ASTM-F1814 Standard Guide for Evaluating Modular Hip and Knee Joint Components

ASTM-F1814 - 2015 EDITION - CURRENT
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Standard Guide for Evaluating Modular Hip and Knee Joint Components
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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 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 and health practices and determine the applicability of regulatory limitations prior to use.

Keywords

arthroplasty; disassembly; hip arthroplasty; knee arthroplasty; modular; orthopaedic medical devices;; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F1814-15

Revision Level

2015 EDITION

Status

Current

Modification Type

Revision

Publication Date

Dec. 31, 2015

Document Type

Guide

Page Count

5 pages

Committee Number

F04.22