ISO/TC 150/SC 4 - Bone and joint replacements

This document specifies a test method for determining the endurance properties, under specified laboratory conditions, of tibial trays used in knee-joint prostheses to support and secure the plastic articulating surface. It applies to tibial trays which cover both the medial and lateral plateaux of the tibia. The test method does not apply to tibial components manufactured solely from plastic materials. This document does not cover methods of examining and reporting the final condition of the test specimen; these can be the subject of agreement between the test laboratory and the parties submitting the specimen for test. NOTE Correlation of test results with in vivo performance has not been established.

This document specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total ankle-joint prostheses in wear-testing machines with load or displacement control. NOTE This document is based on the method described by ISO 14243‑1 and ISO 14243‑3 and allows for the use of the same test equipment as for total knee replacement wear testing.

This document specifies the relative angular movement between articulating patellofemoral joint components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the durability testing of total knee-joint prostheses in wear-testing machines with load control and displacement.

This document specifies methods of determining the compressive (fracture) or the tension (disassembly) loads required, under specific laboratory conditions, to cause failure of a modular head system. This document applies to components made of metallic and non-metallic materials, such as femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection). This document excludes methods of examining and reporting the test specimens.

This document specifies the test conditions to simulate edge loading in hip prostheses due to steep acetabular cup inclination angle and dynamic separation conditions. This document is used in conjunction with ISO 14242‑1 or ISO 14242‑3.

ISO 11491:2017 specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses.

ISO 19233-1:2017 provides requirements for capturing necessary bone geometries, when using a medical X-ray computed tomography apparatus, to provide the information for applications such as preoperative planning, surgical navigation, robotic surgeries, patient matched instruments and personalized total knee joint prosthesis. The conditions to scan images of bones and the conditions to reconstruct three-dimensional bone models are provided. NOTE Requirements for the competence of testing laboratories appropriate to help to ensure the reliability and accuracy of the computational measurements can be found in ISO/IEC 17025.

ISO 7206-12:2016 specifies a test method for determining short-term deformation of a press-fit acetabular component for total hip joint replacement under specific laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account and it describes how the specimen is set up for testing. Furthermore, this part of ISO 7206 specifies the test parameters of press-fit acetabular components tested in accordance with this part of ISO 7206. The described method is intended to be used to evaluate the comparison of various designs and materials used for acetabular components in total hip joint replacement when tested under similar conditions. The loading of the acetabular components in vivo will, in general, differ from the loading defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. ISO 7206-12:2016 does not cover methods of examining the test specimen.

ISO 14242-2:2016 specifies methods of assessment of wear of the acetabular component of total hip-joint prostheses using gravimetric techniques and changes in dimensional form of components tested in accordance with ISO 14242‑1 or ISO 14242‑3 as appropriate.

ISO 14243-2:2016 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243‑1 or ISO 14243‑3 as appropriate.

ISO 7206-13:2016 describes a method of determining the torque required, under specified laboratory conditions, to loosen the fixation of the head of hip joint prostheses in which the head is not intended to rotate relative to the neck. It applies to the femoral component of total or partial hip joint replacements in which the head and neck/stem (in the following referred to as cone) are secured together by a locking conical taper or any other means and in which the head and cone are separate components, and which are made of metallic or non-metallic materials. It does not cover methods of examining the test specimens; these should be agreed between the test laboratory and the party submitting the specimen for test.

ISO 14242-1:2014 specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration, and the test environment to be used for the wear testing of total hip-joint prostheses.

ISO 14243-3:2014 describes a test method that specifies flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control. The kinematics of this part of ISO 14243-3:2014 may not be applicable to knee designs with a high degree of constraint, which could result in damage to the articulating components in the early stages of the test that would not be representative of clinical service.

ISO 7206-6:2013 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of the neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. It is applicable to modular and non-modular designs made of metallic or non-metallic materials. It also specifies the test conditions so that the important parameters that affect the hip femoral components are taken into account and describes how the specimen is set up for testing.

ISO 16087:2013 provides requirements for the clinical assessment of migration of orthopaedic implants with roentgen stereophotogrammetric analysis (RSA).

ISO 7207-2:2011 specifies surface finish requirements for the articulating surfaces of total and partial knee joint prostheses classified in ISO 7207-1. ISO 7207-2:2011 is intended to provide guidance for periodic validation of production processes.

ISO 7206-2:2011 specifies requirements for the articulating surfaces of those types of total and partial hip joint prostheses that provide a joint replacement of ball and socket configuration, as follows: sphericity and surface finish requirements for metallic and ceramic femoral prostheses for partial hip joint replacement that are in accordance with classification a) of ISO 7206-1; sphericity and surface finish requirements for bipolar heads with plastics inner surfaces which articulate on femoral components that are in accordance with classification a) of ISO 7206-1 and with metallic or ceramic outer surfaces which articulate on the biological acetabulum; sphericity and surface finish requirements and dimensional tolerances for plastics acetabular components that are in accordance with classification b) of ISO 7206-1; sphericity and surface finish requirements and dimensional tolerances for metallic or ceramic femoral components of total hip joint prostheses that are in accordance with classification c) of ISO 7206-1, designed to articulate on plastics acetabular components.

