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1.1 This specification covers additive manufacturing of parts via full-melt laser beam powder bed fusion (PBF-LB) processing of maraging steel alloys. Parts made using this processing method are typically used in applications that require mechanical properties similar to wrought products, either as fabricated or heat treated. 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 Maraging steel (MS) is a class of precipitation hardened steel, where aging heat treatment is used to form precipitates and, consequently, achieve significantly increased hardness and strength. This specification focuses specifically on 300 grade maraging steel, which corresponds to UNS K93120 and EN1.2709. MS grade 300 has higher concentrations of cobalt and titanium than lower grades.1.3 This specification is intended for the use of purchasers or producers, or both, of additively manufactured maraging steel parts for defining the requirements and ensuring part properties.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 the addition to the purchase order of one or more supplementary requirements, which include, but are not limited to, those listed in Supplementary Requirements in Sections S1 to S3.1.6 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.1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 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.

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This specification defines the requirements for additive manufacturing of nickel alloy (UNS N07718) using full-melt powder bed fusion such as electron beam melting and laser melting. The standard may be used by purchasers and producers of additively manufactured UNS N07718 components to specify the requirements and ensure component properties, and by users to obtain components that will satisfy the minimum acceptance requirements. The standard covers terminology and classification as well as the requirements with respect to ordering information, manufacturing plan, feedstock, thermal processing, chemical composition, microstructure, mechanical properties, hot isostatic pressing, dimensions and permissible variations, retests, inspection, rejection, certification, product marking and packaging, maintenance of a quality program, and the significance of numerical limits.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.

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This specification defines the requirements for additive manufacturing of nickel alloy (UNS N06625) using full-melt powder bed fusion such as electron beam melting and laser melting. The standard may be used by purchasers and producers of additively manufactured UNS N06625 components to specify the requirements and ensure component properties, and by users to obtain components that will satisfy the minimum acceptance requirements. The standard covers terminology and classification as well as the requirements with respect to ordering information, manufacturing plan, feedstock, thermal processing, chemical composition, microstructure, mechanical properties, hot isostatic pressing, dimensions and permissible variations, retests, inspection, rejection, certification, product marking and packaging, maintenance of a quality program, and the significance of numerical limits.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.

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5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use.NOTE 1: For a fine powder, depending upon application, a new biological risk assessment may be required.5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation.5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device.5.4 This guide provides specific evaluation techniques for measuring the effectiveness of residue removal processes, as they should be able to yield consistent results that meet the respective performance and cleanliness criteria for the intended use.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.

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4.1 The overall objective of this practice is to provide recommendations for the systematic acquisition of image data that indicate the health condition of the wear-sensitive SPW in PBF-LB/M machines. These data may allow a user to determine calibration and maintenance cycles based on the actual health condition of the SPW.4.2 The recommendations are intended for original equipment manufacturers (OEMs) of PBF-LB/M machines to provide guidance for the implementation of sensor systems to acquire spatially resolved data about the health condition of the SPW.4.3 The recommendations are intended for users of PBF-LB/M machines to provide guidance for the assessment of the actual health condition of the SPW to:4.3.1 Flag when a calibration or maintenance of the optical system is needed and alert the user or OEM to perform the calibration or maintenance and4.3.2 Generate statistical estimates for the useful life, or critical health state, of the SPW based on data recorded over the long term. The statistics may be used to derive maintenance cycles that allow a better utilization of the useful life of the SPW than current predetermined maintenance cycles.1.1 This practice provides:1.1.1 Recommendations for the design and integration of an area scan camera system (referred to as “camera system”) into a laser powder bed fusion (PBF-LB/M) machine to assess the health condition of the scanner protective window (SPW),1.1.2 Recommendations for data acquisition with the aforementioned system,1.1.3 Description of a methodology for processing the aforementioned data, and1.1.4 Recommendation on ex-situ measurements of laser beam parameters and part properties suitable for labeling of the processed condition data.1.2 Many of the operational descriptions included in this practice are intended as general overviews. They may not present the detailed information required.1.3 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.1.4 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.

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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. It indicates the classifications of the components, the feedstock used to manufacture Class 1, 2, and 3 components, as well as the microstructure of the components. This specification also identifies the mechanical properties, chemical composition, and minimum tensile properties of the components.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.

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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.

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1.1 This document addresses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) issues directly related to the additive manufacturing system that has a direct influence on the consolidation of material. The first three elements of process validation, process mapping, risk assessment, and validation planning, are necessary pre-conditions to machine qualification, however, they are outside the scope of this document.1.2 This document covers issues directly related to the AM equipment and does not cover feedstock qualification or post processing beyond powder removal.1.3 Physical facility, personnel, process and material issues are only included to the extent necessary to support machine qualification.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.

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4.1 This test method usually requires several minutes per sample. This test method covers eight elements and thus provides more elemental composition data than Test Method D4628 or Test Methods D4927. In addition, this test method provides more accurate results than Test Method D5185, which is intended for used lubricating oils and base oils.4.2 Additive packages are blends of individual additives, which can act as detergents, antioxidants, antiwear agents, and so forth. Many additives contain one or more elements covered by this test method. Additive package specifications are based, in part, on elemental composition. Lubricating oils are typically blends of additive packages, and their specifications are also determined, in part, by elemental composition. This test method can be used to determine if additive packages and unused lubricating oils meet specifications with respect to elemental composition.4.3 Several additive elements and their compounds are added to the lubricating oils to give beneficial performance (Table 1).1.1 This test method covers the quantitative determination of barium, boron, calcium, copper, magnesium, molybdenum, phosphorus, sulfur, and zinc in unused lubricating oils and additive packages.1.2 The precision statements are valid for dilutions in which the mass % sample in solvent is held constant in the range of 1 % to 5 % by mass of oil.1.3 The precision tables define the concentration ranges covered in the interlaboratory study. However, both lower and higher concentrations can be determined by this test method. The low concentration limits are dependent on the sensitivity of the ICP instrument and the dilution factor. The high concentration limits are determined by the product of the maximum concentration defined by the linear calibration curve and the sample dilution factor.1.4 Sulfur can be determined if the instrument can operate at a wavelength of 180 nm.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.

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