Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine http://pih.sagepub.

com/

Development of standards for orthopaedic implants

J P Paul Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 1997 211: 119 DOI: 10.1243/0954411971534746 The online version of this article can be found at: http://pih.sagepub.com/content/211/1/119

Published by:
http://www.sagepublications.com

On behalf of:

Institution of Mechanical Engineers

Additional services and information for Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine can be found at: Email Alerts: http://pih.sagepub.com/cgi/alerts Subscriptions: http://pih.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav Citations: http://pih.sagepub.com/content/211/1/119.refs.html

Downloaded from pih.sagepub.com by guest on June 5, 2011

119

Development of standards for orthopaedic implants

J P Paul Bioengineering Unit, University of Strathclyde, Glasgow, Scotland

Abstract: This article reviews the need for standards for orthopaedic implants and illustrates the dierences in approach of the European Standard Organization compared to National and International Standards. The areas where new work is being undertaken are outlined. Keywords: implants, orthopaedic, standards, materials, testing, hip joint replacements, knee joint replacements

INTRODUCTION

International Standards for orthopaedic implants have been formulated by committee work over the last quarter of a century and in the past three to four years work has been undertaken on what may seem a similar exercise in producing European Standards whose format and philosophy dier markedly. This article considers the relationships and dierences between the two, and areas where new work is progressing.

INTERESTED PARTIES

The people or organizations concerned with aspects of the use of orthopaedic implants include the patient, the surgeon, the theatre nurse, the purchaser, the manufacturer, the designer and possibly the lawyer and some others. Some of the aspects can be the basis for methods of testing the function, for measuring the materials properties, in dening the shape, the surface condition, sterility and necessary packaging to assure this. Obviously the patient will wish to be assured that the implant is satisfactory in every respect to allow his inrmity, disease or deformity to be ameliorated. The surgeon inserting an implant will want to be assured that the accessories which he must use with it are appropriate, that the instruments are made of suitable material and have sizes appropriate to the device he is using, that the materials will be suitable for the purpose and that the implant does not carry with it unwanted bacterial, viral, pyrogenic, carcinogenic or abrasive material and is in a dened state of sterility. The theatre nurse and the sur-

The MS was received on 26 January 1996 and was accepted for publication on 9 July 1996.
H01196 IMechE 1997

geon will both have a strong interest in being able to recognize from marking on the implant or the label on its package, the important dimensions relating to its use and any precautions needed in its storage, sterilization or insertion. As well as considering price, the purchaser of orthopaedic implants whether for a clinic, a hospital board or national health service will wish to be assured that they are appropriate for the patients treated and in accordance with the needs of the surgeon. The cost of initial purchase is not the sole criterion since the cost of replacement of an unsatisfactory implant some years after initial surgery will probably be twice that of the primary procedure. The manufacturer therefore must be aware of the requirements which purchasers may place on him in respect of compliance with a range of standards and he thus will purchase his materials against requirements of material standards. He will lease or purchase equipment capable of complying with the requirements for surface condition in standards; he will also undertake tests or commission the testing of the product to see that it complies with the standards cited by the purchaser or regulatory authority. The designer will have some knowledge of the function required from the device, the loads which it may be required to transmit in normal use and in occasional abnormal circumstances, together with a detailed knowledge of the anatomy of the parts of the body with which the implant will have some relationship. The design itself will be a compromise between the factors of function, loading, strength of materials and the availability of appropriately biocompatible materials. The lawyer in case of complaints from any of the parties mentioned will have recourse to standards with which it is claimed the implants comply and possibly a test house to determine whether in fact the implants composition, mechanical properties and surface condition comply with the standards.
Proc Instn Mech Engrs Vol 211 Part H

