AMable - Standardisation in AM
AMable - Standardisation in AM
Additive Manufacturing
Standards
January 2022
Guide to Additive Manufacturing Standards
Stakeholders from producing industry and machine manufacturing strive for new standards that
regulate Additive Manufacturing activities. Although many were initiated or revised thought the last
couple of years, a lot of work is still to be done.
AMable partners and experts, in collaboration with several experiments and SMEs, have identified
recurrent needs in standardisation. This list compares the identified standard needs to the existing
standards. It therefore also provides information about specific gaps and if those are presently
being considered by any technical committee This list allows all stakeholders from production
companies to equipment providers to see if it is worth waiting for a publicly disclosed standard or if
it is time to engage.
For more information and access to the full and updated list of current standards, please consult
the websites of ISO/TC 261 1 2 and of ASTM Committee F42 3.
1 [Link]
2 [Link]
3 [Link]
Need Status Scope
General
Decision Support: Standard Available? No
Additive vs.
Subtractive
characteristics of the
general AM process
and ranks the
pros/cons or
strengths/weaknesses Is there any Work in No
of each process, Progress?
allowing users to
make informed
decisions about which
AM process best suits
their need
Standard Available? ISO/ASTM DIS 52920 - Additive manufacturing —Qualification principles — Requirements for industrial additive
manufacturing sites
This document defines the requirements for manufacturing sites, in which additive manufacturing techniques are used (referred to
below as additive manufacturing sites), which are independent of the material and manufacturing method used. This document specifies
Standardized Design criteria for additive manufacturing processes as well as quality-relevant characteristics and factors along the process chain and defines
for Additive activities and sequences within an additive manufacturing site. This document is applicable to the additive manufacturing technologies
Manufacturing defined according to E DIN EN ISO/ASTM 52900:2018-06 and follows an approach oriented to the manufacturing process.
Process Chain Note: This standard defines the requirements for an AM facility and has the AM process chain indirectly referred in the document.
Standard Available?
In-Process Monitoring No
ISO/ASTM DTR 52906 - Additive manufacturing — Non-destructive testing and evaluation — Intentionally seeding flaws in
parts
This practice describes the operation and production control of metal powder bed fusion (PBF) machines and processes to meet critical
applications such as commercial aerospace components and medical implants. The requirements contained herein are applicable for
production components and mechanical test specimens using powder bed fusion (PBF) with both laser and electron beams. 1.2 This
standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this
standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations
prior to use. 1.3 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.
Design
Standard Available? ISO/ASTM 52911-1:2019 - Additive manufacturing — Design — Part 1: Laser-based powder bed fusion of metals
This document specifies the features of laser-based powder bed fusion of metals (LB-PBF-M) and provides detailed design
Available only for PBF: recommendations. Some of the fundamental principles are also applicable to other additive manufacturing (AM) processes, provided
- Metals - ISO/ASTM that due consideration is given to process-specific features. This document also provides a state of the art review of design guidelines
52911-1:2019 associated with the use of powder bed fusion (PBF) by bringing together relevant knowledge about this process and by extending the
- Polymers - scope of ISO/ASTM 52910.
ISO/ASTM 52911-
2:2019 ISO/ASTM 52911-2:2019 - Additive manufacturing — Design — Part 2: Laser-based powder bed fusion of polymers
This document specifies the features of laser-based powder bed fusion of polymers (LB-PBF-P) and provides detailed design
recommendations. Some of the fundamental principles are also applicable to other additive manufacturing (AM) processes, provided
that due consideration is given to process-specific features. This document also provides a state-of-the-art review of design guidelines
associated with the use of powder bed fusion (PBF) by bringing together relevant knowledge about this process and by extending the
Process-Specific scope of ISO/ASTM 52910.
