FprEN ISO/ASTM 52920
(Main)Additive manufacturing - Qualification principles - Requirements for industrial additive manufacturing processes and production sites (ISO/ASTM/FDIS 52920:2023)
Additive manufacturing - Qualification principles - Requirements for industrial additive manufacturing processes and production sites (ISO/ASTM/FDIS 52920:2023)
The requirements in this document are for part manufacturers using additive manufacturing techniques and are independent of the used material and manufacturing method.
This document specifies criteria for AM relevant processes as well as quality-relevant characteristics and factors along the additive system operations and defines activities and sequences within an additive manufacturing production site.
This document is applicable to the additive manufacturing technologies defined in ISO/ASTM 52900 and defines quality assurance measures along the manufacturing process.
Environment, health and safety aspects are not covered comprehensively in this document. The corresponding content is addressed in the equipment manufacturer guidelines and ISO/ASTM 52931, ISO 27548, ISO/ASTM 52933 and ISO/ASTM 52938-1.
This document provides requirements that are additional to those provided by a quality management system (such as ISO 9001, ISO/TS 22163, ISO 19443, EN 9100, ISO 13485, IATF 16949). Additionally, this document can be used to establish quality management system relevant content that is specific to AM-technology.
Additive Fertigung - Grundsätze der Qualifizierung - Anforderungen an industrielle additive Fertigungsverfahren und Produktionsstätten (ISO/ASTM FDIS 52920:2023)
Die Anforderungen in diesem Dokument richten sich an Hersteller, die additive Fertigungstechniken anwenden, und sind von dem verwendeten Material und dem Fertigungsverfahren unabhängig.
Dieses Dokument legt Kriterien für AM-relevante Prozesse sowie qualitätsrelevante Merkmale und Faktoren entlang des additiven Systembetriebs fest und definiert Tätigkeiten und Abläufe innerhalb eines additiven Fertigungszentrums.
Dieses Dokument ist anwendbar auf die nach ISO/ASTM 52900 festgelegten additiven Fertigungstechnologien und definiert Qualitätssicherungsverfahren entlang des Fertigungsprozesses.
Umwelt-, Gesundheits- und Sicherheitsaspekte werden in diesem Dokument nicht umfassend behandelt. Die entsprechenden Inhalte werden in den Richtlinien der Ausrüstungshersteller und in ISO/ASTM 52931, ISO 27548 , ISO/ASTM 52933 und ISO/ASTM 52938 1 .
Dieses Dokument enthält zusätzliche Anforderungen zu den durch ein Qualitätsmanagementsystem (wie etwa ISO 9001, ISO/TS 22163, ISO 19443, EN 9100, ISO 13485, IATF 16949) vorgesehenen Anforderungen. Zusätzlich kann dieses Dokument genutzt werden, um für das Qualitätsmanagementsystem relevante Inhalte festzulegen, die spezifisch für die AM-Technologie sind.
Fabrication additive - Principes de qualification - Exigences pour les procédés et les sites industriels de production en fabrication additive (ISO/ASTM/FDIS 52920:2023)
Les exigences du présent document s'adressent aux fabricants de pièces utilisant des techniques de fabrication additive et sont indépendantes du matériau utilisé et de la méthode de fabrication.
Le présent document spécifie les critères des procédés de FA pertinents ainsi que les caractéristiques et les facteurs relatifs à la qualité tout au long des opérations du système additif, et définit les activités et les séquences au sein d'un site de production de fabrication additive.
Le présent document est applicable aux technologies de fabrication additive définies dans l'ISO/ASTM 52900 et définit les mesures d'assurance qualité tout au long du procédé de fabrication.
Les aspects liés à l'environnement, à la santé et à la sécurité ne sont pas couverts de manière exhaustive par le présent document. Les contenus correspondants sont traités dans les lignes directrices du fabricant de l'équipement et dans l'ISO/ASTM 52931, l'ISO 27548, l'ISO/ASTM 52933 et l'ISO/ASTM 52938‑1.
Le présent document fournit des exigences supplémentaires à celles fournies par un système de management de la qualité (tel que l'ISO 9001, l'ISO/TS 22163, l'ISO 19443, l'EN 9100, l'ISO 13485, l'IATF 16949). En outre, le présent document peut être utilisé pour établir du contenu pertinent, spécifique de la technologie de fabrication additive, pour le système de management de la qualité.
