Alkalmazástechnika

.1 This practice is intended to be used to assign part classifications across the aviation industries that use AM to produce parts.

1.2 This practice is applicable to all AM technologies defined in ISO/ASTM 52900 used in aviation.

1.3 This practice is intended to be used to establish a metric for AM parts in downstream documents.

1.4 This practice is not intended to establish criteria for any downstream processes, but rather to establish a metric that these processes can use.

1.5 The part classification metric could be utilized by the engineering, procurement, non-destructive inspection, testing, qualification, or certification processes used for AM aviation parts.

1.6 The classification scheme in this practice establishes a consistent methodology to define and communicate the consequence of failure associated with AM aviation parts.

1.7 This practice is not intended to supersede the requirements and definitions of the applicable regulations or policies, including but not limited to the ones listed in Annex A1.

1.8 Tables A1.1-A1.3 align the existing regulations and guidance with the four part classes established herein. However, this alignment should not be construed as an alignment of the existing regulations to each other.

1.9 The material or process, or both, in general does not affect the consequence of failure of a part, therefore the classification scheme defined in this document may be used outside AM.

1.10 The user of this standard should not assume regulators’ endorsement of this standard as accepted mean of compliance.

1.11 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.

1.12 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.

1.1 Purpose

This standard specifies requirements for qualification of the manufacturing process, production, marking, and documentation of additively manufactured polymer-based components used in the petroleum and natural gas industries when referenced by an applicable API equipment standard or otherwise specified as a requirement for conformance. The qualification process flowchart is shown in Figure 1.

1.2 Applicability

This standard applies to additively manufactured polymer-based components (including composites) produced by material extrusion [also referred to as fused filament fabrication (FFF) or fused deposition modeling (FDM) and fused granulate fabrication (FGF)] and powder bed fusion [also referred to as selective laser sintering (SLS) or multi jet fusion (MJF)].

1.3 Additive Manufacturing Specification Levels (AMSL)

This standard establishes requirements for three additive manufacturing specification levels (AMSL). These three designations—AMSL 1, AMSL 2, and AMSL 3—define increasing levels of additive manufacturing (AM) technical, quality and qualification requirements.

NOTE An AMSL can be assigned to a component by a product specification or standard, the purchaser, or the additive manufacturer. 

1.1 This guide provides a concise approach for users of powder bed fusion (PBF) processes to communicate the method(s) in which feedstock powders are controlled throughout the feedstock lifecycle.

1.1.1 Regulatory bodies may require descriptions of used powder reuse schemes in a submission. This is because a medical device's performance can be affected by the condition of the powder feedstock and current regulations are not prescriptive to powder.

1.1.2 This guide is intended for users of both polymer and metal feedstock powders.

1.2 This guide does not cover powder specifications, recycling strategy, blending processes, lot control, or address contamination prevention.

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.

1.4 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.

1.1 This specification covers additively manufactured titanium-6aluminum-4vanadium with extra low interstitials (Ti-6Al-4V ELI) components using full-melt powder bed fusion such as electron beam melting and laser melting. The components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers or both of additively manufactured Ti-6Al-4V ELI components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in S1-S4 and S1-S16 in Specification F2924.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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.

1.1 This specification covers additively manufactured UNS N07718 components using full-melt powder bed fusion such as electron beam melting and laser melting. The components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured UNS N07718 components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in Supplementary Requirements S1–S16.

1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.

1.6 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.

1.7 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.

1.1 This specification covers additively manufactured UNS N06625 components using full-melt powder bed fusion such as electron beam melting and laser melting. The components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured UNS N06625 components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in Supplementary Requirements S1–S16.

1.5 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.

1.6 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.

1.7 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.

1.1 This specification covers additively manufactured titanium-6aluminum-4vanadium (Ti-6Al-4V) components using full-melt powder bed fusion such as electron beam melting and laser melting. The components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured Ti-6Al-4V components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more Supplementary Requirements, which may include, but are not limited to, those listed in S1-S16.

1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.6 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.

1.7 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.

1.1 This guide discusses the use of established and emerging nondestructive testing (NDT) procedures used to inspect metal parts made by additive manufacturing (AM).

1.2 The NDT procedures covered produce data related to and affected by microstructure, part geometry, part complexity, surface finish, and the different AM processes used.

1.3 The parts tested by the procedures covered in this guide are used in aerospace applications; therefore, the inspection requirements for discontinuities and inspection points in general are different and more stringent than for materials and components used in non-aerospace applications.

1.4 The metal materials under consideration include, but are not limited to, aluminum alloys, titanium alloys, nickel-based alloys, cobalt-chromium alloys, and stainless steels.

1.5 The manufacturing processes considered use powder and wire feedstock, and laser or electron energy sources. Specific powder bed fusion (PBF) and directed energy deposition (DED) processes are discussed.

1.6 This guide discusses NDT of parts after they have been fabricated. Parts will exist in one of three possible states: (1) raw, as-built parts before post-processing (heat treating, hot isostatic pressing, machining, etc.), (2) intermediately machined parts, or (3) finished parts after all post-processing is completed.

1.7 The NDT procedures discussed in this guide are used by cognizant engineering organizations to detect both surface and volumetric flaws in as-built (raw) and post-processed (finished) parts.

