CEN ISO/ASTM TS 52949:2025
(Main)Additive manufacturing of metals - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-EB equipment (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 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)
Dieses Dokument befasst sich mit Fragen der Abnahmebeurteilung (IQ, en: installation qualification), der Funktionsbeurteilung (OQ, en: operational qualification) und der Leistungsbeurteilung (PQ, en: performance qualification), die in direktem Zusammenhang mit dem System der additiven Fertigung stehen und einen direkten Einfluss auf die Konsolidierung des Materials haben. Die ersten drei Elemente der Prozessvalidierung, Prozessabbildung, Risikobewertung und Validierungsplanung sind notwendige Voraussetzungen für die Maschinenbeurteilung, liegen jedoch außerhalb des Anwendungsbereichs dieses Dokuments.
Dieses Dokument behandelt Themen, die in direktem Zusammenhang mit Anlagen zur additiven Fertigung stehen, und behandelt nicht die Beurteilung des Ausgangswerkstoffs oder Nachbearbeitung, welche über die Entfernung von Pulver hinausgeht.
Die physischen Aspekte der Anlage, des Personals, des Prozesses und des Materials werden nur in dem Umfang berücksichtigt, der zur Unterstützung der Beurteilung der Maschine erforderlich ist.
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
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2025
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)
Additive manufacturing of metals - Qualification principles - Installation, operation and
performance (IQ/OQ/PQ) of PBF-EB equipment (ISO/ASTM TS 52949:2025)
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)
Ta slovenski standard je istoveten z: CEN ISO/ASTM TS 52949:2025
ICS:
25.030 3D-tiskanje Additive manufacturing
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/ASTM TS 52949
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
January 2025
TECHNISCHE SPEZIFIKATION
ICS 25.030
English Version
Additive manufacturing of metals - Qualification principles
- Installation, operation and performance (IQ/OQ/PQ) of
PBF-EB equipment (ISO/ASTM TS 52949:2025)
Fabrication additive de métaux - Principes de Additive Fertigung von Metallen - Grundsätze der
qualification - Installation, fonctionnement et Qualifizierung - Installation, Funktion und Leistung
performances (IQ/OQ/PQ) des équipements PBF-EB (IQ/OQ/PQ) von PBF-EB-Anlagen (ISO/ASTM TS
(ISO/ASTM TS 52949:2025) 52949:2025)
This Technical Specification (CEN/TS) was approved by CEN on 23 September 2024 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/ASTM TS 52949:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/ASTM TS 52949:2025) has been prepared by Technical Committee ISO/TC
261 "Additive manufacturing" in collaboration with Technical Committee CEN/TC 438 “Additive
Manufacturing” the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/ASTM TS 52949:2025 has been approved by CEN as CEN ISO/ASTM TS 52949:2025
without any modification.
Technical
Specification
ISO/ASTM TS 52949
First edition
Additive manufacturing of
2025-01
metals — Qualification principles
— Installation, operation and
performance (IQ/OQ/PQ) of PBF-EB
equipment
Fabrication additive de métaux — Principes de qualification —
Installation, fonctionnement et performances (IQ/OQ/PQ) des
équipements PBF-EB
Reference number
ISO/ASTM TS 52949:2025(en) © ISO/ASTM International 2025
ISO/ASTM TS 52949:2025(en)
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© ISO/ASTM International 2025
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© ISO/ASTM International 2025 – All rights reserved
ii
ISO/ASTM TS 52949:2025(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 2025 – All rights reserved
iii
ISO/ASTM TS 52949:2025(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 2025 – All rights reserved
iv
ISO/ASTM TS 52949:2025(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
...
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