11.100 (Laboratory medicine) 标准查询与下载

ASTM D6499-12 天然橡胶及其制品中抗原蛋白免疫测量的标准试验方法

Type 1 latex allergy most commonly manifests as localized urticaria after contact of skin with natural rubber but can also include symptoms of allergic rhinoconjunctivitis, asthma and rarely anaphylaxis. This immediate (Type I) allergy is caused by natural proteins inherent to the rubber tree, which remain on the finished natural rubber products. The quantification of protein levels in NRL products using the standard colorimetric protein assays may give spurious results due to chemical additives in the latex formulations that interfere with the assay (2,3). Furthermore, the amount of protein found in NRL products are often below the detection limits of the standard colorimetric protein assay (4,5). This test method describes an immunological method for quantitation of natural rubber latex proteins using rabbit anti-NRL serum. Rabbits immunized with NRL proteins react to the majority of the proteins present, and their sera have the capability to detect most if not all of the proteins in NRL. Therefore, although rabbit antibody reacts with antigenic material, this should not be considered as quantitative measure of total protein levels.1.1 This test method covers an immunological method to determine the amount of antigenic protein in natural rubber and its products using rabbit antisera specific for natural rubber latex (NRL) proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other rubber product extracts which have been collected in order to measure the latex protein levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established. 1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities. 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.

Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

ASTM F2450-10 组织工程医用产品用聚合物工作台的微观结构的评估的标准指南

The ability to culture functional tissue to repair damaged or diseased tissues within the body offers a viable alternative to xenografts or heterografts. Using the patient’s own cells to produce the new tissue offers significant benefits by limiting rejection by the immune system. Typically, cells harvested from the intended recipient are cultured in vitro using a temporary housing or scaffold. The microstructure of the scaffold, that is, its porosity, the mean size, and size distribution of pores and their interconnectivity is critical for cell migration, growth and proliferation (Appendix X1). Optimizing the design of tissue scaffolds is a complex task, given the range of available materials, different manufacturing routes, and processing conditions. All of these factors can, and will, affect the surface texture, surface chemistry, and microstructure of the resultant scaffolds. Factors that may or may not be significant variables depend on the characteristics of a given cell type at any given time (that is, changes in cell behavior due to the number of passages, mechanical stimulation, and culture conditions). Tissue scaffolds are typically assessed using an overall value for scaffold porosity and a range of pore sizes, though the distribution of sizes is rarely quantified. Published mean pore sizes and distributions are usually obtained from electron microscopy images and quoted in the micrometer range. Tissue scaffolds are generally complex structures that are not easily interpreted in terms of pore shape and size, especially in three dimensions. Therefore, it is difficult to quantifiably assess the batch-to-batch variance in microstructure or to make a systematic investigation of the role that the mean pore size and pore size distribution has on influencing cell behavior based solely on electron micrographs (Tomlins et al, (1)). Fig. 1 gives an indication of potential techniques that can be used to characterize the structure of porous tissue scaffolds and the length scale that they can measure. Clearly a range of techniques must be utilized if the scaffold is to be characterized in detail. The classification and terminology of pore sizes, such as those given in Table 2, has yet to be standardized, with definitions of terms varying widely (as much as three orders of magnitude) between differing applications and industries. Both Table 2 and the supporting detailed discussion included within Appendix X2 describe differences that exist between IUPAC (International Union of Pure and Applied Chemistry) definitions and the common terminology currently utilized within most life science applications, which include both implant and tissue engineering applications. Since the literature contains many other terms for defining pores (Perret et al (3)), it is recommended that the terms used by authors to describe pores be defined in order to avoid potential confusion. Additionally, since any of the definitions in Table 2 can shift, dependending on the pore size determination method (see Table 1 and Fig. 1), an accompanying statement describing the utilized assessment technique is essential. All the techniques listed in Table 1 have limitations for assessing complex porous structures. Fig. 2a and Fig. 2b show a through- and a blind-end pore respectively. Porometry measurements (see 7.4) are only sensitive to the narrowest point along a variable diameter through-pore and therefore can give a lower measure of the pore diameter than other investigative techniques, such as scanning electron microscope (SEM), which may sample at a different point along the pore. The physical basis of porometry depends on the passage of gas through the material. Therefore, the technique is not sensitive to blind-end or closed pore.......