Aditivna proizvodnja - Kvalifikacija - Zahteve za industrijske postopke in mesta za aditivno proizvodnjo (ISO/ASTM FDIS 52920:2023)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
oSIST prEN ISO/ASTM 52920:2021
01-september-2021
Aditivna proizvodnja - Kvalifikacija - 2. del: Zahteve za industrijska mesta za
aditivno proizvodnjo (ISO/ASTM DIS 52920:2021)
Additive manufacturing - Qualification principles - Part 2: Requirements for industrial
additive manufacturing sites (ISO/ASTM DIS 52920:2021)Additive Fertigung - Qualifikationsprinzipien - Anforderungen an Standorte für industrielle
additive Fertigung (ISO/ASTM DIS 52920:2021)Fabrication additive - Principes de qualification - Exigences pour les sites de fabrication
additive industrielle (ISO/ASTM DIS 52920:2021)Ta slovenski standard je istoveten z: prEN ISO/ASTM 52920
ICS:
25.030 3D-tiskanje Additive manufacturing
oSIST prEN ISO/ASTM 52920:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO/ASTM 52920:2021
DRAFT INTERNATIONAL STANDARD
ISO/ASTM DIS 52920
ISO/TC 261 Secretariat: DIN
Voting begins on: Voting terminates on:
2021-08-03 2021-10-26
Additive manufacturing — Qualification principles —
Requirements for industrial additive manufacturing
sites —
Part :
Requirements for industrial additive manufacturing sites
ICS: 25.030
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/ASTM DIS 52920:2021(E)
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 SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO/ASTM 52920:2021
ISO/ASTM DIS 52920:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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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 InternationalCP 401 • Ch. de Blandonnet 8 100 Barr Harbor Drive, PO Box C700
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Published in Switzerland
ii © ISO/ASTM International 2021 – All rights reserved
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oSIST prEN ISO/ASTM 52920:2021
ISO/ASTM DIS 52920:2021(E)
Contents Page
Foreword ........................................................................................................................................................................................................................................iv
Introduction ..................................................................................................................................................................................................................................v
1 Scope ................................................................................................................................................................................................................................. 1
2 Normative references ...................................................................................................................................................................................... 1
3 Terms and definitions ..................................................................................................................................................................................... 2
4 Qualification of the additive system operations .................................................................................................................. 2
4.1 Quality-relevant process steps within the manufacturing process ........................................................... 2
4.2 Requirements for pre-processing: data preparation ............................................................................................. 3
4.3 Requirements for pre-processing: feedstock management ............................................................................. 4
4.4 Requirements for pre-processing: system set-up ..................................................................................................... 5
4.5 Requirements for in-processing: additive manufacturing process............................................................ 6
4.6 Requirements for post-processing: default post-processing .......................................................................... 7
4.7 Requirements for post-processing: end processing ............................................................................................... 8
4.8 Process qualification .......................................................................................................................................................................... 9
4.8.1 General...................................................................................................................................................................................... 9
4.8.2 Scope of qualification ................................................................................................................................................... 9
4.8.3 Process specification .................................................................................................................................................... 9
5 Quality assurance .............................................................................................................................................................................................10
5.1 General ........................................................................................................................................................................................................10
5.2 Personnel requirements ..............................................................................................................................................................10
5.3 Non-conformities ...............................................................................................................................................................................11
5.3.1 Acceptance criteria .....................................................................................................................................................11
5.3.2 Handling of non-conformities ...........................................................................................................................11
5.4 Continuous impr ovement process ......................................................................................................................................12
5.5 Documentation and tracing of the process steps ...................................................................................................12
5.5.1 General...................................................................................................................................................................................12
5.5.2 Compliance with part specifications ...........................................................................................................13
5.6 Infrastructure of the part manufacturer ........................................................................................................................14
5.7 Quality controls ...................................................................................................................................................................................15
5.7.1 General...................................................................................................................................................................................15
5.7.2 Batch approval ................................................................................................................................................................15
