Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

041

Date of Entry 04/04/2016

FR Recognition Number

8-408

Standard

ASTM F3122-14
Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes

Scope/Abstract

1.1 This standard serves as a guide to existing standards or variations of existing standards that may be applicable to determine specific mechanical properties of materials made with an additive manufacturing process.

1.2 As noted in many of these referenced standards, there are several factors that may influence the reported properties, including material, material anisotropy, method of material preparation, porosity, method of specimen preparation, testing environment, specimen alignment and gripping, testing speed, and testing temperature. These factors should be recorded, to the extent that they are known, according to Practice F2971 and the guidelines of the referenced standards.

1.3 The following standards are not referred to directly in the guide but also have information that may be useful in the testing of metal test specimens made via additive manufacturing: A370, A1058, B211, B348, B557, B565, B724, B769, E3, E6, E7, E290, E467, E468, E837, E915, E1049,E1823, E1942.

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 Organization

ASTM

ASTM International