Iso 14243-3

[Nerio Cintron]

ISO14243-3:2004 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.

Almost done!

You are only one step away from joining the ISO subscriber list. Please confirm your subscription by clicking on the email we've just sent to you. You will not be registered until you confirm your subscription. If you can't find the email, kindly check your spam folder and/or the promotions tab (if you use Gmail).

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.

Amendments are issued when it is found that new material may need to be added to an existing standardization document. They may also include editorial or technical corrections to be applied to the existing document.

Wear of total knee endoprostheses as well as the implant kinematics can be determined using a total knee simulator. EndoLab has developed a simulator that allows either a testing in force control (ISO 14243-1) or in displacement control (ISO 14243-3). Due to the servohydraulic actuators, excellent machine accuracy has been reached. Please refer the support section to see the simulator moving. Simultaneous testing of three (plus soak control) specimens enables rapid and economic developments. Routine testing is performed using calf serum as a test fluid. In general, the test is stopped after 5 million cycles. Wear is determined by weight loss and/or geometric measurements.

To see the simulator moving open video on the external service provider YouTube .

The wear of the components is determined gravimetrically, particle analysis can be performed. Calf serum with a protein content of 20 g/l is used for the tests.

The site is secure.

The ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

ISO 14243 is the governing standard for wear testing of knee prostheses, but there is controversy over the correct direction of anterior-posterior (AP) displacement and loading and the correct direction of tibial rotation (TR) angles and torque. This study aimed to analyze how altering the direction of AP and TR affected wear on the tibial insert. Modifications to the conditions specified in ISO 14243-1 and ISO 14243-3 were also proposed. As such, five loading conditions were applied to FEA models of a knee prosthesis: (1) Modified ISO 14243-3 with positive AP displacement and TR angle, (2) ISO 14243-3:2004 with negative AP displacement and positive TR angle, (3) ISO 14243-3:2014 with positive AP displacement and negative TR angle, (4) Modified ISO 14243-1 with positive AP load and TR torque, and (5) ISO 14243-1:2009 with negative AP load and positive TR torque. This study found that changing the input directions for AP and TR according to ISO 14243-1 and 14243-3 had an influence on the wear rate and wear contours on the tibial insert model. However, the extent of wear varies depending on the design features of the tibial insert and shape of the input curves. For displacement control according to ISO 14243-3, changing the direction of AP displacement had a marked influence on the wear rate (272.77%), but changing the direction of TR angle had a much lower impact (2.17%). For load control according to ISO 14243-1, reversing the AP load (ISO 14243-1:2009) only increased the wear rate by 6.73% in comparison to the modified ISO 14243-1 conditions. The clinical relevance of this study is that the results demonstrate that tibial wear is affected by the direction of application of AP and TR. Incorrect application of the loading conditions during the design stage may lead to an ineffective preclinical evaluation and could subsequently influence implant longevity in clinical use.

Currently all our Knee Wear testing is being performed using two Six-station servo-hydraulic Knee simulators designed and manufactured by AMTI. These Knee Simulators currently provide the most advanced, reliable and accurate methods in evaluating the wear between the femoral component and the tibial insert associated with Knee implants. Our AMTI knee simulators are designed to replicate daily activities such as walking, climbing stairs, running etc allowing us to carry out accurate in-vitro wear testing for clients.

The Six Station AMTI Knee Wear Simulator allows us to test up to six implants simultaneously with an additional 4 Load soaked control stations. Our equipment allows us to carry out testing with force or displacement controlled kinematics as per ISO 14243-1 (load control) or ISO 14243-3 (displacement control).

The ISO 14243-3 standard specifies the flexion/extension relative angular movement, the pattern of the applied force, the speed and duration of testing, the sample configuration and the test environment to be used for wear testing of total knee-joint prostheses in wear-testing machines under displacement control.

Knee wear simulators are used to model joint mechanics and detect wear performance, referencing ISO14243-1/3 protocols. In this study, it is aimed to create a system model for a joint knee wear simulator prototype and then obtain input and output signals with the Matlab Simulink program. As a result of the study, transfer functions for torque and position were obtained and a block diagram was created in the Matlab Simulink environment. Based on the ISO 14243-3 protocol, motion curves were modeled in the Matlab Simulink environment and converted to input reference signals. Finally, PID controlled closed loop was integrated into the DC servo motor circuit to obtain output signals, and using these signals, the walking cycle was successfully simulated in Matlab SimMechanics environment in accordance with ISO 14243-3. When the system model is evaluated, it is understood that it has advantages such as being able to work with open source microcontrollers such as Ardunio, low cost, and easy adaptation of any data to the system. In this study, it is aimed to obtain a suitable system model for the knee wear simlatr prototype and to serve as an example for easily accessible test simulators for use in scientific studies or R&D processes.

Les normes ASTM International, American Society of Mechanical Engineers (ASME), CLSI et AIUM/NEMA ne sont pas disponibles en franais. Le titre de ces normes figure en anglais dans la liste. Pour les autres normes qui ne sont pas disponibles en franais, il est spcifi que la norme est Disponible en anglais seulement .

ISO 80601-2-72:2015-Ed.1.0

Appareils lectromdicaux Partie 2-72: Exigences particulires pour la scurit de base et les performances essentielles des ventilateurs utiliss dans l'environnement des soins domicile pour les patients ventilodpendants

IEC 60601-1-8:2012-Ed.2.1

Appareils lectromdicaux - Partie 1-8: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale: Exigences gnrales, essais et guide pour les systmes d'alarme des appareils et des systmes lectromdicaux

ISO 14117:2012-Ed.1.0

Dispositifs mdicaux implantables actifs - Compatibilit lectromagntique - Protocoles d'essai EMC pour pacemakers lectromagntique cardiaques implantables, dfibrillateurs resynchronisation cardiaque

CSA C22.2 NO 60601-1-2-08

Appareils lectromdicaux - Partie 1-2: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale: Compatibilit lectromagntique - Exigences et essais

IEC 60601-1-10:2007-Ed 1.0

Appareils lectromdicaux - Partie 1-10: Exigences gnrales pour la scurit de base et les performances essentielles - Norme collatrale: Exigences pour le dveloppement des rgulateurs physiologiques en boucle ferme

IEC 60601-1-11:2010 -Ed 1.0

Exigences gnrales pour la scurit de base et les performances essentielles - Norme Collatrale: Exigences pour les appareils lectromdicaux et les systmes lectromdicaux utiliss dans l'environnement des soins domicile

IEC 60601-2-2:2009-Ed.5.0

Appareils lectromdicaux - Partie 2-2: Exigences particulires pour la scurit de base et les performances essentielles des appareils d'lectrochirurgie courant haute frquence et des accessoires d'lectrochirurgie courant haute frquence

3a8082e126