BS 3531-23 3-1991 Implants for osteosynthesis - Bone plates - Specification for holes corresponding to screws with asymmetrical thread and spherical undersurfaces《骨接合术用外科植入物 第23部分 .pdf

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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 undersurfacesBS3531-23.3:1991 This British Standard, having been prepared under the directionof the

2、Health Care Standards Policy Committee, waspublished under the authorityof the Standards Boardand comes into effect on 29 November1991 BSI 08-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment 87/50443 DC ISBN 0 580 20266 6 Committees

3、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 represented: British Institute of Surgical Technologists British Investment Casting T

4、rade Association British Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Department of Health Institute of Sterile Services Management Medical Sterile Products Association National Association of Theatre Nurses Royal College of Surgeons

5、of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-23.3:1991 BSI 08-1999 i Contents Page Committees responsible Inside front cover National foreword ii 1 Scope and field of application 1 2 Reference 1 3 Dimensions and tolerances 1 Ann

6、ex A Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools 6 Annex B (informative) Bibliography: International Standards referred to in table of Annex A 7 Figure 1 Type A hole 1 Figure 2 Type B hole for HB6,5 screw specified in ISO5835 3 Figure 3 Type

7、C hole for HB6,5 screw specified in ISO5835 3 Figure 4 Type D1 hole 4 Figure 5 Type D2 hole 4 Figure 6 Type D3 hole 4 Table 1 Dimensions of type A hole 2 Table 2 Dimensions of type C holes 4 Table 3 Dimensions of types D1, D2 and D3 holes 5 Publication(s) referred to Inside back coverBS3531-23.3:199

8、1 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 ISO5836:1988 “Implants for surgery Metal bone plates Holes corresponding to screws with asymmetrical thread and spherical under-surface”

9、, published by the International Organization for Standardization (ISO). 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 surgical implants made of all materia

10、ls. In1980 the first four Parts of a multi-part version of BS3531 were published. Afurther19 Parts of BS3531 were subsequently published. The revision of BS3531-5 offered the opportunity to facilitate the implementation of published and forthcoming standards, and to separate, in different Parts of B

11、S3531, 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 in Sections. BS3531 now only covers

12、implants for osteosynethesis, 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 joint replacement. It is strongly rec

13、ommended that the products specified in this Section of BS3531 should be manufactured according to the recommendations given in the “Quality Systems for Orthopaedic Implants1990 Good Manufacturing Practice” 1) . Product certification. Users of this British Standard are advised to consider thedesirab

14、ility of third party certification of product conformity with this BritishStandard based on testing and continued surveillance, 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 sc

15、hemes 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 anappropriate body from the list of Association members. A British Standard does not purport to include all the necessary provisi

16、ons 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 andii, pages1 to8, an insid

17、e 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 Standard Corresponding British Standard ISO 5835:1991 a BS 3531 Implants

18、 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 from HMSO,49 High Holborn, London WC16HB f

19、or personal callers, or by post from HMSO, P O Box276, London SW85DT.BS3531-23.3:1991 BSI 08-1999 1 1 Scope and field of application This International Standard specifies the dimensions and tolerances of holes in bone plates used as surgical implants so as to facilitate correct fixing using screws c

20、omplying with ISO5835. NOTE 1This International Standard does not deal with the shape and dimensions of the plates or with the spacing (centre-to-centre distance) of the holes. NOTE 2The interrelationship of International Standards dealing with bone screws, bone plates and relevant tools is shown fo

21、r information in Annex A. 2 Reference ISO 5835, Implants for surgery Metal bone screws with hexagonal drive connection Spherical under-surface of head Dimensions 2) . 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

22、at the stage of draft. Figure 1 Type A holeBS3531-23.3:1991 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 ISO5835 d 1 d 2 b min. t a ref. 1,6 3,1 0,15 0,4 1,3 HA1,5 1,9 3,2 0,25 2,1 4,1 0,1 0,4 1,5

