F42.07 - Applications

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1.1 This practice is intended to be used to assign part grade across the automotive industry. For this standard the term classification was changed to grade to avoid confusion with existing classifications in the automotive industry.  
1.2 See Practice F3572 for aviation part classifications and NASA-STD-6030 for spaceflight part classifications.  
1.3 This practice is applicable to all AM technologies defined in ISO/ASTM 52900 used in automotive.  
1.4 This practice is intended to be used to establish a metric for AM parts in downstream documents.  
1.5 This practice is not intended to establish criteria for any downstream processes, but rather to establish a metric that these processes can use.  
1.6 The part grade metric could be utilized by the engineering, procurement, non-destructive inspection, testing, qualification, or certification processes used for AM automotive parts.  
1.7 The grading scheme in this practice establishes a consistent methodology to define and communicate the consequence of failure associated with AM automotive parts.  
1.8 The material or process, or both, in general does not affect the consequence of failure of a part, therefore the grading scheme defined in this document may be used outside AM.  
1.9 The user of this standard should not assume regulators’ endorsement of this standard as accepted mean of compliance.  
1.10 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.  
1.11 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.

SCOPE
1.1 This specification covers additive manufacturing of parts manufactured via laser beam powder bed fusion (PBF-LB) processing of niobium-hafnium alloy used in spaceflight applications. Parts made using this processing method are typically used in applications that require mechanical properties like 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 tolerances.  
1.2 This specification is intended for the use of purchasers or producers, or both, of PBF-LB R04295 parts for defining the requirements based on classification methodology. These requirements shall be agreed upon by the part supplier and purchaser.  
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 committee members.  
1.4 User requirements considered more stringent may be met by the addition to the purchase order.  
1.5 Units—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.

SIGNIFICANCE AND USE
4.1 Overview:  
4.1.1 Assurance of product quality is derived from careful attention to many factors but is not limited to raw material acceptance, software workflow definition, product and process design and control, printing and post processing, equipment and systems installation, maintenance, and in-process and end-product testing.  
4.1.2 By managing these factors, a manufacturer can establish confidence that all finished manufactured units from successive lots will be acceptable and meet lot release criteria.  
4.1.3 The basic principles of quality assurance (QA) have as their goal the production of articles that are fit for their intended use. These principles may be stated as:
4.1.3.1 Quality, safety, and effectiveness shall be designed and built into the product as well as the production process.
4.1.3.2 AM product characteristics all cannot currently be verified after the process without destructive testing and therefore requires validation. Suitable consideration should be designed into the product and controls should be applied to the process during process validation.
4.1.3.3 Critical steps of the production process impacting quality shall be controlled to maximize the probability that the finished product meets all quality and design specifications.  
4.1.4 Process validation is a key element in ensuring that these QA goals are met. Routine end-product testing alone is often not sufficient to assure product quality. Some end-product tests have limited sensitivity. In some cases, destructive testing would be required to show that the manufacturing process is adequate, and in other situations, end-product testing does not reveal all variations that may occur in the product that may have an impact on device performance. However, successfully validating a process may reduce the dependence on intensive in-process and finished product testing. Note that, in most cases, end-product testing plays a major role in supporting QA goals, that is, validati...
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1.1 This practice provides an overview of how to perform process validation for medical devices manufactured using PBF/LB/M. The topics that will be covered include machine qualifications, software used in the manufacturing process, the importance of design specification and verification on process validation, and raw materials.  
1.2 This practice also provides recommendations for process characterization, risk management, additive manufacturing (AM) facility qualification, and process control as a prerequisite for qualification activity, including installation qualification/operational qualification/performance qualification (IQ/OQ/PQ).  
1.3 The practice is primarily focused on non-device-specific AM system(s) validation. Additional information may be needed in reference to the performance of the actual device.  
1.4 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.  
1.5 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.

SCOPE
1.1 This specification covers additive manufacturing of parts manufactured via laser beam powder bed fusion (PBF-LB) processing of Grade 4340 (UNS G43400) used in transportation applications, including automotive applications. Parts made using this processing method require heat treatment to achieve maximum strength and are typically used in applications that require mechanical properties similar to wrought Grade 4340 (UNS G43400) 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 tolerances.  
1.2 This specification describes the required facility, training, equipment, and processing requirements necessary to support the production of parts with properties and associated quality metrics outlined in a part classification structure.  
1.3 This specification is intended for the use of purchasers or producers, or both, of PBF-LB Grade 4340 (UNS G43400) parts for defining the requirements based on classification methodology. These requirements shall be agreed upon by the part supplier and purchaser.  
1.4 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 committee members.  
1.5 User requirements considered more stringent may be met by additional requirements in the purchase order.  
1.6 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.  
1.7 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.

SCOPE
1.1 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.

SIGNIFICANCE AND USE
4.1 In PBF systems, powder is often reused to increase feedstock efficiency by reducing waste. While in many applications the customer can rely on the manufacturer’s validation and verification activities to ensure their PBF process produces parts of the appropriate quality, some medical device regulatory bodies ask for the powder reuse schema to ensure that any effect of powder reuse on final device performance is assessed.5 The intention of this guide is to provide manufacturers, customers, and regulatory bodies concise terminology to describe powder feedstock reuse schema for PBF using metal or polymer feedstock. Additionally, a well-defined powder reuse schema may reduce the risk of feedstock contamination and associated defects within the manufacturer’s quality management system. Each schema represents a broad reuse strategy and is intended to be used as the starting point in describing a powder strategy to customers and regulatory bodies. While the focus of this guide is for medical applications, the schema referenced can be used for non-medical applications.
SCOPE
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.