4.1 The purpose of this practice is to determine if thrombus formation has occurred by comparing platelet and leukocyte counts in the blood exposed to the test material relative to the blood cell counts in the control blood that has not been exposed to the test material. A large number of platelets and leukocytes becoming entrapped/incorporated in thrombi adhering to the material will be reflected by a decrease in their counts in blood. Thrombogenic materials should not be used for cardiovascular medical devices, unless the purpose of the device is to promote thrombosis.1.1 This practice assists in the evaluation of cardiovascular device materials for their ability to induce thrombus formation. Thrombus formation is assessed by means of a reduction in human platelets and leukocytes when consumed by thrombus after activation on the material surface. This assay may be part of the hemocompatibility evaluation for devices and materials contacting human blood, as in accordance with ANSI/AAMI/ISO 10993–4. See also Test Method F2382.1.2 All safety policies and practices shall be observed during the performance of this practice. All human blood and any materials that had contact with human blood shall be bagged in a biohazard bag, properly labeled with the contents, and disposed of by appropriate means.1.3 The human blood should be handled at Biosafety Level 2 (BSL-2) as recommended in the Centers for Disease Control/National Institutes of Health publication, Biosafety in Microbiological and Biomedical Laboratories (BMBL). The human blood donor must have tested negative for Hepatitis B (HBV) and Human Immunodeficiency (HIV) viruses. The blood should be treated like any patient blood and handled/manipulated using standard precautions.NOTE 1: The results of this in-vitro test may not correspond to actual human response.1.4 The values stated in SI (International System of Units) units are to be regarded as 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. Some specific hazards statements are given in Section 8 on Hazards.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 Use of this Methodology: 5.1.1 This guide provides a compendium of information on methods to use fracture data, fatigue life models, and statistical techniques to estimate the structural fatigue durability of an implantable medical device under anticipated in vivo loading modes. The methodology for high-cycle fatigue assessment relies on hyper-physiological tests intended to cause device fractures. Using the FtF methodology, fractures should not be avoided during testing; instead they provide the information required to statistically assess device longevity under a wide variety of physiological and hyper-physiological test conditions.5.1.2 Through evaluation of fracture locations, the geometries after fractures, and the use conditions of the device, this guide may be used to help assess device safety.5.1.3 This guide may be used to help assess differences in fatigue life between different devices or device histories. The effects on fatigue life due to changes to a device’s geometry, processing, or material may be assessed using this guide.5.1.4 Users of this guide must keep in mind that bench tests are simulations of in-use conditions. Adherence to this guide may not guarantee that results translate to individual clinical scenarios. Therefore, in assessing a device’s fatigue performance, the results from Fatigue to Fracture testing should be reviewed in combination with other available data, such as animal studies, clinical experience, and computational simulations.5.2 Significance of this Methodology: 5.2.1 While the FtF methodology applies only to bench tests, it can provide insights into device behavior that would not necessarily be apparent in clinical studies that typically focus on patient outcomes. After appropriate boundary conditions such as loadings, fixturing, and materials have been determined, the FtF methodology can provide extensive information on the expected longevity of a device in a period 10 to 1000 times shorter than a real-time clinical study.5.2.2 FtF is informative in characterizing device behavior over a wide range of loads and cycles. This is especially valuable when the in vivo loading mode is understood but the load magnitude and cycle requirements are not well known or when characterizing device performance over a wide range of patient lifetimes, activity levels, and physiological states is desired.5.2.3 In FtF, test loads greater than the devices’ expected use conditions are used. Thus, factors of safety can be measured relative to expected in vivo use conditions in both loading/deformation severity and number of cycles.5.2.4 In FtF, the nature and location of fractures observed as a function of load can help provide insights into the device response to the applied loading. The identified primary and follow-on fracture locations and modes may be used to assess the credibility of device computational models, as well as to evaluate potential impacts on clinical safety and efficacy, especially post-fracture.5.2.5 The FtF methodology can quickly and reliably assess the impact of changes in processes, materials, or small changes in geometry on in vitro fatigue life. These assessments with respect to fracture can be quantified and used as part of validating design changes, demonstrating that the device meets product specifications, or as part of guiding design improvements.5.2.6 FtF testing can often be completed in a shorter period of time than test-to-success testing since the FtF tests are typically terminated at a smaller number of cycles. Specifically, when extrapolation in cycles is appropriate, comparisons of the loads or the frequency of fracture at a lower number of cycles can provide a useful measure of equivalence.1.1 This guide is intended to provide an experimental methodology to assess and determine the structural fatigue life of implantable cardiovascular medical devices.1.2 This guide is also intended to provide methodologies to determine statistical bounds on fatigue life at in vivo use conditions using measured fatigue life derived in whole or in part from hyper-physiological testing to fracture.1.3 This guide may be used to assess or characterize device durability during design development and for testing to device product specifications.1.4 Fretting, wear, creep-fatigue, and absorbable materials are outside the scope of this guide, though elements of this guide may be applicable.1.5 As a guide, this document provides direction but does not recommend a specific course of action. It is intended to increase the awareness of information and approaches. This guide is not a test method. This guide does not establish a standard practice to follow in all cases.1.6 This guide is meant as a complement to other regulatory and device-specific guidance documents or standards and it does not supersede the recommendations or requirements of such documents.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 Scope 1.1 This International Standard specifies tests to be performed and requirements for test apparatus to be used in determining the physical, biological and mechanical properties of heart valve substitutes of all types, and of the materials and

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