This specification covers the raw material and final product requirements, and the associated test methods for the selection of porous high density and ultra high molecular weight polyethylenes intended for use in surgical implants. The porous polyethylene may be used as a free standing product or as a coating on a substrate in nonloaded applications. Physical properties such as pore size and volume, as well as tensile, compressive, flexural, and shear properties shall be determined, but will be specified in the particular device to which its end use shall be applied.1.1 This specification covers the properties and test methods for porous high-density-polyethylene (HDPE) and porous ultra-high-molecular-weight-polyethylene (UHMWPE) intended for use in surgical implants. The porous polyethylene may be used as a free-standing product or as a coating on a substrate in non-loaded applications.1.2 Materials covered by this standard can have a broad range of mechanical and morphological properties depending on the starting material and fabrication processes. Therefore no attempt has been made to standardize the properties, and the requirements for a specific application are not within the scope of this standard.1.3 Evaluation of the tissue response to a porous polyethylene must be completed. Guidance in establishing biocompatibility may be found in the list of references.1.4 Clinical experience and animal studies have shown that tissue will grow into the open pores of porous polyethylene. The tissue ingrowth into the pores may facilitate the establishment of implant fixation.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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.7 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

4.1 This test method applies to one-dimensional, laminar flow of water within laboratory-compacted, porous materials such as soil.4.2 The hydraulic conductivity of porous materials generally decreases with an increasing amount of air in the pores of the material. This test method applies to porous materials containing little or no air. The test method is designed to minimize the amount of air in the test specimen. However, this test method does not ensure complete saturation of the test specimen with water. In cases where it is essential to saturate the test specimen fully with water, the compacted specimen may be tested using Test Method D5084.4.3 This test method applies to permeation of porous materials with water. Permeation with other liquids, such as chemical wastes, can be accomplished using procedures similar to those described in this test method. However, this test method is only intended to be used when water is the permeant liquid.4.4 It is assumed that Darcy's law is valid and that the hydraulic conductivity is essentially unaffected by hydraulic gradient. The validity of Darcy’s law may be evaluated by measuring the hydraulic conductivity of the specimen at three hydraulic gradients; if all measured values are similar (within 25 %), then Darcy’s law may be taken as valid. However, when the hydraulic gradient acting on a test specimen is changed, the state of stress will also change, and, if the specimen or pore fluid is compressible, the volume of the test specimen or pore fluid will change. Thus, some change in hydraulic conductivity may occur when the hydraulic gradient is altered, even in cases where Darcy’s law is valid.4.5 One potential problem with this method of testing is the possibility that water will flow along the interface between the test specimen and the compaction/permeameter ring. The problem tends to be of minimal significance for materials that swell when exposed to water (for example, compacted, clayey soils) but can be a very serious problem for materials that might tend to shrink and pull away from the walls of the permeameter. Test Method D5084 is recommended for any material that tends to shrink when exposed to the permeant liquid.4.6 The correlation between results obtained with this test method and the hydraulic conductivities of in-place, compacted materials has not been fully investigated. Experience has sometimes shown that flow patterns in small, laboratory-prepared test specimens do not necessarily follow the same patterns on large field scales and that hydraulic conductivities measured on small test specimens are not necessarily the same as larger-scale values. Therefore, the results should be applied to field situations with caution and by qualified personnel.NOTE 1: The quality of the result produced by this standard is dependent on the competence of the personnel performing it, and the suitability of the equipment and facilities used. Agencies that meet the criteria of Practice D3740 are generally considered capable of competent and objective testing/sampling/inspection/etc. Users of this standard are cautioned that compliance with Practice D3740 does not in itself ensure reliable results. Reliable results depend on many factors; Practice D3740 provides a means of evaluating some of those factors.1.1 This test method covers laboratory measurement of the hydraulic conductivity (also referred to as coefficient of permeability) of laboratory-compacted materials with a rigid-wall, compaction-mold permeameter.1.2 This test method may be used with laboratory-compacted specimens that have a hydraulic conductivity less than or equal to 1 × 10−5 m/s. The hydraulic conductivity of compacted materials that have hydraulic conductivities greater than 1 × 10−5 m/s may be determined by Test Method D2434.1.3 Units—The values stated in SI units are to be regarded as the standard, unless other units are specifically given. By tradition in U.S. practice, hydraulic conductivity is reported in cm/s, although the common SI units for hydraulic conductivity are m/s.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 and health practices and determine the applicability of regulatory limitations prior to use.

