本文件规定: -在风险管理过程中管理医疗器械生物学评估的一般原则； -根据与身体接触的性质和持续时间对医疗器械进行一般分类； -评估所有来源的现有相关数据； -根据风险分析确定可用数据集中的差距； -确定分析医疗器械生物安全性所需的其他数据集； -医疗器械的生物安全性评估。 本文件适用于预计直接或间接接触以下物品的材料和医疗器械的评估: -预期使用期间患者的身体； -如果医疗设备用于保护（例如手术手套、口罩等），则为使用者的身体。 本文件适用于所有类型医疗器械的生物学评估，包括主动、非主动、植入式和非植入式医疗器械。 本文件还提供了评估下列生物危害的指南: -作为整体生物安全评估的一部分的风险，如医疗器械随时间的变化； -医疗器械或医疗器械组件破损，使人体组织暴露于新材料或新材料中。 ISO 10993的其他部分涵盖了生物学评估和相关测试的特定方面。设备特定标准或产品标准涉及机械测试。 本文件不包括与细菌、霉菌、酵母菌、病毒、传染性海绵状脑病（TSE）病原体和其他病原体有关的危害。

This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the nature and duration of their contact with the body; — the evaluation of existing relevant data from all sources; — the identification of gaps in the available data set on the basis of a risk analysis; — the identification of additional data sets necessary to analyse the biological safety of the medical device; — the assessment of the biological safety of the medical device. This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: — the patient's body during intended use; — the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices. This document also gives guidelines for the assessment of biological hazards arising from: — risks, such as changes to the medical device over time, as a part of the overall biological safety assessment; — breakage of a medical device or medical device component which exposes body tissue to new or novel materials. Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing. This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.