Design Guidelines
Is there any Work in ISO/ASTM AWI 52911-3 - Design — Part 3: Electron beam PBF of metals
Progress? This document specifies the features of electron beam powder bed fusion of metals (PBF-EBPBF-EB/M) and provides detailed design
recommendations. Some of the fundamental principles are also applicable to other additive manufacturing (AM) processes, provided
that due consideration is given to process-specific features. This document also provides a state of the art review of design guidelines
associated with the use of powder bed fusion (PBF) by bringing together relevant knowledge about this process and by extending the
scope of ISO/ASTM52910.
(ISO/ASTM 52922) - F3413 – 19 - Guide for Additive Manufacturing — Design — Directed Energy Deposition
This document specifies the features of Directed Energy Deposition (DED) and provides detailed design recommendations. This
document also provides a state-of-the-art review of design guidelines associated with the use of DED by bringing together relevant
knowledge about this process and by extending the scope of ISO/ASTM 52910. Some of the fundamental principles are also applicable
to other additive manufacturing (AM) processes, provided that due consideration is given to process-specific features.
Standard Available? No
Standard Available? ISO/ASTM FDIS 52950 - Additive manufacturing — General principles — Overview of data processing
This document covers the principal considerations which apply to data exchange for additive manufacturing. It specifies terms and
Design for 3D Printed definitions which enable information to be exchanged describing geometries or parts such that they can be additively manufactured.
Electronics The data exchange method outlines file type, data enclosed formatting of such data and what this can be used for.
Note: This standard has topics for AM 3D geometry, but nothing directed to printed electronics.
and
IPC-2292: Design Standard for Printed Electronics on Flexible Substrates
Integration of This document establishes specific requirements for the design of printed electronic applications and their forms of component mounting
electronics on AM and interconnecting structures on flexible substrates.
built parts
Is there any Work in No
Progress?
Standard Available? ISO/ASTM 52902 - Additive manufacturing — Test artifacts — Geometric capability assessment of additive manufacturing
systems
Note: Design standards This document covers the general description of benchmarking test piece geometries along with quantitative and qualitative
often describe some of measurements to be taken on the benchmarking test piece(s) to assess the performance of additive manufacturing (AM) systems. This
the features possible performance assessment can serve the following two purposes: — AM system capability evaluation; — AM system calibration. The
for AM parts. benchmarking test piece(s) is (are) primarily used to quantitatively assess the geometric performance of an AM system. This document
Design
describes a suite of test geometries, each designed to investigate one or more specific performance metrics and several example
documentation of
configurations of these geometries into test piece(s). It prescribes quantities and qualities of the test geometries to be measured but
complex structures,
does not dictate specific measurement methods. Various user applications can require various grades of performance. This document
geometries and
discusses examples of feature configurations, as well as measurement uncertainty requirements, to demonstrate low and high grade
features possible by
examination and performance. This document does not discuss a specific procedure or machine settings for manufacturing a test piece,
AM
which are covered by ASTM F 2971 and other relevant process specific specifications.
Note: In this standard, artifacts are described with different features, which demonstrates the capabilities of AM machines. CAD files of
the artifacts are available.
Materials
Standard Available? ISO/ASTM 52907:2019 - Feedstock materials — Methods to characterize metal powders
This document provides technical specifications for metallic powders intended to be used in additive manufacturing and covers the
following aspects: — documentation and traceability; — sampling; — particle size distribution; — chemical composition; —
characteristic densities; — morphology; — flowability; — contamination; — packaging and storage. This document does not deal with
safety aspects. In addition, this document gives specific requirements for used metallic powders in additive manufacturing.
