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

Status
Not Published
Publication Date
29-Aug-2023
Current Stage
6055 - CEN Ratification completed (DOR) - Publishing
Start Date
01-Jul-2023
Completion Date
01-Jul-2023

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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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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

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
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Published in Switzerland
ii © ISO/ASTM International 2021 – All rights reserved
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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

© ISO/ASTM International 2021 – All rights reserved iii
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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.
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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.
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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 — Terminology

ISO/ASTM 52901, Additive manufacturing — General principles — Requirements for purchased AM parts

ISO/ASTM 52902, Additive manufacturing — Test artifacts — Geometric capability assessment of additive

manufacturing systems

ISO/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 — Requirements

ISO 9100:2016, Quality Management Systems — Requirements for Aviation, Space and Defence

Organizations

ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes

1) Work in progress – not published yet.
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ISO/ASTM DIS 52920:2021(E)
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

3.2
used 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 operations
4.1 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).
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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 preparation

A 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;
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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 structure
4.3 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 agents

Depending 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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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-up

Figure 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
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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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