定价： 333元 / 折扣价： 284 元 加购物车

Measurement of chemically induced DNA repair is a means of assessing the ability of a chemical to reach and alter the DNA. DNA repair is an enzymatic process that involves the recognition and excision of DNA-chemical adduct followed by DNA strand polymerization and ligation to restore the original primary structure of the DNA (7). This process can be quantitated by measuring the amount of labeled thymidine incorporated into the nuclear DNA of cells that are not in S-phase and is often called unscheduled DNA synthesis (UDS) (8). Numerous assays have been developed for the measurement of chemically induced DNA repair in various cell lines and primary cell cultures from both rodent and human origin (9). The primary rat hepatocyte DNA repair assay developed by Williams (10) has proven to be particularly valuable in assessing the genotoxic activity and potential carcinogenicity of chemicals (11), (12). Genotoxic activity is often produced by reactive metabolites of a chemical. The in vitro rat hepatocyte assay provides a system in which a metabolically competent cell is itself the target cell for measured genotoxicity. Most other short-term tests for genotoxicity employ a rat liver homogenate (S-9) for metabolic activation, which differs markedly in many important ways from the patterns of activation and detoxification that actually occur in hepatocytes. An extensive literature is available on the use of in vitro hepatocyte DNA repair assays (2, 3, 6, 13-28).1.1 This practice covers a typical procedure and guidelines for conducting the rat in vitro hepatocyte DNA repair assay. The procedures presented here are based on similar protocols that have been shown to be reliable (1-6) . 1.2 Mention of trade names or commercial products are meant only as examples and not as endorsements. Other suppliers or manufacturers of equivalent products are acceptable. 1.3 The values stated in SI 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 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.

定价： 0元 / 折扣价： 0 元

5.1 The conditioning procedures covered in this practice provide methods for saturating PMC specimens in a liquid environment prior to conducting other tests for property evaluation.5.2 The conditioning may affect geometric and dimensional changes in specimens. In some severe cases, chemical changes may occur in the fiber, polymer and fiber-polymer interphase and interface.5.3 Caution must be taken if Procedure B (10.2, Procedure B—Accelerated Moisture Saturation at Elevated Temperature) is followed to condition PMC specimens at an elevated temperature. Physical and chemical reactions in materials are normally temperature dependent. An increase in experimental temperature may accelerate a desirable moisture diffusion process. However, elevated temperatures above 37°C may also cause undesirable reactions that do not represent appropriate responses of materials at 37°C. Consequently, a pilot study is recommended in Procedure B to determine if a selected elevated temperature can be used for accelerated conditioning. If the properties of materials are determined to be irreversibly affected by this pilot study at the selected elevated temperature, then either an appropriate lower elevated temperature should be determined by repeating the pilot study, or Procedure B should not be used.1.1 This practice covers two procedures for conditioning non-absorbable polymer matrix composite (PMC) materials and implant devices in a liquid environment to obtain a state of saturation.1.2 The purpose of this practice is to standardize methods and reporting procedures for conditioning PMC materials and implant devices (PMC specimens) in a user selected liquid environment prior to conducting subsequent tests. It is not the purpose of this practice to determine the diffusion coefficients or actual saturation levels of a given liquid into the materials and devices. For these determinations, other procedures, such as Test Method D5229/D5229M, may be followed.1.3 Diffusion of liquid into a solid material is a slow process. While the time necessary to achieve saturation at 37°C may be sufficiently short for thin specimens, such as fracture fixation plates, it may be prohibitively long in thick sections, such as femoral components for hip arthroplasty. However, the diffusion process may be accelerated at an elevated temperature. Consequently, two separate procedures (Procedures A and B) are presented in this practice. Procedure A covers exposing the specimen to the desired conditioning environment at 37°C. Procedure B prescribes a method to accelerate the diffusion process by conditioning the specimen at a selected elevated temperature.1.4 This practice does not specify the test environment to be used for conditioning. However, the pH value of immersion liquid shall be maintained at 7.4 ± 0.2 to simulate the in vivo environment.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 and health practices and determine the applicability of regulatory limitations prior to use.

