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AS 1580.203.1-2004 Paints and related materials - Methods of test Skin formation 被代替 发布日期 :  2004-11-26 实施日期 : 

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4.1 This guide provides definitions and a classification for CTPs, as well as definitions related to skin tissue, skin wounds and ulcers, wound healing physiology, wound covers, and related medical and surgical procedures. This guide is not intended to prescribe or limit the clinical uses of these products.4.2 One objective of the current guide is to include the wide range of CTPs for which there is a rationale for benefit beyond that achievable with conventional wound coverings. Whether an individual CTP is capable of promoting wound healing must be determined by adequate evidence and is beyond the scope of this standard. Given that some of the materials used in dressings and skin substitutes (defined in Guide F2311) are the same as those used in CTPs, there has been confusion as to how to classify these products.4.3 This guide is distinguished from Guide F2311, which defines terminology and provides classification by clinical use for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions. In contrast, this guide defines terminology for description of CTPs for skin wounds; CTPs are defined primarily by their composition. Neither guide establishes a correspondence between device structure and clinical function.1.1 This guide defines terminology for description of cellular and/or tissue-based products (CTPs) for skin wounds. CTPs are TEMPs (tissue-engineered medical products) that are primarily defined by their composition and comprise viable and/or nonviable human or animal cells, viable and/or nonviable tissues, and may include extracellular matrix components. CTPs may additionally include synthetic components.1.2 This guide also describes categories and terminology for CTPs based on their composition. This systematic categorization is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of these products; the actual biological and clinical functions can depend on characteristics not recognized in the categorization and it should be understood that two products that can be described identically by the categorization should not be presumed to be identical or have the same clinical utility.1.3 This guide defines CTP-related terminology in the context of skin wounds. However, this guide does not provide a correspondence between the CTP composition and its clinical use(s). More than one product may be suitable for each clinical use, and one product may have more than one clinical use.1.4 This guide does not purport to address safety concerns with the use of CTPs. It is the responsibility of the user of this standard to establish appropriate safety and health practices involved in the development of said products in accordance with applicable regulatory guidance documents and in implementing this guide to evaluate the cellular and/or tissue-based products for wounds.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 These procedures should be used to test topical antimicrobial-containing preparations that are intended to be fast-acting in reducing significantly the number of microorganisms on intact skin immediately and, for preoperative and vascular precatheterization preparations, maintenance of some degree of reduction for an extended time.1.1 The practice is designed to measure the reduction of the microflora of the skin.1.2 A knowledge of microbiological techniques is required for these procedures.1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3.1 Exception—In this practice, metric units are used for all applications except for linear measure, in which case inches are used, and metric units follow in parentheses.1.4 Performance of this procedure requires a knowledge of regulations pertaining to the protection of human subjects (1).2NOTE 1: Importantly, it must be noted that the FDA currently does not accept data resulting from procedures in this Method for testing products for approval as Vascular Precatheterization Skin Preparations.1.5 This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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5.1 The guide may be used to demonstrate the effectiveness of topical antimicrobial products using pigskin as a surrogate for human skin and the cup scrub technique for sampling.5.2 The techniques described can be used to simulate Test Method E1174 and will use the pigskin substrate to overcome limitations posed by exposure of human subjects to potentially pathogenic microorganisms, while offering the benefit of applicability to a wide variety of hand-washing conditions that cannot be simulated in test tubes.5.3 Use of the pigskin surrogate offers less expensive and higher throughput screening.1.1 This guide is designed to demonstrate the effectiveness of hand hygiene topical antimicrobial products using pigskin as a surrogate model.1.2 Knowledge of microbiological techniques is required for these procedures.1.3 This standard guide can be used to evaluate topical antimicrobial handwash or handrub formulations.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.

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5.1 The procedures recommended in this guide can be used to assess the sensory characteristics before, during, and after usage of skin care products.5.2 This guide is applicable to product categories that include skin lotions and creams, facial moisturizers, hand lotions and creams, anti-aging lotions and creams, suntan lotions, personal repellents, and other skin care products.5.3 Procedures of the type described herein may be used to communicate perceived sensory properties within and between manufacturers and to the consumer through the media. These guidelines are suggested to meet the need for ascertaining the performance of experimental and commercial products.5.4 These procedures are to be used by assessors who are screened for sensory acuity, trained to use their senses to evaluate products, and in the procedures outlined by the panel method of choice, either technical assessor or consumer behavioral approach.5.5 This guide provides suggested procedures and is not meant to exclude alternate procedures that may be effective in training skinfeel panels and providing sensory evaluation descriptions.1.1 The objective of this guide is to provide procedures for two different descriptive analysis approaches that may be used to qualitatively describe the sensory attributes of skin creams and lotions and quantitatively measure their intensity, similarities, and differences over time. Descriptive analysis can be used to define the sensory experience of skin care products that can then be used to provide direction in product formulation, competitive assessment, ingredient substitutions, research guidance, and advertising claim substantiation.1.2 Guidelines are provided to assist the reader in determining which approach best meets their research objectives, either the (1) technical assessor or (2) consumer behavior approach to language development and evaluation.1.3 Guidelines are provided for the selection and training of assessors, defining sensory attributes, measuring intensities on rating scales, developing procedures for the manipulation of the product alone and the product on the skin, product handling, and evaluation of skin condition before testing.1.4 Units—The values stated in inch-pound units are to be regarded as the standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered 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.

