4.1 The requirements expressed in this practice are intended to control the quality of the digital radiographic image of cast metallic surgical implants.1.1 This practice covers the procedure for digital radiographic testing of cast metallic surgical implants and related weldments.1.2 Digital X-ray is an alternative method for radiography of cast metallic surgical implants and related weldments (see Practice F629).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 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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A1.3 A1.3.1 This test method is used to determine the fatigue resistance of metallic bone staples when subjected to repetitive loading for large numbers of cycles. This information may also be useful for comparing the effect of variations in staple material, geometry, surface condition, or placement under certain circumstances.A1.3.2 It is essential that uniform fatigue practices be established in order that such basic fatigue data be comparable and reproducible and can be correlated among laboratories.A1.3.3 The results of fatigue tests are suitable for direct application to design only when the service conditions parallel the test conditions exactly. This test method may not be appropriate for all types of bone staple applications. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application.AbstractThis specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the muscular skeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples. Different test methods shall be performed in order to determine the following mechanical properties of metallic bone staples: bending fatigue, pull-out fixation strength, soft tissue fixation strength, and elastic static bending.1.1 This specification covers characterization of the design and mechanical function of metallic staples used in the internal fixation of the musculoskeletal system. It is not the intention of this specification to describe or specify specific designs for metallic bone staples.1.2 This specification includes the following four test methods for measuring mechanical properties of metallic bone staples:1.2.1 Test Method for Constant Amplitude Bending Fatigue Tests of Metallic Bone Staples—Annex A1.1.2.2 Test Method for Pull-Out Fixation Strength of Metallic Bone Staples—Annex A2.1.2.3 Test Method for Soft Tissue Fixation Strength of Metallic Bone Staples—Annex A3.1.2.4 Test Method for Elastic Static Bending of Metallic Bone Staples—Annex A4.1.3 The values stated in SI units are to be regarded as standard. Any other units of measurement included in this standard are shown for reference only.1.4 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods.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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This specification provides the minimum requirements for construction, materials, performance, and dimensions of arch-type non-metallic expansion joints. Expansion joints shall be fabricated with an elastomeric tube reinforced with multiple plies of woven cloth or tire cord covered with synthetic rubber. The inner tube shall be a natural rubber, synthetic rubber, or blend of synthetic rubber. The woven cloth or tire cord shall be nylon, polyester, fiberglass, or aramid, and shall not be cotton. The reinforcing fabric shall be impregnated with a compatible friction stock. Additional reinforcement to the fabric may be provided in the body of the expansion joint and may be solid metal rings or wire embedded in the synthetic rubber. Body rings, if used, must be welded before being installed in the expansion joint body. All expansion joints shall be manufactured with a cover of Hypalon or Neoprene (Chloroprene). The requirements for (1) integral rubber and fabric flanges, (2) floating metal flanges, (3) arches, (4) metallic flanges, (5) retaining rings, and (6) expansion joint cover and body. All expansion joints shall be designed for the specified pressure requirement. Performance requirements for single arch expansion movement and multiple arch-joint movement, as well as the pressure rating, are specified. The following tests shall be performed if required: burst test for prototype testing, hydrostatic test for production testing, and flame resistance test.1.1 This specification provides the minimum requirements for construction, materials, performance, and dimensional requirements of arch-type non-metallic expansion joints.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.1.3 The following safety hazards caveat pertains only to the test method described in 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 Sampling inspection permits the estimation of the overall quality of a group of product articles through the inspection of a relatively small number of product items drawn from the group. 4.2 The selection of a sampling plan provides purchasers and sellers a means of identifying the minimum quality levels that are considered to be satisfactory. 4.3 Because sampling plans will only yield estimates of the quality of a product, the results of the inspection are subject to error. Through the use of sampling plans, the risk of error is known and controlled. 1.1 This guide gives sampling plans that are intended for use in the inspection of metallic and inorganic coatings for conformance to ASTM standard specifications. 1.2 The plans in this guide, except as noted, have been selected from some of the single sampling plans of MIL-STD-105D. The specific plans selected are identified in Tables 1-3 of this guide. The plan of Table 4, which is used for destructive testing, is not from the Military Standard. This standard does not contain the Military Standard's requirement for tightened inspection when the quality history of a supplier is unsatisfactory. 1.3 The plans are based on inspection by attributes, that is, an article of product is inspected and is classified as either conforming to a requirement placed on it, or as nonconforming. Sampling plans based on inspection by variables are given in Guide B762. Variables plans are applicable when a test yields a numerical value for a characteristic, when the specification imposes a numerical limit on the characteristic, and when certain statistical criteria are met. These are explained in Guide B762. 1.4 The plans in this guide are intended to be generally suitable. There may be instances in which tighter or looser plans or ones that are more discriminating are desired. Additional plans that may serve these needs are given in Guide B697. Also, Guide B697 describes the nature of attribute sampling plans and the several factors that must be considered in the selection of a sampling plan. More information and an even greater selection of plans are given in MIL-STD-105D, MIL-STD-414, ANSI/ASQC Z1.9-1979, Refs (1-7)2, and in Guide B697. 