Is there any Work in ISO/ASTM DTR 52913-1 – Feedstock materials — Part 1: Parameters for characterization of powder flow properties
Progress? This Technical Report applies the principal requirements to measure the parameters that characterize the flow properties of powders for
powder based additive manufacturing processes. This International Technical Report applies variables which have an influence on flow
properties and the necessary information in a test report. This International Report is aimed for test equipment manufacturers, material
AM Powders (particle
size, distribution, suppliers and additive manufacturing machine users
spreadability, ISO/ASTM AWI 52928 - Feedstock materials — Powder life cycle management
flowability, re-usage,
This document specifies requirements and describes aspects for the lifecycle management of metal feedstock materials for powder
stratification, based additive manufacturing processes. Those aspects include: -Powder properties, -Powder lifecycle, -Test methods and, -Powder
storage...)
quality assurance.
F3049 – 14 - Standard Guide for Characterizing Properties of Metal Powders Used for AM Processes
1.1 This guide introduces the reader to techniques for metal powder characterization that may be useful for powder-based additive
manufacturing processes including binder jetting, directed energy deposition, and powder bed fusion. It refers the reader to other,
existing standards that may be applicable for the characterization of virgin and used metal powders processed in additive manufacturing
systems. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the
user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior
to use.
Standard Available? No
AM Filaments and
Pellets (re-usage,
storage...)
Is there any Work in No
Consumables (AM
Progress?
wires and so on)
Standard Available? No
Is there any Work in ISO/ASTM CD 52908 - Additive manufacturing of metals — Finished Part properties — Post-processing, inspection and
Progress? testing of parts produced by powder bed fusion
This document sets requirements for the qualification, quality assurance and post processing for metal parts made by powder bed
Note 1: Standards fusion. This standard defines methods and procedures for testing and qualification of various characteristics of additively manufactured
ISO/ASTM CD 52908, metal parts, in accordance to ISO 17296-3:2014 Classes H and M. The standard is intended to be used by part providers and/or
ISO/ASTM TS 52930 customers of parts. This standard is a top-level standard in the hierarchy of additive manufacturing standards in that it is intended to
and ISO/ASTM DIS apply to metallic parts made by additive manufacturing. The standard defines qualification procedures where appropriate to meet
52920 mention some defined quality levels.
topics on
characterization and ISO/ASTM TS 52930 - Additive manufacturing — Qualification principles — Installation, operation and performance
acceptance criteria but (IQ/OQ/PQ) of PBF-LB equipment
nothing on AM This guideline addresses IQ, OQ, and PQ issues directly related to the AM machine and connected equipment. Physical facility,
microstructures personnel, process and material issues are only included to the extent necessary to support machine qualification.
Note 2: ISO/ASTM AWI ISO/ASTM DIS 52920 - Additive manufacturing — Qualification principles — Requirements for industrial additive
52939 provides tables manufacturing sites
with criteria and test This document defines the requirements for manufacturing sites, in which additive manufacturing techniques are used (referred to
Characterization and procedure but also below as additive manufacturing sites), which are independent of the material and manufacturing method used. This document specifies
acceptance criteria of nothing on AM criteria for additive manufacturing processes as well as quality-relevant characteristics and factors along the process chain and defines
AM microstructures microstructures activities and sequences within an additive manufacturing site. This document is applicable to the additive manufacturing technologies
defined according to E DIN EN ISO/ASTM 52900:2018-06 and follows an approach oriented to the manufacturing process.
ISO/ASTM AWI 52945 - Additive manufacturing for Automotive — Qualification principles — Generic machine evaluation
and specification of Key Performance Indicators for PBF-LB/M processes
This document defines the methodology for generic AM-machine evaluation in automotive environment using objective test criteria and
provides the framework for an objective AM-machine evaluation and comparison. This document finds application in benchmarks,
preparation of purchase decisions, but also AM-machine evaluation within the machine procurement, acceptance, and qualification
process. The methodology and performance characteristics are introduced to enable evaluation on an objective and quantitative basis.
The documentation resulting from the AM-machine evaluation is used to obtain a reliable orientation selection and evaluation of PBF-
LB/M AM-machines. Furthermore, this document specifies machine KPIs in the context of machine procurement, production planning
and production of PBF-LB/M components. It aims to reach a detailed understanding between machine supplier and machine customer
with respect to the acceptance criteria during the procurement process and evaluation of machine performance during running
production. This document is applicable to the additive manufacturing technology LPBF-M defined in ISO/ASTM 52900.
