BS 3531-15-1992 Implants for osteosynthesis - Specification for devices for the fixation of the ends of the femur in adults《骨结合术 外科植入物 第15部分 成人股骨端固定器件规范》.pdf

1、BRITISH STANDARD BS3531-15: 1992 ISO8615:1991 Implants for osteosynthesis Part15: Specification for devices for the fixation of the ends of the femur in adultsBS3531-15:1992 This British Standard, having been prepared under the directionof the Health Care Standards Policy Committee, waspublished und

2、er the authorityof the Standards Boardand comes into effect on 15July1992 BSI 08-1999 First published May1984 Second edition October1990 Third edition July1992 The following BSI references relate to the work on this standard: Committee reference HCC/22 Draft announced in BSINews 1992 ISBN 0 580 2087

3、4 5 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 Inves

4、tment Casting Trade 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 Ministry of Defence National Association of Theatr

5、e Nurses Royal College of Surgeons of England Royal Veterinary College Scottish Office Amendments issued since publication Amd. No. Date CommentsBS3531-15:1992 BSI 08-1999 i Contents Page Committees responsible Inside front cover National foreword ii Introduction 1 1 Scope 1 2 Normative references 1

6、 3 Materials 1 4 Types of nails and fixation screws 2 5 Dimensions 2 6 Ancillary components for assembly of fixation devices of multi-piece construction 4 7 Surface finish 4 8 Packaging 4 9 Marking 4 Figure 1 Generalized representation and nomenclature of dimensions of one-piece nail plates for use

7、in the upper end of the femur 6 Figure 2 Generalized representation and nomenclature of dimensions of one-piece nail plates for use in the lower end of the femur 7 Figure 3 Generalized representation and nomenclature of dimensions of nails for use alone 8 Figure 4 Generalized representation and nome

8、nclature of fixation screws for use alone 9 Figure 5 Generalized representation and nomenclature of dimensions of plates, with nail or fixation screw, of fixed or adjustable angle for use in the upper end of the femur 10 Figure 6 Generalized representation of plate and sliding nail or fixation screw

9、 for use in the upper end of the femur 11 Figure 7 Generalized representation and nomenclature of dimensions of plate and sliding nail or screw for use on the lower end of the femur 12 Table 1 Expression of sizes of plates, nails and fixation screws 3 Table 2 Minimum wall thickness of cannulation ho

10、les 4 Table 3 Requirements for marking of fixation devices and packages 5 List of references Inside back coverBS3531-15:1992 ii BSI 08-1999 National foreword This Part of BS3531 has been prepared under the direction of the Health Care Standards Policy Committee. It is identical with ISO8615:1991 Imp

11、lants for surgery Fixation devices for use in the ends of the femur in adults, published by the International Organization for Standardization (ISO) and supersedes BS3531-15:1990 which is withdrawn. Requirements for orthopaedic implants (then termed “surgical implants) were published in1962 as BS353

12、1. In1968 a part revision of BS3531:1962 was issued as BS3531-1, which dealt with surgical 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, Part15:1984 giving requirements for femora

13、l fixation devices for use in adults. In view of the increase in the number of Parts, and with a view to facilitating the implementation of published and forthcoming international implant standards, the British Standards relating to implants has been restructured. Accordingly, the number BS3531 now

14、only covers implants for osteosynthesis, BS7251 covers joint prostheses, BS7252 covers metallic material for surgical implants, BS7253 cover non-metallic materials for surgical implants and BS7254 cover orthopaedic implants, i.e.aspects common to both osteosynthesis and joint replacement. The revisi

15、on in1990 introduced editorial changes to reflect this restructuring and updated cross-references but otherwise made no changes to the specification for devices for the fixation of the ends of the femur in adults which was first published as BS3531-15:1984. This edition of BS3531-15 specifies the ma

16、terials, dimensions, surface finish, packaging and marking of metal surgical implants used for the fixation of fractures and osteotomies of the upper and lower ends of the femur in adults. Users of femoral fixation devices should always take care that the correct type and size of instrument is used

17、when fitting and adjusting the device, as failure to do so can result in damage to the device. When using nuts fitted with nylon locking bushes, care should be exercised to ensure that the nut is fully tightened, so that the thread of the nail or screw projects beyond the nylon bush. If, for any rea