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5.1 This test method may be used to measure the net heat transfer rate to a metallic or coated metallic surface for a variety of applications, including:5.1.1 Measurements of aerodynamic heating when the calorimeter is placed into a flow environment, such as a wind tunnel or an arc jet; the calorimeters can be designed to have the same size and shape as the actual test specimens to minimize heat transfer corrections;5.1.2 Heat transfer measurements in fires and fire safety testing;5.1.3 Laser power and laser absorption measurements; as well as,5.1.4 X-ray and particle beam (electrons or ions) dosimetry measurements.5.2 The thin-skin calorimeter is one of many concepts used to measure heat transfer rates. It may be used to measure convective, radiative, or combinations of convective and radiative (usually called mixed or total) heat transfer rates. However, when the calorimeter is used to measure radiative or mixed heat transfer rates, the absorptivity and reflectivity of the surface should be measured over the expected radiation wavelength region of the source, and as functions of temperature if possible.5.3 In 6.6 and 6.7, it is demonstrated that lateral heat conduction effects on a local measurement can be minimized by using a calorimeter material with a low thermal conductivity. Alternatively, a distribution of the heat transfer rate may be obtained by placing a number of thermocouples along the back surface of the calorimeter.5.4 In high temperature or high heat transfer rate applications, the principal drawback to the use of thin-skin calorimeters is the short exposure time necessary to ensure survival of the calorimeter such that repeat measurements can be made with the same sensor. When operation to burnout is necessary to obtain the desired heat flux measurements, thin-skin calorimeters are often a good choice because they are relatively inexpensive to fabricate.5.5 It is important to understand that the calorimeter design (that is, that shown in Fig. 1) will measure the “net” heat flux into the thin-skin calorimeter. This configuration may or may not be the same as the test specimen of interest. If it is the same configuration, then the results from use of Eq 1 can be used directly. But if the configuration is different, then some additional analysis should be performed. For example, if the actual test specimen has an insulated layer on the inside surface of the thin-skin, but the thin-skin calorimeter does not, then the net heat flux from Eq 1 will not be the same as the response of the test specimen. Refer to Appendix X1 for further discussion of this topic.1.1 This test method covers the design and use of a thin metallic calorimeter for measuring heat transfer rate (also called heat flux). Thermocouples are attached to the unexposed surface of the calorimeter. A one-dimensional heat flow analysis is used for calculating the heat transfer rate from the temperature measurements. Applications include aerodynamic heating, laser and radiation power measurements, and fire safety testing.1.2 Advantages: 1.2.1 Simplicity of Construction—The calorimeter may be constructed from a number of materials. The size and shape can often be made to match the actual application. Thermocouples may be attached to the metal by spot, electron beam, or laser welding.1.2.2 Heat transfer rate distributions may be obtained if metals with low thermal conductivity, such as some stainless steels or Inconel 600, are used.1.2.3 The calorimeters can be fabricated with smooth surfaces, without insulators or plugs and the attendant temperature discontinuities, to provide more realistic flow conditions for aerodynamic heating measurements.1.2.4 The calorimeters described in this test method are relatively inexpensive. If necessary, they may be operated to burn-out to obtain heat transfer information.1.3 Limitations: 1.3.1 At higher heat flux levels, short test times are necessary to ensure calorimeter survival.1.3.2 For applications in wind tunnels or arc-jet facilities, the calorimeter must be operated at pressures and temperatures such that the thin-skin does not distort under pressure loads. Distortion of the surface will introduce measurement errors.1.3.3 Interpretation of the heat flux estimated may require additional analysis if the thin-skin calorimeter configuration is different from the test specimen.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.1.4.1 Exception—The values given in parentheses are for information only.1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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4.1 Materials that are to be in contact with the skin should not cause irritation to the skin. Since it is probably the substances leached from a material that cause the irritation, this practice provides for direct material-skin contact testing or for skin exposure to the liquid extract of the test material. The rationale for this rabbit test is that it is a comparatively quick and sensitive method which, through use over the years, has become a generally accepted method. Additionally, the albino rabbit allows for easy visualization of erythema and edema, which are the cardinal signs of skin irritation.1.1 This practice covers a procedure by which the irritancy of a material may be assessed through contact with abraded and intact skin of rabbits.1.2 The results of this practice depend upon the effectiveness with which contact between the skin and the test material is established and maintained. Because of the operator technique included in performing this test, it is important that the test be performed by personnel with appropriate training.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 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.