定价： 0元 / 折扣价： 0 元

4.1 This guidance document describes the components and conditions used for in vitro osteoblast differentiation assays that can be used to screen for the osteogenic capability of progenitor stem cells from various human or animal sources, including mixed tissue-derived connective tissue progenitor populations, or cell populations that may be selectively isolated or manipulated through culture expansion, processing, transfection, or genetic modification.4.2 The osteoblast differentiation assay may be referred to as an osteogenesis assay or a mineralization assay.4.3 It is important to carefully select the components and conditions used for in vitro osteoblast differentiation assays since high amounts of osteogenic medium components can lead to dystrophic, pathologic, or artifactual calcium-based precipitates that do not indicate differentiation of the cells in culture to functional osteoblasts (1).4 For example, when high concentrations of beta-glycerophosphate are used in the medium to function as a substrate for the enzyme alkaline phosphatase secreted by the cells, there is a marked increase in free phosphate, which then precipitates with Ca++ ions in the media to form calcium phosphate crystals independently of the differentiation status of the progenitor cell (2, 3).4.4 Alkaline phosphatase production is an early event associated with osteoblast differentiation, but it can also be stimulated in other cell types by the addition of the osteogenic supplement dexamethasone to the medium. Alkaline phosphatase enhances the formation of calcified deposits prior to their natural occurrence in bone that typically coincides with bone sialoprotein and osteocalcin expression by mineralized matrix-producing osteoblasts. These kinds of calcified/mineral deposits are thus considered dystrophic, pathologic, or artifactual because they were not initiated by a mature osteoblast. A calcium measurement, such as that described in Practice F2997 for the Quantification of Calcium Deposits in Osteogenic Culture of Progenitor Cells Using Fluorescent Image Analysis, may thus result in a potentially false interpretation of the differentiation status of osteoprogenitor cells if used in isolation without gene or protein expression data.4.5 In addition to screening for multipotentiality of undifferentiated stem cells, osteoblast differentiation assays are useful for assessing the osteoinductivity of cell culture substrates or biomaterial scaffolds or drugs or biomolecules, such as cytokines or growth factors.4.6 In vitro osteoblast differentiation assays are not predictive of in vivo bone formation, but are useful for comparison purposes to standardize performance between different types, sources or passages of progenitor cells, biomaterials, or types and concentrations of biomolecules.1.1 This document provides guidance on how to conduct in vitro osteoblast differentiation assays with progenitor stem cells including mesenchymal stromal cells.1.2 This document describes the roles of various osteogenic supplements that are added to the cell culture medium of an osteoblast differentiation assay to encourage and support the differentiation of progenitor cells into matrix-producing osteoblasts.1.3 This document provides recommendations for the concentrations of osteogenic supplements that may prevent the precipitation of artifactual mineral deposits that are not directly produced by osteoblasts, nor correlated with osteoblastic gene expression of the cells.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.

定价： 590元 / 折扣价： 502 元 加购物车

5.1 This test method is intended to help assess the degradation rates (that is, the mass loss rate) and changes in material or structural properties, or both, of HDP materials used in surgical implants. Polymers that are known to degrade primarily by hydrolysis include but are not limited to homopolymers and copolymers of l-lactide, d-lactide, d,l-lactide glycolide, caprolactone, and p-dioxanone.75.2 This test method may not be appropriate for all types of implant applications or for all known absorbable polymers. The user is cautioned to consider the appropriateness of the test method in view of the materials being tested and their potential application (see X1.1.1).5.3 Since it is well known that mechanical loading can increase the degradation rate of absorbable polymers, the presence and extent of such loading needs to be considered when comparing in vitro behavior with that expected or observed in vivo.5.3.1 Mechanically Unloaded Hydrolytic Evaluation—Conditioning of a hydrolysable device under mechanically unchallenged hydrolytic conditions at 37°C in buffered saline is a common means to obtain a first approximation of the degradation profile of an absorbable material or device. It does not necessarily represent actual in vivo service conditions, which can include mechanical loading in a variety of forms (for example. static tensile, cyclic tensile, shear, bending, and so forth). If the performance of a device under its indicated use includes loading, hydrolytic aging alone is NOT sufficient to fully characterize the device.5.3.2 Mechanically Loaded Hydrolytic Evaluation—The objective of loading is to approximate (at 37°C in buffered saline) the actual expected device service conditions so as to better understand potential physicochemical changes that may occur. Such testing can be considered as necessary if loading can be reasonably expected under in vivo service conditions. When feasible, test specimens should be loaded in a manner that simulates in vivo conditions, both in magnitude and type of loading. Clinically relevant cyclic load tests may include testing to failure or for a specified number of cycles followed by testing to evaluate physicochemical properties.5.3.2.1 Static Loading—It is notable that for some polymeric materials it has been shown that a constant load results in the same failure mechanism (for example, creep) and is the worst case when compared to a cyclic load (where the maximum amplitude of the cyclic load is equal to the constant load). Thus, in specific cases it may be acceptable to simplify the test by using a constant load even when the anticipated in vivo loading is cyclic. It is encumbent upon the user of this test method to demonstrate through experiment or specific reference that this simplification is applicable to the polymer under investigation and does not alter the failure mode of the test specimen. If such evidence is not available ,it is necessary to recognize that static loading and cyclic loading are measuring different material properties and are not comparable. Using one to replace the other could lead to misinterpretation of the results.NOTE 3: Caution must be taken to ensure that fixturing does not introduce artifactual performace or degradation issues, or both. An example is the use of rigid foam block, which restricts swelling & expansion and can elevate pull out strength test results from sample compression within the block. Additionally, restricted perfusion due to the closed cell nature of the foam can result in concentration of acidic byproducts that result in accelerated degradation when compared to a normally perfused and buffered in vivo condition.NOTE 4: When performing degradation testing under load, it may be necessary to consider and monitor polymer creep during testing, which may be significant.5.4 Absorbable devices subjected to flow conditions (for example, vascular stents, particularly those with a drug eluting component) may degrade more rapidly than the same device maintained under static degradation test conditions. When it is feasible to estimate the flow conditions that an implant will be subjected to in vivo and replicate them in vitro the degradation study should be conducted under flow conditions. However, details regarding appropriate flow modeling are beyond the scope of this test method.5.5 Sterilization of HDP materials should be expected to cause changes in molar mass or structure, or both, of the polymers. This can affect the initial mechanical and physical properties of a material or device, as well as its subsequent rate of degradation. Therefore, if a test is intended to be representative of actual performance in vivo, specimens shall be packaged and sterilized in a manner consistent with that of the final device. Non-sterilized specimens may be included for comparative purposes.1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.1.2 The requirements of this test method apply to HDPs in various forms:1.2.1 Virgin polymer resins, or1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