ISO/ASTM AWI 52939 - Additive Manufacturing for construction — Qualification principles — Structural and infrastructure
elements
This document defines the requirements for building and construction projects in which additive manufacturing techniques are used. The
requirements are independent of the material and printing method used. This document specifies the criteria for additive manufacturing
processes and quality-relevant characteristics and factors along the process chain and defines activities and sequences within an
additive manufacturing site/project. This standard applies to all additive manufacturing technologies in building and construction of
Standard Available? No
Is there any Work in ISO/ASTM AWI 52909 - Additive manufacturing — Finished part properties — Orientation and location dependence of
Progress? mechanical properties for metal powder bed fusion
This document covers supplementary guidelines for evaluation of mechanical properties including static/quasi-static and dynamic testing
of metals made by additive manufacturing (AM) to standardize terminology that intended to be used when reporting results from testing
of directly printed samples or those excised from printed parts made by this technique or both. This document is provided to leverage
already existing standards. Guidelines are provided to standardize the measurements of mechanical properties and reporting for
additively manufactured metallic samples as well as those excised from components. This document does not purport to address all of
the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety,
health and environmental practices and determine the applicability of regulatory limitations prior to use. This document expands upon
Material Properties the nomenclature of ISO/ASTM 52900 and principles of ISO/ASTM 52921 and extends them specifically to metal additive
(yield strength, manufacturing. The application of this document is primarily intended to provide guidance on orientation designations in cases where
ultimate tensile meaningful orientation/direction for AM cannot be obtained from available test methods.
strength, reduction in
area, elongation, F3122 – 14 - Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via AM Processes
Young’s modulus...) 1.1 This standard serves as a guide to existing standards or variations of existing standards that may be applicable to determine
specific mechanical properties of materials made with an additive manufacturing process. 1.2 As noted in many of these referenced
standards, there are several factors that may influence the reported properties, including material, material anisotropy, method of
material preparation, porosity, method of specimen preparation, testing environment, specimen alignment and gripping, testing speed,
and testing temperature. These factors should be recorded, to the extent that they are known, according to Practice F2971 and the
guidelines of the referenced standards. 1.3 The following standards are not referred to directly in the guide but also have information
that may be useful in the testing of metal test specimens made via additive
manufacturing: A370, A1058, B211, B348, B557, B565, B724, B769, E3, E6, E7, E290, E467, E468, E837, E915, E1049,E1823, E1942.
1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this
standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility
of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations
prior to use.
Data
Standard Available? ISO/ASTM 52950:2021 - Additive manufacturing — General principles — Overview of data processing
This document covers the principal considerations which apply to data exchange for additive manufacturing. It specifies terms and
definitions which enable information to be exchanged describing geometries or parts such that they can be additively manufactured.
Data formats and
The data exchange method outlines file type, data enclosed formatting of such data and what this can be used for. This document —
data management in
enables a suitable format for data exchange to be specified, — describes the existing developments for additive manufacturing of 3D
several stages of the
geometries, — outlines existing file formats used as part of the existing developments, and — enables understanding of necessary
manufacturing
features for data exchange, for adopters of this document. This document is aimed at users and producers of additive manufacturing
workflow (DfAM,
processes and associated software systems. It applies wherever additive processes are used, and to the following fields in particular: —
simulation, path
producers of additive manufacturing systems and equipment including software; — software engineers involved in CAD/CAE systems; —
planning, sensing and
reverse engineering systems developers; — test bodies wishing to compare requested and actual geometries.
monitoring)
ISO/ASTM 52915:2020 - Specification for additive manufacturing file format (AMF) Version 1.2
This document provides the specification for the Additive Manufacturing File Format (AMF), an interchange format to address the
current and future needs of additive manufacturing technology. This document specifies the requirements for the preparation, display
Is there any Work in ISO/ASTM CD TR 52918 - Additive manufacturing– Data formats — File format support, ecosystem and evolutions
Progress? This document aims to provide an updated, comprehensive technical report on the current status of AMF support in the community, its
ecosystem, including alternative standards and consortiums, and to list and evaluate potential features and evolutions which are
susceptible to further extent its support.
