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现行 ISO 14644-14:2016
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Cleanrooms and associated controlled environments — Part 14: Assessment of suitability for use of equipment by airborne particle concentration 洁净室和相关受控环境 - 第14部分:空气中颗粒浓度对设备使用适用性的评估
发布日期: 2016-09-14
ISO 14644-14:2016规定了一种方法,以评估设备(如机械、测量设备、工艺设备、部件和工具)在洁净室和相关受控环境中的适用性,并与ISO 14644-1中规定的空气颗粒清洁度有关。粒径范围从0.1μm到等于或大于5μm(见ISO 14644-1)。 注:如果监管机构施加补充指南或限制,则可能需要对评估方法进行适当调整。 本ISO 14644-14:2016未涵盖以下项目: -生物污染适宜性评估; -去污剂和技术的适用性测试; -设备和材料的清洁性; -设备设计和材料选择的要求; -材料的物理性能(例如静电、热性能); -针对特定工艺应用优化设备性能; -测试统计方法的选择和使用; -当地安全法规的协议和要求。
ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644?1. Particle sizes range from 0,1 μm to equal to or larger than 5 μm (given in ISO 14644?1). NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required. The following items are not covered by this ISO 14644-14:2016: - assessment of suitability with respect to biocontamination; - testing for suitability of decontamination agents and techniques; - cleanability of equipment and materials; - requirements on design of equipment and selection of materials; - physical properties of materials (e.g. electrostatic, thermal properties); - optimizing performance of equipment for specific process applications; - selection and use of statistical methods for testing; - protocols and requirements for local safety regulations.
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归口单位: ISO/TC 209
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