C10 医药综合 标准查询与下载

KS P 1011-2008 重组蛋白质生产菌株验证用二维电泳实验方法

이 표준은 재조합 단백질 생산균주의 검증과 관리에 효율적으로 활용될 수 있는 단백질 2차원

Test method of the 2-D electrophoresis for recombinant bacteria

SANS 598:2008 无菌葡萄糖静脉输液

Covers chemical and biological requirements for a solution of dextrose in water for injections that has been dispensed into suitable containers, sealed and sterilized. It also specifies the required marking.

Sterilized dextrose intravenous infusion

ASTM F2605-08e1 用体积排阻色谱与多角度光散射检测法(SEC-MALS)测定海藻酸钠的摩尔质量的标准试验方法体

The composition and sequential structure of alginate, as well as the molar mass and molar mass distribution, determines the functionality of alginate in an application. For instance, the gelling properties of an alginate are highly dependent upon the composition and molar mass of the polymer. Light scattering is one of very few methods available for the determination of absolute molar mass and structure, and it is applicable over the broadest range of molar masses of any method. Combining light scattering detection with size exclusion chromatography (SEC), which sorts molecules according to size, gives the ability to analyze polydisperse samples, as well as obtaining information on branching and molecular conformation. This means that both the number-average and mass-average values for molar mass and size may be obtained for most samples. Furthermore, one has the ability to calculate the distributions of the molar masses and sizes. Multi-angle laser light scattering (MALS) is a technique where measurements are made simultaneously over a range of different angles. MALS detection can be used to obtain information on molecular size, since this parameter is determined by the angular variation of the scattered light. Molar mass may in principle be determined by detecting scattered light at a single low angle (LALLS). However, advantages with MALS as compared to LALLS are: (1) less noise at larger angles, (2) the precision of measurements are greatly improved by detecting at several angles, and (3) the ability to detect angular variation allows determination of size, branching, aggregation, and molecular conformation. Size exclusion chromatography uses columns, which are typically packed with polymer particles containing a network of uniform pores into which solute and solvent molecules can diffuse. While in the pores, molecules are effectively trapped and removed from the flow of the mobile phase. The average residence time in the pores depends upon the size of the solute molecules. Molecules that are larger than the average pore size of the packing are excluded and experience virtually no retention; these are eluted first, in the void volume of the column. Molecules, which may penetrate the pores will have a larger volume available for diffusion, they will suffer retention depending on their molecular size, with the smaller molecules eluting last. For polyelectrolytes, dialysis against the elution buffer has been suggested, in order to eliminate Donnan-type artifacts in the molar mass determination by light scattering (1, 2). However, in the present method, the size exclusion chromatography step preceding the light scatter detection is an efficient substitute for a dialysis step. The sample is separated on SEC columns with large excess of elution buffer for 30 to 40 min, and it is therefore in full equilibrium with the elution buffer when it reaches the MALS detector.1.1 This test method covers the determination of the molar mass of sodium alginate intended for use in biomedical and pharmaceutical applications as well as in tissue engineered medical products (TEMPs) by size exclusion chromatography with multi-angle laser light scattering detection (SEC-MALS). A guide for the characterization of alginate has been published as Guide F 2064. 1.2 Alginate used in TEMPs should be well characterized, including the molar mass and polydispersity (molar mass distribution) in order to ensure uniformity and correct functionality in the final product. 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 The value......

Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

ASTM F2602-08e1 用多角度光散射器尺寸筛析色谱法(SEC-MALS)测定壳聚糖和壳聚糖盐摩尔质量的标准试验方法

The degree of deacetylation of chitosan, as well at the molar mass and molar mass distribution, determines the functionality of chitosan in an application. For instance, functional and biological effects are highly dependent upon the composition and molar mass of the polymer. This test method describes procedures for measurement of molar mass of chitosan chlorides and glutamates, and chitosan base, although it in principle applies to any chitosan salt. The measured molar mass is that for chitosan acetate, since the mobile phase contains acetate as counter ion. This value can further be converted into the corresponding molar mass for the chitosan as a base, or the parent salt form (chloride or glutamate). Light scattering is one of very few methods available for the determination of absolute molar mass and structure, and it is applicable over the broadest range of molar masses of any method. Combining light scattering detection with size exclusion chromatography (SEC), which sorts molecules according to size, gives the ability to analyze polydisperse samples, as well as obtaining information on branching and molecular conformation. This means that both the number-average and mass-average values for molar mass and size may be obtained for most samples. Furthermore, one has the ability to calculate the distributions of the molar masses and sizes. Multi-angle laser light scattering (MALS) is a technique where measurements of scattered light are made simultaneously over a range of different angles. MALS detection can be used to obtain information on molecular size, since this parameter is determined by the angular variation of the scattered light. Molar mass may in principle be determined by detecting scattered light at a single low angle (LALLS). However, advantages with MALS as compared to LALLS are: (1) less noise at larger angles, (2) the precision of measurements are greatly improved by detecting at several angles, and (3) the ability to detect angular variation allows determination of size, branching, aggregation, and molecular conformation. Size exclusion chromatography uses columns, which are typically packed with polymer particles containing a network of uniform pores into which solute and solvent molecules can diffuse. While in the pores, molecules are effectively trapped and removed from the flow of the mobile phase. The average residence time in the pores depends upon the size of the solute molecules. Molecules that are larger than the average pore size of the packing are excluded and experience virtually no retention; these are eluted first, in the void volume of the column. Molecules, which may penetrate the pores will have a larger volume available for diffusion, they will suffer retention depending on their molecular size, with the smaller molecules eluting last. For polyelectrolytes, dialysis against the elution buffer has been suggested, in order to eliminate Donnan-type artifacts in the molar mass determination by light scattering (1, 2). However, in the present method, the size exclusion chromatography step preceding the light scatter detection is an efficient substitute for a dialysis step. The sample is separated on SEC columns with large excess of elution buffer for 30 to 40 min, and it is therefore in full equilibrium with the elution buffer when it reaches the MALS detector.1.1 This test method covers the determination of the molar mass of chitosan and chitosan salts intended for use in biomedical and pharmaceutical applications as well as in tissue engineered medical products (TEMPs) by size exclusion chromatography with multi-angle laser light scattering detection (SEC-MALS). A guide for the characterization of chitosan salts has been published as Guide F 2103. 1.2 Chitosan and chitosan sal......

Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)

ASTM D6398-08(2014) 增强标签上药物名称的识别的标准实施规程

4.1 Medication errors occur when users are confused by the similar size, shape, color, typeface, and layout of labels that are used for a range of a manufacturer's drugs with widely dissimilar actions or potencies. The human visual system uses shape, size, color, and typeface in the initial recognition of a labeled drug. (See 9.1 – 9.3.) The use of this human visual system has been described in 21 CFR 429.12 for the labeling of insulin. Using the similar label design, color, and typeface throughout a product line makes identifying an individual drug more difficult. 4.2 The objective of this practice is to provide guidance for the design of drug labels which will enable users to easily distinguish between drugs of differing action or potency. See Note 1.Note 1—For specific requirements for these labels and other features of labels for OTC human drugs, see 21 CFR 201.66. 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. 1.4 The values stated in SI units are to be regarded as standard. The values given in parentheses are for information only.

Standard Practice to Enhance Identification of Drug Names on Labels

ASTM F2027-08 组织工程医学产品对原料或生物材料的特性和测试的标准指南

The physico-chemical characteristics of the raw or starting biomaterial used in regenerative medicine scaffolds carries significant potential to affect product performance by influencing cell behavior and/or the release of bioactive molecules or drugs. This guide describes recommended specifications or characterizations of raw or starting biomaterials to ensure reproducibility prior to their fabrication into implantable tissue engineering scaffolds and/or controlled release matrices. 1.1 This document provides guidance on writing a materials specification for raw or starting biomaterials intended for use in tissue engineering scaffolds for growth, support, or delivery of cells and/or biomolecules. This guide does not apply to biomaterials that are already in a scaffold form or are finished tissue-engineered medical products. 1.2 The purpose of this guide is to provide a compendium of relevant existing standards and test methods for biomaterials already commonly used within medical products and to provide characterization guidance for interim use of raw biomaterials for which a standard does not exist. 1.3 This guide covers specifications and characterizations of all the major classes of materials including polymers, ceramics, metals, composites, and natural tissues of human, animal, or plant origin. This guide does not apply to pharmaceuticals. 1.4 This guide is focused on specification of chemical, physical, and mechanical properties of the raw or starting material. It does not include safety and biocompatibility requirements since safety and biocompatibility testing is typically done on materials fabricated into a final form to include all possible effects of fabrication and sterilization techniques. 1.5 Compliance with materials specifications developed in accordance with this standard may not necessarily result in a material suitable for its intended purpose. Additional testing specific to the intend use may be required.

Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products

ASTM F2311-08 治疗皮肤替代品分类指南

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 pr......

Standard Guide for Classification of Therapeutic Skin Substitutes

KS P 0235-2007 下肢插座衬.第2部分:要求事项和试验方法

이 규격은 다리 절단 장애자가 의지를 착용시 사용하는 다리의지 소켓라이너의 물성시험에 대하

Socket liner for lower limb-Part 2:Requirements and test methods

KS P 8010-2007 绝缘保护设备及防护设备的耐电压试验法

이 규격은 7 000 V 이하 전기 회로의 활선 작업 또는 그 근접 작업 등에 있어 감전

Testing method for withstand voltage of personal protective equipment and insulating devices

SANS 11138-1:2007 保健品消毒.生物指示剂.第1部分:一般要求

Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

Sterilization of health care products - Biological indicators Part 1: General requirements

SANS 11138-3:2007 保健品消毒.生物指示剂.第3部分:湿热灭菌用生物指示剂

Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat (dry saturated steam) as the sterilizing agent.

