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1.1 This specification covers the basic data formats to be used by search and rescue computer applications programs (software) for import from and export to other programs.1.2 Additional data or word processing formats may be supported by search and rescue programs.

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1.1 This test method covers the test procedure for determining the axial pull-out strength of medical bone screws. 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 and health practices and determine the applicability of regulatory limitations prior to use.

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This specification covers metal insert fittings with split ring and compression nut (compression joint) and metal insert fittings with copper crimp rings (crimp joint) for four sizes of composite pressure pipe. These fittings are intended for use in cold- and hot-water distribution systems operating at a certain temperature range. These fittings are intended for use in potable water distribution systems for residential and commercial applications, water service, underground irrigation systems, and radient panel heating systems, baseboard, snow- and ice-melt systems, and gases that are compatible with the composite pipe and fittings. The fittings are classified into two classes with split ring and compression nut and fittings with a copper crimp ring, suitable for use with four sizes of PEX/AL/PEX or PE/AL/PE pipe. The fittings shall be made from one of the following metals: wrought copper, cast copper alloy, machined brass, and forged brass. Different tests shall be conducted in order to determine the following properties: hydrostatic burst, hydrostatic sustained pressure strength, thermocycling, and excessive temperature and pressure capability. The sealing surfaces of the insert shall be smooth and free of foreign material. The fitting walls shall be free of cracks, holes, blisters, voids, foreign inclusions or other defects that are visible to the naked eye and that affect the wall integrity.1.1 This specification covers metal insert fittings with split ring and compression nut (compression joint) and metal insert fittings with copper crimp rings (crimp joint) for four sizes of composite pressure pipe. These fittings are intended for use in 125 psi (690 kPa) cold- and hot-water distribution systems operating at temperatures up to and including 180 °F (82 °C). (When used in polyethylene/aluminum/polyethylene systems the maximum operating temperature is limited by the pipe to 140 °F (60 °C) and where applicable 180 °F (82 °C)). Included are the requirements for materials, workmanship, burst pressure, sustained pressure, excessive temperature and pressure, temperature cycling tests, and markings to be used on the fittings and rings. The fittings covered by this specification are intended for use in potable water distribution systems for residential and commercial applications, water service, underground irrigation systems, and radient panel heating systems, baseboard, snow- and ice-melt systems, and gases that are compatible with the composite pipe and fittings.1.2 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.NOTE 1: The tables show the “nominal size” in millimetres with the inch size in parentheses. This exception is made to harmonize the “nominal size” with the two pipe standards, Specifications F1281 and F1282.1.3 The following precautionary caveat pertains only to the test method portion, Section 9, of this specification. 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 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.4.2 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure) is such that the results of a single-lap-shear test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.1.1 This test method is intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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The purpose of this practice is to provide guidance to owners, mechanics, airports, regulatory officials, and aircraft and component manufacturers who may accomplish maintenance, repairs, and alterations on a light unmanned aircraft system (UAS). In addition, this practice covers the format and content of maintenance manuals and instructions for the maintenance, repair, and alteration of light UAS. The light UAS can be operated as a commercial aircraft or as a sport aircraft. This practice states the requirements for the maintenance of light commercial UAS. These same requirements may be used for the sport light UAS with the provisions shown. The maintenance requirements are divided between the aircraft and the ground equipment. The aircraft contains the air data terminal and the ground station controls the nearby ground data terminal. Therefore, the data link is not listed as a separate component, but has elements in the aircraft and near the ground station that is called the ground data terminal.1.1 This practice provides guidelines for the qualifications to accomplish the various levels of maintenance on certificated light unmanned aircraft system (UAS). In addition, it provides the content and structure of maintenance manuals for aircraft, ground control station, and data links that are operated as a light unmanned aircraft system (UAS).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.

