CEN ISO/ASTM/TS 52930:2021
(Main)Additive Manufacturing - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM/TS 52930:2021)
Additive Manufacturing - Qualification principles - Installation, operation and performance (IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM/TS 52930:2021)
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 - Grundlagen der Qualifizierung - Installation, Funktion und Leistung (IQ/OQ/PQ) von PBF-LB-Anlagen (ISO/ASTM/TS 52930:2021)
Dieses Dokument befasst sich mit Fragen der Abnahmebeurteilung (IQ), der Funktionsbeurteilung (OQ) und der Leistungsbeurteilung (PQ), 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 beinhaltet keine andere Rohstoffbewertung oder Nachbearbeitung als die Entfernung von Pulver.
Die physischen Aspekte der Anlage, des Personals, des Prozesses und des Materials werden nur in dem Umfang berücksichtigt, der zur Unterstützung der Bewertung der Maschine erforderlich ist.
Fabrication additive - Principes de qualification - Installation, fonctionnement et performances (IQ/OQ/PQ) de l'équipement de PBF-LB (ISO/ASTM/TS 52930:2021)
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 la fonction physique, au personnel, au procédé et au matériau sont uniquement incluses dans la mesure nécessaire à soutenir la qualification de la machine.
Aditivna proizvodnja - Kvalifikacija - Vgradnja, delovanje in zmogljivost (IQ/OQ/PQ) opreme za lasersko spajanje prahu v postelji (PBF-LB) (ISO/ASTM/TS 52930:2021)
Ta dokument podaja priporočene prakse za kvalifikacijo procesov proizvodnje kovinskih delov, proizvedenih s posteljnimi metodami z uporabo laserskega žarka (PBF-LB/M). Ta dokument zajema samo teme v zvezi s kvalifikacijo procesov, ki so neposredno povezane z opremo za aditivno proizvodnjo (AM), ter ne zajema kvalifikacije vhodnih surovin ali naknadne obdelave, razen odstranjevanja praška. Te smernice obravnavajo teme v zvezi s kvalifikacijo namestitve (IQ), kvalifikacijo delovanja (OQ) in kvalifikacijo učinkovitosti (PQ), ki so neposredno povezane s strojem za aditivno proizvodnjo (AM) in priključeno opremo. Teme v zvezi s fizičnim objektom, osebjem, procesi in materiali so zajete le v obsegu, ki je potreben za podporo pri kvalifikaciji stroja.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2022
Aditivna proizvodnja - Kvalifikacija - Vgradnja, delovanje in zmogljivost (IQ/OQ/PQ)
opreme za posteljne metode z uporabo laserskega žarka (PBF-LB) (ISO/ASTM/TS
52930:2021)
Additive Manufacturing - Qualification principles - Installation, operation and performance
(IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM/TS 52930:2021)
Additive Fertigung - Grundlagen der Qualifizierung - Installation, Funktion und Leistung
(IQ/OQ/PQ) von PBF-LB-Anlagen (ISO/ASTM/TS 52930:2021)
Fabrication additive - Principes de qualification - Installation, fonctionnement et
performances (IQ/OQ/PQ) de l'équipement de PBF-LB (ISO/ASTM/TS 52930:2021)
Ta slovenski standard je istoveten z: CEN ISO/ASTM/TS 52930:2021
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
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
December 2021
ICS 25.030
English Version
Additive Manufacturing - Qualification principles -
Installation, operation and performance (IQ/OQ/PQ) of
PBF-LB equipment (ISO/ASTM/TS 52930:2021)
Fabrication additive - Principes de qualification - Additive Fertigung - Grundlagen der Qualifizierung -
Installation, fonctionnement et performances Installation, Funktion und Leistung (IQ/OQ/PQ) von
(IQ/OQ/PQ) de l'équipement de PBF-LB PBF-LB-Anlagen (ISO/ASTM/TS 52930:2021)
(ISO/ASTM/TS 52930:2021)
This Technical Specification (CEN/TS) was approved by CEN on 23 July 2021 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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/ASTM/TS 52930:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/ASTM/TS 52930:2021) 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/ASTM/TS 52930:2021 has been approved by CEN as CEN ISO/ASTM/TS 52930:2021
without any modification.
TECHNICAL ISO/ASTM TS
SPECIFICATION 52930
First edition
2021-11
Additive manufacturing —
Qualification principles —
Installation, operation and
performance (IQ/OQ/PQ) of PBF-LB
equipment
Fabrication additive — Principes de qualification — Installation,
fonctionnement et performances (IQ/OQ/PQ) de l'équipement de PBF-
LB
Reference number
ISO/ASTM TS 52930:2021(E)
© ISO/ASTM International 2021
ISO/ASTM TS 52930:2021(E)
© ISO/ASTM International 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester. In the United States, such requests should be sent to ASTM International.
