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Description of ASTM-F3575 2024ASTM F3575-24Active Standard: Standard Guide for Model Development for Particulate Generation Testing of Endovascular DevicesASTM F3575Scope 1.1 This standard provides recommendations regarding the development of a simulated use model for particulate generation testing of endovascular devices. 1.2 Corresponding recommendations will be provided for the coronary, peripheral, and neurovascular anatomy respectively, as these different environments each have unique challenges and considerations that should be incorporated into the model development. 1.3 Considerations include, but are not limited to: anatomical considerations (for example, tortuosity, dimensions, disease state), working path length of the human vasculature, model/device interactions (for example, material properties, vessel straightening due to device placement), and device/device interactions (for example, use of delivery catheters and/or guide wires). 1.4 Standardizing the model development allows for better interpretation of the test results and comparison of performance of similar medical devices. 1.5 Explicit models for devices (or groups of devices) are not provided in this document as specific device attributes (for example, device flexibility, device material), anatomical target locations, and intended patient population can strongly impact model design. This document enables the development of a model that appropriately and sufficiently challenges the subject device with respect to particulate generation. 1.6 While this document is intended to aid in the development and design of the simulated use model for the assessment of particulate generation, additional information regarding the evaluation of the particulate matter and particulate measurements can be found in AAMI TIR 42. Similarly, this document is not intended to address testing associated with the use of the model. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. Keywords ICS Code ICS Number Code 11.040.40 (Implants for surgery, prosthetics and orthotics) DOI: 10.1520/F3575-24 This book also exists in the following packages...Subscription InformationMADCAD.com ASTM Standards subscriptions are annual and access is unlimited concurrency based (number of people that can access the subscription at any given time) from single office location. For pricing on multiple office location ASTM Standards Subscriptions, please contact us at info@madcad.com or +1 800.798.9296.
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About ASTMASTM International, formerly known as the American Society for Testing and Materials (ASTM), is a globally recognized leader in the development and delivery of international voluntary consensus standards. Today, some 12,000 ASTM standards are used around the world to improve product quality, enhance safety, facilitate market access and trade, and build consumer confidence. ASTM’s leadership in international standards development is driven by the contributions of its members: more than 30,000 of the world’s top technical experts and business professionals representing 150 countries. Working in an open and transparent process and using ASTM’s advanced electronic infrastructure, ASTM members deliver the test methods, specifications, guides, and practices that support industries and governments worldwide. |
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