定价： 0元 / 折扣价： 0 元

5.1 Microbial decontamination of environmental surfaces by wiping is subject to many variables (4), and failure to standardize them properly during testing of towelettes may give inconsistent test data. (See Practice E2362 and Test Method E2896.) In particular, precise control of the pressure applied during wiping, the normally brief wiping times of a few seconds as well as the style and number of wiping strokes are difficult without a programmable mechanical device. The Wiperator has been designed and tested with these crucial factors in mind. The method described here is to assess the role of wiping in ridding non-porous environmental surfaces of bacterial contamination using prewetted towelettes, and also to determine if the used towelette can transfer viable contamination to clean surfaces on contact.1.1 This standard is designed for use with a mechanized device (the Wiperator; Appendix X1) to test pre-wetted towelettes.1.2 Two species of vegetative bacteria, one Gram-positive coccus (Staphylococcus aureus) and one Gram-negative bacillus (Acinetobacter baumannii), representing important nosocomial pathogens, are used to separately contaminate disks of magnetized and brushed stainless steel in order to test the towelettes for their relative ability to:1.2.1 Decontaminate non-porous environmental surfaces experimentally-contaminated with vegetative bacteria; and1.2.2 Transfer any acquired bacterial contamination on the towelettes to clean surfaces.1.3 This test method is not meant for use with towelettes for decontamination of skin.1.4 The values stated in SI units are to be regarded as the standard. The values given in parentheses, if any, are for information only.1.5 This test method should be performed by persons with training in microbiology in facilities designed and equipped for work with infectious agents at the appropriate biosafety level.1.6 It is the responsibility of the investigator to determine whether Good Laboratory Practice (GLP) regulations are required and to follow them where appropriate.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 and health practices and determine the applicability of regulatory limitations prior to use.

定价： 0元 / 折扣价： 0 元

This test method covers the determination of maximum pore diameter and permeability of rigid porous filters used in the laboratory for filtration or diffusion. They are applicable to filters made of sintered glass, ceramic, metal, or plastic. This test method establishes a uniform designation for maximum pore diameter and also provides a means of detecting and measuring changes which occur through continued use. Maximum pore diameter is determined by immersing the filter in a suitable test liquid and applying air pressure until the first bubble of air passes through the filter. The maximum pore diameter is calculated from the surface tension of the test liquid and the applied pressure. Permeability is determined by measuring the flow of air through the filter when subjected to a pressure differential.1.1 This test method covers the determination of maximum pore diameter and permeability of rigid porous filters used in the laboratory for filtration or diffusion. They are applicable to filters made of sintered glass, ceramic, metal, or plastic. This test method establishes a uniform designation for maximum pore diameter and also provides a means of detecting and measuring changes which occur through continued use.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.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.

定价： 515元 / 折扣价： 438 元 加购物车

5.1 Staining of building materials is an aesthetically undesirable occurrence. This test method evaluates the likelihood of a sealant causing an early stain on a porous substrate due to exudation of materials from the sealant. Since this is an accelerated test, it does not necessarily predict that the tested sealants will not stain or discolor porous substrates over longer periods of time.1.1 This test method covers four types of laboratory tests to determine if a joint sealant has a probability of staining a porous substrate (such as marble, limestone, sandstone, granite, or other similar material). The tests are on compressed samples and include (1) storage under standard laboratory conditions, (2) storage in an oven, and (3) exposure in a fluorescent UV/condensation device, and (4) exposure in a xenon arc device.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 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 standard is similar, but not identical, to ISO 16938-1.1.5 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

