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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 10-129
Standard
ASTM  D790-17
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
Scope/Abstract
1.1 These test methods are used to determine the flexural properties of unreinforced and reinforced plastics, including high modulus composites and electrical insulating materials utilizing a three-point loading system to apply a load to a simply supported beam (specimen). The method is generally applicable to both rigid and semi-rigid materials, but flexural strength cannot be determined for those materials that do not break or yield in the outer surface of the test specimen within the 5.0 % strain limit.

1.2 Test specimens of rectangular cross section are injection molded or, cut from molded or extruded sheets or plates, or cut from molded or extruded shapes. Specimens must be solid and uniformly rectangular. The specimen rests on two supports and is loaded by means of a loading nose midway between the supports.

1.3 Measure deflection in one of two ways; using crosshead position or a deflectometer. Please note that studies have shown that deflection data obtained with a deflectometer will differ from data obtained using crosshead position. The method of deflection measurement shall be reported.
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
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens, Contact (Rigid Gas Permeable), Extended Wear Class 3 MWL
Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 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
 Joseph C. Hutter
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6499
  joseph.hutter@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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