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ASTM F2311-08 Standard Guide for Classification of Therapeutic Skin Substitutes (Withdrawn 2017) Withdrawn, No replacement 发布日期 :  1970-01-01 实施日期 : 

As much as possible, terminology contained herein is based on medical dictionary definitions.This guide provides nomenclature and classifications to accurately and unambiguously describe tissue engineered skin substitutes as well as their clinical functions. These classification systems and their nomenclature are not intended to be prescriptive for product labeling or advertising.In this guide, “replacement” and “substitute” have different meanings, although they can be used synonymously in ordinary English. “Skin substitute,” which is defined in 3.5.2, is a tissue-engineered medical product that a physician or surgeon can use in a medical or surgical procedure. “Skin replacement,” which is defined in 3.7.7, is the therapeutic outcome of successful skin replacement surgery, but this is only one of several clinical uses for skin substitutes.Skin substitutes are used in different medical settings and by different medical and surgical specialties. In order to help clarify the clinical applications of skin substitutes, a discussion of common medical and surgical procedures that use conventional skin tissue grafts (autograft and fresh or frozen allograft and xenograft) is provided in Section 6. This discussion is intended provide context for understanding the categories of Section 7, which model clinical uses of skin substitutes by comparison with the uses of conventional skin grafts. However, the procedures, circumstances, and surgical intentions in section are not intended to limit the possible uses of skin substitutes, nor is the classification in section intended to limit the uses of skin substitutes to only those uses of conventional skin graft tissues.1.1 This guide defines terminology and provides classification for products that can be substituted for tissue grafts of human or animal tissue in medical and surgical therapies of skin lesions.1.2 This guide provides a classification method for skin substitutes by comparing their clinical uses with those of conventional tissue grafts. However, skin substitutes may also have equivalent, superior, or inferior clinical properties in comparison to conventional tissue grafts. Clinical classification is independent of the materials and technology used to make a skin substitute, or whether its components include human or animal tissue or other biological or non-biological materials.1.3 This guide also describes a nomenclature for systematic description of the technologies and components of skin substitutes that is independent of their clinical utilities. This systematic nomenclature is not intended to be prescriptive for product labeling, and it describes only the most salient characteristics of skin substitutes; the actual biological and clinical functions of skin substitutes can depend on characteristics not recognized in the nomenclature, and it should be understood that two products that can be described identically by the nomenclature should not be presumed to be identical or have the same clinical utility.1.4 This guide does not provide a correspondence between the skin substitute composition and the clinical classification. Also, more than one product may be suitable for each clinical use, and one product may have more than one clinical use.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.

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5.1 Epoxy resin systems used in the repair of composite skin sandwich panels for durable, rigidwall, relocatable shelters must have a combination of mechanical property levels and environmental resistance that will assure long-term durability of the skins and the skin-to-core adhesive bonds when exposed to severe climatic exposures. In addition, these epoxy materials must have processability characteristics that permit their use in a variety of repair scenarios and environments.5.2 Intended Use—Epoxy systems conforming to this specification are intended for use in the repair of honeycomb panels at the maintenance field level. The material is intended for use with SAE-AMS-C-9084 glass cloth.5.2.1 This is a procurement control document for the procurement of the epoxy system and designers shall be aware that the test values specified herein are based upon tests performed with specific glass-resin composite adherends and shall not be used for design data.5.2.2 Epoxy systems covered by this specification are not intended for use in production bonding of sandwich construction.AbstractThis specification covers the requirements for an epoxy resin system intended for the repair of sandwich panels for durable, rigidwall, relocatable structures. It must be usable in a field environment and shall not require the use of special equipment such as autoclaves or presses. The epoxy system covered by this specification shall be usable for simultaneous impregnation of a wet-layup composite skin and bonding of that skin to a substrate honeycomb core. The inspection and testing of the epoxy system shall be classified as qualification tests and quality conformance tests. The following test methods shall be performed to conform to the requirements specified: tensile lap shear strength; apparent horizontal shear strength; and flatwise tensile strength.1.1 This specification covers the requirements for an epoxy resin system intended for the repair of sandwich panels for durable, rigidwall, relocatable structures. It must be usable in a field environment and shall not require the use of special equipment such as autoclaves or presses. The epoxy system covered by this specification shall be usable for simultaneous impregnation of a wet-layup composite skin and bonding of that skin to a substrate honeycomb core. The material shall withstand exposure to temperatures from −54 °C to 93 °C (−65 °F to 199 °F) and high relative humidity, and also the combination of stress, temperature, and relative humidity that are expected to be encountered in service.1.2 The values stated in SI units are to be regarded as standard where only SI units are given or where SI units are given first followed by inch-pound units; where inch-pound units are given first followed by SI units, the inch-pound units are to be regarded as standard.1.3 The following safety hazards caveat refers only to the test methods described in this specification. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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