4.1 These test methods apply to one-dimensional, laminar flow of water within porous materials such as soil and rock.4.2 The hydraulic conductivity of porous materials generally decreases with an increasing amount of air in the pores of the material. These test methods apply to water-saturated porous materials containing virtually no air.4.3 These test methods apply to permeation of porous materials with water. Permeation with other liquids, such as chemical wastes, can be accomplished using procedures similar to those described in these test methods. However, these test methods are only intended to be used when water is the permeant liquid. See Section 6.4.4 Darcy's law is assumed to be valid and the hydraulic conductivity is essentially unaffected by hydraulic gradient.4.5 These test methods provide a means for determining hydraulic conductivity at a controlled level of effective stress. Hydraulic conductivity varies with varying void ratio, which changes when the effective stress changes. If the void ratio is changed, the hydraulic conductivity of the test specimen will likely change, see Appendix X2. To determine the relationship between hydraulic conductivity and void ratio, the hydraulic conductivity test would have to be repeated at different effective stresses.4.6 The correlation between results obtained using these test methods and the hydraulic conductivities of in-place field materials has not been fully investigated. Experience has sometimes shown that hydraulic conductivities measured on small test specimens are not necessarily the same as larger-scale values. Therefore, the results should be applied to field situations with caution and by qualified personnel.4.7 In most cases, when testing high swell potential materials and using a constant-volume hydraulic system, the effective confining stress should be about 1.5 times the swell pressure of the test specimen or a stress which prevents swelling. If the confining stress is less than the swell pressure, anomalous flow conditions my occur; for example, mercury column(s) move in the wrong direction.NOTE 1: The quality of the result produced by this standard is dependent of the competence of the personnel performing it and the suitability of the equipment and facilities used. Agencies that meet the criteria of Practice D3740 are generally considered capable of competent and objective testing, sampling, inspection, etc.. Users of this standard are cautioned that compliance with Practice D3740 does not in itself assure reliable results. Reliable results depend on many factors; Practice D3740 provides a means of evaluating some of those factors.1.1 These test methods cover laboratory measurement of the hydraulic conductivity (also referred to as coefficient of permeability) of water-saturated porous materials with a flexible wall permeameter at temperatures between about 15 and 30°C (59 and 86°F). Temperatures outside this range may be used; however, the user would have to determine the specific gravity of mercury and RT (see 10.3) at those temperatures using data from Handbook of Chemistry and Physics. There are six alternate methods or hydraulic systems that may be used to measure the hydraulic conductivity. These hydraulic systems are as follows:1.1.1 Method A—Constant Head1.1.2 Method B—Falling Head, constant tailwater elevation1.1.3 Method C—Falling Head, rising tailwater elevation1.1.4 Method D—Constant Rate of Flow1.1.5 Method E—Constant Volume–Constant Head (by mercury)1.1.6 Method F—Constant Volume–Falling Head (by mercury), rising tailwater elevation1.2 These test methods use water as the permeant liquid; see 4.3 and Section 6 on Reagents for water requirements.1.3 These test methods may be utilized on all specimen types (intact, reconstituted, remolded, compacted, etc.) that have a hydraulic conductivity less than about 1 × 10−6 m/s (1 × 10−4 cm/s), providing the head loss requirements of 5.2.3 are met. For the constant-volume methods, the hydraulic conductivity typically has to be less than about 1 × 10−7 m/s.1.3.1 If the hydraulic conductivity is greater than about 1 × 10−6 m/s, but not more than about 1 × 10−5 m/s; then the size of the hydraulic tubing needs to be increased along with the porosity of the porous end pieces. Other strategies, such as using higher viscosity fluid or properly decreasing the cross-sectional area of the test specimen, or both, may also be possible. The key criterion is that the requirements covered in Section 5 have to be met.1.3.2 If the hydraulic conductivity is less than about 1 × 10−11 m/s, then standard hydraulic systems and temperature environments will typically not suffice. Strategies that may be possible when dealing with such impervious materials may include the following: (a) controlling the temperature more precisely, (b) adoption of unsteady state measurements by using high-accuracy equipment along with the rigorous analyses for determining the hydraulic parameters (this approach reduces testing duration according to Zhang et al. (1)2), and (c) shortening the length or enlarging the cross-sectional area, or both, of the test specimen (with consideration to specimen grain size (2)). Other approaches, such as use of higher hydraulic gradients, lower viscosity fluid, elimination of any possible chemical gradients and bacterial growth, and strict verification of leakage, may also be considered.1.4 The hydraulic conductivity of materials with hydraulic conductivities greater than 1 × 10 −5 m/s may be determined by Test Method D2434.1.5 All observed and calculated values shall conform to the guide for significant digits and rounding established in Practice D6026.1.5.1 The procedures used to specify how data are collected, recorded, and calculated in this standard are regarded as the industry standard. In addition, they are representative of the significant digits that should generally be retained. The procedures used do not consider material variation, purpose for obtaining the data, special purpose studies, or any considerations for the user's objectives; and it is common practice to increase or reduce significant digits of reported data to be commensurate with these considerations. It is beyond the scope of this standard to consider significant digits used in analysis methods for engineering design.1.6 This standard also contains a Hazards section (Section 7).1.7 The time to perform this test depends on such items as the Method (A, B, C, D, E, or F) used, the initial degree of saturation of the test specimen and the hydraulic conductivity of the test specimen. The constant volume Methods (E and F) and Method D require the shortest period-of-time. Typically a test can be performed using Methods D, E, or F within two to three days. Methods A, B, and C take a longer period-of-time, from a few days to a few weeks depending on the hydraulic conductivity. Typically, about one week is required for hydraulic conductivities on the order of 1 × 10–9 m/s. The testing time is ultimately controlled by meeting the equilibrium criteria for each Method (see 9.5).1.8 Units—The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are mathematical conversions, which are provided for information purposes only and are not considered standard, unless specifically stated as standard, such as 0.5 mm or 0.01 in.1.9 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： 843元 / 折扣价： 717 元 加购物车

