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POINT OF VIEW: New Sampling and Classification Methods Set in Revised ISO 14644 Cleanroom Standards

机译:观点要点:修订的ISO 14644洁净室标准中设置了新的采样和分类方法

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The highly anticipated revisions to the world's bedrock cleanroom standards are now available from IEST, the Secretariat for ISO Technical Committee 209 (ISO/TC 209): Cleanrooms and associated controlled environments. The newly released ISO/DIS 14644-1--Cleanrooms and associated controlled environments--Part 1: Classification of air cleanliness by particle concentration and ISO/DIS 14644-2--Cleanrooms and associated controlled environments--Part 2: Specifications for monitoring and periodic testing to prove continued compliance with ISO 14644-1 may necessitate a shift in thinking for the controlled environments community. According to ISO/TC 209 Working Group 1, the global experts who drafted the revisions, new provisions include a simplified classification process based on a more accurate scientific sampling method. The new, statistically-based plan for selecting sample locations calls for a greater number of locations, but in turn eliminates the need to apply a statistical test to the data. This approach reportedly allows for different concentration levels in different parts of the cleanroom and is designed to ensure with a given statistical confidence that at least 90percent of the cleanroom area complies with the maximum particle concentration. The new approach provides a risk-based approach to classification that provides interpretable assumptions and conclusions.
机译:现在可以从IEST,ISO技术委员会209秘书处(ISO / TC 209):洁净室和相关的受控环境中获得对世界基岩洁净室标准的高度期望的修订。新发布的ISO / DIS 14644-1--洁净室和相关受控环境-第1部分:按颗粒浓度和ISO / DIS 14644-2--洁净室和相关受控环境对空气清洁度的分类-第2部分:监测规范定期测试以证明持续符合ISO 14644-1可能需要改变受控环境社区的思维方式。根据草拟修订版的全球专家ISO / TC 209工作组的说法,新规定包括基于更准确的科学采样方法的简化分类过程。基于统计的新计划用于选择样本位置,因此需要更多的位置,但又消除了对数据进行统计检验的需要。据报道,这种方法允许在洁净室的不同部分使用不同的浓度水平,并旨在确保在给定的统计上确保至少洁净室面积的90%符合最大颗粒浓度。新方法提供了一种基于风险的分类方法,该方法提供了可解释的假设和结论。

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