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AS 1961.6-2004 Castors and wheels Hospital bed castors 被代替 发布日期 :  2004-10-15 实施日期 : 

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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.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.

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4.1 Laboratory proofing of ink is necessary to establish a reproducible prediction of print appearance and performance properties, most of which are highly sensitive to ink film thickness. The apparatus described in this practice has found wide use for routine control proofing because it provides an economical method for producing reasonably large prints at film thicknesses comparable to those obtained on production presses.4.2 This practice does not duplicate the dynamics of a high speed press, nevertheless, it is useful for quality control and for specification acceptance between the producer and the user where there is an agreed upon specification for reflection density or standard reference print.1.1 This practice covers the procedure for preparing prints of paste inks using a hand operated flat-bed laboratory proof press. The initial method was developed by the National Printing Ink Research Institute.21.2 This practice is applicable to the preparation of single-color solid-area prints by the dry offset process (also known as Letterset) on a flat substrate such as paper or metal. It can readily be adapted to print by direct letterpress.3NOTE 1: The proofing press described in this practice can also be used with printing gages in accordance with Practice D6846.1.3 This practice is applicable primarily to lithographic and letterpress inks that dry by oxidation or penetration. With the addition of appropriate drying or curing equipment, it is also applicable to other systems such as heat-set or energy-curable.1.4 The instructions in this practice are intended to minimize the within-print and among-operator variability inherent in hand operations.1.5 This practice does not measure the actual film thickness on the print, but evaluates film thickness equivalence by visual or instrumental comparisons of reflection density.1.6 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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 users of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. Specific precautions are given in Section 7.1.8 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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5.1 Assumptions: 5.1.1 The control well discharges at a constant rate, Q.5.1.2 The control well is of infinitesimal diameter and fully penetrates the aquifer.5.1.3 The aquifer is homogeneous, isotropic, and areally extensive.NOTE 2: Slug and pumping tests implicitly assume a porous medium. Fractured rock and carbonate settings may not provide meaningful data and information.5.1.4 The aquifer remains saturated (that is, water level does not decline below the top of the aquifer).5.1.5 The aquifer is overlain, or underlain, everywhere by a confining bed having a uniform hydraulic conductivity and thickness. It is assumed that there is no change of water storage in this confining bed and that the hydraulic gradient across this bed changes instantaneously with a change in head in the aquifer. This confining bed is bounded on the distal side by a uniform head source where the head does not change with time.5.1.6 The other confining bed is impermeable.5.1.7 Leakage into the aquifer is vertical and proportional to the drawdown, and flow in the aquifer is strictly horizontal.5.1.8 Flow in the aquifer is two-dimensional and radial in the horizontal plane.5.2 The geometry of the well and aquifer system is shown in Fig. 1.5.3 Implications of Assumptions: 5.3.1 Paragraph 5.1.1 indicates that the discharge from the control well is at a constant rate. Section 8.1 of Test Method D4050 discusses the variation from a strictly constant rate that is acceptable. A continuous trend in the change of the discharge rate could result in misinterpretation of the water-level change data unless taken into consideration.5.3.2 The leaky confining bed problem considered by the Hantush-Jacob solution requires that the control well has an infinitesimal diameter and has no storage. Abdul Khader and Ramadurgaiah (5) developed graphs of a solution for the drawdowns in a large-diameter control well discharging at a constant rate from an aquifer confined by a leaky confining bed. Fig. 2 (Fig. 3 of Abdul Khader and Ramadurgaiah (5)) gives a graph showing variation of dimensionless drawdown with dimensionless time in the control well assuming the aquifer storage coefficient, S = 10−3, and the leakage parameter,Note that at early dimensionless times the curve for a large-diameter well in a non-leaky aquifer (BCE) and in a leaky aquifer (BCD) are coincident. At later dimensionless times, the curve for a large diameter well in a leaky aquifer coalesces with the curve for an infinitesimal diameter well (ACD) in a leaky aquifer. They coalesce about one logarithmic cycle of dimensionless time before the drawdown becomes sensibly constant. For a value of rw/B smaller than 10−3, the constant drawdown (D) would occur at a greater value of dimensionless drawdown and there would be a longer period during which well-bore storage effects are negligible (the period where ACD and BCD are coincident) before a steady drawdown is reached. For values ofgreater than 10−3, the constant drawdown (D) would occur at a smaller value of drawdown and there would be a shorter period of dimensionless time during which well-storage effects are negligible (the period where ACD and BCD are coincident) before a steady drawdown is reached. Abdul Khader and Ramadurgaiah (5)present graphs of dimensionless time versus dimensionless drawdown in a discharging control well for values of S = 10−1, 10−2, 10−3, 10−4, and 10−5 and rw/B = 10−2, 10−3, 10−4, 10−5, 10−6, and 0. These graphs can be used in an analysis prior to the aquifer test making use of estimates of the hydraulic properties to estimate the time period during which well-bore storage effects in the control well probably will mask other effects and the drawdowns would not fit the Hantush-Jacob solution.FIG. 2 Time—Drawdown Variation in the Control Well for S = δ = 10−3 (from Abdul Khader and Ramadurgaiah (5))FIG. 3 Schematic Diagram of Two-Aquifer System5.3.2.1 The time needed for the effects of control-well bore storage to diminish enough that drawdowns in observation wells should fit the Hantush-Jacob solution is less clear. But the time adopted for when drawdowns in the discharging control well are no longer dominated by well-bore storage affects probably should be the minimum estimate of the time to adopt for observation well data.5.3.3 The assumption that the aquifer is bounded, above or below, by a leaky layer on one side and a nonleaky layer on the other side is not likely to be entirely satisfied in the field. Neuman and Witherspoon (6, p. 1285) have pointed out that because the Hantush-Jacob formulation uses water-level change data only from the aquifer being pumped (or recharged) it can not be used to distinguish whether