ISO/TS 21560:2020 组织工程医疗产品的一般要求

标准编号：ISO/TS 21560:2020

中文名称：组织工程医疗产品的一般要求

英文名称：General requirements of tissue-engineered medical products

发布日期：2020-08

标准范围

本文件规定了用于再生医学的组织工程医疗产品（TEMPs）的一般要求。关于安全性，本文件概述了对材料、制造、质量控制和临时温度引起的无意生物效应的要求。本文件不涉及临床试验和疗效的要求。本文件不适用于用于诊断、离体检测或患者体外治疗（如TEMP成分透析）的组织工程产品。含有活的异种细胞、遗传修饰的细胞或源自异常细胞或组织(例如癌组织)的细胞的TEMPs也被排除在范围之外。TEMPs与医疗器械的组合，由合成和/或天然材料组成的支架除外-衍生（例如动物来源）材料也排除在范围之外。注国际、国家或地区法规或要求或药典也适用于本文件涵盖的特定主题。

This document specifies general requirements for tissue-engineered medical products (TEMPs), which are used in regenerative medicine. With regard to safety, this document outlines requirements for materials, manufacture, quality control, and unintentional biological effects elicited by TEMPs. This document does not address requirements for clinical trials and efficacy.This document is not applicable to tissue-engineered products used for diagnosis, ex-vivo testing or extracorporeal treatments of patients (e.g. dialysis with TEMP components). TEMPs containing viable xenogenic cells, genetically modified cells, or cells derived from abnormal cells or tissues (e.g. cancerous tissues) are also excluded from the scope. The combination of TEMPs with medical devices, with the exception of scaffolds comprised of synthetic and/or naturally-derived (e.g. animal sourced) materials, is also excluded from the scope.NOTE International, national or regional regulations or requirements, or the Pharmacopeia also apply to specific topics covered in this document.

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