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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 056 Date of Entry 06/07/2021 
FR Recognition Number 8-559
Standard
ASTM D412-16e1
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
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.
Transition Period
FDA recognition of ASTM D412-16e1 [Rec# 8-559] will be superseded by recognition of ASTM D412-16(2021) [Rec# 8-596]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-559] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 8-559] will not be accepted.
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.
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