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

ASTM F2148-07e1 使用鼠科动物局部淋巴结化验(LLNA)评估迟发性接触超敏反应的标准实施规程

The propensity of a material to stimulate delayed contact hypersensitivity must be assessed before clinical application of devices containing this material. Delayed hypersensitivity may occur anywhere in the body. Systemic delayed hypersensitivity may have a complex set of reactions and consequences depending on the actual tissue/organ site of reaction. Although the reactions are seldom life-threatening, severe tissue and organ damage my result over time. Skin is the usual test site to determine the propensity of a material to cause delayed hypersensitivity. The standard historical test methods have involved the use of guinea pigs with a cutaneous application and observation of the reaction site. The use of the murine local lymph node assay results in a numerical quantitation of stimulation, rather than subjective evaluation and could be used to determine dose responses. This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748.1.1 This practice provides a methodology to use an in-situ procedure for the evaluation of delayed contact hypersensitivity reactions.1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. The guinea pig maximization test should be used for these substances.1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation within the nodes draining the site of administration on the ears of mice.1.4 The LLNA has been validated only for low molecular weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates.1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.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.

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

ASTM D6499-07 天然橡胶及其制品中抗原蛋白质的免疫测量用标准试验方法

1.1 This test method covers an immunological method to determine the amount of antigenic protein in natural rubber and its products using rabbit antisera specific for natural rubber latex (NRL) proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other rubber product extracts which have been collected in order to measure the latex protein levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established.1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities.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.

Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

ASTM C1473-05 α光谱测定法放化测定尿中铀同位素的标准试验方法

This test method is used to detect possible exposures to uranium isotopes from occupational operations.1.1 This test method is applicable to the determination of uranium in urine at levels of detection dependent on sample size, count time, detector efficiency, background, and tracer yield. It is designed as a screening tool for detection of possible exposure of occupational workers.1.2 This test method is designed for 50 mL of urine. This test method does not address the sampling protocol or sample preservation methods associated with its use.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.

Standard Test Method for Radiochemical Determination of Uranium Isotopes in Urine by Alpha Spectrometry

ASTM F2382-04e1 根据部分促凝血酶原激酶时间评估血管内医疗设备材料的标准试验方法

The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway. Test samples that show a shortened PTT are activators of the intrinsic coagulation pathway. The results are reported as a percent of the negative control. The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate.1.1 This test method covers the screening of cardiovascular device materials for their ability to induce blood coagulation. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood.1.2 All safety policies and practices shall be observed during the performance of this test method.1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labeled with the contents, and disposed by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using universal precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.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.

Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)