1.1 This test method covers the determination of capillary-moisture relationships for coarse- and medium-textured soils as indicated by the soil-moisture tension relations for tensions between 10 and 101 kPa (0.1 and 1 atm). Under equilibrium conditions, moisture tension is defined as the equivalent negative gage pressure, or suction, corresponding to a soil moisture content. This test method determines the equilibrium moisture content retained in a soil subjected to a given soil-water tension. This test method is not suitable for very fine-textured soils.Note 1--For determination of capillary-moisture relationships for fine-textured soils, refer to Test Method D3152.1.2 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.

定价： 0元 / 折扣价： 0 元

5.1 All these test methods are recommended for elementary quantification of the morphological properties of porous coatings bonded to solid substrates.5.2 These test methods may be useful for comparative evaluations of different coatings or different lots of the same coating.5.3 All the methods should be performed on the same set of images of fields.5.4 A statistical estimate can be made of the distributions of the mean coating thickness and the volume percent void. No estimate can be made of the distribution of intercept lengths.5.5 There are limits to the accurate characterization of porosity, depending on spacing between the lines in the line grid (or points in the point grid) and the individual and cumulative fields used for the measurements. Increasing the size of the fields, increasing the number of fields, or decreasing the grid spacing will increase the accuracy of the measurements obtained.5.6 This method may be suitable for ceramic coatings if an accurate coating cross section can be produced. Producing an accurate ceramic coating cross section may require other techniques than standard metallographic techniques.5.7 For coatings having a mean thickness less than 300 microns, it is not recommended to attempt to determine the volume percent void or the mean intercept length.1.1 This test method covers stereological test methods for characterizing the coating thickness, void content, and mean intercept length of various porous coatings adhering to nonporous substrates.1.2 A method to measure void content and intercept length at distinct levels (“Tissue Interface Gradients”) through the porous coating thickness is outlined in 9.4.1.3 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, 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

1.1 This guide covers general procedures for conducting controlled tests for determining the integrity of porous barrier medical packages. These procedures are intended to be a guide in determining overall package integrity and are not intended to be used by themselves in determining component material suitability. Material specifications should be written for each component, and a complete battery of tests should be performed to determine its suitability. 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.

定价： 0元 / 折扣价： 0 元

4.1 The term “surface texture” is used to describe the local deviations of a surface from an ideal shape. Surface texture usually consists of long wavelength repetitive features that occur as results of chatter, vibration, or heat treatments during the manufacture of implants. Short wavelength features superimposed on the long wavelength features of the surface, which arise from polishing or etching of the implant, are referred to as roughness.4.2 This guide provides an overview of techniques that are available for measuring the surface in terms of Cartesian coordinates and the parameters used to describe surface texture. It is important to appreciate that it is not possible to measure surface texture per se, but to derive values for parameters that can be used to describe it.1.1 This guide describes some of the more common methods that are available for measuring the topographical features of a surface and provides an overview of the parameters that are used to quantify them. Being able to reliably derive a set of parameters that describe the texture of biomaterial surfaces is a key aspect in the manufacture of safe and effective implantable medical devices that have the potential to trigger an adverse biological reaction in situ.1.2 This guide is not intended to apply to porous structures with average pore dimensions in excess of approximately 50 nm (0.05 μm).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, 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

5.1 Methods such as D3273 Standard Test Method for Resistance to Growth of Mold on the Surface of Interior Coatings in an Environmental Chamber and D3274 Standard Test Method for Evaluating the Degree of Surface Disfigurement of Paint Films by Fungal or Algal Growth or Soil or Dirt Accumulation provide means for assessing mold and algal staining on paints. The Test Method E1428 Evaluating the Performance of Antimicrobials in or on Polymeric Solids Against Staining by Streptomyces species (A Pink Stain Organism) is used for solid polymeric materials, but is not appropriate for all antimicrobial technologies.5.2 This test method provides a technique for evaluating antimicrobials in or on polymeric materials against staining by Streptomyces species and should assist in the prediction of performance of treated articles under actual field conditions.1.1 This test method is intended to assess susceptibility of polymer materials, as well as products that may directly contact the treated polymer, to staining by the Actinomycete Streptomyces species.1.2 This test method is also suitable for evaluating dark-pigmented test samples since the bacterial growth inhibition can be assessed.1.3 Familiarity with microbiological techniques is required. This test method should not be used by persons without at least basic microbiological training.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： 515元 / 折扣价： 438 元 加购物车