5.7.3 Part approval ....................................................................................................................................................................16
6 V erification of the part requirements .........................................................................................................................................17
6.1 General ........................................................................................................................................................................................................17
6.2 Manufacturing feasibility assessment .............................................................................................................................17
6.3 Validation plan .....................................................................................................................................................................................18
6.4 Execution of validation plan .....................................................................................................................................................19
Annex A (normative) End processing and part approval .............................................................................................................20
Annex B (informative) Supplementary information .........................................................................................................................21
Bibliography .............................................................................................................................................................................................................................27
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oSIST prEN ISO/ASTM 52920:2021
ISO/ASTM DIS 52920:2021(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).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.The committee responsible for this document is 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.iv © ISO/ASTM International 2021 – All rights reserved
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ISO/ASTM DIS 52920:2021(E)
Introduction
Additive manufacturing increasingly represents an attractive alternative to established manufacturing
methods for companies. The trend towards complex parts, decentralised manufacturing and customised
products allows economically viable application for a wider area. This applies to an increasing number
of serial applications, which pose new requirements to the processes’ performance. In particular, high
quality and safety requirements need to be fulfilled for components used industrially (automotive,
mechanical engineering, railway, aerospace, processing plants, medical, etc.). The present lack of
standards means that processes for the manufacturing of parts need to be defined from scratch for
each individual case, which entails a high degree of expense and which permits little transparency and
hence little trust amongst stakeholders in the process.If industrial parts are produced using additive manufacturing techniques, it shall be verified that these
meet the requirements placed on them. To this end, the process chain and environment shall be designed
in a way that the process quality and resultant part quality remain consistent and reproducible at all
times.The document outlines the relevant requirements to establish quality-assured processes in additive
manufacturing.This document has the aim of outlining the requirements as an integral whole (not product specifically),
which are necessary as a basis for designing processes for high-quality additively manufactured parts.
In particular in regulated industries, such as the automotive industry, mechanical engineering, the rail
sector, aerospace, process and industrial systems or medical technology, consideration of the criteria
defined within the framework of this document will establish a basis for fulfilling the requirements for
specific products.Important measures relating to the additive system operations are defined, which are to be controlled
and monitored in order to ensure a reproducible quality of AM parts. As this document is not intended
to be technology-dependent, the subprocesses are either applicable or can be disregarded, depending
on the technology used.This document provides a common approach for the proper manufacturing of additively manufactured
series and replacement parts. In this way, the scope of a supplier audit can be minimised if the
requirements of this document are fulfilled.© ISO/ASTM International 2021 – All rights reserved v
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oSIST prEN ISO/ASTM 52920:2021
DRAFT INTERNATIONAL STANDARD ISO/ASTM DIS 52920:2021(E)
Additive manufacturing — Qualification principles —
Requirements for industrial additive manufacturing
sites —
Part :
Requirements for industrial additive manufacturing sites
1 Scope
This document specifies the requirements, which are independent of the material and manufacturing
method used, for part manufacturers using additive manufacturing techniques.This document specifies criteria for additive manufacturing processes as well as quality-relevant
characteristics and factors along the process chain and defines activities and sequences within an
additive manufacturing production site.This document is applicable to the additive manufacturing technologies defined in ISO/ASTM 52900
and defines quality assurance measures along the manufacturing process.Environment, health and safety aspects are not covered in this standard. The corresponding content
is addressed in the equipment manufacturer guidelines and ISO/ASTM 52931, ISO/ASTM 52932,
ISO/ASTM 52933, ISO/ASTM 52934 and ISO/ASTM 52938-1 .A quality management system (e.g. ISO 9001, ISO/TS 22163, ISO 19443, SAE AS 9100D, ISO 13485,
IATF 16949) should be in place when the AM part manufacturer applies this standard. Additionally, this
standard can be used to establish quality management system relevant content that is specific to AM-
technology.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 — TerminologyISO/ASTM 52901, Additive manufacturing — General principles — Requirements for purchased AM parts
ISO/ASTM 52902, Additive manufacturing — Test artifacts — Geometric capability assessment of additive
manufacturing systemsISO/ASTM 52910, Additive manufacturing — Design — Requirements, guidelines and recommendations
ISO/ASTM 52950, Additive manufacturing — General principles — Overview of data processing
ISO 9001:2015, Quality management systems — RequirementsISO 9100:2016, Quality Management Systems — Requirements for Aviation, Space and Defence
OrganizationsISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
1) Work in progress – not published yet.© ISO/ASTM International 2021 – All rights reserved 1
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3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/ASTM 52900 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 https:// www .electropedia .org/
3.1
rework
unplanned approved process of performing a task that brings the part back into specification
3.2used feedstock
recycled feedstock
feedstock that has been supplied to an AM machine during at least one previous build cycle
4 Qualification of the additive system operations4.1 Quality-relevant process steps within the manufacturing process
The requirements of the additive system operations (4.2 to 4.6) and of the personnel (5.2) shall be met.