18、son, such a nut is removed from the nail of screw during an operation it should be discarded and replaced with a new nut. Similar considerations exist if the components of a fixation device are fastened together by a bolt fitted with a nylon locking insert. Care should be also be taken to avoid the

19、mixing of components from different devices during, for instance, preparation for sterilization. Once implantation has been completed, an implant should never be reused after removal. It is strongly recommended that the products specified in this section of BS3531 should be manufactured according to

20、 the recommendations given in the “Quality Systems for Orthopaedic Implants1990 Good Manufacturing Practice” 1) . Cross-references International Standard Corresponding British Standard ISO261:1973 BS3643 ISO metric screw threads Part1:1981 Principles and basic data (Technically equivalent) ISO272:19

21、82 BS3692:1967 Specification for ISO metric precision hexagon bolts, screws and nuts. Metric units (Technically equivalent) BS7252 Metallic materials for surgical implants ISO5832-1:1987 Part1:1990 Specification for wrought stainless steel (Identical) 1) Compiled by the Department of Health; publish

22、ed and available from Her Majestys Stationery Office,49 High Holborn, London WC16HB for personal callers, or by post from HMSO, P.O.BOX276, London SW85DTBS3531-15:1992 BSI 08-1999 iii The Technical Committee has reviewed the provisions of ISO965-2:1980, ISO5832-3:1990, ISO9268:1988 and ISO9269:1988

23、to which normative reference is made in the text and has decided thay they are acceptable for use in conjunction with this Part of BS3531. Product certification. Users of this British Standard are advised to consider the desirablility of third party certification of product conformity with this Brit

24、ish Standard based on testing and continuing product 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 schemes are forwarded by BSI to the Association of Certificatio

25、n Bodies. If a third party certification scheme does not already exist, users should consider approaching an appropriate body from the list of Association members. International Standard Corresponding British Standard ISO5832-2:1978 Part2:1990 Specification for unalloyed titanium (Identical) ISO5832

26、-4:1978 Part4:1990 Specification for cobalt-chromium-molybdenum casting alloy (Identical) ISO5832-5:1978 Part5:1990 Specification for wrought cobalt-chromium-tungsten-nickel alloy (Identical) ISO5832-6:1980 Part6:1990 Specification for wrought cobalt-nickel-chromium-molybdenum alloy (Identical) ISO5

27、832-7:1984 Part7:1990 Specification for cobalt-chromium-nickel-molybdenum-iron alloy (Identical) ISO5832-8:1987 Part8:1990 Specification for cobalt-nickel-chromium-molybdenum-tungsten-iron-alloy (Identical) BS3531 Implants for osteosynthesis ISO5835:1991 Section5.3:1991 Specification for the dimensi

28、ons of screws having hexagonal drive connection, spherical under-surfaces and asymmetrical thread (Identical) ISO5836:1988 Section23.3:1991 Specification for holes corresponding to screws with asymmetrical thread and spherical undersurfaces (Identical) ISO6018:1987 BS7254 Orthopaedic implants Part1:

29、1990 Specification for marking, packaging and labelling (Identical)BS3531-15:1992 iv BSI 08-1999 A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard doe

30、s not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi to iv, pages1to12, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This w

31、ill be indicated in the amendment table on the inside front cover.BS3531-15:1992 BSI 08-1999 1 Introduction Fixation devices for use in the upper and lower ends of the femur may be made in a variety of configurations, according to the design of the originator or the individual manufacturer. However,

32、 certain dimensions are critical and may not be exceeded without risk of damage to the bone when the device is inserted. Other than specifying this limited number of features, the main object of this International Standard is to ensure uniformity in designating and describing the size of the device

33、in order that devices of different origin but of the same nominal size will not differ significantly in their critical dimensions. It is required that these dimensions be stated on the packaging and marked on the device; it is also required that the packaging carry other information useful to the su

34、rgeon, such as details of instruments and ancillary devices necessary at the implantation of the device. 1 Scope This International Standard specifies the materials, dimensions, surface finish, and packaging and marking of metal surgical implants used for the fixation of fractures and osteotomies of