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This specification defines requirements for the data used in the tracking and traceability base-62 encoding system. It provides the format of the resultant code to characterize various components used in fuel gas piping systems. In this specification, the final output is a 16 digit alpha-numeric code that defines a standardized approach or methodology for encoding certain characteristics of components that have been established based on consensus recommendations from the respective stakeholder group members. The gas distribution component traceability identifier is also provided in this specification wherein the gas distribution component traceability identifier shall be comprised of sixteen alphanumeric characters that specify respective attributes for a given component. The gas distribution component traceability identifiers also include identifications of component manufacturer, identification of component manufacturer's lot code, the component production date, the component material, the component size, and the component type.1.1 This specification defines requirements for the data used in the tracking and traceability base-62 encoding system and the format of the resultant code to characterize various components used in fuel gas piping systems.1.2 The final output of this specification is a 16 digit alpha-numeric code that defines a standardized approach or methodology for encoding certain characteristics of components that have been established based on consensus recommendations from the respective stakeholder group members. The means of marking or affixing the code to the components, and the means of reading and/or transferring the data or codes are outside the scope of this specification.NOTE 1: To facilitate compliance with this specification, a web based application has been developed to manage and maintain unique manufacturer identification numbers. The URL for the website is: http://www.componentid.org.1.3 The web based application is only intended to serve as a useful resource for managing the respective manufacturer identification numbers, codes, and other identifiers as per this specification. Any changes to the contents of the web based application are contingent upon subsequent changes to this specification. This specification shall have primacy.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 The purpose of this guide is to provide guidance for selecting appropriate device size(s) and determining appropriate sample size(s) for design verification of endovascular devices. The device size(s) and sample size(s) for each design input requirement should be determined before testing. The device size(s) selected for verification testing should establish that the entire device matrix is able to achieve the design input requirements. If testing is not performed on all device sizes, justification should be provided.4.2 The sample size justification and statistical procedures used to analyze the data should be based on sound scientific principles and should be suitable for reaching a justifiable conclusion. Insufficient sample size may lead to erroneous conclusions more often than desired.4.3 Guidance regarding methodologies for determining device size selection and appropriate sample size is provided in Sections 5 and 6.1.1 This guide provides guidance for selecting an appropriate device size(s) and determining an appropriate sample size(s) (that is, number of samples) for design verification testing of endovascular devices. A methodology is presented to determine which device size(s) should be selected for testing to verify the device design adequately for each design input requirement (that is, test characteristic). Additionally, different statistical approaches are presented and discussed to help guide the developer to determine and justify sample size(s) for the design input requirement being verified. Alternate methodologies for determining device size selection and sample size selection may be acceptable for design verification.1.2 This guide applies to physical design verification testing. This guide addresses in-vitro testing; in-vivo/animal studies are outside the scope of this guide. This guide does not directly address design validation; however, the methodologies presented may be applicable to in-vitro design validation testing. Guidance for sampling related to computational simulation (for example, sensitivity analysis and tolerance analysis) is not provided. Guidance for using models, such as design of experiments (DOE), for design verification testing is not provided. This guide does not address sampling across multiple manufacturing lots as this is typically done as process validation. Special considerations are to be given to certain tests such as fatigue (see Practice E739) and shelf-life testing (see Section 8).1.3 Regulatory guidance may exist for endovascular devices that should be considered for design verification device size and sample size selection.1.4 Units—The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.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.

