Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

051

Date of Entry 01/14/2019

FR Recognition Number

8-487

Standard

ISO ASTM 52910-18
Additive manufacturing - Design - Requirements, guidelines and recommendations

Scope/Abstract

1.1 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

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.

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 Organizations