1、BRITISH STANDARD BS 3531-5.3: 1991 ISO 5835:1991 Implants for osteosynthesis Part 5: Bone screws and auxiliary equipment Section 5.3 Specification for the dimensions of screws having hexagonal drive connection, spherical under-surfaces and asymmetrical threadBS3531-5.3:1991 This British Standard, ha
2、ving been prepared under the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Standards Boardand comes into effect on 30August1991 BSI 08-1999 First published May 1990 Second edition August 1991 The following BSI references relate to the work on this sta
3、ndard: Committee references HCC/22 Draft announced in BSI News August1991 ISBN 0 580 19969 X 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 fol
4、lowing 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 Managemen
5、t Medical Sterile Products Association Ministry of Defence National Association of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-5.3:1991 BSI 08-1999 i Contents Page Committees responsible
6、 Inside front cover National foreword ii 1 Scope 1 2 Normative references 1 3 Code for screw thread 1 4 Dimensions and tolerances 1 5 Marking and packaging 4 Annex A (informative) Example for combined screw 5 Annex B (informative) Interrelationship of International Standards dealingwithbone screws,
7、bone plates and relevant tools 6 Annex C (informative) Bibliography: International Standards referredtointableofAnnex B 8 Figure 1 Screw with shallow thread (HA) 1 Figure 2 Shallow thread (HA) 2 Figure 3 Screw with deep thread (HB) 3 Figure 4 Deep thread (HB) 4 Figure A.1 Combined screw 5 Figure A.2
8、 Cross-recessed drive connection 6 Table 1 Dimensions of HA series screws 2 Table 2 Dimensions of HA thread 3 Table 3 Dimensions of HB series screws 3 Table 4 Dimensions of HB thread 4 Table A.1 Dimensions of combined screw 5 Table A.2 Dimensions of cross-recessed drive connection 6 Publication(s) r
9、eferred to Inside back coverBS3531-5.3:1991 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 ISO5835:1991 “Implants for surgery Metal bone screws with hexagonal drive connection, spherica
10、l under-surface of head, asymmetrical thread Dimensions”, published by the International Organization for Standardization (ISO) and supersedes BS3531-5.3:1990, which is withdrawn. BS3531-5 was first published in1982 and gave requirements for particular types of bone screw, for taps, drills and screw
11、drivers, and for holes and slots in bone plates. The revision of BS3531-5 offered the opportunity to facilitate the implementation of published and forthcoming International Standards, and to separate, in different Parts of BS3531, requirements for screws and auxiliary equipment from those for bone
12、plates. Requirements for bone screws and their auxiliary equipment are retained in BS3531-5, which is now published in a number of Sections, whilst requirements for bone plates are specified in BS3531-23, also published in Sections. BS3531-5:1982 is withdrawn. This revision of Section5.3 introduces
13、the requirements for screws with hexagonal drive connections. The screws specified in this Section of BS3531 are suitable for use with the keys specified in BS3531-5.1. The mechanical requirements and test methods are given in BS3531-5.6. It is strongly recommended that the products specified in thi
14、s 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 the desirability of third party certification of prod
15、uct 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 will be forwarded by BSI to the Association
16、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. Cross-references International Standard Corresponding British Standard ISO 6018:1987 BS 7254 Orthopaedic implants Part 1:
17、1990 Specification for marking, packaging and labelling (Identical) ISO 6475:1989 BS 3531 Implants for osteosynthesis Section 5.6:1991 Specification for the mechanical requirements and test methods for screws having asymmetrical thread and spherical undersurface (Identical) 1) Compiled by the Depart
