ASTM F564-2017 Standard Specification and Test Methods for Metallic Bone Staples《骨科用金属U形钉的标准规格和试验方法》.pdf
《ASTM F564-2017 Standard Specification and Test Methods for Metallic Bone Staples《骨科用金属U形钉的标准规格和试验方法》.pdf》由会员分享,可在线阅读,更多相关《ASTM F564-2017 Standard Specification and Test Methods for Metallic Bone Staples《骨科用金属U形钉的标准规格和试验方法》.pdf(19页珍藏版)》请在麦多课文档分享上搜索。
1、Designation: F564 10 (Reapproved 2015)F564 17Standard Specification and Test Methods forMetallic Bone Staples1This standard is issued under the fixed designation F564; the number immediately following the designation indicates the year of originaladoption or, in the case of revision, the year of las
2、t revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon () indicates an editorial change since the last revision or reapproval.1. Scope1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internalfixa
3、tion of the muscular skeletal musculoskeletal system. It is not the intention of this specification to describe or specify specificdesigns for metallic bone staples.1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:1.2.1 Test
4、 Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone StaplesAnnex A1.1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone StaplesAnnex A2.1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone StaplesAnnex A3.1.2.4 Test Method for Elastic Static Bending of
5、 Metallic Bone StaplesAnnex A4.1.3 The values stated in SI units are to be regarded as standard. NoAny other units of measurement are included in thisstandard.standard are shown for reference only.1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated
6、 to test using all of thedescribed methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular devicedesign. This may be only a subset of the herein described test methods.1.5 This standard does not purport to address all of the safety concer
7、ns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance
8、 with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Trade (TBT) Committee.2. Referenced Documents2.1 ASTM Standar
9、ds:2E4 Practices for Force Verification of Testing MachinesE122 Practice for Calculating Sample Size to Estimate, With Specified Precision, the Average for a Characteristic of a Lot orProcessE467 Practice for Verification of Constant Amplitude Dynamic Forces in an Axial Fatigue Testing SystemF75 Spe
10、cification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNSR30075)F86 Practice for Surface Preparation and Marking of Metallic Surgical ImplantsF382 Specification and Test Method for Metallic Bone PlatesF565 Practice for Care and Handling of Orthopedic
11、Implants and InstrumentsF601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic Surgical ImplantsF2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment3. Finish3.1 Staples conf
12、orming to this specification shall be finished and identified in accordance with Practice F86, as appropriate.1 This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.21 on Osteosynthesis.Cu
13、rrent edition approved March 1, 2015Sept. 1, 2017. Published April 2015October 2017. Originally approved in 1985. Last previous edition approved in 20102015 asF564 10.F564 10 (2015). DOI: 10.1520/F0564-10R15.10.1520/F0564-17.2 For referencedASTM standards, visit theASTM website, www.astm.org, or con
14、tactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have be
15、en made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current versionof the standard as published by ASTM is to be considered the official documen
16、t.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14. Inspection Practices4.1 Staples made in accordance with Specification F75 should be inspected in accordance with Practice F601 or X-rayed inaccordance with Practice F629.5. Care and
17、 Handling5.1 Staples should be cared for and handled in accordance with Practice F565, as appropriate.5.2 Consider Practice F2503 to identify potential hazards produced by interactions between the device and the MR environmentand for terms that may be used to label the device for safety in the MR en
18、vironment6. Materials6.1 Bone staples shall be fabricated from a metallic material intended for surgical implant applications. In addition, the materialsshall be biocompatible for the intended application. Materials should be chosen based on the design requirements of the particulardevice. ASTM subc
19、ommittee F04.12 maintains a number of specifications for materials that are suitable for surgical implantapplications.7. Keywords7.1 bending test; bone fixation; fatigue test; fixation devices; metallic bone staples; orthopaedic medical devices; pullout test;soft tissue fixation; surgical implantsAN
20、NEXES(Mandatory Information)A1. TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLESA1.1. ScopeA1.1.1 This test method covers procedures for the performance of constant amplitude fatigue testing of metallic staples used ininternal fixation of the musculoskeletal system.
21、This test method may be used when testing in air at ambient temperature or in anaqueous or physiological solution.A1.1.2 The values stated in SI units are to be regarded as standard. NoAny other units of measurement are included in thisstandard.standard are shown for reference only.A1.1.3 This stand
22、ard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibilityof the user of this standard to establish appropriate safety safety, health and healthenvironmental practices and determine theapplicability of regulatory limitations prior to use.A1.
23、1.4 This international standard was developed in accordance with internationally recognized principles on standardizationestablished in the Decision on Principles for the Development of International Standards, Guides and Recommendations issuedby the World Trade Organization Technical Barriers to Tr
24、ade (TBT) Committee.A1.2. Summary of Test MethodA1.2.1 Metallic bone staples are tested under bending loads until the specimen fails or a predetermined number of cycles has beenapplied to it. Bending tests may be performed in one of two modes: either pure, in-plane bending; or tension (or compressio
- 1.请仔细阅读文档,确保文档完整性,对于不预览、不比对内容而直接下载带来的问题本站不予受理。
- 2.下载的文档,不会出现我们的网址水印。
- 3、该文档所得收入(下载+内容+预览)归上传者、原创作者;如果您是本文档原作者,请点此认领!既往收益都归您。
下载文档到电脑,查找使用更方便
5000 积分 0人已下载
下载 | 加入VIP,交流精品资源 |
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- ASTMF5642017STANDARDSPECIFICATIONANDTESTMETHODSFORMETALLICBONESTAPLES 骨科 金属 标准 规格 试验 方法 PDF

链接地址:http://www.mydoc123.com/p-536891.html