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ASTM F3434-20

(Guide)

Guide for Additive manufacturing – Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing

Guide for Additive manufacturing – Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing

SCOPE
1.1 This guide addresses IQ, OQ, and PQ issues directly related to the AM machine and connected equipment. Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.  
1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

Status
Historical
Publication Date
14-Apr-2020
ICS
25.030 - Additive manufacturing
Technical Committee
F42 - Additive Manufacturing Technologies
Drafting Committee
F42.05 - Materials and Processes
Current Stage
Ref Project

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ASTM F3434-20 - Guide for Additive manufacturing – Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production ManufacturingASTM F3434-20 - Guide for Additive manufacturing – Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing
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ASTM F3434-20 - Guide for Additive manufacturing – Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3434 − 20
Guide for
Additive manufacturing – Installation/Operation and
Performance Qualification (IQ/OQ/PQ) of Laser-Beam
Powder Bed Fusion Equipment for Production
1
Manufacturing
This standard is issued under the fixed designation F3434; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
INTRODUCTION
This document provides recommended practices for process qualification of metal production parts
produced with the powder bed fusion by laser beam process (PBF-LB/M).This document covers only
process qualification issues directly related to the AM equipment and does not cover feedstock
qualification or post processing beyond powder removal.
1. Scope 3. Terminology
3.1 Terms and Definitions—For the purposes of this
1.1 This guide addresses IQ, OQ, and PQ issues directly
document, the terms and definitions given in ISO/ASTM
related to theAM machine and connected equipment. Physical
52900 and the following apply.
facility, personnel, process and material issues are only in-
ISO and IEC maintain terminological databases for use in
cludedtotheextentnecessarytosupportmachinequalification.
standardization at the following addresses:
1.2 This international standard was developed in accor-
— ISO Online browsing platform: available at https://
dance with internationally recognized principles on standard-
www.iso.org/obp
ization established in the Decision on Principles for the
— IEC Electropedia: available at http://
Development of International Standards, Guides and Recom-
www.electropedia.org/
mendations issued by the World Trade Organization Technical
3.2 Definitions:
Barriers to Trade (TBT) Committee.
3.2.1 build interruption—unplanned delay during the addi-
tive manufacturing cycle.
2. Referenced Documents
3.2.2 build pause—longer than typical time spacing be-
2.1 The following documents are referred to in the text in
tween layers. It may be planned as part of the print job or part
such a way that some or all of their content constitutes
of automatic machine control function – for example to allow
requirements of this document. For dated references, only the
powder transfer.
edition cited applies. For undated references, the latest edition
3.2.3 calibration—verification of an instrument’s accuracy
of the referenced document (including any amendments) ap-
against a standard.
plies.
3.2.4 factory acceptance test—SystemAcceptance Test per-
formed at equipment manufacturer’s facility.
2.2 Normative References:
ISO/ASTM 52900 Additive Manufacturing — General Prin-
3.2.5 installation qualification—establishing by objective
ciples —Terminology
evidence that all key aspects of the process equipment and
ISO/IEC 17025 General requirements for the competence of ancillary system installation adhere to the manufacturer’s
testing and calibration laboratories
approved specification and that the recommendations of the
supplier of the equipment are suitably considered.
3.2.6 means of compliance—method used to satisfy audit
1
requirement.
This guide is under the jurisdiction of ASTM Committee F42 on Additive
Manufacturing Technologies and is the direct responsibility of Subcommittee
3.2.7 operational qualification—establishing by objective
F42.05 on Materials and Processes.
evidence process control limits and action levels which result
Current edition approved April 15, 2020. Published July 2020. DOI: 10.1520/
F3434-20. in product that meets all predetermined requirements.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F3434 − 20
3.2.8 performance/part qualification—establishing by ob- product testing does not reveal all variations that may occur in
jective evidence that the process, under anticipated conditions, the product that may impact on safety and effectiveness.
consistently produces a product which meets all predetermined However, successfully validating a process may reduce the
requirements. dependence upon intensive in-process and finished product
testing. It should be noted that in most cases, end-product
3.2.9 process validation—Establishing by objective evi-
testing plays a major role in ensuring that quality assurance
dence that a process consistently produces result of product
goalsaremet;thatis,validationandend-producttestingarenot
meeting its predetermined requirements.xcazze
mutually exclusive.
3.2.10 process validation protocol—A document stating
5.1.4 Key process variables should be monitored and docu-
how validation will be conducted, including test parameters,
mented. Analysis
...

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1.1 This specification has been developed to facilitate exchanging and analyzing particle size distribution (PSD) by light scattering data from databases, data management systems, point of origin, or other data sources that may use different data dictionaries, schemas, or formats.  
1.2 This specification prescribes the use of a common exchange format in such a way that PSD data defined through proprietary means can be easily exchanged for process understanding and qualification.  
1.3 This specification facilitates the interoperability of PSD data by identifying the data elements defined in standardized terminology, as well as defining those salient terms with indisputable meanings. In doing so, this specification extends the common AM data dictionary defined in Practice F3490 to encapsulate PSD process-specific data elements. Generic data elements and relationships present in that standard are inherited and applied in this practice where relevant.  
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1.7.1 An exhaustive set of data items that could be exchanged related to PSD by light scattering.  
1.7.2 A definition of a minimum viable data set for PSD by light scattering.  
1.7.3 Data items or an exchange format for PSD methods other than light scattering, for example, imaging or sieving.  
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1.7.6 The implementation details of how data should be exported from proprietary data management systems to the common data exchange format.  
1.7.7 Guidelines for creating unique identifiers for data module records  
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