ASTM F1814 - 22
Standard Guide for Evaluating Modular Hip and Knee Joint Components
| Aviso: | Las normas ASTM en lectura se visualizan a través del área decliente. Los archivos no se pueden descargar |
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| Fecha edición: |
2022-07-15
En Vigor
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| Idiomas disponibles: | Inglés |
| Resumen: | |
| Keywords: | arthroplasty; disassembly; hip arthroplasty; knee arthroplasty; modular; orthopaedic medical devices; |
| Scope: | 1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety. 1.2 This guide does not attempt to define all test methods associated with modular device evaluation. 1.3 The disassembly testing in this guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
| ICS: | 11.040.40 - Implantes quirúrgicos, prótesis y ortesis |
| CTN: | F04.22 - F04.22 |
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Anulaciones Normas |
Anula a F1814-15 |
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Otras Relaciones |
Es referenciada por F2665-21 Es referenciada por F2887-23 Es referenciada por F3018 - 25 |










