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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 046 Date of Entry 12/23/2016 
FR Recognition Number 8-439
Standard
ASTM  F3001-14
Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion
Scope/Abstract
1.1 This specification covers additively manufactured titanium-6aluminum-4vanadium with extra low interstitials (Ti-6Al-4V ELI) components using full-melt powder bed fusion such as electron beam melting and laser melting. The components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers or both of additively manufactured Ti-6Al-4V ELI components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in S1-S4 and S1-S16 in Specification F2924.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Class E material set forth in Clause 4.1.5.
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 in part because:
Class E material set forth in Clause 4.1.5 does not satisfy a requirement under the Food, Drug ,and Cosmetic act.
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 Contacts
 Matthew Di Prima
  FDA/OC/CDRH/OSEL/DAM/
  301-796-2507
  matthew.diprima@fda.hhs.gov
 James Coburn
  FDA/OC/OCS/OCET/
  301-796-0286
  james.coburn@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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