35、 the upper and lower ends of the femur in adults. The types of devices covered are as follows: a) nails and screws intended to be used alone; b) nail plates and blade plates of one-piece construction; c) fixation devices of multi-piece construction having either a fixed or an adjustable angle; d) fi

36、xation devices of multi-piece construction with sliding nail or screw, with or without a compression device. NOTE 1Figure 1 to Figure 7 are intended to illustrate nomenclature and designation of dimensions, but the representation of the components does not otherwise form part of the requirements spe

37、cified in this International Standard. 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 editions indicated were valid. All standards are subject to revision,

38、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 valid International Standards. ISO261:1973, ISO general-purpose m

39、etric screw threads General plan. ISO272:1982, Fasteners Hexagon products Widths across flats. ISO965-2:1980, ISO general purpose metric screw threads Tolerances Part2: Limits of sizes for general purpose bolt and nut threads Medium quality. ISO5832-1:1987, Implants for surgery Metallic materials Pa

40、rt1: Wrought stainless steel. ISO5832-2:1978, Implants for surgery Metallic materials Part2: Unalloyed titanium. ISO5832-3:1990, Implants for surgery Metallic materials Part3: Wrought titanium 6-aluminium4-vanadium alloy. ISO5832-4:1978, Implants for surgery Metallic materials Part4: Cobalt-chromium

41、-molybdenum casting alloy. ISO5832-5:1978, Implants for surgery Metallic materials Part5: Wrought cobalt-chromium-tungsten-nickel alloy. ISO5832-6:1980, Implants for surgery Metallic materials Part6: Wrought cobalt-nickel-chromium-molybdenum alloy. ISO5832-7:1984, Implants for surgery Metallic mater

42、ials Part7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy. ISO5832-8:1987, Implants for surgery Metallic materials Part8: Wrought cobalt-nickel-chromium-molybdenum-tungsten-iron alloy. ISO5835:1991, Implants for surgery Metal bone screws with hexagonal drive connection, sphe

43、rical under-surface of head, asymmetrical thread Dimensions. ISO5836:1988, Implants for surgery Metal bone plates Holes corresponding to screws with asymmetrical thread and spherical under-surface. ISO6018:1987, Orthopaedic implants General requirements for marking, packaging and labelling. ISO9268:

44、1988, Implants for surgery Metal bone screws with conical under-surface of head Dimensions. ISO9269:1988, Implants for surgery Metal bone plates Holes and slots corresponding to screws with conical under-surface. 3 Materials 3.1 Metallic materials used shall be in accordance with ISO5832, parts1 to

45、8. 3.2 Locking bushes and inserts shall be made from plastics materials. These materials shall not be used for any other part of any of the devices.BS3531-15:1992 2 BSI 08-1999 The plastics materials should be biocompatible and of sufficient strength to provide permanent locking, e.g.by swelling. At

46、 present only polyamide homopolymer type66 (nylon66) is known to be suitable. 4 Types of nails and fixation screws Nails and fixation screws may be divided into three types: Type A nails of rectangular cross-section; Type B nails and fixation screws designed to be inserted without preparation of the

47、 femoral neck and head; Type C nails and fixation screws designed to be inserted only after drilling or other preparation of the femoral neck and head. NOTE 2The use of a nail or screw of too large a cross-sectional dimension might result in bursting of the femoral neck during insertion of the devic

48、e. 5 Dimensions 5.1 General 5.1.1 The expression of sizes of plates, nails and fixation screws shall be as given in Table 1. 5.1.2 The nomenclature of dimensions shall be as shown in Figure 1 to Figure 7. The most important dimension for the surgeon is the effective length of nails and fixation scre

49、ws. 5.2 Cross-sectional dimensions of types A and B nails and fixation screws 5.2.1 Type A nails shall have a maximum width of16mm and a maximum depth of6,5mm (seedimensions b and d respectively in Figure 1 and Figure 2). 5.2.2 In type B implants, the effective length of the nail or fixation screws, as designated in Figure 1 to Figure 7, shall be able to pass through a circle of13mm diameter. NOTE 3Nails and fixation screws of type C are intended for use only where prior drilling or oth