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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 14-517
Standard
ASTM F3293-18
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
Scope/Abstract
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.
Extent of Recognition
Complete standard
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
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Steven Turtil
  FDA/OMPT/CDRH/ODE/DOD/PSDB/
  301-796-6305
  steven.turtil@fda.hhs.gov
 Shanil Haugen
  FDA/OMPT/CDRH/ODE/DRGUD/ULDB/
  301-796-0301
  shanil.haugen@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
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