BS 3531-5 2-1990 Implants for osteosynthesis Bone screws and auxiliary equipment Specification for screwdrivers for screws having heads with single slot cruciate slot or cross-rece.pdf

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1、BRITISH STANDARD BS 3531-5.2: 1990 ISO 8319-2: 1986 Implants for osteosynthesis Part 5: Bone screws and auxiliary equipment Section 5.2 Specification for screwdrivers for screws having heads with single slot, cruciate slot or cross-recessBS3531-5.2:1990 This British Standard, having been prepared un

2、der the directionof the Health Care Standards Policy Committee, waspublished under the authorityof the Board of BSIandcomes into effect on 31 May 1990 BSI 09-1999 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft for comment 84/53919 DC ISBN 0 580 180

3、97 2 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 represented: British Institute of Surgical Technologists British Inve

4、stment Casting Trade Association British Medical Association British Orthopaedic Association British Steel Industry British Surgical Trades Association Incorporated Department of Health Institute of Sterile Services Management Medical Sterile Products Association Ministry of Defence National Associa

5、tion of Theatre Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Coopted members Amendments issued since publication Amd. No. Date of issue CommentsBS3531-5.2:1990 BSI 09-1999 i Contents Page Committees responsible Inside front cover National foreword ii 0 Introdu

6、ction 1 1 Scope and field of application 1 2 References 1 3 Designs and dimensions 1 4 Materials and grades 5 5 Performance requirements 5 6 Marking 7 Annex Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools 8 Figure 1 Hand screwdriver bit for singl

7、e slot head screws 2 Figure 2 Power-driven screwdriver bit for single slot head screws 3 Figure 3 Screwdriver for screws with cruciate slot 4 Figure 4 Screwdriver bit for cross-recessed head screw 5 Figure 5 Diagrammatic representation of the principle of a torque-testing device 6 Figure 6 Torque-te

8、sting die for bits for cross-recessed head screws 7 Table 1 Dimensions of screwdriver bit 4 Table 2 Hardness of screwdriver blades 6BS3531-5.2:1990 ii BSI 09-1999 National foreword This Section of BS3531-5 has been prepared under the direction of the Health Care Standards Policy Committee and is ide

9、ntical with ISO8319-2:1986 “Orthopaedic Instruments Drive connections Part2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws”, published by the International Organization for Standardization (ISO). BS3531-5 was first published in1982and gave require

10、ments for particular types of bone screw, for taps, drills and screwdrivers, and for holes and slots in bone plates. The revision of BS3531-5:1982 offered the opportunity to facilitate the implementation of published and forthcoming International Standards, and to separate, in different Parts of BS3

11、531, requirements for screws and auxiliary equipment from those for bone plates. Accordingly therefore, requirements for bone screws and 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

12、to be published in Sections. The requirements for screwdrivers in this Section of BS3531-5 supersede those in BS3531-5:1982, which is withdrawn. The screwdrivers specified in this Section of BS3531-5 are suitable for use with the bone screws specified in BS3531-5.4. It is strongly recommended that t

13、he products specified in this Section of BS3531 should be manufactured according to the recommendations given in the “Guide to Good Manufacturing Practice for Orthopaedic implants” 1) . The Technical Committee has reviewed the provisions of ISO683-13, ISO2380 and ISO9268, to which reference is made

14、in the text, and has decided that they are acceptable for use with this standard. Note that the first edition of ISO9268 was published in1988. The publications and drafts referred to in the annex are for information only, and do not affect the validity of this standard. Note that the first edition o

15、f ISO6475 (referred to in footnote3 to the Annex), and the first edition of ISO9269 were published in 1988. It is expected that corresponding British Standards will be prepared in due course to implement ISO5836, ISO6475, ISO9268 and ISO9269. The relationship between British Standards and the other

16、ISO Standards and drafts mentioned in the annex are as follows: 1) Compiled by the Department of Health and Social Security; published and available from Her Majestys Stationary Office. ISBN 0 11 320846 4 Cross-references International Standard Corresponding British Standard ISO 5832-5:1975 BS 7252

17、Metallic materials for surgical implants Part 5:1990 Specification for wrought cobalt-chromium-tungsten-nickel alloy (Identical) ISO 6508:1986 BS 891 Method for Rockwell hardness test Part 1:1962 Testing of metals (Technically equivalent) International Standard British Standard ISO 5835-1:1985 BS 35