ISO 17853:2011 specifies methods for sampling wear particles generated by joint replacement implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissues excised from around the joint replacement implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).

ISO 7206‑4:2010 specifies a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints under specified laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account, and describes how the specimen is set up for testing. Furthermore, ISO 7206‑4:2010 specifies the test parameters and the requirements for the endurance limit of stemmed femoral components tested in accordance with this document. The value of the endurance limit test forces and the corresponding number of load cycles are specified.

ISO 14243‑1:2009 specifies the flexion/extension relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines with load control.

ISO 14242-3:2009 specifies relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the orbital bearing type wear testing of total hip joint prostheses.

ISO 7206-1:2008 provides a means of classification and standardizes the designation of dimensions for partial and total hip joint prostheses.

ISO 21536:2007 provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

ISO 21534:2007 specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, referred to as implants in the text. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term "implant". ISO 21534:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer.

ISO 21535:2007 provides specific requirements for hip joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer, and methods of test.

ISO 7207-1:2007 classifies femoral, tibial and patellar components for knee joint prostheses in which the bearing surfaces of one or more compartments of the knee are replaced. It also gives definitions of components and the designation of dimensions.

ISO 14242-1:2012 specifies the relative angular movement between articulating components, the pattern of the applied force, the speed and duration of testing, the sample configuration and the test environment to be used for the wear testing of total hip-joint prostheses.

ISO 17853:2010 specifies methods for sampling wear particles generated by joint implants in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate and characterize both polymer and metal wear particles from samples of tissue excised from around the joint implant, obtained at revision surgery or post mortem, and from samples of joint simulator test fluids. Some of these procedures could certainly be adapted for isolation and characterization of particles from human biological fluids (e.g. synovial fluid).

ISO 14243-2:2009 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243-1.

ISO 14243-3:2004 specifies relative movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines having axial load control, flexion/extension angular motion control, AP displacement control and tibial rotation control. The kinematics of ISO 14243-3:2004 may not be applicable to knee designs with a high degree of constraint, which could result in damage to the articulating components in the early stages of the test that would not be representative of clinical service.

ISO 7206-10:2003 applies to femoral heads of partial or total hip-joint replacements of modular construction (i.e. a head/neck conical taper connection) and describes methods of determining the load required, under specified laboratory conditions, to cause failure of the head (disassembly or fracture). It applies to components made of metallic and non-metallic materials. ISO 7206-10:2003 does not cover methods of examining and reporting the test specimens.

ISO 17853:2003 specifies methods for sampling wear debris generated by total joint prostheses in humans and in joint simulators. It specifies the apparatus, reagents and test methods to isolate, characterize and quantify both polymer and metal wear debris from samples of tissue excised from around the joint prosthesis, obtained at revision surgery or post mortem, and from samples of joint-simulator test fluids. The method given in ISO 17853:2003 does not quantify the level of wear the implant produces, nor does it determine the amount of wear from any particular surface. ISO 17853:2003 does not cover the biological effect of wear debris or provide a method for evaluation of biological safety. The method given in ISO 17853:2003 is not applicable to the measurement of poly(methyl methacrylate) (PMMA) debris.

This International Standard provides specific requirements for knee-joint replacement implants. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer and methods of test.

This International Standard specifies particular requirements for total and partial joint replacement implants, artificial ligaments and bone cement, hereafter referred to as implants. For the purposes of this International Standard, artificial ligaments and their associated fixing devices are included in the term implant, hereinafter referred to as implants. It specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information to be supplied by the manufacturer. Some tests required to demonstrate compliance with this International Standard are contained in or referenced in level 3 standards.

This International Standard provides specific requirements for hip-joint replacement implants. With regard to safety, this International Standard gives requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and methods of test.

This part of ISO 7206 specifies a test method for determining the endurance properties, under specified laboratory conditions, of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints. It also defines the conditions of testing so that the important parameters that affect the components are taken into account, and describes how the specimen is set up for testing. This part of ISO 7206 is applicable to prostheses that have a plane of symmetry, or have preformed anteversion or double curvature of the stem, and to prostheses designed for use in revision surgery. This part of ISO 7206 does not specify methods of examining the test specimen; these should be agreed between the test laboratory and the party submitting the specimen for test.

This part of ISO 14243 specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total knee-joint prostheses in wear-testing machines with load control.

This part of ISO 14242 specifies the relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the wear testing of total hip-joint prostheses.