ASTM C1379-04 用感应耦合等离子体质谱法分析铀235和铀238同位素用尿的标准试验方法

DOE Order 5480.11 and ANSI N13.30 require that internal dose assessments be made as part of the bioassay program for nuclear facility workers. For indirect bioassay of uranium workers, the uranium isotopes must be measured along with the total uranium in urine samples. The RMDA for each uranium isotope is 0.1 pCi/L. This method is applicable for measuring 235U and 238U at the RMDA. Because of extremely low mass concentration (because of the high specific activity), 234U cannot be measured without additional sample preconcentration. Note 28212;Column chromatography separations and concentration of 234U using manual or flow-injection preconcentration followed by ICP-MS isotopic determination are described in Test Methods C 1310 and C 1345. These methods focus on environmental soil sample analysis, but with some development, may be applicable to digested urine samples. The 234U concentration can be calculated based on an enrichment gradient for workers in uranium enrichment plants, and internal dose assessments can be made. Note 38212;Use of high resolution ICP-MS may also be used to obtain lower detection limits, see 1.1.1 This test method covers the determination of the concentration of uranium-235 and uranium-238 in urine using Inductively Coupled Plasma-Mass Spectrometry. This test method can be used to support uranium facility bioassay programs.1.2 This method detection limits for 235U and 238U are 6 ng/L. To meet the requirements of ANSI N13.30, the minimum detectable activity (MDA) of each radionuclide measured must be at least 0.1 pCi/L (0.0037 Bq/L). The MDA translates to 47 ng/L for 235U and 300 ng/L for 238U. Uranium- 234 cannot be determined at the MDA with this test method because of its low mass concentration level equivalent to 0.1 pCi/L. 1.3 The digestion and anion separation of urine may not be necessary when uranium concentrations of more than 100 ng/L are present.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.The ICP-MS is a source of intense ultraviolet radiation from the radio frequency induced plasma. Protection from radio frequency radiation and UV radiation is provided by the instrument under normal operation.

Standard Test Method for Analysis of Urine for Uranium-235 and Uranium-238 Isotopes by Inductively Coupled Plasma-Mass Spectrometry

ASTM F2450-04 组织工程医疗产品中使用的聚酯脚手架的微观结构评估的标准指南

1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore size distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and for providing reliable quality control data. This guide 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 to determine the applicability of regulatory limitations prior to use.

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products

ASTM D6499-03 天然橡胶及其制品中抗原性蛋白质的免疫测量的标准试验方法

Type 1 latex allergy most commonly manifests as localized urticaria after contact of skin with natural rubber but can also include symptoms of allergic rhinoconjunctivitis, asthma and rarely anaphylaxis. This immediate (Type I) allergy is caused by natural proteins inherent to the rubber tree, which remain on the finished natural rubber products. The quantification of protein levels in NRL products using the standard colorimetric protein assays may give spurious results due to chemical additives in the latex formulations that interfere with the assay (2,3). Furthermore, the amount of protein found in NRL products are often below the detection limits of the standard colorimetric protein assay (4,5). This test method describes an immunological method for quantitation of natural rubber latex proteins using rabbit anti-NRL serum. Rabbits immunized with NRL proteins react to the majority of the proteins present, and their sera have the capability to detect most if not all of the proteins in NRL. Therefore, although rabbit antibody reacts with antigenic material, this should not be considered as quantitative measure of total protein levels.1.1 This test method covers an immunological method to determine the amount of antigenic protein in natural rubber and its products using rabbit antisera specific for natural rubber latex (NRL) proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other rubber product extracts which have been collected in order to measure the latex protein levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established.1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities.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.

Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

ASTM E1969-01 甲基苯异丙胺法医检定法中微晶体试验的标准指南

1.1 This guide describes some standard procedures applicable to the analysis of methamphetamine and amphetamine using microcrystal tests.1.2 These procedures are applicable to methamphetamine and amphetamine, which are present in solid dosage form or an injectable liquid form. These procedures are not typically applicable to the analysis of methamphetamine and amphetamine in biological samples.

Standard Guide for Microcrystal Testing in the Forensic Analysis of Methamphetamine and Amphetamine

ASTM F2103-01 作物生物化学和组织工程医疗产品原材料的脱乙酰壳多糖盐的表征和试验标准指南

1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.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.

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM F2103-01(2007)e1 作物生物化学和组织工程医疗产品原材料的脱乙酰壳多糖盐的表征和试验标准指南

1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS).1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts.1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy.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./p>

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM F2148-01 用鼠的局部淋巴结分析法评定延迟接触性过敏反应的标准实施规范