5.1 The exposure-chamber method is a quantitative procedure for determining the microbial-barrier properties of porous materials under the conditions specified by the test. Data obtained from this test is useful in assessing the relative potential of a particular porous material in contributing to the loss of sterility to the contents of the package versus another porous material. This test method is not intended to predict the performance of a given material in a specific sterile-packaging application. The maintenance of sterility in a particular packaging application will depend on a number of factors, including, but not limited to the following:5.1.1 The bacterial challenge (number and kinds of microorganisms) that the package will encounter in its distribution and use. This may be influenced by factors such as shipping methods, expected shelf life, geographic location, and storage conditions.5.1.2 The package design, including factors such as adhesion between materials, the presence or absence of secondary and tertiary packaging, and the nature of the device within the package.5.1.3 The rate and volume exchange of air that the porous package encounters during its distribution and shelf life. This can be influenced by factors including the free-air volume within the package and pressure changes occurring as a result of transportation, manipulation, weather, or mechanical influences (such as room door closures and HVAC systems).5.1.4 The microstructure of a porous material which influences the relative ability to adsorb or entrap microorganisms, or both, under different air-flow conditions.1.1 This test method is used to determine the passage of airborne bacteria through porous materials intended for use in packaging sterile medical devices. This test method is designed to test materials under conditions that result in the detectable passage of bacterial spores through the test material.1.1.1 A round-robin study was conducted with eleven laboratories participating. Each laboratory tested duplicate samples of six commercially available porous materials to determine the Log Reduction Value (LRV) (see calculation in Section 12). Materials tested under the standard conditions described in this test method returned average values that range from LRV 1.7 to 4.3.1.1.2 Results of this round-robin study indicate that caution should be used when comparing test data and ranking materials, especially when a small number of sample replicates are used. In addition, further collaborative work (such as described in Practice E691) should be conducted before this test method would be considered adequate for purposes of setting performance standards.1.2 This test method requires manipulation of microorganisms and should be performed only by trained personnel. The U.S. Department of Health and Human Services publication Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH-HHS Publication No. 84-8395) should be consulted for guidance.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, 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

4.1 Harmful biological or particulate contaminants may enter the medical package through leaks. These leaks are frequently found at seals between package components of the same or dissimilar materials. Leaks may also result from a pinhole in the packaging material.4.2 It is the objective of this test method to visually observe the presence of channel defects by the leakage of dye through them.4.3 This dye penetrant procedure is applicable only to individual leaks in a package seal. The presence of a number of small leaks, as found in porous packaging material, which could be detected by other techniques, will not be indicated.4.4 There is no general agreement concerning the level of leakage that is likely to be deleterious to a particular package. However, since these tests are designed to detect leaks, components that exhibit any indication of leakage are normally rejected.4.5 These procedures are suitable to verify and locate leakage sites. They are not quantitative. No indication of leak size can be inferred from these tests. The methods are usually employed as a pass/fail test.4.6 The dye solution will wick through any porous material over time, but usually not within the maximum time suggested. If wicking does occur, it may be verified by observing the porous side of the subject seal area. The dye will have discolored the surface of the material. Refer to Appendix X1 for details on wicking and guidance on the observance of false positives.1.1 This test method defines materials and procedures that will detect and locate a leak equal to or greater than a channel formed by a 50 µm (0.002 in.) wire in package edge seals formed between a transparent material and a porous sheet material. A dye penetrant solution is applied locally to the seal edge to be tested for leaks. After contact with the dye penetrant for a specified time, the package is visually inspected for dye penetration.1.2 Three dye application methods are covered in this test method: injection, edge dip, and eyedropper.1.3 These test methods are intended for use on packages with edge seals formed between a transparent material and a porous sheet material. The test methods are limited to porous materials which can retain the dye penetrant solution and prevent it from discoloring the seal area for a minimum of 5 seconds. Uncoated papers are especially susceptible to leakage and must be evaluated carefully for use with each test method.1.4 These test methods require that the dye penetrant solution have good contrast to the opaque packaging material.1.5 The values are stated in International System of Units (SI units) and English units. Either is to be regarded as 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： 590元 / 折扣价： 502 元 加购物车

