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

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