本文件规定了医疗器械成分的鉴定框架，如有必要，还规定了对医疗器械成分进行量化的框架，允许对生物危害进行鉴定，并对物质成分的生物风险进行估计和控制，采用通常的逐步化学特征化方法，包括或更多以下情况:-建筑材料的标识（医疗器械配置）；-通过鉴定和量化建筑材料的化学成分（材料成分），对其进行表征；-制造过程中引入的化学物质（如脱模剂、工艺污染物、灭菌残留物）医疗器械的特性；-估计（使用实验室提取条件）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潜力（可提取）；-医疗器械在其临床使用条件下释放出的化学物质的测量。本文件也可用于降解产物的化学表征（如鉴定和/或量化）。ISO 10993-9、ISO 10993-13、ISO 10993-14和ISO 10993-15涵盖了有关降解评估其他方面的信息。当材料或医疗器械有直接或间接身体接触时，ISO 10993系列适用（按身体接触性质分类，见ISO 10993-1）。本文件旨在为材料供应商和医疗器械制造商提供生物评估支持。

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.