标准摘要
[中文适用范围]： 本文件规定了细胞活力分析方法的通用要求以及细胞活力报告的通用要求。本文件给出了选择和建立适合目的的细胞活力分析方法的通用指南。本文件规定了制定细胞活力分析方法标准操作程序的要求。本文件还给出了在分析前、分析中和分析后阶段管理细胞活力测量变异来源的指南。本文件适用于悬浮细胞、贴壁细胞和复杂基质中的细胞。本文件主要适用于有核哺乳动物细胞的细胞活力测量。注1：目前存在若干部门/应用特定的国际和国家标准。适用时，用户可在其范围内参考现有标准。 [外文原描述]： This document specifies the general requirements for cell viability analytical methods and for reporting cell viability. This document gives general guidelines for selecting and establishing fit for purpose cell viability analytical methods. This document specifies requirements for establishing standard operating procedures for cell viability analytical methods. This document also gives guidelines for managing sources of variability for cell viability measurements during pre-analytical, analytical, and post-analytical phases. This document is applicable to cells in suspension, cells adhered to a substrate, and cells in complex matrices. This document is primarily applicable to cell viability measurements of nucleated mammalian cells. NOTE 1 Several sector/application-specific international and national standards for cell viability currently exist. NOTE 2 When applicable, the user can consult existing standards when operating within their scope.
英文名称Biotechnology — Cell viability analytical methods — Part 1: General requirements and considerations