the leaking beds are above or below (or from both sides) of the aquifer. Hantush (7) presents a refinement that allows the parameters determined by the aquifer field test analysis to be interpreted as composite parameters that reflect the combined effects of overlying and underlying confined beds. Neuman and Witherspoon (6) describe a method to estimate the hydraulic properties of a confining layer by using the head changes in that layer.5.3.4 The Hantush-Jacob theoretical development requires that the leakage into the aquifer is proportional to the drawdown, and that the drawdown does not vary in the vertical in the aquifer. These requirements are sometimes described by stating that the flow in the confining beds is essentially vertical and in the aquifer is essentially horizontal. Hantush's (8) analysis of an aquifer bounded only by one leaky confining bed suggested that this approximation is acceptably accurate wherever5.3.5 The Hantush-Jacob method requires that there is no change in water storage in the leaky confining bed. Weeks (9) states that if the “leaky” confining bed is thin and relatively permeable and incompressible, the solution of Hantush and Jacob (2) will apply, whereas the solution of Hantush (7), which is described in Practice D6028/D6028M, that considers storage in confining beds will apply in most cases if one confining bed is thick, of low permeability, and highly compressible. For the case where one layer confining the aquifer is sensibly impermeable, and the other confining bed is leaky and bounded on the distal side by a layer in which the head is constant it follows from Hantush (7) that when time, t, satisfiesthe drawdowns in the aquifer will be described by the equationwhereNote that in Hantush's (7) solution, the termappears instead of the expression given for u in Eq 3, namelyThe implication being from Hantush (7) that after the time criterion given by Eq 9 is satisfied, the apparent storage coefficient of the aquifer will include the aquifer storage coefficient and one third of the storage coefficient for the confining bed. If the storage coefficient of the confining bed is very much less than that of the aquifer, then the effect of storage in the confining bed will be very small or sensibly nil. To illustrate the use of Hantush's time criterion, suppose a confining bed is characterized by b′ = 3 m, K′ = 0.001 m/day, and S′s = 3.6 × 10−6 m−1, then the Hantush-Jacob solution Eq 10 would apply everywhere whenorIf the vertical hydraulic conductivity of the confining bed was an order of magnitude larger, K′ = 0.01 m/day, then the Hantush-Jacob (2) solution would apply when t > 23 min.5.3.5.1 It should be noted that the Hantush (7) analysis assumes that well bore storage is negligible.5.3.5.2 Moench (10) presents numerical results that give insight into the effects of control well storage and changes in storage in the confining bed on drawdowns in the aquifer for various parameter values. However, Moench does not offer an explicit formula for when those effects diminish enough for subsequent drawdown data to fit the Hantush-Jacob solution.5.3.6 The assumption stated in 5.1.5, that the leaky confining bed is bounded on the other side by a uniform head source, the level of which does not change with time, was considered by Neuman and Witherspoon (11, p. 810). They considered a confined system of two aquifers separated by a confining bed as shown schematically in Fig. 3. Their analysis concluded that the drawdowns in an aquifer in response to discharging from a well in that aquifer would not be affected by the properties of the other, unpumped, aquifer for times that satisfy1.1 This practice covers an analytical procedure for determining the transmissivity and storage coefficient of a confined aquifer and the leakance value of an overlying or underlying confining bed for the case where there is negligible change of water in storage in a confining bed. This practice is used to analyze water-level or head data collected from one or more observation wells or piezometers during the pumping of water from a control well at a constant rate. With appropriate changes in sign, this practice also can be used to analyze the effects of injecting water into a control well at a constant rate.1.2 This analytical procedure is used in conjunction with Test Method D4050.1.3 Limitations—The valid use of the Hantush-Jacob method is limited to the determination of hydraulic properties for aquifers in hydrogeologic settings with reasonable correspondence to the assumptions of the Theis nonequilibrium method (Practice D4106) with the exception that in this case the aquifer is overlain, or underlain, everywhere by a confining bed having a uniform hydraulic conductivity and thickness, and in which the gain or loss of water in storage is assumed to be negligible, and that bed, in turn, is bounded on the distal side by a zone in which the head remains constant. The hydraulic conductivity of the other bed confining the aquifer is so small that it is assumed to be impermeable (see Fig. 1).FIG. 1 Cross Section Through a Discharging Well in a Leaky Aquifer (from Reed (1)3). The Confining and Impermeable Bed Locations Can Be Interchanged1.4 Units—The values stated in either SI units or inch-pound units are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in nonconformance with the standard. Reporting of results in units other than SI shall not be regarded as nonconformance with this standard.1.5 All observed and calculated values shall conform to the guidelines for significant digits and round established in Practice D6026, unless superseded by this standard.1.5.1 The procedures used to specify how data are collected/recorded or calculated, in this standard are regarded as the industry standard. In addition, they are representative of the significant digits that generally should be retained. The procedures used do not consider material variation, purpose for obtaining the data, special purpose studies, or any considerations for the user’s objectives; and it is common practice to increase or reduce significant digits of reported date to be commensurate with these considerations. It is beyond the scope of this standard to consider significant digits used in analysis method for engineering design.1.6 This practice offers a set of instructions for performing one or more specific operations. This document cannot replace education or experience and should be used in conjunction with professional judgment. Not all aspects of the practice may be applicable in all circumstances. This ASTM standard is not intended to represent or replace the standard of care by which the adequacy of a given professional service must be judged, nor should this document be applied without the consideration of a project’s many unique aspects. The word “Standard” in the title of this document means only that the document has been approved through the ASTM consensus process.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 document specifies the features of laser-based powder bed fusion of metals (PBF-LB/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 the 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/ASTM 52910.

