ISO 10993-18:2005 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 10993-18:2005

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 materials

发布日期：2005-07

标准范围

ISO 10993-18:2005描述了一种材料鉴定及其化学成分鉴定和量化的框架。生成的化学特性信息可用于一系列重要应用，例如，作为医疗器械整体生物安全性评估的一部分（ISO 10993-1和14971），作为对医疗器械中可浸出物质水平的测量，以便评估该物质是否符合基于健康的风险评估（ISO 10993-17）得出的允许限值，判断拟用材料与临床确定材料的等效性，用于判断最终设备与原型设备的等效性，以检查用于支持前者评估的原型设备数据的相关性，或用于筛选潜在的新材料，以确定医疗设备是否适合拟议的临床应用。ISO 10993-18:2005没有涉及降解产物的识别或量化，这在ISO 10993-9、ISO 10993-13、ISO 10993-14和ISO 10993-15中有所涉及。当材料或装置直接或间接接触人体时，ISO 10993系列标准适用（见ISO 10993-1的4.2.1）。ISO 10993-18:2005适用于进行生物安全评估时的材料供应商和医疗器械制造商。

ISO 10993-18:2005 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example, as part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971), as a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17), for judging equivalence of a proposed material to a clinically established material, for judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.ISO 10993-18:2005 does not address the identification or quantification of degradation products, which is covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.The ISO 10993 series of standards is applicable when the material or device comes into contact with the body directly or indirectly (see 4.2.1 of ISO 10993-1).ISO 10993-18:2005 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

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