Downloaded from pih.sagepub.com by guest on June 5, 2011

120

J P PAUL

BRIEF HISTORY

The rst standards relating to orthopaedic implants were national standards and specically related to the metals found to be suitable for use within the aggressive environment of the body. The compositions of the metals and alloys were changed by small amounts as knowledge was developed of the reactions between body uids and the metallic oxides on the surface of the materials which resist aggressive corrosion. Biocompatibility has continued to be a major problem and indeed it is now recognized that absolute biocompatibility is generally not achievable: in all uses there is some tissue reaction to a material introduced into the body. Materials are used which are known to be acceptably biocompatible in a particular physical condition when used for a specied purpose, i.e. the bodys reaction to the implant is not so serious as to prejudice the function of the implant or the health of the patient. Countries of the developed world with their own committees developed standards on a range of metals and alloys and it transpired that in dierent countries these were largely of the same composition with minor dierences in respect of, for instance, the amount of inclusions or trace elements allowable. Countries aliated to the International Standards Organization (ISO) therefore agreed compromise compositions, metallurgical treatment and specications for mechanical strength of appropriate metals. Each International Standard is now generally circulated with dual numbering corresponding to ISO and each national body and the original national standards for each material are discontinued. For the development of standards for implants, the methods of mechanical testing and of chemical analysis were already in place in standards and thus compliance (or not) with the requirements of the international standard could be demonstrated in any well-equipped and staed testing laboratory. In some countries the test laboratories have been under government control but it has always been possible although sometimes expensive for an interested person or body to commission an independent test house to nd whether a particular implant satised a particular set of requirements.

NATIONAL AND INTERNATIONAL STANDARDS

National and International Standards generally deal with an individual topic and several need to be consulted to determine the aspects of individual joint replacements. Some standards prescribe metal, ceramic and polymeric materials for use in implants. These generally quote the chemical composition in respect of the ranges of acceptable proportions of the basic constituents and the corresponding maximum amounts of undesirable constituents or trace elements. They also quote the physical or metalProc Instn Mech Engrs Vol 211 Part H

lurgical condition of the material and the corresponding mechanical strength characteristics which are generally stated for the material delivered to the nal manufacturer for use in the fabrication of the implant. Only rarely are the material properties quoted for the implant in its nal condition. This leads naturally to diculties in assessment of failures! Other standards indicate specic ways of designating the dimensions of implants, for example in respect of femoral components of total hip joints, the stem and neck lengths and the dimensions of the collar, if present. Thus in clinical use the implant required for a particular patient may be selected from the catalogue dimensions of a range of products by comparing them with for instance the X-ray images of the patient. A third category of standard relates to mechanical testing to establish for instance the endurance properties of implants. Other categories of standards relate for instance to care and handling of implants and procedures for retrieval and analysis of implants following surgical removal or post-mortem examination. One feature always foreseen as a major attribute of standardization is interchangeability and this has been achieved in certain areas such as the shape of the contact surfaces of plates for fracture xation and the corresponding screws. These are either spherical of a specic radius for each diameter of screw or of a specied conical form. The same has been achieved largely in respect of instruments used in the insertion or removal of devices so that the skier fracturing a limb in Switzerland and treated in that country may expect that an orthopaedic department anywhere in Britain would have the appropriate instruments to remove the implant. Unfortunately, this accord has not penetrated to one particular area of construction, namely modular heads for the femoral component of joint replacements at the hip. These have a spherical articulating surface and an internal cone to connect with the cone on the stem of the implant. Progress towards a standard for the dimensions and tolerances for the tapers has been terminated, largely because there has been too great a proliferation of dierent sizes and angles by individual companies. If the cones do not match the bores exactly, ceramic spherical heads may be broken and metallic heads may be subjected to fretting; this results in production of debris and an undesirable tissue reaction. If it is not clear before surgery what size of implant will be necessary, more than one set may be present in the operating theatre and a mistake in matching may occur because there is little obvious dierence between them. The other risk situation is exemplied by the patient with a loose acetabular cup which needs to be replaced. If the femoral component is rmly secured it makes good sense to remove the spherical head and replace it. Unfortunately no external imaging system allows the precise identication of the characteristics of the taper connection before surgery. If the surgeon proceeds with removal he is faced with a major problem if an exact replacement is not available.
H01196 IMechE 1997

Downloaded from pih.sagepub.com by guest on June 5, 2011

DEVELOPMENT OF STANDARDS FOR ORTHOPAEDIC IMPLANTS

121

He may even be unable to identify the taper when he holds the detached head in his hand since many manufacturers do not provide identication marks. Even if they did, the hospital is unlikely to stock the whole range of implants even from one country. It is unfortunate that orthopaedics has not so far been able to bite the bullet in the way that the manufacturers of tubing connectors agreed on a standard Luer connector for medical use.

