1.1本指南讨论了与在海藻酸钠凝胶中固定或封装活细胞或组织相关的信息。固定化或胶囊化细胞适用于生物医学和制药应用，或两者兼有，包括但不限于组织工程医疗产品（TEMP）。 1.2本指南阐述了成功固定和封装在海藻酸钠凝胶中的关键参数。 1.3以国际单位制表示的数值应视为标准值。本标准不包括其他计量单位。 1.4 本标准并非旨在解决与其使用相关的所有安全问题（如有）。本标准的用户有责任在使用前制定适当的安全和健康实践，并确定监管要求的适用性。 ====意义和用途====== 主要用途是固定、支持或悬浮基质中的活细胞或组织。使用封装/固定系统可以保护细胞或组织免受免疫排斥。在海藻酸钠凝胶中固定生物材料时，必须控制许多参数。本指南包含这些参数的列表，并描述了正确表征、评估和确保使用海藻酸钠的封装系统性能一致性所需的测试方法和类型。本指南仅涵盖单凝胶珠粒，无论是否有涂层，而不是双胶囊或其他结构。 本指南涵盖的海藻酸钠凝胶技术可以将细胞和组织制成生物医学设备，用作组织工程医疗产品或药物输送设备。 基于支持性生物相容性和物理测试数据，这些产品可能适合植入。本指南中的建议不应被解释为任何组织工程医疗产品或药物递送应用中临床成功的保证。

1.1 This guide discusses information relevant to the immobilization or encapsulation of living cells or tissue in alginate gels. Immobilized or encapsulated cells are suitable for use in biomedical and pharmaceutical applications, or both, including, but not limited to, Tissue Engineered Medical Products (TEMPs). 1.2 This guide addresses key parameters relevant for successful immobilization and encapsulation in alginate gels. 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 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 requirements prior to use. ====== Significance And Use ====== The main use is to immobilize, support, or suspend living cells or tissue in a matrix. The use of an encapsulation/immobilization system may protect cells or tissues from immune rejection. When immobilizing biological material in alginate gels, there are numerous parameters that must be controlled. This guide contains a list of these parameters and describes the methods and types of testing necessary to properly characterize, assess, and ensure consistency in the performance of an encapsulation system using alginate. This guide only covers single gelled beads, coated or not, and not double capsules or other constructs. The alginate gelation technology covered by this guide may allow the formulation of cells and tissues into biomedical devices for use as tissue engineered medical products or drug delivery devices. These products may be appropriate for implantation 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.