C10 医药综合 标准查询与下载

ASTM F2382-04(2010) 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 via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4. 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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

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

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 E2363-04 医药工业中与过程分析技术相关的标准术语

1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

ASTM F2382-04 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

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 E2363-04a 医药工业中与过程分析技术相关的标准术语

1.1 This terminology covers process analytical technology in the pharmaceutical industry. Terms are defined as they are used relative to the PAT framework in the pharmaceutical industry. Terms that are generally understood and in common usage or adequately defined in other readily available references are not included except where particular delineation to process analytical technology may be more clearly stated.1.2 This terminology is therefore intended to be selective of terms used generally in process analytical technology as it is applied in the pharmaceutical industry and published in a number of documents, such as those listed in the succeeding sections. The listing is also intended to define terms that appear prominently within other related ASTM standards and do not appear elsewhere.1.3 The definitions are substantially identical to those published by the U.S. Food and Drug Administration and other authoritative bodies, such as ISO, IEC, ITU, and national standards organizations.1.4 This terminology supplements current documents on terminology that concentrate on process analytical technology as it is applied in the pharmaceutical industry.1.5 An increasing number of product designations and designations for chemical, physical, mechanical, analytical, and statistical tests and standards are coming into common usage in the literature, regulatory environment, and commerce associated with process analytical technology in the pharmaceutical industry. Section 2 lists those documents referenced in this terminology.

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

ASTM E2329-04 抓药识别的标准实施规程

These are minimum standards applicable to the identification of seized drugs. It is recognized that the correct identification of a drug or chemical depends on the use of an analytical scheme based on validated methods and the competence of the analyst. This practice requires the use of multiple uncorrelated techniques. It does not discourage the use of any particular method within an analytical scheme. Unique requirements in different jurisdictions may dictate the actual practices followed by a particular laboratory. These are minimum standards for identification of commonly seized drugs. However, it should be noted that they may not be sufficient for identification of all drugs in all circumstances. Within this practice, it is up to the individual laboratory to determine which combination of analytical techniques best satisfies the requirements of its jurisdictions.1.1 This practice describes minimum criteria for the qualitative analysis (identification) of seized drugs.1.2 Listed are a number of analytical techniques for the identification of seized drugs. These techniques are grouped on the basis of their discriminating power. Analytical schemes based on these groupings are described.

Standard Practice for Identification of Seized Drugs

ASTM F2259-03 用质子核磁共振(1H NMR)光谱法测定藻酸盐的化学成分和顺序用标准试验方法

1.1 This test method covers the determination of the composition and monomer sequence of alginate intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of alginate has been published as Guide F 2064.1.2 Alginate, a linear polymer composed of 946;-D-mannuronate (M) and its C-5 epimer 945;-L-guluronate (G) linked by 946;-(1->4) glycosidic bonds, is characterized by calculating parameters such as mannuronate/guluronate (M/G) ratio, guluronic acid content (G-content), and average length of blocks of consecutive G monomers (that is, NG62;1). Knowledge of these parameters is important for an understanding of the functionality of alginate in TEMP formulations and applications. This test method will assist end users in choosing the correct alginate for their particular application. Alginate may have utility as a scaffold or matrix material for TEMPs, in cell and tissue encapsulation applications, and in drug delivery formulations.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 Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy

ASTM F2260-03(2008) 用质子核磁共振(1H NMR)光谱法测定脱乙酰壳多糖盐的脱乙酰作用程度的标准试验方法

The degree of deacetylation of chitosan salts is an important characterization parameter since the charge density of the chitosan molecule is responsible for potential biological and functional effects. The degree of deacetylation (% DA) of water-soluble chitosan salts can be determined by 1H nuclear magnetic resonance spectroscopy (1H NMR). Several workers have reported on the NMR determination of chemical composition and sequential arrangement of monomer units in chitin and chitosan. The test method described is primarily based on the work of V?/span>rum et al. (1991), which represents the first publication on routine determination of chemical composition in chitosans by solution state 1H NMR spectroscopy. This test method is applicable for determining the % DA of chitosan chloride and chitosan glutamate salts. It is a simple, rapid, and suitable method for routine use. Quantitative 1H NMR spectroscopy reports directly on the relative concentration of chemically distinct protons in the sample, consequently, no assumptions, calibration curves or calculations other than determination of relative signal intensity ratios are necessary. In order to obtain well-resolved NMR spectra, depolymerization of chitosans to a number average degree of polymerization (DPn) of ~15 to 30 is required. This reduces the viscosity and increases the mobility of the molecules. Although there are several options for depolymerization of chitosans, the most convenient procedure is that of nitrous acid degradation in deuterated water. The reaction is selective, stoichiometric with respect to GlcN, rapid, and easily controlled (Allan & Peyron, 1995). The reaction selectively cleaves after a GlcN-residue, transforming it into 2,5-anhydro-D-mannose (chitose), consequently, depletion of GlcN after depolymerization is expected. On the other hand, the chitose unit displays characteristic 1H NMR signals the intensity of which may be estimated and utilized in the calculation of % DA, eliminating the need for correction factors. Using the intensity of the chitose signals, the number average degree of polymerization can easily be calculated as a control of the depolymerization. Samples are equilibrated and analyzed at a temperature of 90 ± 1°C. Elevated sample temperature contributes to reducing sample viscosity and repositions the proton signal of residual water to an area outside that of interest. While samples are not stored at 90°C but only analyzed at this elevated temperature, the NMR tubes should be sealed with a stopper to avoid any evaporation. At a sample pH* of 3.8-4.3 (see 6.1.5 below), artifactual deacetylation of the sample does not occur during the short equilibration and analysis time. A general description of NMR can be found in <761> of the USP24-NF19.1.1 This test method covers the determination of the degree of deacetylation in chitosan and chitosan salts intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of chitosan salts has been published as Guide F 2103. 1.2 The test method is applicable for determining the degree of deacetylation (% DA) of chitosan chloride and chitosan glutamate salts and is valid for % DA values from 50 up to and including 99. It is simple, rapid, and suitable for routine use. Knowledge of the degree of deacetylation is important for an understanding of the functionality of chitosan salts in TEMP formulations and applications. This test method will assist end users in choosing......

Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy

ASTM F2260-03 用质子核磁共振(1H NMR)光谱法测定脱乙酰壳多糖盐的脱乙酰作用程度的标准试验方法

1.1 This test method covers the determination of the degree of deacetylation in chitosan and chitosan salts intended for use in biomedical and pharmaceutical applications as well as in Tissue Engineered Medical Products (TEMPs) by high-resolution proton NMR (1H NMR). A guide for the characterization of chitosan salts has been published as Guide F 2103.1.2 The test method is applicable for determining the degree of deacetylation (% DA) of chitosan chloride and chitosan glutamate salts and is valid for % DA values from 50 up to and including 99. It is simple, rapid, and suitable for routine use. Knowledge of the degree of deacetylation is important for an understanding of the functionality of chitosan salts in TEMP formulations and applications. This test method will assist end users in choosing the correct chitosan for their particular application. Chitosan salts may have utility in drug delivery applications, as a scaffold or matrix material, and in cell and tissue encapsulation applications.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 Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (¹H NMR) Spectroscopy

BS EN 13867:2002+A1:2009 血液透析和有关治疗用浓缩物

This European Standard specifies requirements for dry and liquid concentrates to be diluted for use as dialysing fluids in haemodialysis or related therapies. It addresses chemical and microbiological quality and purity, handling and labelling of concentrates, the requirements for containers and the tests to monitor chemical and microbiological contents and quality of such concentrates. This European standard does not address the final mixing and use of these concentrates or the treated water used in connection with haemodialysis and related therapies. This European standard does not apply to dialysing fluid regeneration systems.

