ISO 10993-18:2020 医学装置的生物学评估 第18部份： 化学药品材料的描述

标准编号：ISO 10993-18:2020

中文名称：医学装置的生物学评估 第18部份： 化学药品材料的描述

英文名称：Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

发布日期：2020-01

标准范围

本文件规定了医疗器械成分的鉴定框架，如有必要，还规定了医疗器械成分的量化框架，允许使用化学特性的一般逐步方法，对生物危害进行鉴定，并对材料成分的生物风险进行估计和控制，该方法可包括以下一项或多项:-其结构材料（医疗器械配置）的标识；-通过鉴定和量化其化学成分（材料成分），对建筑材料进行表征；-医疗器械在制造过程中引入的化学物质（例如脱模剂、过程污染物、灭菌残留物）的特征；-医疗器械或其结构材料在临床使用条件下释放化学物质的可能性的估计（使用实验室提取条件）；-测量医疗器械在临床使用条件下释放的化学物质（可浸出物）。本文件也可用于降解产物的化学表征（例如识别和/或量化）。ISO 10993-9、ISO 10993-13、ISO 10993-14和ISO 10993-15涵盖了降解评估的其他方面的信息。当材料或医疗器械直接或间接与身体接触时，ISO 10993系列适用（根据身体接触的性质分类，见ISO 10993-1）。本文件适用于材料供应商和医疗器械制造商，以支持生物学评估。

This document specifies a framework for the identification, and if necessary, quantification of constituents of a medical device, allowing the identification of biological hazards and the estimation and control of biological risks from material constituents, using a generally stepwise approach to the chemical characterization which can include one or more of the following:— the identification of its materials of construction (medical device configuration);— the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);— the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g. mould release agents, process contaminants, sterilization residues);— the estimation (using laboratory extraction conditions) of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);— the measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).This document can also be used for chemical characterization (e.g. the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.The ISO 10993 series is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

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