EUROPEAN STANDARDS

Countries of the European Union are now moving rapidly towards a set of European Standards for medical devices. These were set up as a result of the Medical Device Directives from the EU Council ( 1 ) with regard to the requirements for the manufacturer to ensure all aspects of safety to the patient and others involved in the delivery of the implant within the body. These Directives comprise 13 clauses, many of them with as many as 12 subclauses written in very general terms. These have required interpretation into the form of sets of European Standards compiled so that manufacturers who comply with them can demonstrate that their product has been designed, manufactured, tested, sterilized, packaged and labelled in accordance with the Directives. From 1 January 1997 no surgical implant may be marketed in the community unless it carries the CE mark. Additionally any implant carrying the CE mark may be sold or used in any EU country regardless of its country of origin. These standards are written at three levels of generality. Of interest to this article is the level 1 standard on surgical implants prEN 14630 ( 2 ) which deals with all categories of non-active surgical implants. There is also a level 1 standard dealing with instruments used in association with surgical implants ( 3 ). One of the level 2 standards prEN12010 ( 4 ) deals more specically with joint replacement implants. Others of the family at this level deal with implants for osteosynthesis and other topics not relevant to the present discussion such as vascular or mammary replacements and IU devices. Level 3 standards for hip joint replacements ( 5 ) and knee joint replacements ( 6 ) have been circulated for public inquiry to the member countries of the EC and the level 1 and level 2 standards are at correspondingly further advanced stages. Relating to joint replacements there are major dierences between the philosophies of the EC standards and those of the International Standards Organization (ISO). The philosophy adopted in the non-active surgical implants area of European Standards is to prescribe how the manufacturer should begin the design process for a specic implant by specifying and recording the intended function of the implant. This will include information related to functional characteristics, typical intended application and intended conditions for use, all
H01196 IMechE 1997

with particular regard to safety. The design attributes to allow these intended aspects of performance to be achieved must be identied and recorded. Account must be taken of the factors shown in Table 1. Records must be made of the materials and manufacturing aspects of the nal component and the preclinical and clinical tests necessary to demonstrate that the implant satises the Essential Requirements of the EC directive. Preclinical evaluation can be by literature review and/or analysis or preclinical testing. Clinical evaluation may also comprise literature review and analysis or specify clinical investigations. The manufacturer must also record the sterilization procedures required and dene the packaging requirements; in addition he is required to mark and label the components, and if necessary warn about aspects of their use or insertion which might involve risk of injury to the patient or any other person. This information may be on the package or in the literature supplied with the device or in the manufacturers manual of instructions, which should incorporate any restrictions on the type, design or material of other devices with which it might be assembled. The philosophy adopted in the European Standards is to cite relevant International Standards for materials, features of implants and methods of test and thus overlap between the two families has largely been avoided. The European Standards relate exclusively to actions to be taken by the manufacturer which, if successfully undertaken, will allow him to claim compliance with the Directives and thus apply the CE mark to his product. As far as the surgeon is concerned by a reading of the literature supplied by the manufacturer he should be able to decide which implant of a particular kind is appropriate for each patient in his care, but the process of surgical implantation is not covered by standards at all. As far as the patient is concerned the manufacturers information supplied to the surgeon will generally indicate any warnings that should be transmitted about recommended maximum body weight or level of activity in daily living or in recreation and these are necessarily couched in very brief and vague terms. The surgeon and manufacturer therefore may equally have diculty in defending themselves from a claim if the implant has failed because of the patients activity level.

6 MATERIALS FOR ORTHOPAEDIC IMPLANTS In general, standards reect past experience and consequently it is important to write them in such a way that they are not restrictive of new developments. Metals used in orthopaedic implants are covered by a series of standards which are subject to minor changes as they come up for review every ve years. The last major innovation in this eld was the international standard for highnitrogen stainless steel. It is interesting to consider the situation of titanium and its alloys which rst progressed
Proc Instn Mech Engrs Vol 211 Part H