1.1 This practice provides a methodology to use an in situ procedure for the evaluation of delayed contact hypersensitivity reactions.1.2 This practice is intended to provide an alternative to the use of guinea pigs for evaluation of the ability of a device material to stimulate delayed contact hypersensitivity reactions. This alternative is particularly applicable for materials used in devices that contact only intact skin. However, the guinea pig maximization test is still the recommended method when assessing the delayed hypersensitivity response to metals or when testing substances that do not penetrate the skin but are used in devices that contact deep tissues or breached surfaces. The guinea pig maximization test should be used for these substances.1.3 This practice consists of a protocol for assessing an increase in lymphocyte proliferation within the nodes draining the site of administration on the ears of mice.1.4 The LLNA has been validated only for low molecular weight chemicals that can penetrate the skin. The absorbed chemical or metabolite must bind to macromolecules, such as proteins, to form immunogenic conjugates.1.5 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.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.1.7 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.

Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA)

ASTM C1473-00 α光谱法放化测定尿中铀同位素含量的标准试验方法

1.1 This test method is applicable to the determination of uranium in urine at levels of detection dependent on sample size, count time, detector efficiency, background, and tracer yield. It is designed as a screening tool for detection of possible exposure of occupational workers.1.2 This test method is designed for 50 mL of urine. This test method does not address the sampling protocol or sample preservation methods associated with its use.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.

Standard Test Method for Radiochemical Determination of Uranium Isotopes in Urine by Alpha Spectrometry

ASTM F756-00 材料的溶血特性评定的标准规程

The presence of hemolytic material in contact with the blood may cause loss of, or damage to, red blood cells and may produce increased levels of free plasma hemoglobin capable of inducing toxic effects or other effects which may stress the kidneys or other organs. This practice may not be predictive of events occurring during all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748.1.1 This practice provides a protocol for the assessment of hemolytic properties of materials used in the fabrication of medical devices that will contact blood.1.2 This practice is intended to evaluate the acute in vitro hemolytic properties of materials intended for use in contact with blood.1.3 This practice consists of a protocol for a hemolysis test under static conditions with either an extract of the material or direct contact of the material with blood.1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.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.1.6 Identification of a supplier of materials or reagents is for the convenience of the user and does not imply single source. Appropriate materials and reagents may be obtained from many commercial supply houses.

Standard Practice for Assessment of Hemolytic Properties of Materials

ASTM D6499-00 天然橡胶及其制品中抗原性蛋白质的免疫测量的标准试验方法

1.1 This test method covers an immunological method to determine the amount of antigenic protein in natural rubber and its products using rabbit antisera specific for natural rubber latex (NRL) proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other rubber product extracts which have been collected in order to measure the latex protein levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established.1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities.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.

Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

ASTM E1969-98 甲基苯异丙胺法医检定法中微晶体试验的标准指南

1.1 This guide describes some standard procedures applicable to the analysis of methamphetamine and amphetamine using microcrystal tests.1.2 These procedures are applicable to methamphetamine and amphetamine, which are present in solid dosage form or an injectable liquid form. These procedures are not typically applicable to the analysis of methamphetamine and amphetamine in biological samples.

Standard Guide for Microcrystal Testing in the Forensic Analysis of Methamphetamine and Amphetamine

ASTM E788-97 血液稀释移液管用标准规范

1.1 This specification covers requirements for glass reusable blood diluting pipets that are used for performing red and white cell corpuscle determinations.

Standard Specification for Pipet, Blood Diluting

ASTM E788-97(2003) 血液稀释移液管用标准规范

1.1 This specification covers requirements for glass reusable blood diluting pipets that are used for performing red and white cell corpuscle determinations.

Standard Specification for Pipet, Blood Diluting

ASTM E1639-97 临床实验室信息管理系统功能要求标准指南

1.1 This guide covers the capabilities needed for a Clinical Laboratory Information Management System (CLIMS). It was written so that both the vendors or developers of CLIMS and laboratory managers would have a common understanding of the requirements and logical structure of a laboratory data system. This guide will also help answer many of the questions faced by designers of CLIMS and provide more uniformity in the way that requirements are expressed from one laboratory to another. It is therefore applicable to users who are involved with acquiring or operating a CLIMS.

Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems