Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
051
|
Date of Entry 01/14/2019
|
FR Recognition Number
|
8-487
|
Standard | |
ASTM ISO 52910-18 Additive manufacturing - Design - Requirements, guidelines and recommendations |
|
Scope/Abstract1.1 This document gives requirements, guidelines and recommendations for using additive manufacturing (AM) in product design.
1.2 It is applicable during the design of all types of products, devices, systems, components or parts that are fabricated by any type of AM system. This document helps determine which design considerations can be utilized in a design project or to take advantage of the capabilities of an AM process.
1.3 General guidance and identification of issues are supported, but specific design solutions and process-specific or material-specific data are not supported.
1.4 The intended audience comprises three types of users:
1.4.1 designers who are designing products to be fabricated in an AM system and their managers;
1.4.2 students who are learning mechanical design and computer-aided design; and
1.4.3 developers of AM design guidelines and design guidance systems. |
|
Extent of Recognition
|
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. |
|
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
|
Standards Development Organizations
|
FDA Specialty Task Group (STG)
|
|
*These are provided as examples and others may be applicable. |