INTERNATIONAL STANDARD ISO 5835 First edition 1991 01 15 lmplants for surgery Metal bone screws with hexagonal drive connection, spherical under surface of head, asymmetrical thread Dimensions Implant[.]
INTERNATIONAL STANDARD ISO 5835 First edition 1991-01-15 lmplants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions Implants chirurgicaux - Vis m@talliques pour OS raccord d’entrainement hexagonal, ti embase sph&ique et filetage asymetrique - Dimensions Reference nurnber ISO 5835: 1991 (E) `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) 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 International organizations, governrepresented on that committee mental 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 voting Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote International Standard ISO 5835 was prepared ISO/TC 150, Implants for surgery by Technical This first edition cancels and replaces the ISO 5835-1:1985 Clause and the annexes are new Annexes A, B and C of this International only Standard ISO 1991 All rights reserved No part of this publication may be reproduced or by any means, electronie or mechanical, including photocopying Permission in writing from the publisher International Organizati on for Standardization Case Postale 56 l CH-l 211 Geneve 20 l Switzerland Printed in Switzerland first Committee edition of are for information or utilired In any form and microfilm, without `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - ii Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) Introduction `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - This International Standard lays down requirements for surgical bone screws as given in clause lt is necessary, however, to bear in mind that there may be a need for bone screws for particular applications, which are not covered by this Standard or by ISO 9268 Such special bone screws may differ in part from the standardized forms or may combine Parts from these two product Standards (see annex A) However, there are certain areas of the design of screws such as the drive connections, the shape of the under-surface of the head and the thread form that are critical from the Point of view of surgical use These areas are those where there is an interface with bone plates (ISO 5836 and ISO 9269) or with surgical instruments or other devices such as hexagon keys (ISO 8319-1) or taps, drills and countersink Cutters No Variation is permitted in these areas Ill Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT This page intentionally left blank `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT INTERNATIONAL STANDARD ISO 5835:1991 (E) Implants for surgery - Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread - Dimensions ISO 6018:1987, Orthopaedic implants - General requirements for marking, packaging and labeliing Scope This International Standard specifies dimensions and tolerantes for metal bone screws used in surgery, having hexagonal drive connection, spherical under-surface of the head, and shallow and deep asymmetrical threads NOTES The mechanical in this International requirements for screws that are cited Standard are specified in ISO 6475 The interrelationship ing with bone screws, shown for information Normative ISO 6475:1989, Implants for surgery - Metal bone screws with asymmetrical thread and spherical under-surface - Mechanical requirements and fest methods of International Standards dealbone plates and relevant tools is in annex B Code for screw thread The following code shall be used to identify the type of screw thread conforming to this International Standard: Shallow thread (for cortical screws): Code HA Deep thread Code HB references The following Standards contain provisions which, through reference in this text, constitute provisions of this International Standard At the time of publication, the editions indicated were valid All standards are subject to revision, and Parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the Standards indicated below Members of IEC and ISO maintain registers of currently valid International Standards Dimensions All dimensions metres 4.1 Screw (for spongiosakancellous and tolerantes and tolerantes with shaifow thread are given Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT in milli- (HA) HA screws shall be as given in figures tables and `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS screws): and and ISO 5835:1991(E) 1) This may be 60° for self-cutting screws - Table Code and diameter Nominaf diameter HA 2,7 277 HA 3,s 375 HA 4 HA 4,s 45 HA 5 1) Dimensions J HA 2,0 I k of HA series screws l Y I toi N t-o,25 0 18 175 175 093 175 078 17g 2 094 195 170 2.3 23 23 295 04 295 192 23 2,5 195 410 -0,15 Fl0 = +0,047 +0,007 for SW G mm Fl0 = +0,058 +O,OlO forSW>3mm Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS with shallow thread (HA) Screw 2,4 I N - I 2,5 A- rv - I - FlO’) I 22 - 33 Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT I 13 - 28 `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Figure ISO 5835:1991(E) Figure - Table -0,15 HA 1,s 195 L tol HA 2,0 193 HA 2,7 297 199 HA 3,5 HA4 HA 4,5 HA 1) Variation 395 24 279 4,5 33 in thread The total Parameters Profile to be defined lt1 -0,lO -0,15 of HA thread e N - P r4 ?