CSA Preface This is the first edition of CAN/CSA-C22.2 No. 61010-2-101, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment, whi

定价： 910元 / 折扣价： 774 元

4.1 The European Pharmacopoeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) describe several dissolution and drug release setups for tablets, capsules, transdermal patches and suppositories (USP <711>, USP <724>, Ph. Eur. 2.9.3, Ph. Eur. 2.9.4). However, up to this point no pharmacopoeia standardized in-vitro release test has been established for parenteral dosage forms which provide sustained drug release, for example, implants.4.2 An appropriately designed in-vitro release test would be favorable in the early stage of development of biomolecule-releasing scaffolds for TEMPs, as well as in quality control, and may help to reduce the number of animal experiments.4.3 Appendix X1 provides a tabulated overview of published in-vitro release studies performed with biomaterial scaffolds loaded with biomolecules.4.4 One goal of in-vitro release studies is to simulate the in-vivo conditions as closely as possible, but with sufficiently simplifying abstraction. The simplification comprises two general aspects: the amount of fluid or release medium in contact with the implant to simulate the physiological environment, and the composition of that release medium.1.1 To describe general principles of developing and/or using an in vitro assay to evaluate biomolecule release from biomaterials scaffolds for TEMPs, with examples from the literature1.2 The guide will address scaffolds that do not contain seeded cells; general principles may still apply but may need to be modified if cells are part of the TEMPs.1.3 In vitro release assessment of biomolecules from matrices is a valuable tool for screening biomolecule-scaffold interactions, as well as characterization, and/or quality control.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 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.

定价： 646元 / 折扣价： 550 元 加购物车

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.