5.1 Harmful biological or particulate contaminants may enter the package through incomplete seals or imperfections such as pinholes or cracks in the trays.5.2 After initial instrument set-up and calibration, the operations of individual tests and test results do not need operator interpretation. The non-destructive nature of the test may be important when testing high value added products.5.3 Leak test results that exceed the permissible threshold setting are indicated by audible or visual signal responses, or both, or by other means.5.4 This non-destructive test method may be performed in either laboratory or production environments. This testing may be undertaken on either a 100 % or a statistical sampling basis. This test method, in single instrument use and current implementation, may not be fast enough to work on a production packaging line, but is well suited for statistical testing as well as package developmental design work.1.1 This non-destructive test method detects leaks in non-porous rigid thermoformed trays, as well as the seal between the porous lid and the tray. The test method detects channel leaks in packages as small as 100 μm (0.004 in.) diameter in the seal as well as 50 μm (0.002 in.) diameter pinholes, or equivalently sized cracks in the tray, subject to trace gas concentration in the package, package design and manufacturing tolerances.NOTE 1: This test method does not claim to challenge the porous (breathable) lidding material. Any defects that may exist in the porous portion of the package will not be detected by this test method.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 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.

定价： 590元 / 折扣价： 502 元 加购物车

5.1 Porous articles (often textiles) are often treated with antimicrobial agents to reduce the growth of microorganisms during use, in storage, or while waiting to be laundered, or both. Additionally, antimicrobial agents are added to reduce or control the overall microbial growth on porous articles that may affect the material’s odor, visual, chemical or physical integrity, or both.5.2 Antimicrobial textile test methods that measure the antimicrobial behavior of treated textiles do exist but they are often specific for one type of antimicrobial agent or are designed to or may artificially (not expected in real life) promote the release of some specific antibacterial agents over others. This test method is designed to be able to measure the antimicrobial activity from all common antimicrobial agents used to treat porous articles, including textiles, without giving either positive or negative bias to one type of chemistry or product over another.5.3 In an effort to avoid excessive use or abuse of antimicrobial agents in the environment, it is important to understand if untreated porous articles are susceptible to microbial contamination and growth. In this test method, a small amount of nutrients is added to each test sample in order to promote some microbial growth on susceptible test samples but not enough to overwhelm potential antimicrobial agents that may be effective in real life situations. Furthermore, low levels of nutrients allow investigators to add soiling agents that may be more reflective of a specific treated product’s end use or expected performance.5.4 Very specific parameters are identified within this method to limit any variability that may be seen between laboratories. Identifying and clarifying potential variables found in other guides or methods used in the industry will allow for better reproducibility and repeatability between and within laboratories.5.5 This test method provides the foundation for conducting tests on porous antibacterial treated articles. Modifications of this method that simulate intended use, durability and compatibility of the treated article should be outlined to ensure an accurate assessment of antimicrobial activity with each particular biocide that substantiates end use claims made for the article. A list of these typical modifications and current test methods for textiles can be found in Guide E2922.5.6 This test method is appropriate for porous materials such as textiles, paper, or similar porous materials. It is intended to measure the antibacterial properties of such materials. In most instances, further studies will be required to support and substantiate actual claims being made for the performance of treated materials in practice or as part of a regulatory process.5.7 This test method or indicated modifications may be used to determine antimicrobial activity as indicated in 5.6 or may be used as a routine bioassay in standard quality control programs.1.1 To determine the bactericidal or bacteriostatic properties of porous articles treated with an active biocidal agent, samples of porous treated materials, such as textiles or paper, are inoculated with a defined suspension of microorganisms and then incubated. The changes in numbers of the bacterial populations on the treated article are compared with untreated articles either over designated time or they are compared to the initial bacterial population at “zero time” for the treated article to measure antibacterial properties.1.2 This test method is used for measuring the quantitative antibacterial activity of porous materials that have been treated with a biocide to inhibit the growth of bacteria on the treated materials. This method may also be used to measure the ability of the treated material to inhibit the growth of a microorganism. It can measure both bactericidal and bacteriostatic activity.1.3 This test method shall be performed by individuals experienced and adept in microbiological procedures and in facilities suitable for the handling of the microorganisms under test.1.4 This test method may involve hazardous materials, operations, and equipment. 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