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4.1 This guide is designed to assist medical device manufacturers as they develop new devices or qualify existing devices (e.g., catheters, needles) for delivering clinical cell therapies. Cytocompatibility considers the impact of the delivery device on the cells passing through the device during the delivery procedure. The biological safety of the device (e.g., the device’s cytotoxicity) should be addressed via other methods, such as ISO 10993-5. It is understood that this guide does not address testing of specific cellular products with specific delivery devices. Such testing may be required by regulatory authorities prior to clinical trial of cellular product or marketing applications. This guide outlines considerations to make the product qualification procedures more likely to succeed and more cost effective.4.2 The key aspects of assessing device cytocompatibility include selecting a test cell line or cell lines and determining the cell physiology parameters that will be measured to make a determination of cytocompatibility. Acceptance criteria for designating a device as cytocompatible are not detailed here. It will be up to the delivery device end user to determine if the results of a cytocompatibility assessment are sufficient to consider that device cytocompatible. Delivery device lot to lot variability may impact cytocompatibility, therefore validated manufacturing processes should be considered when producing devices for cytocompatibility assessments.1.1 This guide outlines the parameters to consider when designing in vitro tests to assess the potential impact of a delivery device on a cellular product being dispensed. This guide does not provide specific protocols, but rather suggests what should be considered the minimum characterization necessary to assess device cytocompatibility. Topics discussed include selecting an appropriate cell line(s), cell physiology parameters to measure, and relevant test procedure variables. Only cells suspended in liquid and infused through a device are considered. Cell therapies paired with scaffolds, suspended in hydrogels, or administered via other methods (e.g., tissue grafting) are not included in the scope of this document. This document does not address physical characterization of delivery devices, such as mechanics, composition, or degradation.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.1.3 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 加购物车

定价： 571元 加购物车

定价： 571元 加购物车

定价： 590元 加购物车

定价： 515元 加购物车

定价： 646元 加购物车

This specification covers foaming agents specifically formulated for making preformed foam for use in the production of cellular concrete. The function of this specification is to provide the means for evaluating the performance of a specific foaming agent. The test batch shall conform to the physical requirements prescribed such as density, compressive strength, tensile splitting strength, water absorption and air loss during pumping. The foaming agent being tested shall be used in making test specimens required.1.1 This specification covers foaming agents specifically formulated for making preformed foam for use in the production of cellular concrete.1.2 The function of this specification is to provide the means for evaluating the performance of a specific foaming agent. This is accomplished by using the foaming agent in making a standard cellular concrete test batch (see Test Method C796) from which test specimens are cast. Then, significant properties of the concrete are determined by tests and compared with the requirements of Section 3.1.3 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.

定价： 515元 加购物车

This test method establishes standard procedure for determining the tensile and tensile adhesion properties of rigid cellular plastics in the form of test specimens of standard shape under defined conditions of temperature, humidity, and testing machine speed. Tensile properties shall be measured using any of three types of specimens: Type A shall be the preferred specimen in those cases where enough sample material exists to form the necessary specimen; Type B shall be the preferred specimen when only smaller specimens are available, as in sandwich panels, etc.; Type C shall be the preferred specimen for the determination of tensile adhesive properties of a cellular plastic to a substrate as in a sandwich panel or the bonding strength of a cellular plastic to a single substrate. This test method requires the use of the following apparatuses: a constant-rate-of-crosshead-movement type testing machine; self-aligning type grips for holding test specimens; an extension indicator; and a lathe specimen cutter.1.1 This test method covers the determination of the tensile and tensile adhesion properties of rigid cellular materials in the form of test specimens of standard shape under defined conditions of temperature, humidity, and testing machine speed.1.2 Tensile properties shall be measured using any of three types of specimens:1.2.1 Type A shall be the preferred specimen in those cases where enough sample material exists to form the necessary specimen.1.2.2 Type B shall be the preferred specimen when only smaller specimens are available, as in sandwich panels, etc.1.2.3 Type C shall be the preferred specimen for the determination of tensile adhesive properties of a cellular plastic to a substrate as in a sandwich panel (top and bottom substrate) or the bonding strength of a cellular plastic to a single substrate.1.3 The values stated in SI units are to be regarded as standard. The values given in parentheses are mathematical conversions to inch-pound units that are provided for information only and are not considered standard.NOTE 1: There is no known ISO equivalent to this test method.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.