23、 HA2 2,6 4,3 0,25 2,9 5,2 0,15 0,6 1,9 HA2,7 3,4 5,4 0,3 3,7 6,2 0,25 0,9 2,4 HA3,5 4,2 6,4 0,4 HA3,5; HA4; HB4 4,7 8,2 0,35 1,4 3,5 HA4,5 5,5 0,75 5,2 0,6 1,4 3,5 HA5 6 8,2 1 6,6 1,3 HB6,5 NOTEThe values b and t in Table 1 relate to plates of thickness a ref . If the thickness of the plate is great

24、er than a ref , the value oft shall not exceed that shown in Table 1 so as not to weaken the plate. The value of b would then be increased. If the thickness of the plate is less than a ref , the value of b shall not be less than is shown in Table 1 so as to prevent protrusion of the head of the scre

25、w through the plate. The value of t would then be reduced and may reach zero. The formulae below present the above statements in mathematical terms: if aW a ref t = t 1 if a a ref b = b 1+ (a a ref ) where a ref , t 1and b 1are the value of a, b and t in Table 1. +02 , 0 +02 , 0 0 02 ,BS3531-23.3:19

26、91 BSI 08-1999 3 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 HB6,5 screw specified in ISO5835 Figure 3 Type C hole for HB6,5 screw specified in ISO5835BS3531-23.3:

27、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 orFigure 6 respectively and Table 3. Dimensions in millimetres d 1 d 2 b min. Cylindrical part of countersink (dependent on a) t a ref. 4,7 8,2

28、 0,35 1,4 3,5 5,5 0,75 NOTESeenote below Table 1. Figure 4 Type D1 hole Figure 5 Type D2 hole Figure 6 Type D3 hole +02 , 0 +02 , 0 0 02 ,BS3531-23.3:1991 BSI 08-1999 5 Table 3 Dimensions of types D1, D2 and D3 holes Dimensions in millimetres d 1 r e b min. Screws in accordance with ISO5835 1,6 1,5

29、0,1 0,2 HA1,5 1,9 2,1 2 0,2 0,4 HA2 2,6 2,9 2,5 0,2 0,4 HA2,7 3,4 3,7 3 0,2 0,4 HA3,5 4,2 HA3,5; HA4; HB4 4,7 a 4 0,4 0,5 HA 4,5 5,5 a HB6,5 5,2 a 4 0,4 0,5 HA4,5; HA5 5,9 a HB6,5 6,6 b 4 0,4 0,5 HB6,5 a Diameter d 1may be threaded for the passage of an HB6,5 screw. b This value should be used only

30、in exceptional cases. +02 , 0 +0075 , +0050 , +015 , 0BS3531-23.3:1991 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 has been decided that the set of Interna

31、tional 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

32、simplified schematic guide illustrating the interrelationship between screws, plates and tools covered by the two parallel series of International Standards is given below. ISO5835 ISO9268 Screws Thread Head under-surface Drive connection Mechanical requirements ISO6475 Breaking torque/angle ofrotat

33、ion In preparation Holes and slots ISO5836 ISO9269 Plates Mechanical requirements ISO9585 ISO9585 ISO8319-1 ISO8319-2 Driving tools Keys and screwdrivers Drill bits, taps, countersink cutters ISO9714-1 In preparationBS3531-23.3:1991 BSI 08-1999 7 Annex B (informative) Bibliography: International Sta

34、ndards referred to in table of Annex A 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) .

35、ISO6475:, Implants for 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 instruments

36、Drive connectionsPart2: 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 head Dimensions 4) . ISO9269:1988, Implants for surgeryMetal bone platesHoles and slots correspond

37、ing to screws with conical 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 revis

38、ion stage. (ISO5835-1 cancelled and replaced ISO5835-1:1978 and ISO5835-2:1978.) 4) To be published. 5) Will cancel and replace ISO6475-1:1980 and ISO6475-2:1980.8 blankBS3531-23.3:1991 BSI 08-1999 Publication(s) referred to See national foreword.BS 3531-23.3: 1991 ISO 5836:1988 BSI 389 Chiswick Hig

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