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ASTM F3047M-15
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations- 발행일 : 2015-03-15
- 발행기관 : ASTM
상세정보
| 분야 | 13.02 : 긴급 의료 서비스; 수색 및 구조 |
|---|---|
| 적용범위 | 1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard on hard articulations. This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. Device articulating components manufactured from other metallic alloys, ceramics or with coated or elementally modified surfaces could possibly be evaluated with this guide. However such materials may include risks and failure mechanisms which are not adressed in this guide. 1.2 Hard-on-hard hip bearing systems include metal-on-metal, ceramic-on-ceramic, ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements. 1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal on polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement. 1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6). 1.5 The values stated in SI units are to be regarded as the standard. 1.6 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. |
| 국제분류(ICS)코드 | 11.040.40 : 외과. 보철술. 교정술용 이식 |
| 페이지수 | 8 |
| Edition | 15 |
이력정보
| No. | 표준번호 | 표준명 | 발행일 | 상태 |
|---|---|---|---|---|
| 1 | ASTM F3047M-23상세보기 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations | 2023-06-01 | 표준 |
| 2 | ASTM F3047M-23 REDLINE상세보기 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations | 2023-06-01 | 표준 |
| 3 | ASTM F3047M-15상세보기 | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations | 2015-03-15 | 구판 |
관련상품
- 관련상품이 존재하지 않습니다.
다른 사람이 함께 구입한 상품
- ISO 14242-3:2009/Amd 1:2019 - Implants for surgery — Wear of total hip-joint prostheses — Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test — Amendment 1
- ASTM F1875-98(2022) - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
- ISO 21535:2007/Amd 1:2016 - Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint replacement implants — Amendment 1
- ISO 12189:2008 - Implants for surgery — Mechanical testing of implantable spinal devices — Fatigue test method for spinal implant assemblies using an anterior support
- ISO 14243-2:2016 - Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
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