SIST-TS CEN ISO/ASTM TS 52949:2025

Additive manufacturing of metals - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-EB equipment (ISO/ASTM TS 52949:2025)

This document addresses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence on the consolidation of material. The first three elements of process validation, process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine qualification, however, they are outside the scope of this document.
This document provides recommended practices for machine-related process qualification for serial production of metal parts produced with the powder bed fusion, by electron beam process (PBF-EB/M). Since this process is very similar to the PBF-LB/M, this document references ISO/ASTM TS 52930, pointing only the differences on the validation processes.  This document is addressed to organizations that already have a comprehensive quality system in place.
This document covers issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal.
Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.

Additive Fertigung von Metallen - Grundsätze der Qualifizierung - Installation, Funktion und Leistung (IQ/OQ/PQ) von PBF-EB-Anlagen (ISO/ASTM TS 52949:2025)

Fabrication additive de métaux - Principes de qualification - Installation, fonctionnement et performances (IQ/OQ/PQ) des équipements PBF-EB (ISO/ASTM TS 52949:2025)

Le présent document traite des questions de qualification de l’installation (IQ), de qualification opérationnelle (OQ), et de qualification des performances (PQ) directement associées au système de fabrication additive qui a une influence directe sur la consolidation du matériau. Les trois premiers éléments de validation du procédé, de cartographie du procédé, d’évaluation du risque, et de planification de la validation, sont des conditions préalables nécessaires à la qualification des machines, cependant, ils sortent du domaine d’application du présent document.
Le présent document couvre les questions directement liées à l’équipement de FA et ne couvre pas la qualification de la matière première ni le post-traitement au-delà du retrait de la poudre.
Les questions relatives à l'installation physique, au personnel, au procédé et au matériau sont uniquement incluses dans la mesure nécessaire à soutenir la qualification de la machine.

Dodajalna izdelava kovinskih izdelkov - Kvalifikacija - Vgradnja, delovanje in zmogljivost (IQ/OQ/PQ) opreme za spajanje kovinskega prahu na podlagi z elektronskim snopom (ISO/ASTM TS 52949:2025)

General Information

• Status: Not Published
• Public Enquiry End Date: 01-Aug-2024
• ICS: 25.030 - Additive manufacturing
• Technical Committee: VAR - Welding
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 23-Jan-2025
• Due Date: 30-Mar-2025
• Ref Project: CEN ISO/ASTM TS 52949:2025 - Additive manufacturing of metals - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-EB equipment (ISO/ASTM TS 52949:2025)

Standards Content (Sample)

SLOVENSKI STANDARD
kSIST-TS FprCEN ISO/ASTM TS 52949:2024
01-julij-2024
Aditivna proizvodnja kovinskih izdelkov - Kvalifikacija - Vgradnja, delovanje in
lastnosti (IQ/OQ/PQ) opreme za spajanje kovinskega prahu v postelji z
elektronskim snopom (ISO/ASTM/DTS 52949:2024)
Additive manufacturing of metals - Qualification principles - Installation, operation and
performance (IQ/OQ/PQ) of PBF-EB equipment (ISO/ASTM/DTS 52949:2024)
Additive Fertigung von Metallen - Grundsätze der Qualifizierung - Installation, Funktion
und Leistung (IQ/OQ/PQ) von PBF-EB-Anlagen (ISO/ASTM/DTS 52949:2024)
Fabrication additive de métaux - Principes de qualification - Installation, fonctionnement
et performances (IQ/OQ/PQ) des équipements PBF-EB (ISO/ASTM/DTS 52949:2024)
Ta slovenski standard je istoveten z: FprCEN ISO/ASTM TS 52949
ICS:
25.030 3D-tiskanje Additive manufacturing
kSIST-TS FprCEN ISO/ASTM TS en,fr,de
52949:2024
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

kSIST-TS FprCEN ISO/ASTM TS 52949:2024

kSIST-TS FprCEN ISO/ASTM TS 52949:2024
FINAL DRAFT
Technical
Specification
ISO/ASTM DTS
ISO/TC 261
Additive manufacturing of
Secretariat: DIN
metals — Qualification principles
Voting begins on:
— Installation, operation and
2024-05-30
performance (IQ/OQ/PQ) of PBF-EB
Voting terminates on:
equipment
2024-08-22
Fabrication additive — Principes de qualification — Installation,
fonctionnement et performances (IQ/OQ/PQ) des équipements
PBF-EB
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/ASTM DTS 52949:2024(en) © ISO/ASTM International 2024