ISO/ASTM DIS 52920 - Additive manufacturing — Qualification principles — Requirements for industrial additive
manufacturing sites
This document defines the requirements for manufacturing sites, in which additive manufacturing techniques are used (referred to
below as additive manufacturing sites), which are independent of the material and manufacturing method used. 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 site. This document is applicable to the additive manufacturing technologies
defined according to E DIN EN ISO/ASTM 52900:2018-06 and follows an approach oriented to the manufacturing process.
Standard Available? ISO/ASTM 52918 – Additive manufacturing — Data formats — File format support, ecosystem and evolutions
This document aims to provide an updated, comprehensive technical report on the current status of AMF support in the community, its
ecosystem, including alternative standards and consortiums, and to list and evaluate potential features and evolutions which are
susceptible to further extent its support.
Is there any Work in ISO/ASTM CD 52931 - Additive manufacturing of metals — Environment, health and safety — General principles for use of
Progress? Yes metallic materials
Environmental Health This document provides a guide for risk assessment and implementation of prevention and protection measures relating to additive
and Safety: ISO/ASTM AWI manufacturing with metallic feedstocks (e.g. powders, wires, …). The risks covered by this document concern the entire process value
52938-1 - AM of chain, from the reception of the raw material to the output of the parts for delivery. The management of waste and discharges is also
Protection of Machine
metals — Environment, taken into account.
Operators
health and safety —
Part 1: Safety ISO/ASTM CD 52932 - Additive manufacturing of polymers — Environment, health and safety — Test method for the
requirements for PBF- determination of particle emission rates from desktop ME printers
LB machines This standard specifies test methods to determine particle emissions (including ultrafine particles) and chemical substances (VOC,
aldehydes) from Material Extrusion (ME) processes often used in nonindustrial environments such as school, homes and office spaces in
ISO/ASTM WD 52933 - Environment, health and safety — Consideration for the reduction of hazardous substances
emitted during the operation of the non-industrial ME type 3D printer in workplaces, and corresponding test method
This international standard has been developed in close cooperation of ISO/TC 261 and ASTM F 42 on 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. This
standard refers to the assessment of hazardous substances emitted during operation of ME-type 3D printers installed in schools or
public places for educational and hands-on purposes, and basic countermeasures for reducing the substances. This standard provides
the necessary information and test procedures to reflect the characteristics of AM process based on the previous international standards
related to indoor air quality and to assess hazardous substances from AM workplace. With the temporal and spatial elements of AM
workplace excluded, it can be performed by using the following standard to measure hazardous substances emitted during operation of
the ME-type 3D printer. ISO/ASTM CD 52932, Additive manufacturing - Environment, Health, and Safety - Test method for
determination of particle and chemical emission rates from desktop 3D printer material extrusion.
ISO/ASTM AWI 52938-1 - Additive manufacturing of metals — Environment, health and safety — Part 1: Safety
requirements for PBF-LB machines
This document deals with the technical requirements and the means for their verification for Additive Manufacturing (AM) machines
using a bed of metallic powder and a laser herein designated as machine. This document deals with all significant hazards, hazardous
situations or hazardous events during all phases of the life of the machine (ISO 12100:2010, 5.4), as listed in Annex A, caused by AM
machines using a bed of metallic powder and a laser when used as intended and under conditions of misuse which are reasonably
foreseeable by the manufacturer. This document does not deal with hazards which can occur: —during construction; —operating in
potentially explosive atmospheres. This document is not applicable to machines manufactured before the date of its publication
Standard Available? ISO/ASTM 52904 - Additive manufacturing — Process characteristics and performance — Practice for metal powder bed
fusion process to meet critical applications
1.1 This practice describes the operation and production control of metal powder bed fusion (PBF) machines and processes to meet
critical applications such as commercial aerospace components and medical implants. The requirements contained herein are applicable
for production components and mechanical test specimens using powder bed fusion (PBF) with both laser and electron beams. 1.2 This
standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this
standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations
prior to use. 1.3 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.