The relevant areas of the process chain are shown in Figure 1. All terms shown in figures are underlined
throughout the document. This comprises:1) quality assurance: activities performed throughout the entire process chain that focus on providing
confidence that the part quality will satisfy the specified requirements and ensure production
traceability;2) verification of part requirements: activities to establish clear, well-defined and measurable physical
and chemical characteristics upon which part acceptance or rejection is specified;
3) data preparation: digital activities on the as-designed part occurring before the additive
manufacturing process;4) feedstock management: material flows occurring within the additive system operations;
NOTE Feedstock management occurs before the additive manufacturing process only for some
technologies (e.g. MEX)a) system set-up: feedstock loading;
b) build cycle: feedstock availability and consumption;
c) default post-processing: feedstock recovery for intended reconditioning and reuse;
5) system set-up: manual activities occurring in the immediate environment of the additive system
and serving to initiate the additive manufacturing process;6) additive manufacturing process: build cycle in which parts are produced additively;
7) default post-processing: activities on the as-built part occurring in the environment of the additive
system and performed downstream of the additive manufacturing process;8) end processing: activities on the near net shape part occurring outside the immediate environment
of the additive system, after the additive system operations (see Annex A).2 © ISO/ASTM International 2021 – All rights reserved
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oSIST prEN ISO/ASTM 52920:2021
ISO/ASTM DIS 52920:2021(E)
Figure 1 — Quality ensured process in an additive manufacturing production site
Quality assurance requires a comprehensive specification of the manufacturing process and defined
part requirements (Figure 1).4.2 Requirements for pre-processing: data preparation
Figure 2 shows the individual steps of the data preparation to be performed by the part manufacturer.
Figure 2 — Elements of the data preparationA uniform data and information structure according to ISO/ASTM 52950 shall be applied.
If technically applicable, the following process steps shall be specified including verification and
documentation as specified in the process qualification:1) data check: an inspection regarding error-free, processability of the 3D data shall be carried out.
If necessary, data fixing is carried out. If applicable, documentation of the conversion parameters
from CAD, digital scanning software or other design creation software to STL or AMF is required;
EXAMPLE Software versions, configuration settings that directly impact resolution, size and middle
tolerances of the 3D data set.2) geometrical adjustments for manufacturing: allowances, cutting, hollowing, closure of holes, etc.;
structural changes of the 3D data may be required for a manufacturing-compliant design (e.g.
adequate end processing). Considerations need to be given to the following:a) approval may need to be obtained from the customer;
b) traceability shall be maintained;
EXAMPLE Digital part marking can be applied.
c) all adaptations shall be documented in comprehensible and verifiable form (this comprises
versioning of the modified data set).3) part placement: orientation, positioning of the single part as well as arrangement of all parts
within the build envelope, with consideration of individual manufacturing plans and of material
behaviour;© ISO/ASTM International 2021 – All rights reserved 3
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ISO/ASTM DIS 52920:2021(E)
EXAMPLE Material-specific characteristics comprise minimum part spacing, wall thickness, supporting
area of the part or self-supporting angle.4) support generation: where support structures are required, if these are not calculated fully
automatically, a defined and user-independent workflow for the generation of supporting
geometries shall be ensured;5) slice data generation: conversion of the slice data with complete process parameters (see
parameter set in 4.8.3) for the AM machine to be used;a) in case of software updates, input and output data should be used to check that the generated
data corresponds to a referenced output data;b) the parameters for the data conversion shall be specified and complied with in the
corresponding procedure. If slice data are not calculated fully automatically, a defined and
user-independent application of process parameters shall be ensured;EXAMPLE Layer thickness
6) data archiving: unique, versioned archive of the digital files used for the build cycle. Record
retention period according to the regulatory or application-specific requirements.
EXAMPLE 3D CAD files, drawings, build file, virtual support structure4.3 Requirements for pre-processing: feedstock management
Figure 3 shows the individual steps for the feedstock management to be performed by the part
manufacturer.Figure 3 — Elements of the feedstock management
A feedstock specification is required to ensure its suitability for the respective manufacturing process.
