Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 9-142
Standard
ASTM  D1894-14
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
Scope/Abstract
1.1 This test method covers determination of the coefficients of starting and sliding friction of plastic film and sheeting when sliding over itself or other substances at specified test conditions. The procedure permits the use of a stationary sled with a moving plane, or a moving sled with a stationary plane. Both procedures yield the same coefficients of friction values for a given sample.

Note 1-For the frictional characteristics of plastic films partially wrapped around a cylinder, or capstan, see Test Method G143 under the jurisdiction of ASTM Subcommittee G02.50.

1.2 Test data obtained by this test method is relevant and appropriate for use in engineering design.

1.2.1 As an option to this test, coefficient of friction may be run at temperatures other than 23°C by heating only the plane while the sled is at ambient temperature.

1.3The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.

1.4 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 and health practices and determine the applicability of regulatory limitations prior to use. For a specific precautionary statement, see the end of 6.5.

Note 2-This test method is not equivalent to ISO 8295-1995, and results cannot be directly compared between the two methods.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§876.5130 Catheter, Straight Class 2 EZD
§876.5130 Catheter, Retention Type, Balloon Class 2 EZL
Relevant FDA Guidance and/or Supportive Publications*
Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters, issued September 1994.

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 Contact
 Angel Soler-Garcia
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIB/
  301-796-6535
  Angel.Soler-Garcia@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
ObGyn/Gastroenterology/Urology
*These are provided as examples and others may be applicable.
-
-