1、BRITISH STANDARD BS3531-23.2: 1993 ISO 9269:1988 Implants for osteosynthesis Part 23: Bone plates Section 23.2 Specification for holes and slots for use with screws of4.5mm,4.2mm,4.0mm,3.9mm, 3.5 mm and2.9mm nominal sizes UDC 616.7177:66941:621.882.15BS3531-23.2:1993 This British Standard, havingbee
2、n prepared under thedirection of the Health CareStandards Policy Committee, was published under the authorityof the Standards Boardand comes into effect on 15May1993 BSI 08-1999 First published April1990 Second edition May1993 The following BSI references relate to the work on this standard: Committ
3、ee reference HCC22 Draft for comment87 50452 DC ISBN 0 580 22154 7 Committees responsible for this British Standard The preparation of this British Standard was entrusted by the Health Care Standards Policy Committee (HCC/-) to Technical Committee HCC/22, upon which the following bodies were represe
4、nted: Association of British Health-care Industries British Institute of Surgical Technologists British Investment Casting Trade Association British Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Department of Health Institute of Steril
5、e Services Management Medical Sterile Products Association National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-23.2:1993 BSI 08-1999 i Contents Page Committees responsibl
6、e Inside front cover National foreword ii 1 Scope 1 2 Normative reference 1 3 Dimensions and tolerances 1 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools 5 Annex B (informative) Bibliography: International Standards referred
7、 to in table of Annex A 6 Figure 1 Hole for HC screws 1 Figure 2 Slot for HC screws 2 Figure 3 Hole for HD screws 3 Figure 4 Slot for HD screws 3 Table 1 Dimensions of holes and slots for HC screws2 Table 2 Dimensions of holes and slots for HD screws 4 List of references Inside back coverBS3531-23.2
8、:1993 ii BSI 08-1999 National foreword This Section of BS3531 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO9269:1988 Implants for surgeryMetal bone platesHoles and slots corresponding to screws with conical under-surface, published by t
9、he International Organization for Standardization (ISO) and supersedes BS3531-23.2:1990 which is withdrawn. Requirements for orthopaedic implants (then termed “surgical implants”) were first published in1962 as BS3531. In1968 a part revision of BS3531:1962 was issued as BS3531-1, which dealt with su
10、rgical implants made of all materials. In1980 the first four Parts of a multi-part version of BS3531 were published. A further19 Parts of BS3531 were subsequently published. The revision of BS3531-5 offered the opportunity to facilitate the implementation of published and forthcoming standards, and
11、to separate, in different Parts of BS3531, requirements for bone plates from those for bone screws and auxiliary equipment. Accordingly, therefore, bone plates are covered by BS3531-23, published in a number of Sections, whilst screws and auxiliary equipment are retained in BS3531-5, also published
12、in Sections. BS3531 now only covers implants for osteosynthesis, BS7251 covers joint prostheses, BS7252 covers metallic materials for surgical implants, BS7253 covers non-metallic materials for surgical implants and BS7254 covers orthopaedic implants, i.e.aspects common to both osteosynthesis and jo
13、int replacement. BS3531-23.2 was first published in1990 and specified dimensions and tolerances for bone plates for use with bone screws of nominal sizes4mm, 3.5mm and3.0mm. This revision of BS3531-23.2 now gives dimensions and tolerances for bone plates for use with the bone screws of nominal sizes
14、4.5mm,4.2mm,4.0mm,3.9mm,3.5mm and2.9mm. The holes and slots specified in this Section of BS3531 are suitable for use with the screws specified in BS3531-5.4. It is strongly recommended that the products specified in this Section of BS3531 should be manufactured according to the recommendations given
15、 in Quality Systems for Orthopaedic Implants1990 Good Manufacturing Practice 1) . Product certification. Users of this British Standard are advised to consider the desirability of third party certification of product conformity with this British Standard based on testing and continuing surveillance
16、which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. Enquiries as to the availability of third party certification schemes are forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does not already ex
17、ist, users should consider approaching an appropriate body from the list of Association members. Cross-reference International Standard Corresponding British Standard ISO9268:1988 BS3531 Implants for osteosynthesis Section5.4:1993 Specification for screws having symmetrical and asymmetrical thread a
18、nd conical under-surfaces (Identical) 1) Compiled by the Department of Health; published and available from HMSO,49 High Holborn, London WC16HB for personal callers, or by post from HMSO, PO Box276, London SW85DT.BS3531-23.2:1993 BSI 08-1999 iii A British Standard does not purport to include all the
19、 necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi toiv, pag
20、es1to6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.iv blankBS3531-23.2:1993 BSI 08-1999 1 1 Scope This International Standard specifies th
21、e dimensions and tolerances of holes and slots in bone plates used as surgical implants so as to facilitate correct fixing using screws complying with ISO9268. NOTE 1This International Standard does not deal with the shape and dimensions of the plates or with the spacing (centre-to-centre distance)
22、of the holes and slots. NOTE 2The interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is shown in Annex A. 2 Normative reference The following standard contains provisions which, through reference in this text, constitute provisions of this Internati
23、onal Standard. At the time of publication, the edition indicated was 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 edition of the standard indicated below. Members