Machine Calibration Note: it includes some points of Preventive Maintenance – maintenance intervals, maintenance manual.
and Preventative
Maintenance Is there any Work in ISO/ASTM 52908 - Additive manufacturing of metals — Finished Part properties — Post-processing, inspection and testing
Progress? of parts produced by powder bed fusion
This document sets requirements for the qualification, quality assurance and post processing for metal parts made by powder bed
Standards that provide fusion. This standard defines methods and procedures for testing and qualification of various characteristics of additively manufactured
some info but not metal parts, in accordance to ISO 17296-3:2014 Classes H and M. The standard is intended to be used by part providers and/or
extensive on the topic: customers of parts. This standard is a top-level standard in the hierarchy of additive manufacturing standards in that it is intended to
apply to metallic parts made by additive manufacturing. The standard defines qualification procedures where appropriate to meet
ISO/ASTM 52908
defined quality levels.
Only for PBF
ISO/ASTM 52920 - Qualification principles — Requirements for industrial additive manufacturing sites
This document defines the requirements for manufacturing sites, in which additive manufacturing techniques are used (referred to
below as additive manufacturing sites), which are independent of the material and manufacturing method used. This document specifies
Processes
Standard Available? No
Is there any Work in F3187 – 16 - Standard Guide for Directed Energy Deposition of Metals
Progress? 1.1 Directed Energy Deposition (DED) is used for repair, rapid prototyping and low volume part fabrication. This document is intended
to serve as a guide for defining the technology application space and limits, DED system set-up considerations, machine operation,
process documentation, work practices, and available system and process monitoring technologies. 1.2 DED is an additive
manufacturing process in which focused thermal energy is used to fuse materials by melting as they are being deposited. 1.3 DED
Standardization of Systems comprise multiple categories of machines using laser beam (LB), electron beam (EB), or arc plasma energy sources. Feedstock
DED processes typically comprises either powder or wire. Deposition typically occurs either under inert gas (arc systems or laser) or in vacuum (EB
systems). Although these are the predominant methods employed in practice, the use of other energy sources, feedstocks and
atmospheres may also fall into this category. 1.4 The values stated in SI units are to be regarded as standard. All units of measure
included in this guide are accepted for use with the SI. 1.5 This standard does not purport to address all of the safety concerns, if any,
associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and
determine the applicability of regulatory limitations prior to use.
Note: This document is intended to serve as a guide for defining the technology application space and limits, DED system set-up
considerations, machine operation, process documentation, work practices, and available system and process monitoring technologies.
Standard Available? No
Design guidelines for
medical devices to Is there any Work in ASTM F3357-19 - Standard Guide for Designing Reusable Medical Devices for Cleanability
assure cleanability Progress? 1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention
after production at after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also
different stages (at prepare for subsequent processing steps (for example, sterilization or disinfection). 1.2 This standard does not purport to address all of
the manufacturing the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety,
process, after health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.3 This international standard
processing, for was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for
reusage of the the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers
device) to Trade (TBT) Committee.
Standard Available? No
AM in producing
medicine Is there any Work in No
Progress?
Standard Available? ISO 10993 - Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management
process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the
evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyze the biological safety of the medical device; — the assessment of the
biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have
direct or indirect contact with: — the patient's body during intended use; — the user’s body, if the medical device is intended for
protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices
including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment
of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety
assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other
parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address
mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform
Cleanliness of Medical encephalopathy (TSE) agents and other pathogens.