定价： 590元 / 折扣价： 502 元 加购物车

5.1 It is important to consider the durability of stent designs in deformation modes that are intended to model in vivo conditions. The appropriate amplitude and number of cycles in each of the modes have to be determined independently for the particular clinical use proposed for the stent. These tests do not replicate all varieties and aspects of the deployment process nor the in vivo mechanical environment in its entirety, and as such they cannot be proofs of durability. Instead, the tests provide evidence of durability. The durability tests can also provide a means of assessing design, material or processing changes.5.1.1 This guide might be useful for development testing, specification acceptance testing, and regulatory submission testing and filings as it provides a basic assurance that the tests are designed, executed, and reported in a suitable fashion.5.1.2 If the tests are conducted using a well defined FTF methodology, they can be useful in:5.1.2.1 Potential design improvement through identification of better and worse geometries, materials, and manufacturing processes;5.1.2.2 Understanding product durability by estimating the effects of changes in geometry, materials, or manufacturing processes;5.1.2.3 Estimating the safety factor relative to the amplitudes and other factors in use conditions; and5.1.2.4 Validating finite element analysis (FEA) and fatigue life models.5.1.3 As stated in the scope, this guide is not intended to provide the in vivo physiologic deformation conditions to which a vascular stent can be subjected. Reliable clinical data characterizing cyclic vascular deformation may be lacking for some indications. The user should develop and justify the boundary conditions (e.g., by literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) for the chosen durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, deformation excursions (e.g., exercise), and vessel remodeling.5.1.4 Test methods other than those provided in the annexes of this document might be appropriate, depending upon stent design. However, these methods are beyond the scope of this guide.1.1 This guide includes three separate cyclic deformation durability guides related to vascular stents: bending, axial, and torsional.1.2 This guide does not address flat plate, local crush durability, or multi-mode testing. Although this guide does not address multi-mode testing, the information included herein could be applicable to developing this type of test.1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys. It does not specifically address any attributes unique to coated stents (i.e., stents with a surface layer of an additional material(s)), monolithically polymeric stents, or absorbable stents, although the application of this standard to those products is not precluded.1.4 This guide applies to endovascular grafts (“stent-grafts”) and other conduit products commonly used to treat aneurismal disease, peripheral vessel trauma, or to provide vascular access. The information provided herein does not address all issues related to testing of these devices.1.5 This guide is applicable to testing of stent(s) (or a representative portion of a stent). While durability testing of coupon samples (e.g., a scaled-up portion of the stent structure) can provide useful information, it is not within the scope of this guide.1.6 This guide applies to in vitro modeling of stent durability from non-radial arterial motions. Such motions may arise from musculoskeletal activities, including walking and breathing, and cardiac motion. Test Methods F2477 addresses pulsatile (i.e., radial) durability of vascular stents.1.7 This guide does not provide the in vivo physiologic deformation conditions for a vascular stent. It is incumbent upon the user of the standard to develop and justify these boundary conditions (e.g., by literature review, in vivo studies, cadaver studies, or modeling of stent vessel interaction) in these durability bench tests. Additional conditions that may be considered include vessel calcification, vessel taper, eccentric lesions, loading excursions (e.g., exercise), and vessel remodeling.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.

定价： 646元 / 折扣价： 550 元 加购物车

5.1 This test method will assess whether the test nanoparticulate material has chemoattractant activity.5.2 This test method will provide a rapid and quantitative measure of the ability of nanoparticulate material to recruit immune cells.5.3 Recruitment of immune cells by chemotaxis plays an important part in all phases of both humoral and cell-mediated immune responses.5.4 Testing the capacity of a nanoparticulate material to recruit immune cells in vitro helps in predicting the influence of such material on the immune cell response.1.1 This test method provides a protocol for rapid and quantitative measurement of the chemoattractant capacity of a nanoparticulate material (nanoparticles and their aggregates and agglomerates).1.2 Immune cells recruitment (by chemotaxis) plays a central role in the immune system function especially in the inflammatory process.1.3 This test method uses an in vitro model. In this model, peripheral blood human acute promyelocytic leukemia cells HL-60 are separated from control chemoattractant or test nanoparticulate material by a 3-µm pore size filter; the cell migration through the filter is monitored and quantified using the fluorescent dye calcein AM (Figs. 1 and 2).FIG. 1 Chemotaxis Chamber (Boyden Chamber)FIG. 2 Chemotaxis Assaya (left)—Parts of the chemotaxis assay assembly.b (right)—Procedure for testing the chemoattractant capacity of a nanoparticulate material.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

1 Scope This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells either directly or through diffusion a) with extracts of a device, and/or; b) in