18、31 Implants for osteosynthesis Part 5 Bone screws and auxiliary equipment Section 5.3:1990 Specification for screws having asymmetrical thread and spherical under-surfaces (Previously BS 3531-18:1986) (Identical)BS3531-5.2:1990 BSI 09-1999 iii Product certification. Users of this British Standard ar

19、e advised to consider the desirability of third party certification of product conformity with this British Standard based on testing and continuing surveillance, which may be coupled with assessment of a suppliers quality systems against the appropriate Part of BS5750. Enquiries as to the availabil

20、ity 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 purport

21、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. International Standard British Standard ISO 5835-1:1978 (now withdrawn) No re

22、lated or corresponding British Standard ISO 5835-2:1978 (now withdrawn) No related or corresponding British Standard ISO/DIS 5835-3:1983 No related or corresponding British Standard ISO 5835-4:1983 (now withdrawn) BS 3531 Surgical implants Part 5:1982 Specification for surgical bone screws of 4 mm,

23、3.5 mm and 3 mm nominal sizes, countersunk surfaces on bone plates, twist drills, taps and screwdrivers Clause 3 was related and has been superseded by BS 3531-5.4:1990 ISO/DIS 5836-3:1984 No related or corresponding British Standard ISO 5836-4:1984 (now withdrawn) BS 3531 Surgical implants Part 5:1

24、982 Specification for surgical bone screws of 4 mm, 3.5 mm and 3 mm nominal sizes, countersunk surfaces on bone plates, twist drills, taps and screwdrivers Clauses 4 and 5 were technically equivalent and have been superseded by BS3531-23.2:1990 ISO 6475-1:1980 No related or corresponding British Sta

25、ndard ISO 6475-2:1980 No related or corresponding British Standard ISO 8319-1:1986 BS 3531 Implants for osteosynthesis Part 5 Bone screws and auxiliary equipment Section 5.1:1990 Specification for keys for use with screws having heads with hexagon sockets (Identical) ISO 8319-2:1986 This British Sta

26、ndard Summary of pages This document comprises a front cover, an inside front cover, pages i to iv, pages1to 8 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 bl

27、ankBS3531-5.2:1990 BSI 09-1999 1 0 Introduction Essential requirements for all varieties of screwdrivers are the following: the point should accurately engage the head of the screw; the materials used for the manufacture of the blade should be satisfactory from all clinical aspects; the screwdriver

28、should have adequate strength. The purpose of this part of ISO8319is to ensure that this is achieved without imposing undue restriction on design features. 1 Scope and field of application This part of ISO8319specifies requirements for screwdrivers used in orthopaedic surgery for inserting and remov

29、ing bone screws with single slot heads, with cruciate slot or cross-recessed heads. Screwdrivers specified in this part of ISO8319are suitable for use with screws which conform to ISO9268. 2 References ISO 683-13, Heat-treated steels, alloy steels and free-cutting steels Part13: Wrought stainless st

30、eels. ISO 2380, Screwdriver blades for slotted head screws 2) . ISO 5832-5, Implants for surgery Metallic materials Part5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO 6508, Metallic materials Hardness test Rockwell test (scales A B C D E F G H K) 3) . ISO 9268, Implants for surgery Metal bone

31、 screws Dimensions Screws with conical under-surfaces 4) . 3 Designs and dimensions 3.1 Screwdrivers for single slot head screws 3.1.1 Hand screwdrivers Hand screwdrivers for single slot head screws shall either have a bit as shown inFigure 1 and dimensions in accordance with Table 1 or have a bit i

32、n accordance with3.1.2. 2) At present at stage of draft. (Revision of ISO 2380:1979.) 3) At present at the stage of draft. (Revision of ISO/R 80:1968 and ISO 2713:1973.) 4) At present at the stage of draft. (Revision of ISO/DIS 5835-3 and ISO 5835-4:1983.) See the annex for information on the interr

33、elationship between International Standards dealing with bone screws, bone plates and relevant tools.BS3531-5.2:1990 2 BSI 09-1999 3.1.2 Power-driven screwdrivers Power-driven screwdrivers for single slot head screws shall have a bit as shown in Figure 2 and dimensions in accordance withTable 1. Fig

34、ure 1 Hand screwdriver bit for single slot head screwsBS3531-5.2:1990 BSI 09-1999 3 3.2 Screwdrivers for screws with cruciate slot Screwdrivers for screws with cruciate slot shall have a bit as shown in Figure 3 and dimensions in accordance with Table 1. Figure 2 Power-driven screwdriver bit for sin

