17704692435
This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubing containing nominally 54.5 % to 57.0 % nickel and used for the manufacture of medical devices and surgical implants. The material shall be made from ingot made from nickel and titanium with no other intentional alloy additions. The material shall be vacuum or inert atmosphere melted to control metallurgical cleanliness and alloy chemistry. Bar, plate, and tubing shall be supplied as hot finished or cold finished and annealed or heat treated. Surface condition may be oxidized, descaled, pickled, blasted, machined, ground, mechanically polished, or electropolished. Major elements shall be analyzed by direct current plasma spectrometry, atomic absorption, inductively coupled plasma spectrometry, X-ray spectrometer, glow discharge mass spectrometry, or an equivalent method. Carbon shall be measured by combustion and hydrogen shall be measured by inert gas fusion or vacuum hot extraction. Nitrogen and oxygen shall be measured by inert gas fusion. The nickel and titanium contents of nickel-titanium shape memory alloys cannot be measured to a precision required to guarantee shape memory or superelastic properties. Calorimetry or an equivalent thermomechanical test method must be used to assure the alloy formulation in terms of transformation temperature. Mechanical properties of the samples such as tensile strength and elongation shall be determined after annealing.1.1 This specification covers the chemical, physical, mechanical, and metallurgical requirements for wrought nickel-titanium bar, flat rolled products, and tubes containing nominally 54.5- to 57.0-weight percent nickel and used for the manufacture of medical devices and surgical implants.1.2 Requirements are for mill product, measuring 5.50 to 94.0 mm [0.218 to 3.70 in.] in diameter or thickness. Mill product is not intended to have the final shape, final surface finish, or final properties of the medical device, implant, or their components. Finished NiTi cold-worked tube should be considered under Specification F2633.1.3 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 non-conformance with the standard.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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This specification establishes the requirements and test methods for the materials, dimensions, workmanship, and finished quality of injection molded polyvinyl chloride (PVC) profile sections used for the field fabrication of a PVC liner inside existing man-entry size circular and non-circular sewers; circular, non-circular, and box culverts, conduits, and vertical shafts or manholes having dimensions of 39.4 in. and larger (1000 mm and larger). It covers segmental panel system for non-pressure applications where the PVC liner is installed in the existing structure and the annular space between the liner and the existing structure is grouted with a low viscosity, high strength cementitious grout.1.1 This specification covers the requirements and test methods for the materials, dimensions, workmanship, and finished quality of injection molded poly vinyl chloride (PVC) profile sections used for the field fabrication of a PVC liner inside existing man-entry size circular and non-circular sewers; circular, non-circular, and box culverts, conduits, and vertical shafts or manholes having dimensions of 39.4 in. and larger (1000 mm and larger).1.2 The segmental panel system produced under this specification is for non-pressure applications where the PVC liner is installed in the existing structure and the annular space between the liner and the existing structure is grouted with a low viscosity, high strength cementitious grout.1.3 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 non-conformance with the 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.
5.1 Hydrogen is evolved during metal electrodeposition in aqueous baths. Some of this hydrogen enters parts during plating. If the absorbed hydrogen is at a level presenting embrittlement hazards to high-strength steel, it is removed by baking parts after plating to expel this hydrogen. However, the lack of plate porosity itself may block hydrogen egress. Thus, it becomes important to know both the relative amount of hydrogen absorbed and the plate porosity.5.2 This test provides a quantitative control number for cadmium plate porosity that can be used to control a cadmium plating process and the status of cadmium-plated hardware. It can also be used for plating process troubleshooting and research and development to determine the effects on plate porosity by process variables, contaminants, and materials. When used to control a critical process, control numbers for plate porosity must be determined by correlation with stress rupture specimens or other acceptable standards.5.3 There is no prime standard for plate porosity. For this reason, two ovens must be used, with tests alternated between ovens. Data from the ovens are compared to ensure no equipment change has occurred.1.1 This test method covers an electronic hydrogen detection instrument procedure for measurement of plating permeability to hydrogen. This method measures a variable related to hydrogen absorbed by steel during plating and to the hydrogen permeability of the plate during post plate baking. A specific application of this method is controlling cadmium-plating processes in which the plate porosity relative to hydrogen is critical, such as cadmium on high-strength steel.1.2 The values stated in SI units are to be regarded as the standard. The values given in parentheses are for information only.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. For specific hazard statement, see Section 8.1.4 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.
5.1 This guide is designed to be used both onboard a vessel and by the operating entity ashore. It should be recognized that this guide provides general information applicable across all sectors of the maritime industry. Because of the nature of pandemics, it cannot provide detailed information concerning a specific type of pandemic, nor can it provide specific recommendations applicable to all sectors of the maritime industry. It should be used to provide a starting point and reference as to the best practices and actions that should be taken to protect the vessel and its crew and passengers.1.1 This guide covers information, best practices, or a series of options, or combinations thereof, to be used by the maritime industry to assist with continuity of international and domestic maritime operations during a pandemic. The information provided herein may also be useful when a vessel is in an area with a localized epidemic as well. The focus of this guide is on actions to protect a vessel’s crew and passengers from the effects of a pandemic to the greatest extent possible.1.2 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 are not necessarily exact equivalents; therefore, to ensure conformance with the standard, each system shall be used independently of the other, and values from the two systems shall not be combined.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.
4.1 This practice is to be used to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to evaluate any irritation caused by device materials by gross assessment.4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of this practice in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.NOTE 1: Some materials (e.g., absorbables) may result in an extract pH (e.g., ≤2.0 or ≥11.5) that cannot be used with this practice.4.3 The only applicable limitation is the extract preparation. Refer to Section 4.3 of Practice F619 for a description of this limitation.1.1 This practice is an intracutaneous reactivity test used to assess the potential of the material under test to produce irritation following intradermal injections of extracts of the material.1.2 The liquids injected into the rabbits are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.1.3 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.1.4 The values stated in SI units, including units officially accepted for use with the SI, are to be regarded as standard. No other systems of measurement are included in this standard.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.
3.1 Corrosion test results often show more scatter than many other types of tests because of a variety of factors, including the fact that minor impurities often play a decisive role in controlling corrosion rates. Statistical analysis can be very helpful in allowing investigators to interpret such results, especially in determining when test results differ from one another significantly. This can be a difficult task when a variety of materials are under test, but statistical methods provide a rational approach to this problem.3.2 Modern data reduction programs in combination with computers have allowed sophisticated statistical analyses on data sets with relative ease. This capability permits investigators to determine if associations exist between many variables and, if so, to develop quantitative expressions relating the variables.3.3 Statistical evaluation is a necessary step in the analysis of results from any procedure which provides quantitative information. This analysis allows confidence intervals to be estimated from the measured results.1.1 This guide covers and presents briefly some generally accepted methods of statistical analyses which are useful in the interpretation of corrosion test results.1.2 This guide does not cover detailed calculations and methods, but rather covers a range of approaches which have found application in corrosion testing.1.3 Only those statistical methods that have found wide acceptance in corrosion testing have been considered in this guide.1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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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