AM Parts
ASTM F2100-11 - Standard Specification for Performance of Materials Used in Medical Face Masks
This specification covers the classifications, performance requirements, and test methods for the materials used in the construction of
medical face masks that are used in health care services such as surgery and patient care. Medical face mask material performance is
based on testing for bacterial filtration efficiency, differential pressure, sub-micron particulate filtration efficiency, resistance to
penetration by synthetic blood, and flammability. This specification does not address all aspects of medical face mask design and
performance, the effectiveness of medical face mask designs as related to the barrier and breathability properties, and respiratory
protection, which may be necessary for some health care services.
Note: ISO has compiled a list to support global efforts in dealing with the COVID-19 crisis, some of them related to the cleanliness of
medical parts. They are freely available in read-only format, at [Link]
Personnel Qualification
Standard Available? ISO/ASTM 52942:2020 - Additive manufacturing — Qualification principles — Qualifying machine operators of laser metal
powder bed fusion machines and equipment used in aerospace applications
Note: Only for PBF This document specifies requirements for the qualification of operators of laser metal powder bed fusion machines and equipment for
additive manufacturing in aerospace applications. This document is applicable if the operator qualification testing is required by contract
or by application standards in the field of aerospace.
Is there any Work in ISO/ASTM CD 52926-1 - Additive Manufacturing of metals — Qualification principles — Part 1: General qualification of
Progress? operators
This document describes the activities and responsibilities of the operators on the field of the Additive Manufacturing technologies
dealing with metallic parts production. This document is intended to provide guidance for qualification of machine operators in general
industrial applications. Where industry-specific requirements exist for the qualification of operators, such as ISO/ASTM 52942 for
aerospace applications, those industry-specific standards shall be used instead of this document.
Machine Operator
Training and ISO/ASTM CD 52926-X – AM of metals — Qualification principles — Part X: General qualification of machine operators
Qualification (The following scope is the same for all the parts, with exception of the process: PBF-LB, PBF-EB, DED-LB, DED-Arc)
X= 1
X=2 - for PBF-LB
X=3 - for PBF-EB
X=4 - for DED-LB
X=5 - for DED-Arc
This document describes the capabilities and responsibilities required for the qualification of the operators on the field of the Additive
Manufacturing technologies dealing with metallic parts production, specifically for the employment of “X”.
This document defines criteria for the theoretical and practical assessment of personnel operating PBF-LB/M machines. The activities
and procedures foreseen to be performed by the “X” operator are also part of the standard.
This document is intended to provide an outline for qualification of machine operators in general industrial applications. Where
industry-specific requirements exist for the qualification of operators, such as ISO/ASTM 52942 for aerospace applications, those
industry-specific standards shall be used instead of this document.
Standard Available? No
Is there any Work in ISO/ASTM CD 52935 - Additive manufacturing of metals — Qualification principles — Qualification of coordinators for
Progress? metallic parts production
This standard specifies personnel qualification requirements for industrial manufacturing centres regarding coordination of additive
manufacturing (AM) production. The AM Coordinator is responsible for translating part requirements into manufacturing requirements,
Training/qualification such as: - Assessing whether part information (likely beyond 3d file) is complete - Assessing whether the part can be manufactured as
i.e. of AM engineers
specified and selecting appropriate manufacturing processes. - Managing the quality control aspects of manufacturing (e.g. route card).