In case of used feedstock, the part manufacturer shall define allowable limits for production. The
feedstock supplier, as all suppliers, should be managed according to general quality management
system requirements.EXAMPLE Chemical composition or alloying elements
EXAMPLE Degradation criteria include operating conditions, humidity, chemical by-products, organic
compounds, biological agentsDepending on the feedstock and on the customer requirements, it is possible to establish a closed loop by
resupplying material in a controlled manner. To ensure the required properties of the feedstock (refer
to ISO/ASTM 52928 for powders), the following process steps shall be specified including verification
and documentation as specified in the process qualification:1) batch control: the part manufacturer shall establish instructions to ensure the feedstock meets the
defined specification and is subsequently labelled to ensure traceability. A material history record
can be re-created for the material states in Table 1. Corresponding to the use, a unique relation
between the finished part and used feedstock may be required;EXAMPLE In a closed loop, some steps of the system set-up (see 4.4) may be carried out before item 1.
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oSIST prEN ISO/ASTM 52920:2021
ISO/ASTM DIS 52920:2021(E)
Table 1 — Traceability, iteration of recycling, batch purity
Lot use
Batch from an individual lot Batch from more than one lot
Material use
New feedstock Clear allocation to the lot; Limited allocation to the lots;
(Filament, pellets, Unique characteristics of the feedstock Limited characteristicsa of the feedstock
powder, liquid)Used feedstock Clear allocation to the lot; Difficult allocation to the lots;
(Powder, liquid) Limited characteristicsa of the feedstock Limited characteristicsa of the feedstock
Limited characteristics: key characteristics with specified allowable limits.EXAMPLE Material, batch number. For metallic powders, see ISO/ASTM 52907.
2) storage: monitoring and control of storage climate (in particular moisture, temperature or light
source), with defined acceptable limits. Specific storage requirements stated on the feedstock data
sheet shall also be adhered to. The feedstock container may deviate from the original packaging
but shall be compatible with the stored feedstock.3) preparation for the build cycle: if applicable, adaptation of the feedstock for the build cycle:
a) sieving – only applicable for powder and liquids: supplied and sieved mass, mesh width, sieve
condition, protective gas used;b) blending – only applicable for powder and liquids: reuse of used feedstock which can be sieved
beforehand and added to the virgin feedstock in a defined blending ratio. If different batches
are blended together with a different ratio, it shall be ensured that the feedstock specifications
and traceability are still met.EXAMPLE Avoidance of cross-contamination, overpressure, cleaning schedule, conveying system.
c) homogenizing – only applicable for powder and liquids: procedures to achieve a homogeneous
blend and, if needed, conclusive sampling;4) transport into AM machine: to avoid cross-contamination where step 3 occurs outside the AM
machine, transport and mount cartridges or powder containers in sealed form. Minimise or exclude
contact with the environment. The material history shall be documented: this includes supplied
and removed amount to the build cycle as well as batch allocation;5) transport from AM machine – applicable for powder: unique marking of used feedstock is maintained
for batch control until the next process step is determined to avoid cross-contamination.
4.4 Requirements for pre-processing: system set-upFigure 4 shows the individual steps of the system set-up to be performed by the part manufacturer.
Figure 4 — Elements of the system set-up© ISO/ASTM International 2021 – All rights reserved 5
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oSIST prEN ISO/ASTM 52920:2021
ISO/ASTM DIS 52920:2021(E)
If technically applicable, the following process steps shall be specified including verification and
documentation as specified in the process qualification:1) AM machine preparation: restoration of the initial machine state for the following build cycle:
a) proper preparation of the machine by corresponding personnel (see 5.2). The preparatory
steps indicated by the equipment manufacturer for the machine start shall be observed;
b) cleaning processes shall be carried out according to equipment manufacturer procedures;
c) filter state – applicable for PBF/M and DED techniques: Depending on the material and
protective gas, the filter service life or filter type shall be allocated uniquely in order to ensure
a reproducible build process and protective gas control;NOTE Consider the potential pyrophoric nature of the dust on the media when removing or
replacing filters.2) set-up for build cycle:
a) build platform: depending on the material, minimum requirements shall be specified;
b) feedstock state (see Table 1) in the machine;EXAMPLE In the PBF-LB/M technique in DIN 65124 or after acceptance by the equipment manufacturer.
c) dependin...
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