not cons titute an endors ement For an explanation on the meaning o f ISO specific terms and expressions related to formity assessment, as well as information about I SO ’s adherence to the World Trade O rganization ( WTO) principles in the Technical B arriers to Trade (TB T ) see the following URL: www.iso.org/iso/foreword html T he committee res p ons ible for this document is I SO/ TC , Implants for surgery, Sub committee S C , Materials This third edition cancels and replaces the second edition (ISO 5832-7:1994), which has been technically revised A lis t of al l p ar ts in the I SO 83 series can b e found on the I SO web s ite iv I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 83 -7: 01 6(E) Introduction No known s u rgic a l i mpl ant materia l h as ever b e en s hown to b e comple tely fre e o f advers e re ac tion s i n the hu man b o dy H owever, long-term cl i n ic a l e xp erience o f the u s e o f the materia l re ferre d to i n th i s document has shown that an acceptable level of biological response can be expected when the material is used in appropriate conditions © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n v I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n INTERNATIONAL STANDARD ISO 83 -7: 01 6(E) Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickelmolybdenum-iron alloy Scope T h i s c u ment s p e c i fie s the ch arac teri s tics o f, and corre s p ond i ng te s t me tho d s forme d cob a lt- ch rom ium-n ickel-molyb denu m-i ron NO TE a l loy T he me ch a n ic a l p rop er tie s o f a s a mp le o b ta i ne d for u s e from for, forge able and cold- i n the manu fac tu re o f s urgic a l i mplants a fi n i s he d p ro duc t m ade o f th i s a l lo y no t ne ce s s a r i l y comp l y with tho s e s p e c i fie d i n th i s c u ment T he Normative references fol lowi ng c u ments are re ferre d to i n the tex t i n s uch a way th at s ome or a l l o f thei r content s titute s re qu i rements o f th i s c u ment For date d re ference s , on ly the e d ition cite d appl ie s For u ndate d re ference s , the late s t e d ition o f the re ference d c ument (i nclud i ng a ny amend ments) appl ie s ISO 643, Steels — Micrographic determination of the apparent grain size ISO 4967, Steel — Determination of content of non-metallic inclusions — Micrographic method using standard diagrams ISO 6892-1, Metallic materials — Tensile testing — Part 1: Method of test at room temperature Terms and definitions No term s and defi nition s a re l i s te d i n th i s c u ment ISO and IEC maintain terminological databases for use in standardization at the following addresses: — IEC Electropedia: available at http://www.electropedia.org/ — ISO Online browsing platform: available at http://www.iso.org/obp Chemical composition T he he at ana lys i s o f the a l loy when de term i ne d as s p e ci fie d i n comp o s ition s p e ci fie d i n Table Table Clause T he a na lys i s o f s a mp le s ta ken from sh a l l comply with the chem ic a l pro duc ts manu fac tu re d from the a l loy sh a l l a l s o comply with © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n ISO 83 -7: 01 6(E) Table — Chemical composition Element compositional limits, Element mm % ( C ob a lt / ) to 42 C h rom ium , to , Nickel 14 to Molybdenum , to , M anganes e , to , Si l icon ma x C arb on ,1 ma x Pho s phor us , 01 ma x Su l fur , 01 ma x Beryllium , 01 ma x I ron 5 B a lance Microstructure Grain size The microscopic structure shall be uni form The grain size, determined as specified in C laus e 7, shal l b e no co arser than grain s i ze No Inclusion content The non-metallic inclusion content o f the alloy, determined as specified in C lause 7, shal l not exceed the limits given in Table Table — Inclusion content limits Type of inclusion I nclusion content thin a A – Sulfides B – Alum i nates C – Si lic ates D – O xides , globu lar a T here s h a l l b e no th ick i nclu s io n s Mechanical properties The mechanical properties, determined as specified in requirements of Table I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n C lause 7, shal l b e in accordance with the ISO 83 -7: 01 6(E) Table — Mechanical properties Proof s tress of nonTensile s trength Condition Annealed Hot worked 30 % cold-worked Spring tempera a MPa 950 950 450 650 proportional elongation MPa 450 600 300 400 Percentage elongation % 65 20 Fo r s p e c i fic ap p l ic atio n s Test methods The test methods to be used in determining compliance with the requirements of this document shall be those given in Table Table — Test methods Requirement Chemical composition Inclusion content Grain size Mechanical properties Tensile strength Percentage elongation Proof stress of non-proportional elongation © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n Relevant clause or subclause Clause 5.2 5.1 Clause Tes t method Recognized analytical procedures (I SO methods where these exist) ISO 4967 ISO 643 ISO 6892-1 ISO 83 -7: 01 6(E) ICS 1 040.40 Price based on pages © ISO 2016 – All rights reserved I n tern ati o n al Org an i z ati o n fo r S tan d ard i z ati o n