35、gle slot head screwsBS3531-5.2:1990 4 BSI 09-1999 Table 1 Dimensions of screwdriver bit 3.3 Screwdrivers for cross-recessed head screws 5) Screwdrivers for cross-recessed head screws shall have a bit as shown in Figure 4 and dimensions in accordance withFigure 4. Figure 3 Screwdriver for screws with

36、 cruciate slot Dimensions in millimetres Screwdriver bits Screws in accordance with ISO 9268 Thickness Width a b max. 1,1 4,8 HC 2,9 1,1 5,6 HC 3,5; HC 3,9; HC 4,2 HD 4; HD 4,5 5) These screws are also widely known as “modified Phillips screws”. + 0,03 0,07BS3531-5.2:1990 BSI 09-1999 5 4 Materials a

37、nd grades Screwdriver blades shall be made of one of the following metals: a) martensitic stainless steel (for example, in accordance with grade 5, 6 or 6a of ISO 683-13); b) cold-worked wrought cobalt-chromium-tungsten-nickel alloy in accordance with ISO 5832-5. 5 Performance requirements 5.1 Hardn

38、ess The Rockwell hardness shall be within the range given inTable 2 when tested in accordance with ISO6508. Figure 4 Screwdriver bit for cross-recessed head screwBS3531-5.2:1990 6 BSI 09-1999 Table 2 Hardness of screwdriver blades 5.2 Torque test 5.2.1 Screwdrivers for single slot head screws The sc

39、rewdriver blade shall meet the test conditions laid down in ISO2380 and the blade-to-handle connection shall withstand the appropriate test torque specified in ISO2380. 5.2.2 Screwdrivers for screws with cruciate slot The screwdriver blade shall meet the test conditions as laid down in 5.2.1; howeve

40、r, the test disc used shall comprise two slots that bisect each other at right angles. The dimensions and tolerances of the slots and the characteristics of the test disc shall be in accordance with ISO2380. 5.2.3 Screwdrivers for cross-recessed head screws The screwdriver shall be capable of satisf

41、ying the requirements of the test given in5.2.3.1 and5.2.3.2. NOTEThe test is to be carried out in two stages, the first (see5.2.3.1) being on the screwdriver blade or screwdriver bit with the handle not fitted for the test. The second stage (see5.2.3.2) includes the handle, which in this case, is u

42、sed for the application of torque, thus checking the soundness of the grip of the handle on the blade. Material Rockwell hardness HRC Stainless steel 48 to 54 Wrought cobalt-chromium-tungsten-nickel alloy 48 to 50 Figure 5 Diagrammatic representation of the principle of a torque-testing deviceBS3531

43、-5.2:1990 BSI 09-1999 7 5.2.3.1 Blades and bits Grip the screwdriver blade or bit in a pair of jaws in the tailstock of a torque-testing device (seeFigure 5). Fit the headstock of the machine with a die which complies with the requirements ofFigure 6. Apply a torque of9,7 Nm. Following the applicati

44、on of the minimum test torque, the screwdriver shall not fracture or show permanent deformation. 5.2.3.2 Screwdrivers complete with handles After the test specified in5.2.3.1 has been completed on the screwdriver blade, fit the handle and carry out the following test. Apply a torque of at least9,7Nm

45、 through the handle. Following the application of the minimum test torque, no sign either of any loosening of the grip of the handle on the blade or of other damage shall become apparent. NOTEShape and outside dimensions of the testing die should be suitable for the torque-testing device being used.

46、 6 Marking The screwdriver shall be permanently and legibly marked with the following information: a) the size of the screw (code and thread diameter), in accordance with ISO9268, with which it is intended to be used; b) the manufacturers name or trademark; c) the number of this part of ISO 8319, if

47、 there is space available; d) the material of which it is made, if there is space available. Figure 6 Torque-testing die for bits for cross-recessed head screwsBS3531-5.2:1990 8 BSI 09-1999 Annex Interrelationship of International Standards dealing with bone screws, bone plates and relevant tools (T

48、his annex does not form an integral part of the standard.) 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 o

49、f 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 below. NOTEAttention is drawn to the fact that the breakdown of these International Standards into two parallel series is different from the way in which they were previously categorized; footnotes have been added to clarify