定价： 590元 加购物车

5.1 The test procedures provide a standard method of obtaining data for research and development, quality control, acceptance and rejection under specifications, and special purposes.5.2 The data obtained by these test methods are applicable to the material under conditions of the particular test and are not necessarily the same as obtained in other environments or use conditions.1.1 These test methods apply to flexible closed cell materials made from olefin polymers or blends of olefin polymers with other polymers as defined in Section 3.1.2 These test methods cover test procedures only. Product requirements are outlined in Specification D4819.1.3 Unless specifically stated otherwise, by agreement between the purchaser and supplier, all tests shall be performed in accordance with the test methods specified in this standard.1.4 The values stated in SI units are to be regarded as the 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.NOTE 1: This standard and ISO 7214 address the same subject matter, but differ in technical content.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： 646元 加购物车

定价： 515元 加购物车

4.1 This test method quantifies the water absorption characteristics of cellular elastomeric gaskets and sealing materials. It is a test that enables the specifier to exercise engineering judgment in the selection of materials.1.1 This test method covers cellular elastomeric compounds that are manufactured in preformed shapes such as gaskets, to be used as compression seals for glazing purposes and as sealing materials in other applications within the building construction sector.1.2 The values stated in SI units are to be regarded as the standard. The values given in U.S. customary units in parentheses are provided for information purposes 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 and health 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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5.1 This test method is designed to differentiate the flame propagation characteristics of dense or cellular elastomeric compounds used in gaskets, setting blocks, shims, or spacers. It is a small scale test which enables the specifier to exercise engineering judgment in the selection of materials.5.2 In this test method, the specimens are subjected to a specific laboratory fire test exposure condition. If different test conditions are substituted or the anticipated end-use conditions are changed, it may not be possible by or from this test method to predict changes in the performance characteristics. Therefore, the results are valid only for the fire test exposure condition described in this test method.5.3 If the results obtained by this test method are to be considered in the total assessment of fire risk, then all pertinent established criteria for fire risk assessment developed by ASTM Committee E-5 must be included in the consideration.1.1 This test method covers a laboratory procedure for determining flame propagation characteristics of a dense or cellular elastomeric gasket (such as expansion, lock-strip or compression gasket) or an accessory (such as a setting block, spacer or shim) when exposed to heat and flame, with no significance being attached to such matters as fuel contribution, rate of flame spread, smoke developed, or the nature and temperature of the products of combustion.1.2 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.1.3 This standard should be used to measure and describe the response of materials, products, or assemblies to heat and flame under controlled conditions and should not be used to describe or appraise the fire-hazard or fire-risk of materials, products, or assemblies under actual fire conditions. However, results of the test may be used as elements of a fire-hazard assessment or a fire-risk assessment which takes into account all of the factors which are pertinent to an assessment of the fire hazard or fire risk of a particular end use.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 The committee with jurisdiction over this standard is not aware of any comparable standards published by other organizations.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 加购物车

4.1 Because of the wide variety of potential uses of rigid cellular plastics, artificial exposure to estimate the effective behavior of these materials must be based, to a great extent, on the intended application. Toward this end, this test method is intended to recommend a variety of conditions from which one or more of the desired exposure conditions can be selected. (Note 3)4.2 The conditions recommended in this test method have been widely used in artificially exposing rigid cellular plastics and in determining the effects of various temperatures and humidities on these materials. Final test measurements are determined after the specimens return to room temperature. Where specified, the specimens will be tested at the exposure condition, but must be reported as such.4.3 Dimensional changes measured by this test method can be used to compare the performance of materials in a particular environment, to assess the relative stability of two or more cellular plastics, or to specify an acceptance criterion for a particular material. The results of this test method are not suitable for predicting end-use product performance or characteristics, nor are they adequate for engineering or design calculations.NOTE 3: Where thermal shock is known or suspected to occur due to rapid heating to (or cooling from) a particular temperature, guidance on the permissible heating or cooling rates, or both, shall be obtained from the manufacturer of the material concerned.NOTE 4: The dimensional change of a specimen can vary depending upon the age of the sample or the length of time between specimen preparation and the beginning of the test, or both.4.4 Before proceeding with this test method, reference shall be made to the specification of the material being tested. Any test specimen preparation, conditioning, dimensions, or testing parameters covered in the materials specification, or combination thereof, shall take precedence over those mentioned in this test method. If there are no specifications, then the default conditions apply.1.1 This test method covers procedures for the thermal and humid exposure of rigid cellular plastics. Conditions used shall be agreed upon between the purchaser and the supplier.NOTE 1: A list of commonly used exposure conditions is found in Table 1.1.2 The values stated in SI units are to be regarded as the standard. The values 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.NOTE 2: This test method is equivalent to ISO 2796 in the sampling and calculation sections. It is not equivalent to ISO 2796 in the procedure section.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.

定价： 515元 加购物车

定价： 515元 加购物车