定价： 364元 / 折扣价： 310 元

5.1 This standard provides an itemization of potential in vitro test methods to evaluate the degradation of absorbable metals. The provided approach defers to the user of this standard to pick most appropriate method(s) based on the specific requirements of the intended application. However, a minimum of at least two different corrosion evaluation methods is considered necessary for basic profiling of the material or device, with additional methods potentially needed for an adequate characterization. However, in some instances there may be only one method that correlates to in vivo degradation results.5.2 It is recognized that not all test methods will be meaningful for every situation. In addition, some methods carry different potential than others regarding their relative approximation to the in vivo conditions within which actual use is to occur. As a result, some discussion and ranking of the relevance of the described methods is provided by this guidance.5.3 It should be noted that degradation of absorbable metals is not linear. Thus, precautions should be taken that evaluations of the degradation profile of a metal or metal device are appropriately adapted to reflect the varying stages and rates of degradation. Relevant factors can include the amount or percentage (%) of tissue coverage of the implanted device and the metabolic rate of surrounding tissue, which is not necessarily accompanied by a high perfusion rate.5.4 It is recognized that in vivo environments will impart specialized considerations that can directly affect the corrosion rate, even when compared with other in vivo locations. Thus, a basic understanding of the biochemistry and physiology of the specific targeted implant location (e.g. hard tissue; soft tissue; high, low or zero perfusion areas/tissue; high, low or zero loading environments) is needed to optimize in vitro and in vivo evaluations.5.5 Within the evaluation of absorbable metals, rate uniformity is considered to be the principle concern and design goal. The recognized primary value for the herein described in vitro testing under static (i.e. not dynamic) conditions is to monitor and screen materials and/or devices for their corrosion consistency. Such an evaluation may provide a practical understanding of the uniformity of the device prior to any subsequent in vivo testing - where device consistency is considered to be critical for optimizing the quality of the obtained observations.5.6 Once a suitable level of device corrosion consistency has been established (either directly or historically), static and/or dynamic fatigue testing can then be undertaken, if needed, to further enhance the understanding of the corrosion process within the context of the device’s overall design and its intended application/use.5.7 Depending on the intended application, appropriate levels of implant loading may range from minimal to severe. Thus, this standard does NOT directly address the appropriate level of loading of absorbable metallic devices, guidance for which may be found in documents specific to the intended implant application and the design requirements for the product.5.8 This standard does NOT directly address dynamic fatigue testing of absorbable metallic devices.1.1 The purpose of this standard is to outline appropriate experimental approaches for conducting an initial evaluation of the in vitro degradation properties of a device or test sample fabricated from an absorbable metal or alloy.1.2 The described experimental approaches are intended to control the corrosion test environment through standardization of conditions and utilization of physiologically relevant electrolyte fluids. Evaluation of a standardized degradation control material is also incorporated to facilitate comparison and normalization of results across laboratories.1.3 The obtained test results may be used to screen materials and/or constructs prior to evaluation of a more refined fabricated device. The described tests may also be utilized to define a device’s performance threshold prior to more extensive in vitro performance evaluations (e.g. fatigue testing) or in vivo evaluations.1.4 This standard is considered to be applicable to all absorbable metals, including magnesium, iron, and zinc-based metals and alloys.1.5 The described tests are not considered to be representative of in vivo conditions and could potentially provide a more rapid or slower degradation rate than an absorbable metal’s actual in vivo corrosion rate. The herein described test methods are to be used for material comparison purposes only and are not to act as either a predictor or substitute for evaluation of the in vivo degradation properties of a device.1.6 This standard only provides guidance regarding the in vitro degradation of absorbable metals and does not address any aspect regarding either in vivo or biocompatibility evaluations.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.

定价： 646元 / 折扣价： 550 元 加购物车

CSA Preface This is the first edition of CAN/CSA-ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, which is an adoption without modification of the identicall

定价： 1092元 / 折扣价： 929 元

5.1 This practice describes a procedure for producing spore suspensions of C. difficile ATCC 700792, C. difficile ATCC 43598, or C. difficile ATCC 43599. The spore suspensions may be used in antimicrobial efficacy testing, or other laboratory testing requiring C. difficile spores. A spore crop is considered acceptable if the titer is >8 log10 spores/mL, purity of 95 %, and is resistant to 2.5M HCl after 10 min of exposure.1.1 This practice is designed to propagate spores of Clostridioides difficile using liver broth.1.2 It is the responsibility of the user of this practice to determine whether Good Laboratory Practices are required and follow when appropriate.1.3 This practice should only be performed by those trained in microbiological techniques.1.4 Units—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 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.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 In vitro hemolysis test results for blood pumps may be substantially affected by donor species, sex, age, fasting, the method of harvesting, the anticoagulant properties, the period of storage, the biochemical state of the blood, and the hemoglobin and hematocrit level of blood.3,4 Therefore, standardization of proper whole blood collection and preparation for the dynamic in vitro evaluation of blood pumps is essential, and this recommended practice will allow an acceptable comparison of test results among hemolysis tests involving similar testing methods.1.1 This practice covers whole blood that will be used for the in vitro performance assessment of hemolysis in blood pumps intended for clinical use.1.2 This practice covers the recommended standard collection, preparation, handling, storage, and utilization of whole blood for the in vitro evaluation (see Practice F1841) of the following devices:1.2.1 Continuous flow blood pumps (roller pumps, centrifugal pumps, axial flow pumps, etc.).1.2.2 Pulsatile and intermittent flow blood pumps (pneumatically driven, electro-mechanically driven, with an artificial pulse, etc.).1.3 The source and preparation of whole blood utilized for the dynamic in vitro evaluation of red blood cell (erythrocyte) trauma caused by blood pumps can substantially influence the hemolysis performance of these devices. Thus, standardized whole blood collection and preparation methods are required.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.

定价： 515元 / 折扣价： 438 元 加购物车