ISO/TS 21726:2019 医疗器械的生物评价 用于评估医疗器械成分的生物相容性的毒理学关注阈值（TTC）的应用

标准编号：ISO/TS 21726:2019

中文名称：医疗器械的生物评价 用于评估医疗器械成分的生物相容性的毒理学关注阈值（TTC）的应用

英文名称：Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents

发布日期：2019-02

标准范围

本文件描述了存在于医疗器械中/上或从医疗器械中释放的成分的毒理学关注阈值（TTC）值的依据、选择和一般适用性。本文件中的TTC值可用于:-与提取物中已识别或未识别成分的最大浓度进行比较（见ISO 10993-18）；-支持毒理学等效性；-与确定成分的最大暴露剂量估计值进行比较（见ISO 10993-17）。注:成分定义见3.1。ISO 10993-18规定了如何将TTC（μg/d）转化为浓度（μg/ml）。TTC不适用于具有足够毒性数据以得出耐受摄入量（TI）值的成分（见ISO 10993-17）。本文件中确定的TTC值对致癌物、全身毒物和生殖毒物具有保护作用（见第5条）。根据ISO 10993，本文件不包括作为医疗器械生物学评估一部分评估的其他生物学终点的TTC值-1.例如:-细胞毒性；-刺激；-致敏；-血液相容性；-物质介导的热原性；-发生在医疗器械与身体接触部位的组织中的局部效应（例如，植入研究的观察结果）。本文件中的TTC值不适用于通过医疗设备的气体通道进行的潜在接触。对于这些设备中存在/释放的成分的TTC应用，请参见ISO 18562系列。本文件中给出的TTC值不适用于相关队列的安全性评估（见5.3）。

This document describes the basis for, selection of, and general applicability of a threshold of toxicological concern (TTC) value for a constituent present in/on a medical device or released from a medical device. The TTC values in this document can be used for:— comparing to a maximum concentration of an identified or unidentified constituent in an extract (see ISO 10993-18);— supporting toxicological equivalence;— comparing to a maximum exposure dose estimate of an identified constituent (see ISO 10993-17).NOTE Constituent is defined in 3.1.ISO 10993-18 specifies how to convert TTC (μg/d) into a concentration (μg/ml).TTC is not applicable to constituents with adequate toxicity data for deriving a tolerable intake (TI) value (see ISO 10993-17).The TTC values established in this document are protective for carcinogens, systemic toxicants, and reproductive toxicants (see Clause 5). This document does not include TTC values for other biological endpoints assessed as part of the biological evaluation of a medical device, per ISO 10993-1, for example:— cytotoxicity;— irritation;— sensitization;— hemocompatibility;— material mediated pyrogenicity;— local effects that occur in tissues at the site of contact between a medical device and the body (e.g. the observations from implantation studies).The TTC values in this document do not apply to potential exposure via gas pathways of medical devices. For application of TTC for constituents present/released from these devices, see the ISO 18562 series.The TTC values presented in this document are not applicable for the safety assessment of cohort of concern (see 5.3).

标准预览图