Downloaded from pih.sagepub.com by guest on June 5, 2011

122

J P PAUL

Table 1 Design attributes to be addressed for joint replacement implants as specied in draft European Standards
Level 1 Standard for non-active surgical implants Materials and their biocompatibility Physical, mechanical and chemical properties of materials, including endurance properties and ageing Materials wear characteristics and the eect of wear and wear products on the implant and the body Eect on material characteristics and performance of sterilization processes The possible eects on the implant and its function of interactions between its constituent materials and other materials and substances The extent and eect of leakage and/or diusion of substances used to ll implants Interconnecting parts and their eects on the intended performance Interface between the implant and body tissue, particularly relative to xation and connection, and surface conditions Shape and dimensions including their possible eects on tissues and body uids Biocompatibility of the product in its implantable state The physical and chemical eects of the body and external environment on the implant The eect of radiation and electromagnetic elds on the implant and the body The ability to implant, to remove and to replace Microbiological and particulate contamination levels The strength of the adhesion and durability of surface coatings and surface treatments The wear of the articulating and other surfaces Stability of the implant while allowing prescribed minimum and maximum relative movements between the skeletal parts Avoidance of cutting or abrading tissue during function other than insertion or removal The creep resistance and rupture characteristics, particularly as they relate to ligaments Radio-opacity of acetabular components made of plastics alone Tolerances and dimensions Thickness of UHMWPE Fit of modular acetabular components Thickness of UHMWPE in tibial components Finish of non-articulating regions of metallic knee joint components

Level 2 Standard for joint replacement implants

Draft Level 3 Standard for hip joint replacements

Draft Level 3 Standard for knee joint replacements

to International Standards in the late 1960s and early 1970s as the aerospace industry was developing a wide range of appropriate new materials based on titanium; from these a list of suitable alloys was approved for surgical use. Titanium and its alloys have been found to be acceptably biocompatible and indeed appear to be receptive to integration with growing bone. Some years after the introduction of the list a note was circulated suggesting withdrawal of the standards relating to several of the titanium alloys, since they were no longer in use in the aerospace industry. The consequence of these decisions made by the aerospace industry was that the particular titanium alloys were unlikely to be produced by the manufacturers, since internationally the quantities required for medical use would not be justiable in commercial terms. Titanium has progressed from its initial popularity in a negative direction since revision surgery involving titanium and titanium alloy implants has shown that articulating surfaces of titanium in many cases produce material that causes extensive blackening of body tissues and progressive wear. Titanium alloys appear to have good wear characteristics in laboratory pin-on-disc tests but much less so in service, where it appears that harder materials such as bone cement or chips of bone have been drawn into the lubricating lm. Mahmoud et al. ( 7 ) report an increased rate of osteolysis in the presence of titanium wear debris and Lilley et al. ( 8 ) also report on a titanium component of a complete femoral replacement which showed denite wear patterns on a surface on which only soft tissue was moving
Proc Instn Mech Engrs Vol 211 Part H

and pressing. It is claimed, however, that with appropriate surface treatments titanium and titanium alloys can be made wear resistant to a sucient degree to justify their use as an articulating surface; but it is also suggested that despite appropriate surface treatment wear will still occur at an unacceptable rate in the presence of a third body. In this developing situation the current drafts of the level 3 European Standards indicate that titanium and titanium alloys should in general be used for articulating surfaces of joint replacements at the hip and at the knee only if particular attention is paid to surface treatment. Plastic materials are represented by ultra-high molecular weight polyethylene ( UHMWPE ), which is extensively used for the concave surface articulating with a convex metallic or ceramic material. The standard for UHMWPE is at present under revision because of concern that the materials wear properties are or may be aected by sterilization procedures, storage conditions and duration of storage prior to implantation. The quality of UHMWPE seems also to vary with the manufacturer and the manufacturing process. The current standard under revision will, it is hoped, incorporate a criterion to assess the eectiveness of the fusion between the polyethylene particles when they are moulded into block form. The other polymer material widely utilized in orthopaedic implants is polymethyl methacrylate or bone cement. The present standard has remained in force since a revision in 1992, although as a material some
H01196 IMechE 1997

