| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-524
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| Standard | |
ASTM F3276-19
Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device |
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Scope/Abstract
1.1 This guide describes methods for characterizing the efficacy, under prescribed laboratory conditions, of a brush part designed to clean the external surface of a medical device. The method utilizes force testers to mechanically actuate a brush part across a surface at a constant rate and constant pressure. In the first method, the force required to actuate across the surface is measured. In the next method, which utilizes the same force testers and protocol (actuation motion), the brush part is actuated on a soiled surface and the amount of soil removed is measured, as another indicator of performance.
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued August 2015.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
