Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

049

Date of Entry 06/07/2018

FR Recognition Number

8-463

Standard

ISO ASTM 52901 First edition 2017-08
Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts

Scope/Abstract

This document defines and specifies requirements for purchased parts made by additive manufacturing. It gives guidelines for the elements to be exchanged between the customer and the part provider at the time of the order, including the customer order information, part definition data, feedstock requirements, final part characteristics and properties, inspection requirements and part acceptance methods. It is applicable for use as a basis to obtain parts made by additive manufacturing that meet minimum acceptance requirements. More stringent part requirements can be specified through the addition of one or more supplementary requirements at the time of the order.

Extent of Recognition

Complete standard

Rationale for Recognition

Standard is recognized on a scientific basis: Material characterization.

Public Law, CFR Citation(s) and Procode(s)*

All additively manufactured medical devices

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