ISO/ASTM AWI 52937 - Additive Manufacturing of metals — Qualification principles — Qualification of designers
This standard specifies personnel qualification criteria for the theoretical and practical assessment of designers covering multiple Metal
Additive Manufacturing (AM) processes. The activities and procedures foreseen to be performed by the designer are also part of the
standard. The Designer’s responsibilities related to AM are to: - Finalise a part request for processing by the manufacturing responsible
for the coordination and supervision tasks (ISO/ASTM 52935); - Consider the economic viability of the CAD file for the selected material
Post-Processing
Standard Available? No
Is there any Work in ISO/ASTM AWI 52908 - Additive manufacturing — Post-processing methods — Standard specification for quality
Progress? Yes assurance and post processing of powder bed fusion metallic parts
This document sets requirements for the qualification, quality assurance and post processing for metal parts made by powder bed
Note: Only for PBF fusion. This standard defines methods and procedures for testing and qualification of various characteristics of additively manufactured
metal parts, in accordance to ISO 17296-3:2014 Classes H and M. The standard is intended to be used by part providers and/or
customers of parts. This standard is a top-level standard in the hierarchy of additive manufacturing standards in that it is intended to
Process-specific Post- apply to metallic parts made by additive manufacturing. The standard defines qualification procedures where appropriate to meet
processing (heat defined quality levels.
treatments, HIP,
Surface finishing, F3301-18ª - Standard for Additive Manufacturing – Post Processing Methods – Standard Specification for Thermal Post-
post cure) Processing Metal Parts Made Via Powder Bed Fusion
1.1 This standard specifies the requirements for thermal post-processing of parts produced via metal powder bed fusion to achieve the
required material properties and microstructure to meet engineering requirements. This standard is intended to be referenced by
Material Part Property specifications for powder bed fusion. Currently, this standard includes thermal post-processing for the materials
including titanium alloys, cobalt 28 chromium 6 molybdenum, alloy UNS N07718, alloy UNS N06625, alloy, UNS 31603 and AlSi10Mg.
This specification will be updated as new powder bed fusion material heat treatments are developed. 1.2 The values stated in SI units
are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to
address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish
appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
Is there any Work in ISO/ASTM DTR 52905 - Additive manufacturing of metals — Non-destructive testing and evaluation — Defect detection in
Progress? parts
Terminology for AM
This document categorizes Additive Manufacturing (AM) defects in DED and PBF laser and electron category of processes, provides a
Flaws review of relevant current NDT standards, details NDT methods that are specific to AM and complex 3D geometries and outlines existing
non-destructive testing techniques that are applicable to some AM types of defects. This document is aimed at users and producers of
AM processes and it applies, in particular, to the following: — Safety critical AM applications; — Assured confidence in AM; — Reverse
engineered products manufactured by AM; — Test bodies wishing to compare requested and actual geometries.
Standard Available? No
ISO/ASTM PRF TR 52916 - Additive manufacturing for medical — Data — Optimized medical image data
This standard includes the creation of optimized data for Medical Additive Manufacturing (MAM). These data are generated from static
modalities, such as magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), and single
Dimensioning and photon emission computed tomography (SPECT), and from dynamic modalities, such as ultrasound and optical image data. The
Tolerancing standard addresses medical-specific data quality requirements, and medical image data acquisition processing and optimization
Requirements approaches for accurate solid medical models, based on real human and animal data. Acquisition of medical computer-aided design
(CAD) data for sophisticated medical technology is based on two-dimensional (2D) medical images such as CT and MRI images. In order
to obtain accurate and precise data, the resolution and quality of the original image are important. However, results may differ based
on the operator behavior during editing, because anatomical medical images may have lower boundary clarity and there are points that
cannot be automatically classified. In addition, the non-uniform intensity of noise and radiation of the original image can cause errors.
Therefore, as the efforts to evaluate for medical image data acquisition processing and to reduce errors are closely related to the quality
of medical care, it is necessary to standardize a series of optimization methods in order to digitize medical images and integrate them
for utilization.
Note: High relevance in tolerancing. Has plenty of information and examples but very focused in Medical AM.
Published by
AMable Projectoffice
Fraunhofer ILT
Ulrich Thombansen
Steinbachstrasse 15
D-52064 Aachen
Germany
[Link]