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Description of ASTM-F3487 2020ASTM F3487-20Active Standard: Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical DeviceASTM F3487Scope 1.1 This guide describes methods for assessing the service life, under prescribed laboratory conditions, of a brush part designed to clean a medical device. The method utilizes force testers to mechanically actuate a brush part at a constant rate. This action continues until the brush part demonstrates a significant reduction in cleaning power as measured by the force exerted during testing. 1.2 The test methods utilized in this guide are those described in Guides F3275 and F3276. In this guide, the number of repetitions is open-ended and determined by the measurable fatigue of the brush part as measured by a reduction in force, as well as any observation of wear or damage to the brush part. 1.3 Brushes designed to clean medical devices after clinical use play an important role in the effective reprocessing of those medical devices. Instructions for use from the brush manufacturer should supply information related to the service life of the brush. This may be stated in terms of (1) a time period; (2) the number of uses; (3) inspection of the brush for wear and damage. 1.4 Inspection for wear should always be a part of the instructions for use of a brush. Application of this guide can help to determine like mode(s) of observable failure of a brush part. 1.5 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 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 brush part; service life; ICS Code ICS Number Code 11.040.01 (Medical equipment in general) DOI: 10.1520/F3487-20 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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