生物制品生產用動物細胞檢測

生物制品生產用動物細胞檢測項目報價？??解決方案？??檢測周期？??樣品要求？

點 擊 解 答??

YY/T 0606.12-2007組織工程醫療產品 第12部分：細胞、組織、器官的加工處理指南

1．1 YY/T 0606的本部分規定了用于組織工程醫療產品(TEMPs)的細胞、組織和器官的加工處理、檢定、生產以及質量保證的要求，包括： a) 細胞、組織及器官的加工處理（即：設施、試劑、接收程序、檢查以及貯存；組織培養成分，生物危險因子以及操作區域）； b)供體（人源或非人源）及篩查； c)細胞、組織和器官的檢定及加工。1．2本部分不適用于現行藥品管理法中按照生物制品進行管理的產品。

DIN EN ISO 29701-2011納米技術.實驗室系統條件下納米材料內毒素的檢定.內毒素鱟試劑(LAL)測定法(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含活性人體細胞的醫療產品. 風險管理的應用和生產實踐要求(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.