Sterilization of health care products - Biological indicators Part 3: Biological indicators for moist heat sterilization processes

SANS 11138-2:2007 保健品消毒.生物指示剂.第2部分:环氧乙烷消毒工艺的生物指示剂

Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ehtylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.

Sterilization of health care products - Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes

ASTM E2548-07 收缴药品定性和定量分析的标准指南

1.1 This guide covers minimum considerations for sampling of seized drugs for qualitative and quantitative analysis.

Standard Guide for Sampling Seized Drugs for Qualitative and Quantitative Analysis

ASTM E1232-07(2013) 化学药剂可燃性温度极限的标准试验方法

5.1 The lower temperature limit of flammability is the minimum temperature at which a liquid (or solid) chemical will evolve sufficient vapors to form a flammable mixture with air under equilibrium conditions. Knowledge of this temperature is important in determining guidelines for the safe handling of chemicals, particularly in closed process and storage vessels.Note 1—As a result of physical factors inherent in flash point apparatus and procedures, closed-cup flash point temperatures are not necessarily the minimum temperature at which a chemical will evolve flammable vapors (see Appendix X2 and Appendix X3, taken in part from Test Method E502). The temperature limit of flammability test is designed to supplement limitations inherent in flash point tests (Appendix X2). It yields a result closely approaching the minimum temperature of flammable vapor formation for equilibrium situations in the chemical processing industry such as in closed process and storage vessels.Note 2—As a result of flame quenching effects existing when testing in standard closed-cup flash point apparatus, there are certain chemicals that exhibit no flash point but do evolve vapors that will propagate a flame in vessels of adequate size (X3.2). The temperature limit of flammability test chamber is sufficiently large to overcome flame quenching effects in most cases of practical importance, thus, usually indicating the presence of vapor-phase flammability if it does exist (6.2).Note 3—The lower temperature limit of flammability (LTL) is only one of several characteristics that should be evaluated to determine the safety of a specific material for a specific application. For example, some materials are found to have an LTL by this test method when, in fact, other characteristics such as minimum ignition energy and heat of combustion should also be considered in an overall flammability evaluation. 5.2 The vapor concentration present at the lower temperature limit of flammability equals the lower flammable limit concentration as measured by Test Method E681 and extrapolated back to the same temperature. (This permits estimation of lower temperature limits of flammability if vapor pressure and concentration limit of flammability data are available (A2.3). A comparison of results of the tests, thus, affords a check on test reliability, the reliability of vapor pressure data, or both.) 1.1 This test method covers the determination of the minimum temperature at which vapors in equilibrium with a liquid (or solid) chemical will be sufficiently concentrated to form flammable mixtures in air at atmospheric pressure. This test method is written specifically for determination of the temperature limit of flammability of systems using air as the source of oxidant and diluent. It may also be used for other oxidant/diluent combinations, including air plus diluent mixtures; however, no oxidant/diluent combination stronger than air should be used. Also, no unstable chemical capable of explosive decomposition reactions should be tested (see 8.3). 1.2 This test method is designed and writt......

Standard Test Method for Temperature Limit of Flammability of Chemicals

KS P 1001-2006 医用道具切削和耐久力试验方法

이 규격은 의료용으로 사용하는 칼류의 끊김 시험 방법에 대하여 규정한다.

Cut and durability test methods for surgical knives

ISO 24214:2006 造口术辅助器用皮肤屏障.词汇

This International Standard defines terms dealing with skin barriers for ostomy aids as defined below. The International Standard does not cover medical terms or general adhesive terms. The terms do not individually or collectively define or recommend a product of a specific design, style or size. NOTE See also the terms and definitions given in ISO 8670-1 and ISO 8670-

Skin barrier for ostomy aids - Vocabulary

ISO 11138-1:2006 医疗保健产品灭菌.生物指示物.第1部分:一般要求

1.1 General 1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. 1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies. NOTE National or regional regulations may apply. 1.2 Exclusions This part of ISO 11138 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test systems.

Sterilization of health care products - Biological indicators - Part 1: General requirements

ASTM E2363-06a 关于制药业过程技术分析的标准术语

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 lists those documents referenced in this terminology.

Standard Terminology Relating to Process Analytical Technology in the Pharmaceutical Industry

ASTM E2363-06 关于制药业过程技术分析的标准术语

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 E1298-06 测定生物药品中纯净度、杂质和污染物标准指南

This guide suggests analytical methods generally applied within the pharmaceutical industry to identify and quantitate the level of impurities and contaminants present in the preparation of a biological drug product. These methods are not intended to be all-inclusive. The methods used by an individual manufacturer must be specific to the product and process of production.1.1 This guide covers the concepts of purity, impurity, and contamination in biological drug products.1.2 This guide suggests methods for determination of impurities and contaminants in such products.1.3 This guide is arranged as follows: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 Determination of Purity, Impurities, and Contaminants in Biological Drug Products