-5 N - N - a ß N - N O,l 03 013 011 35” 3O O,l 096 04 091 35” 3” 3O 35” 3” 35” 3O 1,75 35” 3” 1,75 02 092 092 03 093 35O 1,511 2) 096 018 098 35” 3” 071 Oll OJ 091 091 1,25 Profile: of values d,, &, e, t-4, yS, Bưand ß allow the theoretical lt is recommended that the maximum thread from should not exceed: - Dimensions Variation from the theoretical Profile maximum thread at any Point on 0,050 mm for HA 1,5 and HA 0,075 mm for HA 2,7 to HA These values may be reconsidered in course of revision 2) Attention is drawn to the pitch of the HA screw, of the HB screw, which is 1,75 mm (see table4) Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS which is 1,5 mm as compared Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT to that `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Code and diameter of thread Shallow thread (HA) ISO 5835:1991(E) 4.2 Screw with deep thread (HB) HB screws shall be as given in figures and and tables and c Table - Code and diameter of thread Nominal diameter 1) Screw with deep thread (HB) Dimensions d -0,15 d4 -0,lS Fl0 = -t0,047 +0,007 for SW < mm Fl0 = +0,058 -tO,OlO for SW > mm of HB series screws k r1 - to.25 N Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Figure - Figure - I Code and diameter of thread Deep thread (HB) Dimensions Table I of HB thread l & e -0,15 -0,15 N - `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - ISO 5835:1991(E) P I I I r4 55 a N - N - N - ß w - T8 013 25” 5” 0,8 25” t I HB HB 6,s 13 6,5 Oll 0,2 1,751) 2) 2,75 1,2 1 5” l 1) See footnote 2) Variation 2) in table2 in thread Profile: The total Parameters of values thread Profile to be defined > A,, &, e, y4, Y5r a and ß allow the theoretical lt is recommended that the maximum Variation Point on thread form should not exceed: II Marking the theoretical Profile at any 0,075 mm for HB This value from maximum may be reconsidered l in course of revision and packaging The marking and the packaging ante with ISO 6018 Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS shall be in accord- Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT I ISO 58351991 (E) Annex A (informative) Example for combined screw This screw is an example as mentioned in the introduction for a combination of shallow thread HA 4,5 as given in figure2 and table2 in this International Standard whereas the Cross-recessed drive connection is in accordante with figure and table in ISO 9268:1988 (For information, the illustration and the dimensions of the drive connection are given in tables A.l and A.2, and figures A.l and A.2 The dimensions of head and thread, which are critical from the Point of view of interface with screwdrivers, taps, drills, etc., are specified in ISO 9268 and this International Standard respectively, and the mechanical requirements are specified in ISO 6475 A.1 Dimensions Figure A.1 - Combined Table A.1 - Dimensions bined screw screw of com- T Nominal diameter `,````,``,`,````,`,,,`,,,`,`,-`-`,, Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS d k -0,15 max 495 8,O 398 Y 575 Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) A.2 Cross-recessed drive connection Figure A.2 - d rive connection Cross-recessed Table A.2 - Dimensions of crossrecessed drive connection n b d max I I J `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) Annex B (informative) Interrelationship of International Standards dealing and relevant tools with bone screws, bone plates It has been decided that the set of International Standards dealing with bone screws, bone plates and relevant tools should be divided into two parallel series The basis of the division into two series is the essentially different designs of the screw threads of the bone screws (HA and HB type screws as opposed to HC and HD type screws) A simplified schematic guide illustrating the interrelationship between screws, plates and tools covered by the two parallel series of International Standards is given on the following Page `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) Thread HB HA \““7 \900/ / Head under-surface Conical Spherical Screws Drive connection Single slot Cruciate slot Crossrecessed head Combined drive connections Single slot and crossrecessed head I Cruciate s(ot and crossreces?3ed head ISO 6475 Mechanical requirements In preparation Breaking torque/ angle of rotation Holes and Slots ISO 5836 ISO 9269 Mechanical ISO 9585 ISO 9585 Plates requirements I I ISO 6319-1 Keys and screwdrivers Driving tools Hexagon keys I Drill bits, taps, countersink Cutters Screwdrivers I I I1 ISO 9714-1 i In preparation `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) Annex C (informative) [l] International Standards referred to in table ISO 5835:1990, Implants for surgery - Metal bone screws with hexagonal under-surface of head, asymmetrica! thread - Dimensions [2] ISO 5836:1988, Implants for surgery - Metal bone plafes rical thread and spherical under-surface - Holes corresponding [3] ISO 6475:1989, implants for surgery - Metal bone screws with asymmetrical and test methods surface - Mechanical requirements [4] ISO 8319-1: 1986, Orthopaedic hexagon socket heads [5] instruments - Drive connections of annex drive connection, Implants for surgery - Metal bone screws thread and spherical ISO 9585:1990, Implants for surgery - Determination [ 91 ISO 9714-1: 19901), Orthopaedic drilling with conical for Single slot head under-surface of head to screws with of bending strength and stiffness of bone plates instrumen ts - Part 1: Drill bits, taps and countersink 1) To be published 10 Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS under- - Part 1: Keys for use with screws with [7] ISO 9269:1988, Implants for surgery - Metal bone plates - Holes and Slots corresponding conical under-surface [8] spherical to screws with asymmet- ISO 8319-2:1986, Orthopaedic instruments - Drive connections - Part 2: Screwdrivers screws, screws with cruciate slot and Cross-recessed head screws Cs) ISO 9268:1988, Dimensions B Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT Cutters `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Bibliography: `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - This page intentionally Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS lef? blank Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT ISO 5835:1991(E) w-P - UDC 616.71-089.8-74:615.465:621.882.2Descriptors: medical equipment, surgical implants, screws, dimensions Price based on 10 pages -~ `,````,``,`,````,`,,,`,,,`,`,-`-`,,`,,`,`,,` - Copyright International Organization for Standardization Provided by IHS under license with ISO No reproduction or networking permitted without license from IHS Licensee=University of Alberta/5966844001, User=sam, albert Not for Resale, 06/21/2013 03:05:21 MDT -. -