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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 scope of ISO/ASTM 52910.

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This specification establishes the requirements for additive manufacturing of stainless steel alloy (UNS S31603) components by means of laser and electron beam-based full melt powder bed fusion processes. The components produced by these processes are typically used 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.1.1 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, 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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1.1 This document provides guidance and recommendations for the qualification of polymeric materials intended for laser-based powder bed fusion of polymers (PBF-LB/P). The parameters and recommendations presented in this document relate mainly to the material polyamide 12 (PA12), but references are also made to polyamide 11 (PA11). The parameters and recommendations set forth herein cannot be applicable to other polymeric materials.1.2 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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This safety specification establishes the performance requirements for adult portable bed rails, related products, and adult portable bedrail accessories, including requirements for resistance to entrapment, marking and adhered labels, instructional literature, and advertising. It is intended to minimize entrapment and strangulation hazards that are attributed to design components, whether these hazards arise from normal installation and use, reasonably foreseeable mis-installation/misuse, or changes to the stability of the attachment over time, or combinations thereof. This specification applies to adult portable bed rails that meet the definition of a medical device and are therefore under the jurisdiction of the Food and Drug Administration (FDA), and to adult portable bed rails that are not medical devices, and which therefore fall under the jurisdiction of the Consumer Product Safety Commission (CPSC).This specification also covers test set-up requirements, test equipment, test requirements and methods, labels and warnings requirements, permanency of labels and warnings, and product instructions.1.1 This safety specification establishes performance requirements for adult portable bed rails, related products, and adult portable bedrail accessories, including requirements for resistance to entrapment, marking and adhered labels, instructional literature, and advertising.1.2 This standard is applicable to any such product (as defined below) that is not designed as part of the bed by the bed manufacturer, and is installed on, against or adjacent to the side of an adult bed and is for use by adults to reduce the risk of falling from the bed, assist in repositioning in the bed, assist in transitioning into or out of the bed, or other similar purposes as stated by the manufacturer.1.3 This safety specification includes adult portable bed rails that meet the definition of a medical device and are therefore under the jurisdiction of the Food and Drug Administration (FDA), and adult portable bed rails that are not medical devices, and which therefore fall under the jurisdiction of the Consumer Product Safety Commission (CPSC).21.4 This safety specification does not cover guardrails or side rails intended for use on FDA regulated hospital beds, or portable rails for children which are included in Consumer Safety Specification F1821 for toddler beds, Consumer Safety Specification F2085 for portable bed rails for children, or IEC 60601-2-52 for medical beds.1.5 This safety specification is intended to minimize entrapment and strangulation hazards that are attributed to design components, whether these hazards arise from normal installation and use, reasonably foreseeable mis-installation/misuse, or changes to the stability of the attachment over time, or combinations thereof. Other hazards may exist (for example, falls) that are not within the scope of this specification. Such hazards will be the subject of additional standards.1.6 No adult portable bed rail, or related product as defined in this specification, shall, either by label or other means, indicate compliance with this specification unless it conforms to all the requirements contained herein.1.7 Units—The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversion to SI units that are provided for information only and are not considered 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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1.1 This document specifies requirements and test methods for the qualification and re-qualification of laser beam machines for metal powder bed fusion additive manufacturing for aerospace applications.1.2 It can also be used to verify machine features during periodic inspections or following maintenance and repair activities.

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1.1 This document specifies requirements for the qualification of operators of laser metal powder bed fusion machines and equipment for additive manufacturing in aerospace applications.1.2 This document is applicable if the operator qualification testing is required by contract or by application standards in the field of aerospace.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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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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