ISO 10993-18:2005描述了一种用于鉴定材料以及其化学成分的鉴定和定量的框架。生成的化学特征信息可用于一系列重要应用，例如作为对医疗设备（ISO 10993-1和14971）的整体生物安全性的评估的一部分，作为可浸出水平的量度物质在医疗设备中，以便允许评估对健康风险评估（ISO 10993-17）中为该物质获得的允许限度的符合性，用于判断拟议材料与临床建立的材料的等效性，以判断等同物一个最终的设备，用于检查后者的数据的相关性，以便用于支持前者的评估，或筛选潜在的新材料以适用于医疗设备以用于所提出的临床应用。 ISO 10993-18:2005不涉及ISO 10993-9，ISO 10993-13，ISO 10993-14和ISO 10993-15中涵盖的降解产物的鉴定或定量。 当材料或设备直接或间接接触身体时，ISO 10993系列标准适用（见ISO 10993-1的4.2.1）。 ISO 10993

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.