Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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8-596
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Standard | |
ASTM D412-16(2021) Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
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Scope/Abstract1.1 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. |
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Extent of Recognition
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |