S.R. CWA 17253-2:2018
Current
The latest, up-to-date edition.
JOINT IMPLANTS - PART 2: TIERED TOOLKIT APPROACH TO EVALUATE THE BIOLOGICAL IMPACT OF WEAR PARTICLES FROM JOINT REPLACEMENTS AND RELATED DEVICES
24-04-2018
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 |
| 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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