ISO copyright office ASTM International
CP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
CH-1214 Vernier, Geneva West Conshohocken, PA 19428-2959, USA
Phone: +41 22 749 01 11 Phone: +610 832 9634
Fax: +610 832 9635
Email: copyright@iso.org Email: khooper@astm.org
Website: www.iso.org Website: www.astm.org
Published in Switzerland
ii
© ISO/ASTM International 2021 – All rights reserved
ISO/ASTM TS 52930:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 General concepts . 3
5.1 General . 3
5.2 Preliminary considerations . 4
6 Elements of process validation . 4
6.1 General . 4
6.2 Installation qualification (IQ) . 5
6.2.1 General . 5
6.2.2 Specific considerations for installation qualification . 5
6.3 Operational qualification (OQ) . 8
6.3.1 General . 8
6.3.2 Specific considerations for operational qualification . 9
6.4 Performance qualification (PQ) . 11
6.4.1 General . 11
6.4.2 Specific considerations for performance qualification . 11
6.4.3 Deterioration of products . 13
7 Revalidation .13
Annex A (normative) Process capability evaluation (Statistical process control) .15
Bibliography .19
iii
© ISO/ASTM International 2021 – All rights reserved
ISO/ASTM TS 52930:2021(E)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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.
iv
© ISO/ASTM International 2021 – All rights reserved
ISO/ASTM TS 52930:2021(E)
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 laser beam process (PBF-LB/M). 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 com
...
SLOVENSKI STANDARD
01-september-2022
Aditivna proizvodnja - Kvalifikacija - Vgradnja, delovanje in zmogljivost (IQ/OQ/PQ)
opreme za lasersko spajanje prahu v postelji (PBF-LB) (ISO/ASTM/TS 52930:2021)
Additive Manufacturing - Qualification principles - Installation, operation and performance
(IQ/OQ/PQ) of PBF-LB equipment (ISO/ASTM/TS 52930:2021)
Additive Fertigung - Grundlagen der Qualifizierung - Installation, Funktion und Leistung
(IQ/OQ/PQ) von PBF-LB-Anlagen (ISO/ASTM/TS 52930:2021)
Fabrication additive - Principes de qualification - Installation, fonctionnement et
performances (IQ/OQ/PQ) de l'équipement de PBF-LB (ISO/ASTM/TS 52930:2021)
Ta slovenski standard je istoveten z: CEN ISO/ASTM/TS 52930:2021
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
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
December 2021
ICS 25.030
English Version
Additive Manufacturing - Qualification principles -
Installation, operation and performance (IQ/OQ/PQ) of
PBF-LB equipment (ISO/ASTM/TS 52930:2021)
Fabrication additive - Principes de qualification - Additive Fertigung - Grundlagen der Qualifizierung -
Installation, fonctionnement et performances Installation, Funktion und Leistung (IQ/OQ/PQ) von
(IQ/OQ/PQ) de l'équipement de PBF-LB PBF-LB-Anlagen (ISO/ASTM/TS 52930:2021)
(ISO/ASTM/TS 52930:2021)
This Technical Specification (CEN/TS) was approved by CEN on 23 July 2021 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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/ASTM/TS 52930:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/ASTM/TS 52930:2021) 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/ASTM/TS 52930:2021 has been approved by CEN as CEN ISO/ASTM/TS 52930:2021
without any modification.
TECHNICAL ISO/ASTM TS
SPECIFICATION 52930
First edition
2021-11
Additive manufacturing —
Qualification principles —
Installation, operation and
performance (IQ/OQ/PQ) of PBF-LB
equipment
Fabrication additive — Principes de qualification — Installation,
fonctionnement et performances (IQ/OQ/PQ) de l'équipement de PBF-
LB
Reference number
ISO/ASTM TS 52930:2021(E)
© ISO/ASTM International 2021
ISO/ASTM TS 52930:2021(E)
© ISO/ASTM International 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester. In the United States, such requests should be sent to ASTM International.
ISO copyright office ASTM International
CP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
CH-1214 Vernier, Geneva West Conshohocken, PA 19428-2959, USA
Phone: +41 22 749 01 11 Phone: +610 832 9634
Fax: +610 832 9635
Email: copyright@iso.org Email: khooper@astm.org
Website: www.iso.org Website: www.astm.org
Published in Switzerland
ii
© ISO/ASTM International 2021 – All rights reserved
ISO/ASTM TS 52930:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 General concepts . 3
5.1 General . 3
5.2 Preliminary considerations . 4
6 Elements of process validation . 4
6.1 General . 4
6.2 Installation qualification (IQ) . 5
6.2.1 General . 5
6.2.2 Specific considerations for installation qualification . 5
6.3 Operational qualification (OQ) . 8
6.3.1 General . 8
6.3.2 Specific considerations for operational qualification . 9
6.4 Performance qualification (PQ) . 11
6.4.1 General . 11
6.4.2 Specific considerations for performance qualification . 11
6.4.3 Deterioration of products . 13
7 Revalidation .13
Annex A (normative) Process capability evaluation (Statistical process control) .15
Bibliography .19
iii
© ISO/ASTM International 2021 – All rights reserved
ISO/ASTM TS 52930:2021(E)
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 documents 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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
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.
iv
© ISO/ASTM International 2021 – All rights reserved
ISO/ASTM TS 52930:2021(E)
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 laser beam process (PBF-LB/M). 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 mach
...
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