1.8 The NDT procedures discussed in this guide are computed tomography (CT, Section 7, including microfocus CT), eddy current testing (ET, Section 8), optical metrology (MET, Section 9), penetrant testing (PT, Section 10), process compensated resonance testing (PCRT, Section 11), radiographic testing (RT, Section 12), infrared thermography (IRT, Section 13), and ultrasonic testing (UT, Section 14). Other NDT procedures such as leak testing (LT) and magnetic particle testing (MT), which have known utility for inspection of AM parts, are not covered in this guide.

1.9 Practices and guidance for in-process monitoring during the build, including guidance on sensor selection and in-process quality assurance, are not covered in this guide.

1.10 This guide is based largely on established procedures under the jurisdiction of ASTM Committee E07 on Nondestructive Testing and is the direct responsibility of the appropriate subcommittee therein.

1.11 This guide does not recommend a specific course of action for application of NDT to AM parts. It is intended to increase the awareness of established NDT procedures from the NDT perspective.

1.12 Recommendations about the control of input materials, process equipment calibration, manufacturing processes, and post-processing are beyond the scope of this guide and are under the jurisdiction of ASTM Committee F42 on Additive Manufacturing Technologies. Standards under the jurisdiction of ASTM F42 or equivalent are followed whenever possible to ensure reproducible parts suitable for NDT are made.

1.13 Recommendations about the inspection requirements and management of fracture critical AM parts are beyond the scope of this guide. Recommendations on fatigue, fracture mechanics, and fracture control are found in appropriate end user requirements documents, and in standards under the jurisdiction of ASTM Committee E08 on Fatigue and Fracture.

NOTE 1: To determine the deformation and fatigue properties of metal parts made by additive manufacturing using destructive tests, consult Guide F3122.

NOTE 2: To quantify the risks associated with fracture critical AM parts, it is incumbent upon the structural assessment community, such as ASTM Committee E08 on Fatigue and Fracture, to define critical initial flaw sizes (CIFS) for the part to define the objectives of the NDT.

1.14 This guide does not specify accept-reject criteria used in procurement or as a means for approval of AM parts for service. Any accept-reject criteria are given solely for purposes of illustration and comparison.

1.15 Units—The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.

1.16 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.

1.17 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.

1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies.

1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide.

1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components.

1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components.

1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream.

1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse.

1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk.

1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards).

1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.8 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.

1.9 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.

1.1 This specification covers additive manufacturing of components via full-melt powder bed fusion processing of titanium alloys. Components made using this processing method are typically used in applications that require mechanical properties similar to wrought products. Products built to this specification may require additional post-processing in the form of machining, polishing, etc., to meet necessary surface finish and dimensional requirements.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured titanium components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of committee members.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which include, but are not limited to, those listed in Supplementary Requirements S1-S16.

1.5 The values stated in SI units are to be regarded as the standard. Other units are included only for informational purposes.

1.6 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.

1.1 This specification covers additively manufactured AlSi10Mg (similar to DIN EN 1706:2013-12 EN AC-43000) parts using powder bed fusion such as laser melting. The parts produced by these processes are used typically in applications that require mechanical properties similar to or exceeding those of cast aluminum products of equivalent alloys. Parts manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured AlSi10Mg parts for defining the requirements and ensuring part properties.

1.3 Users are advised to use this specification as a basis for obtaining parts that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in Supplementary Requirements S1–S16.

1.5 The values stated in SI units are to be regarded as the standard. Other units are included only for informational purposes.

1.6 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.

1.7 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.

1.1 This specification covers additively manufactured cobalt-28 chromium-6 molybdenum alloy components with similar chemical composition to UNS R30075 by means of laser and electron beam-based full melt powder bed fusion processes. The components produced by these processes are used typically in applications that require mechanical properties similar to cast or wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured cobalt-28 chromium-6 molybdenum alloy components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent than requirements in Sections 1–22 may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in Supplementary Requirements S1–S14.

1.5 The values stated in SI units are to be regarded as the standard. Other units are included only for informational purposes.

1.6 The chemical composition requirements in this specification for cobalt-28 chromium-6 molybdenum alloy components are similar to Specification F1537 Alloys 1 and 2 for wrought cobalt-28 chromium-6 molybdenum and Specification F75 for cast cobalt-28 chromium-6 molybdenum.

1.7 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.

1.1 This specification covers additive manufacturing of UNS S31603 components by means of laser and electron beam-based full melt powder bed fusion processes. The components produced by these processes are used typically in applications that require mechanical properties similar to machined forgings and wrought products. Components manufactured to this specification are often, but not necessarily, post processed via machining, grinding, electrical discharge machining (EDM), polishing, and so forth to achieve desired surface finish and critical dimensions.

1.2 This specification is intended for the use of purchasers or producers, or both, of additively manufactured UNS S31603 components for defining the requirements and ensuring component properties.

1.3 Users are advised to use this specification as a basis for obtaining components that will meet the minimum acceptance requirements established and revised by consensus of the members of the committee.

1.4 User requirements considered more stringent may be met by the addition to the purchase order of one or more supplementary requirements, which may include, but are not limited to, those listed in Supplementary Requirements S1–S16.

1.5 The compositional requirements specified in this specification do not meet the compositional requirements for surgical implant grade UNS S31673.

1.6 The values stated in SI units are to be regarded as the standard. Other units are included only for informational purposes.

1.7 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.