Downloaded from pih.sagepub.com by guest on June 5, 2011

DEVELOPMENT OF STANDARDS FOR ORTHOPAEDIC IMPLANTS

123

questions arise about its use in surgery due to its low mechanical strength in tension and shear, and also due to the exothermic nature of the reaction of the cement following mixing of the constituents prior to implantation. Where this cement is in contact with bone and there is no large heat sink in the form of a substantial metal component, the temperatures may rise to a level at which the viability of the surface layer of the bone with which it is in contact may be prejudiced. Developments have been reported for suggested alternatives to the present bone cement but no data relating to long-term clinical use have been published to allow prescription of standards. Ceramics have been found to be useful materials for the articulating surfaces of convex components for joint replacements and their major use currently is in the form of components with a spherical surface attached to a metal component implanted within the medullary cavity of the femur by means of a tapered connection. Reference has been made to this previously. Mention has been made to the wear characteristics of material pairs and there is currently concern that wear particles, particularly of UHMWPE, are nding their way into the medullary cavity of the femur and, because of the inability of the macrophages to cope with them adequately, are responsible for progressive loss of bone material by an osteolytic process. This osteolysis results in there being insucient bone remaining to form adequate support for the implant and failure may occur by fracture of the implant or of the bone (or both) requiring immediate palliative surgery. Consequently there is considerable interest in the revived use of metal-on-metal and ceramic-on-ceramic material pairs for the articulating surfaces of total hip joint replacements.

MECHANICAL TESTING

Attempts are being made at the present time to develop standards for machines to undertake wear tests of components of joint replacements and to dene precisely the test procedures. After this is accomplished standards will be written for the performance of implants when subjected to such wear tests. These performance requirements will be written in terms of maximum amounts of wear either measured gravimetrically or on a volumetric basis following multiple cycles involving displacements and loads deemed to suciently represent the conditions to which the implants will be subjected during use within the patient over an extended number of years. Pin-ondisc tests of material pairs require scrupulous care in their conduct and interpretation of their end results, but unfortunately have not been found to correspond totally to the clinical experience of cycles of loading of implants within the body and are not covered in standards relating to joint replacement. There appears to be a consensus that the ultimate laboratory test of a joint replacement
H01196 IMechE 1997

requires simulation of the cyclic three-dimensional movements and forces on implants in their nal condition before implantation. As an approach to controlling the factors known to be important in reducing wear of articulating surfaces, the current standards specify surface roughness R and, a if they are spherical, their deviation from sphericity. The tolerances on the nominal dimensions for the diameter of the sphere in the femoral component and of the socket in the acetabular component are also specied for articulation between metal and UHMWPE and ceramic and UHMWPE. Proposals have been put forward for other material pairs, such as metal-on-metal and ceramic-onceramic. Fatigue failure of orthopaedic implants was a problem in the 1970s. Failure of the stems of the femoral component of total hip joint replacements was found to occur at a distance from the tip of the stem equal to about one third of the stem length. The biomechanical situation corresponds to the loss of proximal support due to bone resorption or fracture of the surrounding cement while the lower end of the stem remained rmly xed in cement. The head of the femoral component is subjected to a three-dimensional cyclic force system due to the ground to foot forces and the tensions in the muscles combining to give a joint reaction force of magnitude several times body weight whose direction changes during the walking cycle. In the early history of joint replacements patient selection concentrated on those of advanced years with comparatively limited activity level. Consequently their walk could be thought of more as a shue than a normal gait cycle and the loads on the early joint replacements were estimated to correspond to the forces developed in one-legged standing ( 9 ). Fatigue tests were set up in manufacturers laboratories considering this form of loading in the plane including the stem and neck of the implant. In some cases the load was applied in the physiological direction as shown by the Inman analysis ( 9 ) and in others it was applied parallel to the nominal stem axis for no very good reason. Studies on joint loading based on gait analysis of normal subjects by Paul ( 10, 11 ) and Brown et al. ( 12 ) showed that in the normal individual the loading on the proximal femur was three-dimensional in nature, corresponding to bending about the two axes of the cross-section of the prosthetic stem together with longitudinal force and torsion. The British Standard and subsequently an International Standard were compiled for fatigue testing of femoral stems in a way corresponding to the load system predicted from gait analysis, as shown in Fig. 1. This type of test was justied by the work of Wroblewski ( 13 ), whose analysis of a large number of failed femoral components showed the fracture surface to be on a plane inclined to the stem axis at the angle predicted from the gait analysis. The International Standard for the planar testing has now been recommended for withdrawal. Modern designs of femoral component have avoided the
Proc Instn Mech Engrs Vol 211 Part H

Downloaded from pih.sagepub.com by guest on June 5, 2011

124

J P PAUL

Fig. 1 Schematic diagram of the arrangements for fatigue testing of femoral components of hip joint replacements (adapted from ISO 7206, Part 4) slender stems corresponding to those found to fail earlier, and it has been suggested that it is now unnecessary to conduct fatigue tests of the type specied. However, although the test was devised for implants tted with the use of bone cement, it has been found relevant to some failures of non-cemented implants. One of the present trends intended to ensure osseointegration of noncemented stems has been texturing of the surface and it is obviously necessary to determine the notch eect of these on the fatigue strength. Additionally, as dierent materialssome of them nonmetallicare suggested for these implants, it is still important that their fatigue strength be demonstrated to be adequate. Recent studies have shown fatigue failures of the metal trays supporting UHMWPE articulating surfaces of total knee replacements. An ASTM (American Society for Testing Materials) test has been drafted for a fatigue test reproducing the in vivo loading conditions and an International Standard is being developed, based on the system shown in Fig. 2.

