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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 056 Date of Entry 06/07/2021 
FR Recognition Number 8-560
Standard
ASTM  D1415-18
Standard Test Method for Rubber Property - International Hardness
Scope/Abstract
1.1 This test method covers a procedure for measuring the hardness of vulcanized or thermoplastic rubber. The hardness is obtained by the difference in penetration depth of a specified dimension ball under two conditions of contact with the rubber: (1) with a small initial force and (2) with a much larger final force. The differential penetration is taken at a specified time and converted to a hardness scale value.

1.2 This test method is technically similar to ISO 48.
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/ORR/DSCA
  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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