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Description of ASTM-F3335 2020ASTM F3335-20Active Standard: Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed FusionASTM F3335Scope 1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies. 1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide. 1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components. 1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components. 1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream. 1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse. 1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk. 1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards). 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.8 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. 1.9 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 device cleanliness; e-beam sintering; laser sintering; residual particles; ICS Code ICS Number Code 11.020.01 (Quality and environmental management in health care) DOI: 10.1520/F3335-20 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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