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ASTM F1814-97a
Standard Guide for Evaluating Modular Hip and Knee Joint Components (Includes all amendments And changes 8/16/2017).
Automatically translated name:
Standard Guide for Evaluating Modular Hip and Knee Joint Components
STANDARD published on 10.11.1997
The information about the standard:
Designation standards: ASTM F1814-97a
Note: WITHDRAWN
Publication date standards: 10.11.1997
SKU: NS-51682
The number of pages: 5
Approximate weight : 15 g (0.03 lbs)
Country: American technical standard
Category: Technical standards ASTM
Annotation of standard text ASTM F1814-97a :
Keywords:
arthroplasty, disassembly, hip arthroplasty, knee arthroplasty, modular, orthopaedic medical devices
Additional information
| 1. Scope | ||||||||
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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 This guide does not cover intentional intraoperative diassembly 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 and health practices and determine the applicability of regulatory limitations prior to use. |
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| 2. Referenced Documents | ||||||||
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