Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

050

Date of Entry 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*

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

Steven Turtil   FDA/OC/CDRH/OPEQ/OHTVI/DHTVIB/   301-796-6305   steven.turtil@fda.hhs.gov

Shanil Haugen   FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIA/   301-796-0301   shanil.haugen@fda.hhs.gov

Standards Development Organization

ASTM ASTM International http://www.astm.org/

FDA Specialty Task Group (STG)

Sterility

*These are provided as examples and others may be applicable.