18、ment of Health; published and available from Her Majestys Stationery, Office,49 High Holborn, London WC16HB for personal callers or by post from HMSO, PO Box276, London SW85DT.BS3531-5.3:1991 BSI 08-1999 iii A British Standard does not purport to include all the necessary provisions of a contract. U
19、sers 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, pages1to8, an inside back cover and a bac
20、k 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 blankBS3531-5.3:1991 BSI 08-1999 1 1 Scope This International Standard specifies dimensions and tolerances for metal bone
21、screws used in surgery, having hexagonal drive connection, spherical under-surface of the head, and shallow and deep asymmetrical threads. NOTE 1The mechanical requirements for screws that are cited in this International Standard are specified in ISO6475. NOTE 2The interrelationship of International
22、 Standards dealing with bone screws, bone plates and relevant tools is shown for information in Annex B. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this International Standard. At the time of publication, the edit
23、ions 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
24、 valid International Standards. ISO6018:1987, Orthopaedic implants General requirements for marking, packaging and labelling. ISO6475:1989, Implants for surgery Metal bone screws with asymmetrical thread and spherical under-surface Mechanical requirements and test methods. 3 Code for screw thread Th
25、e following code shall be used to identify the type of screw thread conforming to this InternationalStandard: Shallow thread (for cortical screws): Code HA Deep thread (for spongiosa/cancellous screws): Code HB 4 Dimensions and tolerances All dimensions and tolerances are given in millimetres. 4.1 S
26、crew with shallow thread (HA) HA screws shall be as given in Figure 1 and Figure 2 and Table 1 and Table 2. Figure 1 Screw with shallow thread (HA)BS3531-5.3:1991 2 BSI 08-1999 Table 1 Dimensions of HA series screws Code and diameter of thread Nominal diameter d 2 k r 1 r 2 r 3 SW t d 1 tol. F10 a m
27、in. HA 1,5 HA 2,0 1,5 2 3 4 1,6 1,9 1,5 2 1,5 2 0,3 0,4 1,5 1,5 0,8 1,0 HA 2,7 HA 3,5 HA 4 HA 4,5 HA 5 2,7 3,5 4 4,5 5 5 6 6 8 8 2,3 2,6 2,4 4,6 4,6 2,5 3 3 4 4 2,5 2,5 2,5 2,5 2,5 0,4 1 1 1 1 2,5 2,5 2,5 3,5 3,5 1,2 1,5 1,5 2,8 2,8 a F10 = for SW u 3 mm F10 = for SW 3 mm +0,25 0 0 0,10 0 0,15 +0,04
28、7 +0,007 +0,058 +0,010 Figure 2 Shallow thread (HA)BS3531-5.3:1991 BSI 08-1999 3 Table 2 Dimensions of HA thread 4.2 Screw with deep thread (HB) HB screws shall be as given in Figure 3 and Figure 4 and Table 3 and Table 4. Table 3 Dimensions of HB series screws Code and diameter of thread d 1 d 5 e
29、P r 4 r 5 tol. HA 1,5 HA 2,0 1,5 2 1,1 1,3 0,1 0,1 0,5 0,6 0,3 0,4 0,1 0,1 35 35 3 3 HA 2,7 HA 3,5 HA 4 HA 4,5 HA 5 2,7 3,5 4 4,5 5 1,9 2,4 2,9 3 3,5 0,1 0,1 0,1 0,1 0,1 1 1,25 1,5 ab 1,75 1,75 0,6 0,8 0,8 1 1 0,2 0,2 0,2 0,3 0,3 35 35 35 35 35 3 3 3 3 3 a Variation in thread profile: The total para
30、meters of values d 1 , d 5 , e, r 4 , r 5 , and allow the theoretical maximum thread profile to be defined. It is recommended that the maximum variation from the theoretical profile at any point on thread from should not exceed: 0,050mm for HA1,5 andHA2 0,075mm for HA2,7 to HA5 These values may be r
31、econsidered in course of revision. b Attention is drawn to the pitch of the HA4screw, which is1,5mm as compared to that of the HB4screw, which is1,75mm (seeTable 4). 0 0,15 0 0,10 0 0,15 Figure 3 Screw with deep thread (HB) Code and diameter of thread Nominal diameter d 2 d 4 k r 1 r 2 SW t d 1 F10
32、a min. HB4 HB6,5 4 6,5 6 8 2,4 4,5 2,9 4,6 3 4 2,5 2,5 2,5 3,5 1,5 2,8 a F10 = for SW u 3 mm F10 = for SW 3 mm 0 0,15 0 0,15 +0,25 0 +0,047 +0,007 +0,058 +0,010BS3531-5.3:1991 4 BSI 08-1999 Table 4 Dimensions of HB thread 5 Marking and packaging The marking and the packaging shall be in accordance w
