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STP 1431
SPINAL IMPLANTS: Are We Evaluating Them Appropriately?
133 стр.
Действует
Печатное издание
184.08 $ (включая НДС 20%)
Разработчик:
Зарубежные/ASTM
Тематика:
Medical Devices & Implants
Описание
Краткое описание

Meet the challenges and demands facing professionals in thedynamic field of spinal implants. Sections cover:

Spinal Constructs presents developments and resultsassociated with the application of ASTM F1717 test methods. Papersdescribe the clinical results from spinal constructs havingmarketing clearance or approval using these test methods; addressdevice failure modes; and examine corrosion seen with explanteddevices. Other papers evaluate impact on results due to gaugelength used in tests; mobility or constraint of the test blocks;and use of transverse rod connections.

Spinal Device Components, Subassemblies, andInterconnections using ASTM F1798, this section discusses testmethods for new components or modifications to existing componentsof a construct. Papers describe the impact from application ofdifferent transverse connector designs on clinical outcomes; andevaluate impact on bench testing results due to protection of thelongitudinal member, anchoring materials, gauge length, mobility orconstraint of the test blocks.

Interbody Spacers and Intervertebral Body Fusion Devicesprovides the latest developments and results associated with theapplication of ASTM F2077 test methods for intervertebral bodyfusion devices. Papers cover the clinical results from lumbarinterbody fusion devices; the causes of some of these devices thatextruded; strength testing methodologies; and the usefulness ofpull-out or push-out testing for spinal cages.

Functional Spinal Devices and/or Artificial Discsexamines comparative cadaveric testing, durability testing, andalternative test methods for spinal constructs intended forposterior stabilization without fusion.

Suggested Test Methods, Models, Fixtures, or NeededImprovements addresses today's limitations and tomorrow'sconcerns in spinal implants standards. Some papers describe theresults from alternative models for fusion, non-fusion, orfunctional spinal implants; and others examine the impact ontesting due to preload, block design, and material properties.

Audience: This new publication is a valuable resource fordesigning engineers, surgeons, researchers, and regulatory entitieswho test and evaluate the appropriateness of a devices' design andmaterials.