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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5.1 Sampling inspection permits the estimation of the overall quality of a group of product articles through the inspection of a relatively small number of product articles drawn from the group.5.2 The specification of a sampling plan provides purchasers and sellers a means of identifying the minimum quality level that is considered to be satisfactory.5.3 Because sampling plans yield estimates of the quality of a product, the results of the inspection are subject to error. Through the selection of a sampling plan, the potential error is known and controlled.5.4 Sampling inspection is used when a decision must be made about what to do with a quantity of articles. This quantity may be a shipment from a supplier, articles that are ready for a subsequent manufacturing operation, or articles ready for shipment to a customer.5.5 In sampling inspection, a relatively small number of articles (the sample) is selected randomly from a larger number of articles (the inspection lot); the sample is inspected for conformance to the requirements placed on the articles. Based on the results, a decision is made whether or not the lot conforms to the requirements.5.6 Since only a portion of a production lot is inspected, the quality of the uninspected articles is not known. The possibility exists that some of the uninspected articles are nonconforming. Therefore, basic to any sampling inspection plan is the willingness of the buyer to accept lots that contain some nonconforming articles. The number of nonconforming articles in accepted lots is controlled by the size of the sample and the criteria of acceptance that are placed on the sample.5.7 Acceptance sampling plans are used for the following reasons:5.7.1 When the cost of inspection is high and the consequences of accepting a nonconforming article are not serious.5.7.2 When 100 % inspection is fatiguing and boring and, therefore, likely to result in errors.5.7.3 When inspection requires a destructive test, sampling inspection must be used.5.8 In acceptance sampling by variables, the coating characteristic of each article in the sample is measured. Using the arithmetic mean of these values, the standard deviation of the process, and the factor k that is found in the Tables, a number is calculated (see 9.3). If this number equals or exceeds the specified minimum, the inspection lot conforms to the requirements. If it is less, the lot does not conform. If the standard deviation of the process is not known, the standard deviation of the sample is calculated and used.5.9 The use of a sampling plan involves the balancing of the costs of inspection against the consequences of accepting an undesirable number of nonconforming articles. There is always a risk that a random sample will not describe correctly the characteristics of the lot from which it is drawn, and that an unacceptable lot will be accepted or an acceptable lot will be rejected. The larger the sample, the smaller this risk but the larger the cost of inspection.5.10 To understand the risks, consider that if every article in an inspection lot conforms to its requirements, every article in the sample will conform also. Such lots will be accepted (Note 1). If only a few articles in an inspection lot are nonconforming, the sample probably will indicate that the lot is acceptable; but there is a small probability that the sample will indicate that the lot is unacceptable. The larger the proportion of nonconforming articles in an inspection lot, the more likely it will be that the sample will indicate that the lot is unacceptable. If every article in an inspection lot is nonconforming, a sample will always indicate that the lot is unacceptable.NOTE 1: Throughout this method, it is assumed that no mistakes are made in sampling, measurement, and calculation.5.11 The probability of accepting an inspection lot that contains nonconforming items is often described in terms of the Acceptable Quality Level (AQL) and the Limiting Quality Level (LQL). The AQL is the quality level that is considered to be acceptable. The LQL is a quality level that is considered to be barely tolerable. A sampling plan is selected that has a high probability of accepting lots of AQL quality and of rejecting lots of LQL quality. In this method, the AQL given for a sampling plan is the quality level of lots (expressed as the percentage of nonconforming articles) that have a 95 % probability of being accepted. The LQL is the quality level of lots that have a 10 % probability of being accepted or, in other words, a 90 % probability of being rejected. The tables in this method give the AQL and LQL of each plan. They also give the 50/50 point, the quality level of a lot that is just as likely to be accepted as rejected.5.12 The disposition of nonconforming inspection lots is beyond the scope of this method because, depending on the circumstances, lots may be returned to the supplier, kept and used, put to a different use, scrapped, reworked, or dealt with in some other way. An alternative is rectifying inspection in which rejected lots are screened and used.5.13 In rectifying inspection, when an inspection lot is rejected, all of the articles in the lot are inspected and nonconforming ones are removed. They may be replaced with conforming articles. The now 100 % conforming lot is accepted. With this practice, the average quality level for a series of lots taken as a whole will be better because of the addition of the 100 % conforming lots. When the incoming lots are of a good quality level, the average quality level of a series of lots will be even better when the rejected lots are screened and resubmitted. When incoming lots are of a poor quality level, the average quality of a series of accepted lots will again be good because many of the incoming lots will be rejected and upgraded. At intermediate quality levels of incoming lots, the average quality level of a series of accepted lots will again be improved, but it will not be improved as much as in either of the above cases; and there will be an intermediate quality level where the degree of improvement is the least. This improved quality level is called the Average Outgoing Quality Limit (AOQL). It is the worst condition that can occur under rectifying inspection. The tables give the AOQL for each plan. There is no AOQL for the plans used with destructive tests because destructive tests cannot be used to screen rejected lots.NOTE 2: The AOQLs given in the tables are strictly correct only when the sample is small with respect to the lot. If this is not the case, the correct AOQL will be smaller than the tabulated value. The correct values are obtained by multiplying the tabulated values by the following equation:5.14 Rectifying inspection will substantially increase the cost of inspection if the incoming lots are much worse than AQL quality.5.15 Rectifying inspection is used only when required by the purchaser.1.1 This guide provides sampling plans that are intended for use in the inspection of metallic and inorganic coatings on products for the purpose of deciding whether submitted lots of coated products comply with the specifications applicable to the coating.1.2 The sampling plans are variables plans. In plans of this type, several articles of product are drawn from a production lot. A characteristic of the coating on the drawn articles is measured. The values obtained are used to estimate the number of articles in the lot that do not conform to a numerical limit, for example a minimum thickness. The number is compared to a maximum allowable.1.3 Variables plans can only be used when the characteristic of interest is measurable, the test method gives a numerical measure of the characteristic, and the specification places a numerical limit on the measured value. It is also necessary that the variation of the characteristic from article to article in a production lot be normally distributed (see Appendix X2). Each article must be tested in the same way (for example, coating thickness must be measured at the same location, see X2.7) so that the values from article to article are comparable. If one or more of these conditions are not met, a variables plan cannot be used. Instead, an attributes plan must be used. These are given in Guide B602 and Guide B697.1.4 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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