JOINT IMPLANTS - PART 2: TIERED TOOLKIT APPROACH TO EVALUATE THE BIOLOGICAL IMPACT OF WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES

Published date

24-04-2018

Publisher

National foreword
European foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
4 The tiered toolkit
5 Experimental preparation
6 Test methods: cells, repeats and controls
7 Tier 1 test method
8 Tier 2 test methods

Gives a tiered approach for evaluating the biological impact in vitro, of wear particles generated in joint replacements and related medical devices, such as screws and trauma plates used in treating fractures.

DocumentType	Standard
PublisherName	National Standards Authority of Ireland
Status	Current

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 14242-1:2014	Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
ISO 18192-1:2011	Implants for surgery Wear of total intervertebral spinal disc prostheses Part 1: Loading and displacement parameters for wear testing and corresponding environmental conditions for test
ISO 29701:2010	Nanotechnologies Endotoxin test on nanomaterial samples for in vitro systems Limulus amebocyte lysate (LAL) test
ASTM F 732 : 2017 : REDLINE	Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
ISO 18192-3:2017	Implants for surgery — Wear of total intervertebral spinal disc prostheses — Part 3: Impingement-wear testing and corresponding environmental conditions for test of lumbar prostheses under adverse kinematic conditions
ISO 17853:2011	Wear of implant materials Polymer and metal wear particles Isolation and characterization
EN ISO 8655-2:2002/AC:2009	PISTON-OPERATED VOLUMETRIC APPARATUS - PART 2: PISTON PIPETTES
ASTM F 1537 : 2011 : REDLINE	Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)
ISO 18158:2016	Workplace air Terminology
ISO 14243-3:2014	Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
EN 12469:2000	Biotechnology - Performance criteria for microbiological safety cabinets

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S.R. CWA 17253-2:2018

JOINT IMPLANTS - PART 2: TIERED TOOLKIT APPROACH TO EVALUATE THE BIOLOGICAL IMPACT OF WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES

Table of Contents

Abstract

General Product Information

Standards Referencing This Book

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