Concentrates for haemodialysis and related therapies

DOD MIL-PRF-89035 A-2002 城市矢量图(UVMAP)

This specification defines requirements for the U.S. National Imagery and Mapping Agency (NIMA) Urban Vector Map (UVMap).

URBAN VECTOR MAP (UVMAP)

SN/T 0989-2001 出口中成药中铜、铅、汞、砷含量检验方法 原子吸收分光光度法

Atomic absorption spectrophotometric method for the determination of copper, lead, mercury and arsenic content in Chinese patent medicines for export

SN/T 1021-2001 进出口活沙蚕检验规程

Rules for the inspection of living lugworm for import and export

DOD MIL-PRF-89039 (2)-2001 0级矢量图(VMAP)

This amendment forms part of MIL-PRF-89039, dated 9 February 1995,and is approved for use by all Departments and Agencies of the Department of Defense.

VECTOR MAP (VMAP) LEVEL 0

ASTM F2103-01(2007)e2 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

This guide contains a listing of those characterization parameters that are directly related to the functionality of chitosan. This guide can be used as an aid in the selection and characterization of the appropriate chitosan or chitosan salt for a particular application. This standard is intended to give guidance in the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of a particular chitosan. It may have use in the regulation of devices containing chitosan by appropriate authorities. The chitosan salts covered by this guide may be gelled, extruded, or otherwise formulated into biomedical devices for use as tissue-engineered medical products or drug delivery devices for implantation as determined to be appropriate, based on supporting biocompatibility and physical test data. Recommendations in this guide should not be interpreted as a guarantee of clinical success in any tissue-engineered medical product or drug delivery application. To ensure that the material supplied satisfies requirements for use in TEMPs, several general areas of characterization should be considered. These include identity of chitosan, physical and chemical characterization and testing, impurities profile, and performance-related tests.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 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercury-containing products, or both, in your state may be prohibited by state law. 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 Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

ASTM D6398-01e1 增强标签上药物名称的识别的标准实施规程

1.1 This practice covers the shape, size, color, layout, typeface, and barcoding on drug container labels intended for prescription product packaging such as might be used in hospitals, pharmacies, and nursing centers.1.1.1 This practice does not apply to bulk product shipping containers; in-process transfer containers; or primary, secondary, or tertiary finished goods containers.1.2 This practice does not apply to over-the-counter drug product labeling.1.3 This practice does not apply to retail product labeling.

Standard Practice to Enhance Identification of Drug Names on Labels

ASTM D6398-01 增强标签上药物名称的识别的标准实施规程

1.1 This practice covers the shape, size, color, layout, typeface, and barcoding on drug container labels intended for prescription product packaging such as might be used in hospitals, pharmacies, and nursing centers.1.1.1 This practice does not apply to bulk product shipping containers; in-process transfer containers; or primary, secondary, or tertiary finished goods containers.1.2 This practice does not apply to over-the-counter drug product labeling.1.3 This practice does not apply to retail product labeling.

Standard Practice to Enhance Identification of Drug Names on Labels

DOD MIL-D-89010 NOTICE 1-2000 5分钟等深线数椐资料库(DBDB5)

This notice should be filed in front of MIL-D-89010, dated 4 March 1994.

DIGITAL BATHYMETRIC DATA BASE 5-MINUTE (DBDB5)

DOD MIL-PRF-89020 B-2000 高程数据地形图(DTED)

This specification is approved for use by all Departments and Agencies of the Department of Defense.

DIGITAL TERRAIN ELEVATION DATA (DTED)

DOD MIL-PRF-28003 B-2000 图例数据交流数字表示:CGM应用概况

This performance specification is a revision of MIL-PRF-28003A. This revision supersedes MIL-PRF-28003A in its entirety. This revision adopts the Computer Graphics Metafile (CGM) standard ISO/IEC 8632:1999 Parts 1,3,and 4 and the following profiles

DIGITAL REPRESENTATION FOR COMMUNICATION OF ILLUSTRATION DATA: CGM APPLICATION PROFILE