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1、BRITISH STANDARD BS 3531-23.3: 1991 ISO 5836:1988 Implants for osteosynthesis Part 23: Bone plates Section 23.3: Specification for holes corresponding to screws with asymmetrical thread and spherical undersurfaces Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncont
2、rolled Copy, (c) BSI BS 3531-23.3:1991 This British Standard, having been prepared under the direction of the Health Care Standards Policy Committee, was published under the authority of the Standards Board and comes into effect on 29 November 1991 BSI 08-1999 The following BSI references relate to
3、the work on this standard: Committee reference HCC/22 Draft for comment 87/50443 DC ISBN 0 580 20266 6 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 whi
4、ch the following bodies were represented: 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 Sterile Services
5、 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.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 200
6、6, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 BSI 08-1999i Contents Page Committees responsibleInside front cover National forewordii 1Scope and field of application1 2Reference1 3Dimensions and tolerances1 Annex A Interrelationship of International Standards dealing with bone screws, bone plates
7、and relevant tools6 Annex B (informative) Bibliography: International Standards referred to in table of Annex A7 Figure 1 Type A hole1 Figure 2 Type B hole for HB 6,5 screw specified in ISO 58353 Figure 3 Type C hole for HB 6,5 screw specified in ISO 58353 Figure 4 Type D1 hole4 Figure 5 Type D2 hol
8、e4 Figure 6 Type D3 hole4 Table 1 Dimensions of type A hole2 Table 2 Dimensions of type C holes4 Table 3 Dimensions of types D1, D2 and D3 holes5 Publication(s) referred toInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
9、3531-23.3:1991 ii BSI 08-1999 National foreword This Section of BS 3531 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO 5836:1988 “Implants for surgery Metal bone plates Holes corresponding to screws with asymmetrical thread and spherical
10、 under-surface”, published by the International Organization for Standardization (ISO). Requirements for orthopaedic implants (then termed “surgical implants”) were first published in 1962 as BS 3531. In 1968 a part revision of BS 3531:1962 was issued as BS 3531-1, which dealt with surgical implants
11、 made of all materials. In 1980 the first four Parts of a multi-part version of BS 3531 were published. A further 19 Parts of BS 3531 were subsequently published. The revision of BS 3531-5 offered the opportunity to facilitate the implementation of published and forthcoming standards, and to separat
12、e, in different Parts of BS 3531, requirements for bone plates from those for bone screws and auxiliary equipment. Accordingly, therefore, bone plates are covered by BS 3531-23, published in a number of Sections, whilst screws and auxiliary equipment are retained in BS 3531-5, also published in Sect
13、ions. BS 3531 now only covers implants for osteosynethesis, BS 7251 covers joint prostheses, BS 7252 covers metallic materials for surgical implants, BS 7253 covers non-metallic materials for surgical implants and BS 7254 covers orthopaedic implants, i.e. aspects common to both osteosynthesis and jo
14、int replacement. It is strongly recommended that the products specified in this Section of BS 3531 should be manufactured according to the recommendations given in the “Quality Systems for Orthopaedic Implants 1990 Good Manufacturing Practice”1). Product certification. Users of this British Standard
15、 are advised to consider the desirability of third party certification of product conformity with this British Standard based on testing and continued surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS 5750. Enquiries as to the availa
16、bility of third party certification schemes will be forwarded by BSI to the Association of Certification Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. A British Standard does not purpo
17、rt to include all the 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 co
18、ver, pages i and ii, pages 1 to 8, 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. Cross-reference International StandardCorresponding British
19、 Standard ISO 5835:1991aBS 3531 Implants for osteosynthesis Section 5.3:1991 Specification for the dimensions of screws having hexagonal drive connection, spherical under-surfaces and asymmetrical thread (Identical) a Now published. 1) Compiled by the Department of Health; published and available fr
20、om HMSO, 49 High Holborn, London WC1 6HB for personal callers, or by post from HMSO, P O Box 276, London SW8 5DT. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 BSI 08-19991 1 Scope and field of application This Internatio
21、nal Standard specifies the dimensions and tolerances of holes in bone plates used as surgical implants so as to facilitate correct fixing using screws complying with ISO 5835. NOTE 1This International Standard does not deal with the shape and dimensions of the plates or with the spacing (centre-to-c
22、entre distance) of the holes. NOTE 2The interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is shown for information in Annex A. 2 Reference ISO 5835, Implants for surgery Metal bone screws with hexagonal drive connection Spherical under-surface of h
23、ead Dimensions2). 3 Dimensions and tolerances 3.1 Type A (with cylindrical hole) Type A holes shall be as given in Figure 1 and Table 1. 2) At present at the stage of draft. Figure 1 Type A hole Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BS
24、I BS 3531-23.3:1991 2 BSI 08-1999 Table 1 Dimensions of type A hole Dimensions in millimetres Cylindrical part of countersink (dependent on a) Screws in accordance with ISO 5835 d1d2b min. t a ref. 1,63,10,15 0,41,3HA 1,5 1,93,20,25 2,14,10,1 0,41,5HA 2 2,64,30,25 2,95,20,15 0,61,9HA 2,7 3,45,40,3 3
25、,76,20,25 0,92,4 HA 3,5 4,26,40,4HA 3,5; HA 4; HB 4 4,7 8,2 0,35 1,43,5HA 4,5 5,50,75 5,20,6 1,43,5 HA 5 68,21 6,61,3HB 6,5 NOTEThe values b and t in Table 1 relate to plates of thickness aref. If the thickness of the plate is greater than aref, the value of t shall not exceed that shown in Table 1
26、so as not to weaken the plate. The value of b would then be increased. If the thickness of the plate is less than aref, the value of b shall not be less than is shown in Table 1 so as to prevent protrusion of the head of the screw through the plate. The value of t would then be reduced and may reach
27、 zero. The formulae below present the above statements in mathematical terms: if a W areft = t1 if a arefb = b1 + (a aref) where aref, t1 and b1 are the value of a, b and t in Table 1. +0 2, 0 +0 2, 0 0 0 2, Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled
28、 Copy, (c) BSI BS 3531-23.3:1991 BSI 08-19993 3.2 Type B (with conical hole) Type B holes shall be as given in Figure 2. 3.3 Type C (with thread) Type C holes shall be as given in Figure 3 and Table 2. Figure 2 Type B hole for HB 6,5 screw specified in ISO 5835 Figure 3 Type C hole for HB 6,5 screw
29、specified in ISO 5835 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 4 BSI 08-1999 Table 2 Dimensions of type C holes 3.4 Type D (with spherical countersink) Type D1, D2 or D3 holes shall be as given in Figure 4, Figure 5
30、or Figure 6 respectively and Table 3. Dimensions in millimetres d1d2b min. Cylindrical part of countersink (dependent on a) t a ref. 4,7 8,2 0,35 1,43,5 5,50,75 NOTESee note below Table 1. Figure 4 Type D1 hole Figure 5 Type D2 hole Figure 6 Type D3 hole +0 2, 0 +0 2, 0 0 0 2, Licensed Copy: sheffie
31、ldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 BSI 08-19995 Table 3 Dimensions of types D1, D2 and D3 holes Dimensions in millimetres d1reb min. Screws in accordance with ISO 5835 1,6 1,50,10,2HA 1,5 1,9 2,1 20,20,4HA 2 2,6 2,9 2,50,20,4HA 2,7
32、3,4 3,7 30,20,4 HA 3,5 4,2HA 3,5; HA 4; HB 4 4,7a 40,40,5 HA 4,5 5,5aHB 6,5 5,2a 40,40,5 HA 4,5; HA 5 5,9aHB 6,5 6,6b40,40,5HB 6,5 a Diameter d1 may be threaded for the passage of an HB 6,5 screw. b This value should be used only in exceptional cases. +0 2, 0 +0 075, +0 050, +0 15, 0 Licensed Copy:
33、sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 6 BSI 08-1999 Annex A Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools (This annex does not form an integral part of this Standard.) It h
34、as 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 a
35、s 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 below. ISO 5835ISO 9268 Screws Thread Head under-surface Drive connection Mechanical requiremen
36、ts ISO 6475 Breaking torque/angle of rotation In preparation Holes and slotsISO 5836ISO 9269 Plates Mechanical requirementsISO 9585ISO 9585 ISO 8319-1ISO 8319-2 Driving tools Keys and screwdrivers Drill bits, taps, countersink cutters ISO 9714-1In preparation Licensed Copy: sheffieldun sheffieldun,
37、na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 BSI 08-19997 Annex B (informative) Bibliography: International Standards referred to in table of Annex A ISO 5835:, Implants for surgery Metal bone screws with hexagonal drive connection Spherical under-surface of h
38、ead Dimensions3). ISO 5836:, Implants for surgery Metal bone plates Holes corresponding to screws with asymmetrical thread and spherical under-surface4). ISO 6475:, Implants for surgery Metal bone screws with asymmetrical thread and spherical under-surface Mechanical requirements and test methods5).
39、 ISO 8319-1:1986, Orthopaedic instruments Drive connections Part 1: Keys for use with screws with hexagon socket heads. ISO 8319-2:1986, Orthopaedic instruments Drive connections Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws. ISO 9268:, Im
40、plants for surgery Metal bone screws with conical under-surface of head Dimensions4). ISO 9269:1988, Implants for surgery Metal bone plates Holes and slots corresponding to screws with conical under-surface. ISO 9585:, Implants for surgery Method for testing bending strength and stiffness of bone pl
41、ates4). ISO 9714-1:, Orthopaedic instruments Drilling instruments Part 1: Drill bits, taps and countersink cutters4). 3) Will cancel and replace ISO 5835-1 at next revision stage. (ISO 5835-1 cancelled and replaced ISO 5835-1:1978 and ISO 5835-2:1978.) 4) To be published. 5) Will cancel and replace
42、ISO 6475-1:1980 and ISO 6475-2:1980. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 8 blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3:1991 BSI 08-1999 Publication
43、(s) referred to See national foreword. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 29 03:37:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS 3531-23.3: 1991 ISO 5836:1988 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsib
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