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 8-596
Standard
ASTM  D412-16(2021)
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension
Scope/Abstract
1.1 These test methods cover procedures used to evaluate the tensile (tension) properties of vulcanized thermoset rubbers and thermoplastic elastomers. These methods are not applicable to ebonite and similar hard, low elongation materials. The methods appear as follows:

Test Method A-Dumbbell and Straight Section Specimens
Test Method B-Cut Ring Specimens

Note 1: These two different methods do not produce identical results.
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.

This standard is recognized on a regulatory basis as being incorporated by reference in the Code of Federal Regulations.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 801.410
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 Contact
 Shuliang Li
  FDA/OC/CDRH/OSPTI/DAHRSSP/SCAP/
  240-402-3798
  SHULIANG.LI@FDA.HHS.GOV
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Materials
*These are provided as examples and others may be applicable.
-
-