kSIST-TS FprCEN ISO/ASTM TS 52949:2024
FINAL DRAFT
ISO/ASTM DTS 52949:2024(en)
Technical
Specification
ISO/ASTM DTS 52949
ISO/TC 261
Additive manufacturing of
Secretariat: DIN
metals — Qualification principles
Voting begins on:
— Installation, operation and
performance (IQ/OQ/PQ) of PBF-EB
Voting terminates on:
equipment
Fabrication additive — Principes de qualification — Installation,
fonctionnement et performances (IQ/OQ/PQ) des équipements
PBF-EB
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
© ISO/ASTM International 2024
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
IN ADDITION TO THEIR EVALUATION AS
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
or ISO’s member body in the country of the requester. In the United States, such requests should be sent to ASTM International.
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
ISO copyright office ASTM International TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
CP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
CH-1214 Vernier, Geneva West Conshohocken, PA 19428-2959, USA
Phone: [phone] Phone: [phone]
Fax: [phone]
Email: [e-mail] Email: [e-mail]
Website: www.iso.org Website: www.astm.org
Published in Switzerland Reference number
ISO/ASTM DTS 52949:2024(en) © ISO/ASTM International 2024

© ISO/ASTM International 2024 – All rights reserved
ii
kSIST-TS FprCEN ISO/ASTM TS 52949:2024
ISO/ASTM DTS 52949:2024(en)
Contents Page
Foreword .iv
Introduction .v
1  Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4  Abbreviated terms . 1
5  General concepts . 1
6  Elements of process validation .2
6.1 General .2
6.2 Installation qualification (IQ) .2
6.2.1 General .2
6.2.2 Specific considerations for installation qualification .2
6.3 Operational qualification (OQ) .3
6.3.1 General .3
6.3.2 Specific considerations for operational qualification .3
6.4 Performance qualification (PQ) .4
6.4.1 General .4
6.4.2 Specific considerations for performance qualification .4
7  Revalidation .5

© ISO/ASTM International 2024 – All rights reserved
iii
kSIST-TS FprCEN ISO/ASTM TS 52949:2024
ISO/ASTM DTS 52949:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 261, Additive manufacturing, in cooperation
with ASTM Committee F42, Additive Manufacturing Technologies, on the basis of a partnership agreement
between ISO and ASTM International with the aim to create a common set of ISO/ASTM standards on
Additive Manufacturing, and in collaboration with the European Committee for Standardization (CEN)
Technical Committee CEN/TC 438, Additive manufacturing, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

© ISO/ASTM International 2024 – All rights reserved
iv
kSIST-TS FprCEN ISO/ASTM TS 52949:2024
ISO/ASTM DTS 52949:2024(en)
Introduction
Additive manufacturing is a machine-centric process. This document provides recommended practices
for machine-related process qualification for serial production of metal parts produced with the powder
bed fusion, by electron beam process (PBF-EB/M). Since this process is very similar to the PBF-LB/M this
document references ISO/ASTM TS 52930 pointing only the differences on the validation processes. This
document is addressed to organizations that already have a comprehensive quality system in place.
While this document is process specific, it is intended to apply to any industry with strict quality
requirements. In such industries, it is not possible to complete machine qualification without ensuring
repeatable production of the desired process result, given the current state of AM process knowledge.
Operational quality and part performance quality sections are included for this reason.

© ISO/ASTM International 2024 – All rights reserved
v
kSIST-TS FprCEN ISO/ASTM TS 52949:2024

kSIST-TS FprCEN ISO/ASTM TS 52949:2024
FINAL DRAFT Technical Specification ISO/ASTM DTS 52949:2024(en)
Additive manufacturing of metals — Qualification principles
— Installation, operation and performance (IQ/OQ/PQ) of
PBF-EB equipment
1  Scope
This document addresses installation qualification (IQ), operational qualification (OQ), and performance
qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence
on the consolidation of material. The first three elements of process validation, process mapping, risk
assessment, and validation planning, are necessary pre-conditions to machine qualification, however, they
are outside the scope of this document.
This document covers issues directly related to the AM equipment and does not cover feedstock qualification
or post processing beyond powder removal.
Physical facility, personnel, process and material issues are only included to the extent necessary to support
machine qualification.
2  Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO/ASTM 52900, Additive manufacturing — General principles — Fundamentals and vocabulary
ISO/ASTM/TS 52930, Additive manufacturing — Qualification principles — Installation, operation and
performance (IQ/OQ/PQ) of PBF-LB equipment
3  Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/ASTM 52900, ISO/ASTM TS 52930
and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4  Abbreviated terms
For the purpose of this document the abbreviated terms in ISO/ASTM TS 52930 apply.
5  General concepts
In accordance with ISO/ASTM TS 52930, assurance of product quality is derived from careful attention to
many factors including selection of
...