| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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8-489
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| Standard | |
ASTM F3302-18
Standard for Additive Manufacturing - Finished Part Properties - Standard Specification for Titanium Alloys via Powder Bed Fusion |
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Scope/Abstract1.1 This specification covers additive manufacturing of components via full-melt powder bed fusion processing of titanium alloys. Components made using this processing method are typically used in applications that require mechanical properties similar to wrought products. Products built to this specification may require additional post-processing in the form of machining, polishing, etc., to meet necessary surface finish and dimensional requirements.
1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured titanium 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 committee members.
1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which include, but are not limited to, those listed in Supplementary Requirements S1-S16. |
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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. |
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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 Contacts
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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. |