33、ith ISO6018. Figure 4 Deep thread (HB) Code and diameter of thread d 1 d 5 e P r 4 r 5 HB 4 HB 6,5 4 6,5 1,9 3 0,1 0,2 1,75 ab 2,75 0,8 1,2 0,3 0,8 25 25 5 5 a Seefootnoteb) in Table 2. b Variation in thread profile: The total parameters of values d 1 , d 5 , e, r 4 , r 5 , and allow the theoretical
34、 maximum thread profile to be defined. It is recommended that the maximum variation from the theoretical profile at any point on thread form should not exceed: 0,075mm for HB This value may be reconsidered in course of revision. 0 0,15 0 0,15BS3531-5.3:1991 BSI 08-1999 5 Annex A (informative) Exampl
35、e for combined screw This screw is an example as mentioned in the introduction for a combination of shallow thread HA4,5 as given in Figure 2 and Table 2 in this International Standard whereas the cross-recessed drive connection is in accordance with Figure7 and Table6in ISO9268:1988. (For informati
36、on, the illustration and the dimensions of the drive connection are given in Table A.1 andTable A.2, and Figure A.1 and Figure 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 ISO9268 and this Intern
37、ational Standard respectively, and the mechanical requirements are specified in ISO6475. A.1 Dimensions Table A.1 Dimensions of combined screw Figure A.1 Combined screw Nominal diameter d 2 k r d 1 max. 4,5 8,0 3,8 5,5 0 0,15BS3531-5.3:1991 6 BSI 08-1999 A.2 Cross-recessed drive connection Table A.2
38、 Dimensions of cross-recessed drive connection Annex B (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 di
39、vided 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 (HAandHB type screws as opposed toHC andHD type screws). A simplified schematic guide illustrating the interrelationship between screws, plates and t
40、ools covered by the two parallel series of International Standards is given on the following page. Figure A.2 Cross-recessed drive connection d b max. n 5,0 3,8 1,4BS3531-5.3:1991 BSI 08-1999 7 Screws Thread Head under-surface Drive connection ISO5835 ISO9268 Mechanical requirements ISO6475 Breaking
41、 torque/angle of rotation In preparation Plates Holes and slots ISO5836 ISO9269 Mechanical requirements ISO9585 ISO9585 Driving tools Keys and screwdrivers ISO8319-1 ISO8319-2 Drill bits, taps, countersink cutters ISO9714-1 In preparationBS3531-5.3:1991 8 BSI 08-1999 Annex C (informative) Bibliograp
42、hy: International Standards referred to in table of Annex B 1 ISO 5835:1990, Implants for surgery Metal bone screws with hexagonal drive connection, spherical under-surface of head, asymmetrical thread Dimensions. 2 ISO 5836:1988, Implants for surgery Metal bone plates Holes corresponding to screws
43、with asymmetrical thread and spherical under-surface. 3 ISO 6475:1989, Implants for surgery Metal bone screws with asymmetrical thread and spherical under-surface Mechanical requirements and test methods. 4 ISO 8319-1:1986, Orthopaedic instruments Drive connections Part 1: Keys for use with screws w
44、ith hexagon socket heads. 5 ISO 8319-2:1986, Orthopaedic instruments Drive connections Part2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws. 6 ISO 9268:1988, Implants for surgery Metal bone screws with conical under-surface of head Dimensions. 7 I
45、SO 9269:1988, Implants for surgery Metal bone plates Holes and slots corresponding to screws with conical under-surface. 8 ISO 9585:1990, Implants for surgery Determination of bending strength and stiffness of bone plates. 9 ISO 9714-1:1990, Orthopaedic drilling instruments Part1: Drill bits, taps a
46、nd countersink cutters 2) . 2) To be published.BS3531-5.3:1991 BSI 08-1999 Publication(s) referred to See national foreword.BS 3531-5.3: 1991 ISO5835:1991 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishSta
47、ndards. It presents the UK view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions BritishStandards are updated by amendment or revision. Users of BritishStandards should make sure that they possess the latest amendments or editions. It is the const
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