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4.1 This standard practice provides one means for determining fatigue load spectra for aeroplane durability assessments. This information can be used in conjunction with Specification F3115/F3115M, Section 5, Load Considerations.4.1.1 Users of this practice may propose alternate spectra, subject to the approval of their CAA.4.2 The methods are applicable to the durability evaluation of wings of small aeroplanes. Additional calculation (such as methods noted in ACE-100-01) are needed to properly develop load spectra for fatigue evaluation of empennage and/or configurations with canards (or forward wings) and/or winglets (or tip fins), fuselage, and potentially other components, with approval from appropriate regulatory agency.4.3 Much of the material presented herein is directly taken from AC 23-13A. The FAA developed the flight load spectra, presented herein, based on a statistical analysis of the data presented in DOT/FAA/CT-91/20. The ground load spectra are directly from AFS-120-73-2.4.4 The flight load spectra, presented in Section 7, includes an adjustment (1.5 standard deviations) to the average measured load frequency. The adjustment accounts for the variability in the loading spectra experienced by individual aeroplanes, as well as across aeroplane types. The magnitude of the adjustment was selected to maintain the probability that a component will reach its safe-life without a detectable fatigue crack established by scatter factor (see paragraph 2–15 of AC 23-13A).1.1 This practice provides data to develop simplified loading spectra that can be used to perform structural durability analysis for aeroplanes, specifically for wings of small aeroplanes. The material was developed through open consensus of international experts in general aviation. The information was created by focusing on Level 1, 2, 3, and 4 Normal Category aeroplanes. The content may be more broadly applicable; it is the responsibility of the applicant to substantiate broader applicability as a specific means of compliance.1.2 An applicant intending to propose this information as Means of Compliance for a design approval must seek guidance from their respective oversight authority (for example, published guidance from applicable civil aviation authorities, or CAAs) concerning the acceptable use and application thereof. For information on which oversight authorities have accepted this standard (whole or in part) as an acceptable Means of Compliance to their regulatory requirements (hereinafter “the Rules”), refer to the ASTM Committee F44 web page (www.astm.org/COMMITTEE/F44.htm).1.3 The values stated in inch-pound units are to be regarded as 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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ASTM F623-19 Standard Performance Specification for Foley Catheter Active 发布日期 :  1970-01-01 实施日期 : 

1.1 This performance specification establishes performance requirements for the short-term utilization of a single-use, balloon-retention catheter, French sizes 12 through 26 inclusive, used by the medical professions for providing a means of bladder drainage by means of the urethra. The product is manufactured in various sizes and materials such as latex, silicone, rubber, and various polymers (as well as combinations of these) and is provided non-sterile for sterilization and sterile for single use only. Catheters whose surface has been chemically treated to effect biocompatibility or microbial properties may be tested to this specification.1.2 Catheters whose surface has been chemically treated to enhance their lubricity with a coating may be tested to this specification.1.3 The annexes in this specification include detailed information, such as apparatus or materials for this specification.1.4 The appendixes in this specification contain information intended to provide guidance only and are not a mandatory part of the specification.1.5 Regulatory bodies may require additional information, such as clinical data, to support different design features.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 Exclusions—Long-term indwelling usage (over 30 days) is encountered with this product, but not commonly, and is therefore considered an exception to this specification. Similarly, the use of such catheters for nonurethral catheterization (such as for nephrostomy, suprapubic cystostomy, ureterostomy, gastrostomy, enemas, and so forth) is excluded from the scope of this specification. Likewise, three lumen catheters, 30-cm3 balloon and pediatric catheters, and catheters whose surface has been enhanced for lubricity using liquids or gels.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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Hermeticity test methods, for example, Test Methods F 134, deal with sealed packages only and do not apply directly to unsealed packages. This test method is most applicable for determining the hermeticity of a package before it has been sealed with a lid or a cover. Packages that are intended for hermetic seal use are manufactured so as to prevent leakage of helium at a rate in excess of 1 × 10 −8 atm cc/s under a pressure differential of 1 atm when tested on a helium mass spectrometer leak detector. This test should be conducted in a clean work area such as would be provided by a laminar flow clean bench as specified in Fed. Std. No. 209. This test method is not recommended for use in commerce until the precision has been determined.Acceptance and rejection criteria for this test method shall be agreed upon by the purchaser and the supplier as part of the purchase contract.Note 1—Packages that are not capable of meeting a maximum leak rate of 1 × 10 −8 atm cc/s of helium at a pressure differential of 1 atm are customarily rejected on the basis that good quality assurance is achieved with this performance level.1.1 The hermetic integrity of hybrid microcircuit packages is an important material or parts acceptance requirement. Determination of this parameter should be made before the hybrid circuit is assembled and sealed inside the package.1.2 This test method covers a test for leaks in a package that is intended to be hermetically sealed after hybrid circuit assembly. Various types of hybrid packages may be tested by this test method. The test method is nondestructive and therefore suitable for 100% inspection.1.3 This standard may involve hazardous materials, operations, and equipment. This standard does not purport to address all of the safety problems 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.

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定价: 590元 / 折扣价: 502 加购物车

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ASTM D1048-24 Standard Specification for Rubber Insulating Blankets Active 发布日期 :  1970-01-01 实施日期 : 

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