生物制品生产用动物细胞检测

生物制品生产用动物细胞检测项目报价？  解决方案？  检测周期？  样品要求？

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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。

DIN EN ISO 29701-2011纳米技术.实验室系统条件下纳米材料内毒素的检定.内毒素鲎试剂(LAL)测定法(ISO 29701-2010);德文版本EN ISO 29701-2010

This International Standard describes the application of a test using Limulus amebocyte lysate (LAL) reagent for the evaluation of nanomaterials intended for cell-based in vitro biological test systems. The test is suitable for use with nanomaterial samples dispersed in aqueous media, e. g. water, serum or reaction medium, and to such media incubated with nanomaterials for an appropriate duration at 37 °C. This International Standard is restricted to test samples for in vitro systems, but the methods can also be adapted to nanomaterials to be administered to animals by parenteral routes.

DIN ISO 13022-2014含活性人体细胞的医疗产品. 风险管理的应用和生产实践要求(ISO 13022-2012)

This standard specifies a procedure to identify the hazards and hazardous situations and to manage the risk associated with viable cellular component (s) of products regulated as medicals products, biological, medical devices and active implantable medical devices or combination thereof. It covers viable human materials of autologous as well allogenic human origin. For the manufacturer of medical products containing viable cells of human origin, this standard specifies a procedure to identify the hazards and hazardous situations associated with such cells, to estimate and evaluate the resulting risks, to control this risk, and to monitor the effectiveness of the control. Furthermore the standard outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, and expected medical benefit as compared to available alternatives.