组织工程医疗产品壳聚糖检测

发布时间：2024-06-21 作者：中析研究所浏览：

YY/T 0606.3-2007组织工程医疗产品第3部分：通用分类

YY/T 0606的本部分规定了组织工程医疗产品分类标准的相关方面，以保证组织工程医疗产品对病人和使用者的安全和有效性。本部分不包括传统意义上的器官和组织移植以及活细胞治疗。本部分适用于组织工程产品的分类要求，不包括其他标准中包括的特定内容。

YY/T 0606.10-2008组织工程医疗产品.第10部分:修复或再生关节软骨的植入物体内评价指南

YY/T 0606的本部分规定了修复或再生关节软骨的植入物体内评价的通则。本部分中的植入物可由天然或合成生物材料（具有生物相容性，可生物降解），或其复合物构成，可含有细胞、药物，或生长因子、合成多肽、质粒或cDNA等生物活性因子。本部分描述了兔、犬、猪、山羊、绵羊等不同种属的动物模型和相应的试验程序，以及形态学、组织生物化学和生物力学分析等结果测定和评价的方法。

YY/T 0606.12-2007组织工程医疗产品第12部分：细胞、组织、器官的加工处理指南

1．1 YY/T 0606的本部分规定了用于组织工程医疗产品(TEMPs)的细胞、组织和器官的加工处理、检定、生产以及质量保证的要求，包括： a) 细胞、组织及器官的加工处理（即：设施、试剂、接收程序、检查以及贮存；组织培养成分，生物危险因子以及操作区域）； b)供体（人源或非人源）及筛查； c)细胞、组织和器官的检定及加工。1．2本部分不适用于现行药品管理法中按照生物制品进行管理的产品。

YY/T 0606.13-2008组织工程医疗产品.第13部分:细胞自动计数法

YY/T 0606的本部分所述的原理和方法适用于绝大部分类型细胞的自动计数，包括黏附生长细胞和悬浮生长细胞。

YY/T 0606.14-2014组织工程医疗产品第14部分:评价基质及支架免疫反应的试验方法:ELISA法

YY/T 0606的本部分规定了评价组织工程医疗产品基质或支架所致哺乳动物体液免疫反应的试验方法:ELISA法。本部分适用于组织工程医疗产品基质或支架的生物学评价。除本部分所选方法外,可采纳其他等效方法。并非所有的材料和应用均需要按照本部分进行检测,因此应仔细考虑本部分中方法的适用性。在实施本部分推荐的试验前,应考虑GB/T 16886.1或管理部门所推荐的试验结果所提示的信息。

YY/T 0606.20-2014组织工程医疗产品第20部分评价基质及支架免疫反应的试验方法:细胞迁移试验

YY/T 0606的本部分规定了评价组织工程医疗产品基质或支架所致哺乳动物细胞免疫反应的试验方法:细胞迁移试验。本部分适用于组织工程医疗产品基质或支架的生物学评价。除本部分所选方法外,可采纳其他等效方法。并非所有的材料和应用均需要按照本部分进行检测,因此应仔细考虑本部分中方法的适用性。在实施本部分推荐的试验前,应考虑GB/T 16886.1或管理部门所推荐的试验结果所提示的信息。

YY/T 0953-2020医用羧甲基壳聚糖

本标准规定了医用羧甲基壳聚糖原料的要求、试验方法、包装、运输和贮存等。本标准适用于以壳聚糖或甲壳素为原料，经脱乙酰化、羧化、纯化而成的用于制造组织工程医疗器械产品的医用羧甲基壳聚糖。

YY/T 1435-2016组织工程医疗器械产品水凝胶表征指南

本标准给出了用于表征组织工程医疗器械产品中水凝胶的生物学特性、形成动力学、物理与化学特性及稳定性，以及物质传递等特性的方法指南。

YY/T 1445-2016组织工程医疗器械产品术语

本标准规定了组织工程医疗器械产品的基本术语和定义。

YY/T 1574-2017组织工程医疗器械产品海藻酸盐凝胶固定或微囊化指南

本标准规定了海藻酸盐凝胶固定或微囊化评价的要求，包括海藻酸盐凝胶固定或微囊化、微胶囊或微胶珠的性能及其考察、海藻酸盐凝胶的生物相容性的考察。本标准适用于海藻酸盐凝胶固定或微囊化的评价。

YY/T 1699-2020组织工程医疗器械产品壳聚糖

本标准规定了用于制备组织工程医疗器械产品的壳聚糖及其盐的要求、试验方法等。本标准适用于制备组织工程医疗器械产品的壳聚糖及其盐。

ASTM F2103-2001(2007)表征和测试壳聚糖盐作为原料用于生物医学和组织工程医疗产品应用的标准指南

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.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.

ASTM F2103-2018用于生物医学和组织工程医疗产品应用的壳聚糖盐作为起始材料的表征和测试的标准指南

4.1x00a0;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. 4.2x00a0;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. 4.3x00a0;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. 1.1x00a0;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). 1.2x00a0;This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts. 1.3x00a0;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. 1.4x00a0;Warningx2014;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 EPAx2019;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. 1.5x00a0;The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6x00a0;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 applicabilit......