24、 of IEC and ISO maintain registers of currently valid International Standards. ISO9268:, Implants for surgeryMetal bone screws with conical under-surface of head Dimensions 2) . 3 Dimensions and tolerances 3.1 Holes and slots in bone plates for use with screws of2,9mm nominal diameter (HC2,9 screw i
25、n accordance with ISO9268) Holes and slots in plates for HC2,9 screws shall be in accordance with Figure 1 and Figure 2 and Table 1. The depth of the countersink for holes or slots in flat plates having a thickness of2mm or greater shall be such that at least half of the parallel depth of the head o
26、f the HC2,9 screw shall be below the superficial surface of the plate. The depth of the countersink for holes or slots in flat plates having a thickness of1,6mm or1,4mm shall be such as just to accommodate the countersunk surface of the screw head. For bone plates having a curved surface, the depth
27、of the countersink for holes or slots shall be such that the land of the HC2,9 screw lies between the upper and lower countersunk surfaces of the plates. 3.2 Holes and slots in bone plates for use with screws of3,5mm,3,9mm and4,2mm nominal diameters (HC3,5, HC3,9 and HC4,2 screws in accordance with
28、ISO9268) Holes and slots in plates for HC3,5, HC3,9 and HC4,2 screws shall be in accordance with Figure 1 and Figure 2 and Table 1. The depth of the countersink for holes or slots in flat plates having a thickness of2,8mm or greater shall be such that at least half of the parallel depth of the head
29、of the HC4,2 screw shall be below the external surface of the plate. 2) To be published; will cancel and replace ISO/DIS5835-3 and ISO5835-4:1983. Figure 1 Hole for HC screwsBS3531-23.2:1993 2 BSI 08-1999 Table 1 Dimensions of holes and slots for HC screws The depth of the countersink for holes or s
30、lots in flat plates having a thickness of2mm,2,2mm or2,5mm shall be such as just to accommodate the countersunk surface of the screw head. For bone plates having a curved surface, the depth of the countersink for holes or slots shall be such that the land of the HC4,2 screw lies between the upper an
31、d lower countersunk surfaces of the plate. 3.3 Holes and slots in bone plates for use with screws of4,0and4,5mm nominal diameters (HD4 and HD4,5 screws in accordance with ISO9268) Holes and slots in plates for HD4 screws and HD4,5 screws shall be in accordance with Figure 3 and Figure 4 and Table 2.
32、 The depth of the countersink for holes or slots in flat plates having a thickness of2,8mm or greater shall be such that at least half of the parallel depth of the head of the HD4 screw shall be below the external surface of the plate. The depth of the countersink for holes or slots in flat plates h
33、aving a thickness of2mm,2,2mm or2,5mm shall be such as just to accommodate the countersunk surface of the screw head. For bone plates having a curved surface, the depth of the countersink for holes or slots shall be such that the land of the HD4 screw lies between the upper and lower countersunk sur
34、faces of the plate. Dimensions in millimeters Figure 2 Slot for HC screws Dimensions in millimetres d + 0,1 0 Screws in accordance with ISO9268 (Code and nominal diameter of thread) 3 HC2,9 4,3 HC3,5 HC3,9 HC4,2BS3531-23.2:1993 BSI 08-1999 3Figure 3 Hole for HD screws 1)In practice, countersinks of9
35、0 and80 are, at present, manufactured and appear acceptable. Figure 4 Slot for HD screwsBS3531-23.2:1993 4 BSI 08-1999 Table 2 Dimensions of holes and slots for HD screws Dimensions in millimetres d +0,1 0 Screws in accordance with ISO9268 (Code and nominal diameter of thread) 4,4 HD4 5 HD4,5BS3531-
36、23.2:1993 BSI 08-1999 5 Annex A (informative) Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools 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
37、 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
38、 two parallel series of International Standards is given below. Screws Thread Head under-surface Drive connection ISO5835 ISO9268 Mechanical requirements ISO6475 Breaking torque/angle of rotation In preparation Plates Holes and slots ISO5836 ISO9269 Mechanical requirements ISO9585 ISO9585 Driving to
39、ols Keys and screwdrivers ISO8319-1 ISO8319-2 Hexagon keys Screwdrivers Drill bits, taps, countersink cutters ISO9714-1 In preparationBS3531-23.2:1993 6 BSI 08-1999 Annex B (informative) Bibliography: International Standards referred to in table of Annex A (Thisannex does not form an integral part o
40、f the Standard.) ISO5835:, Implants for surgeryMetal bone screws with hexagonal drive connectionSpherical under-surface of headDimensions 3) . ISO5836:, Implants for surgeryMetal bone platesHoles corresponding to screws with asymmetrical thread and spherical under-surface 4) . ISO6475:, Implants for
41、 surgeryMetal bone screws with asymmetrical thread and spherical under-surfaceMechanical requirements and test methods 5) . ISO8319-1:1986, Orthopaedic instrumentsDrive connectionsPart1: Keys for use with screws with hexagon socket heads. ISO8319-2:1986, Orthopaedic instrumentsDrive connectionsPart2
42、: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws. ISO9268:, Implants for surgeryMetal bone screws with conical under-surface of headDimensions 4) . ISO9269:1988, Implants for surgeryMetal bone platesHoles and slots corresponding to screws with coni
43、cal under-surface. ISO9585:, Implants for surgeryMethod for testing bending strength and stiffness of bone plates 4) . ISO9714-1:, Orthopaedic instrumentsDrilling instrumentsPart1: drill bits, taps and countersink cutters 4) . 3) Will cancel and replace ISO5835-1 at next revision stage. (ISO5835-1 c
44、ancelled and replaced ISO5835-1:1978 and ISO5835-2:1978.) 4) To be published. 5) Will cancel and replace ISO6475-1:1980 and ISO6475-2:1980.BS3531-23.2:1993 BSI 08-1999 List of references See national foreword.BS3531-23.2: 1993 ISO 9269:1988 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandard
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