| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
053
|
Date of Entry 12/23/2019
|
|
FR Recognition Number
|
8-523
|
| Standard | |
ASTM F3275-19
Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device |
|
Scope/Abstract| 1.1 Brushes used to clean a medical device after clinical use play an important role in effective reprocessing. This guide describes methods for characterizing, under prescribed laboratory conditions, the efficacy of brush parts designed to clean the internal channels of medical devices. The methods utilize a force tester to mechanically actuate a brush part within a channel: (1) Methods to measure, at an established speed, the force required to move a brush within a channel; (2) Methods utilize the same force tester and protocols to measure soil removal from a soiled tube, another indicator of performance. |
|
| Extent of Recognition
|
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. |
|
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. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