Fig. 2 Schematic diagram of the arrangements for fatigue testing of tibial trays of total knee joint replacements cannot be assessed by use of the existing (historical ) standards. Continuous review of standards must therefore be carried out. The ISO and CEN standards are automatically revised every ve years and at intermediate times as new information becomes available. One of the diculties in standard writing for orthopaedic implants is exemplied by comparison of the service life of loading and articulating of the 65 years old patient who received a total hip replacement in 1969 expecting a sedentary life up to the age possibly of 75 years with that of a patient who might at present be aged 40 to 50 years and may receive a hip joint replacement which he hopes will allow an active life style up to age 70 and less
H01196 IMechE 1997

PROBLEMS FOR THE FUTURE

Standards are written based on clinical experience; they take account of the materials and surface treatments available and the manufacturing capability. Thus there will always be situations where new design concepts
Proc Instn Mech Engrs Vol 211 Part H

Downloaded from pih.sagepub.com by guest on June 5, 2011

DEVELOPMENT OF STANDARDS FOR ORTHOPAEDIC IMPLANTS

125

actively up to age 80 years. In other words, the implants which performed satisfactorily over a 10 year period have to be compared with the expectations of patients which may extend to 30 years survival with considerably greater load cycles. Additionally, a newly developed implant may require a clinical assessment over a period of at least 10 years before it can be determined that it has any advantage over competitive products and time would elapse after this nding before the aspects of the new design could be incorporated into standards. REFERENCES
1 Council Directive 92/93 EEC 1993 Essential requirements for non active medical devices (EU Council ). 2 prEN 14630, 1995 Level 1 Standard for non-active surgical implants (CEN, Brussels). 3 prEN 14631, 1995 Level 1 Standard for instrumentation for use in association with surgical implants (CEN, Brussels). 4 prEN 12010, 1995 Level 2 Standard for joint replacement implants (CEN, Brussels). 5 prEN 12563, 1996 Level 3 Standard for hip joint replacement implants (CEN, Brussels). 6 prEN 12564, 1996 Level 3 Standard for knee joint replacement implants (CEN, Brussels). 7 Mahmoud, S. N., Hunter, J. D., Wallace, W. A. and Joliusson, R. One step forwardtwo steps back: early femoral component loosening in the newer design of cemented hip replacement. BOA meeting, Aberdeen, 1995. 8 Lilley, P. A., May, D. R., Walker, P. S. and Blunn, G. W. Dynamic erosion of large implant surfaces by soft tissue. In Advances in Biomaterials (Eds P. J. Doherty et al.), Vol. 10, pp. 153157 ( Elsevier Science Publishers). 9 Inman, V. T. Functional aspects of the abductor muscles of the hip: J. Bone Jt Surg., 1947, 23, 607619. 10 Paul, J. P. Forces transmitted by joints in the human body. Proc. Instn Mech. Engrs, 1967, 181, Part 3J, 815. 11 Paul, J. P. Force actions transmitted by joints in the human body. Proc. R. Soc. Lond. B, 1970 192, 163172. 12 Brown, T. R. M., Nicol, A. C. and Paul, J. P. Comparison of forces transmitted by Charnley and CAD Muller total hip arthroplasties. Proceedings of Conference on Engineering and Clinical Aspects of Endoprosthetic Fixation, Institution of Mechanical Engineers, London, 1984, pp. 6368. 13 Wroblewski, B. M. Mechanism of fracture of the femoral prosthesis in total hip replacement. Int. Orthop., 1979, 3 (2), 137139.

ISO 5832-4

APPENDIX International Standards for orthopaedic implant materials ISO 5832-1 ISO 5832-2 ISO 5832-3 Implants for surgeryMetallic materialsPart 1: Wrought stainless steel Implants for surgeryMetallic materialsPart 2: Unalloyed titanium Implants for surgeryMetallic materialsPart 3: Wrought titanium 6aluminium 4vanadium alloy

Implants for surgeryMetallic materialsPart 4: Cobaltchromiummolybdenum casting alloy ISO 5832-5 Implants for surgeryMetallic materialsPart 5: Wrought cobaltchromiumtungstennickel alloy ISO 5832-6 Implants for surgeryMetallic materialsPart 6: Wrought cobaltnickel chromiummolybdenum alloy ISO 5832-7 Implants for surgeryMetallic materialsPart 7: Forgeable and cold-formed cobalt chromiumnickelmolybdenum iron alloy ISO 5832-8 Implants for surgeryMetallic materialsPart 8: Wrought cobaltnickel chromium molybdenum tungsten iron alloy ISO 5832-9 Implants for surgeryMetallic materialsPart 9: Wrought high nitrogen stainless steel ISO 5832-10 Implants for surgeryMetallic materialsPart 10: Wrought titanium 5aluminium 2.5iron alloy ISO 5832-11 Implants for surgeryMetallic materialsPart 11: Wrought titanium 6aluminium 7niobium alloy ISO 5832-12 Implants for surgeryMetallic materialsPart 12: Wrought cobaltchromiummolybdenum alloy ISO 5833-1 Implants for surgery. Acrylic resin cementsPart 1: Orthopaedic applications ISO 5834-1 Implants for surgeryUltra-high molecular weight polyethylenePart 1: Composition A Note 1: The material described in ISO 5834-1 as composition B is at present more accurately specied in ASTM F 648-84. The Standard ISO 5834-1 is currently under revision. ISO 5834-2 Implants for surgeryUltra-high molecular weight polyethylenePart 2: Moulded form ISO 6474 Implants for surgeryCeramic materials based on high purity alumina Note 2: Work is at present in progress in ISO TC 150/SC1 to produce Standards for zirconia ceramic (ISO DIS 13356), ceramic hydroxyapatite and polyaryletherketone (PAEK ). Pending the publication of ISO standards, ceramic hydroxyapatite specied in ASTM F 1185-93, has been shown to be acceptable.

Selected National Standards relating to implants BS 6324-1 BS 6324-2 Terms relating to surgical implantsPart 1: Glossary of general medical terms Terms relating to surgical implantsPart
Proc Instn Mech Engrs Vol 211 Part H

H01196 IMechE 1997

Downloaded from pih.sagepub.com by guest on June 5, 2011

126

J P PAUL

BS 6324-3 BS 6324-4 BS 6324-5 ASTM F746 ASTM F897 ASTM F1147 ASTM F1223 ASTM F370 ASTM F604 ASTM F997

2: Glossary of terms relating to mechanics Terms relating to surgical implantsPart 3: Glossary of terms relating to materials Terms relating to surgical implantsPart 4: Glossary of orthopaedic surgical terms Terms relating to surgical implantsPart 5: Use of the terms Varus and Valgus Test method for pitting or crevice corrosion of metallic surgical implants Test method for measuring fretting corrosion of osteosynthesis plates and screws Test method for tension testing of porous coatings Test method for determination of total knee replacement constraint Specication for proximal femoral prosthesis Classication of silicone elastomers used in medical applications Specication for polycarbonate resin for medical applications

ASTM F1185 Specication for ceramic hydroxylapatite for surgical implants ASTM F1351 Specication for articulating total wrist implants ASTM F1378 Specication for shoulder prosthesis DIN 58840-1 Hip joint prosthesesMethod for determination of endurance properties of metallic stemmed femoral components NF 594-063 Mate riaux pour implants chirurgicaux Produits ce ramiques a ` base de zircone te tragonale stabilise e a ` yttrium. (English translation: Materials for surgical implantszirconia ceramic of tetragonal form stabilized with yttrium). NF 594-065 Mate riaux pour implants chirurgicaux Dosage darsenic, du mercure, du cadmium et du plomb sur les reve ` tements a base de phosphate de calcium. (English translation: Materials for surgical implantsdosage of arsenic, mercury, cadmium and lead in coatings based on calcium phosphate).

Proc Instn Mech Engrs Vol 211 Part H

H01196 IMechE 1997

Downloaded from pih.sagepub.com by guest on June 5, 2011