a National Personal Protective Technology Laboratory , National Institute for Occupational Safety and Health , Pittsburgh , Pennsylvania.
J Occup Environ Hyg. 2014;11(2):117-25. doi: 10.1080/15459624.2013.816434.
Improved respirator test headforms are needed to measure the fit of N95 filtering facepiece respirators (FFRs) for protection studies against viable airborne particles. A Static (i.e., non-moving, non-speaking) Advanced Headform (StAH) was developed for evaluating the fit of N95 FFRs. The StAH was developed based on the anthropometric dimensions of a digital headform reported by the National Institute for Occupational Safety and Health (NIOSH) and has a silicone polymer skin with defined local tissue thicknesses. Quantitative fit factor evaluations were performed on seven N95 FFR models of various sizes and designs. Donnings were performed with and without a pre-test leak checking method. For each method, four replicate FFR samples of each of the seven models were tested with two donnings per replicate, resulting in a total of 56 tests per donning method. Each fit factor evaluation was comprised of three 86-sec exercises: "Normal Breathing" (NB, 11.2 liters per min (lpm)), "Deep Breathing" (DB, 20.4 lpm), then NB again. A fit factor for each exercise and an overall test fit factor were obtained. Analysis of variance methods were used to identify statistical differences among fit factors (analyzed as logarithms) for different FFR models, exercises, and testing methods. For each FFR model and for each testing method, the NB and DB fit factor data were not significantly different (P > 0.05). Significant differences were seen in the overall exercise fit factor data for the two donning methods among all FFR models (pooled data) and in the overall exercise fit factor data for the two testing methods within certain models. Utilization of the leak checking method improved the rate of obtaining overall exercise fit factors ≥100. The FFR models, which are expected to achieve overall fit factors ≥ 100 on human subjects, achieved overall exercise fit factors ≥ 100 on the StAH. Further research is needed to evaluate the correlation of FFRs fitted on the StAH to FFRs fitted on people. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: a file providing detailed information on the advanced head form design and fabrication process.].
需要改进呼吸防护器测试头模，以测量 N95 过滤式面罩呼吸器（FFR）的贴合度，从而开展针对活体空气传播颗粒物的防护研究。本研究开发了一种静态（即，非移动、非言语）高级头模（StAH），用于评估 N95 FFR 的贴合度。StAH 是基于美国国家职业安全与健康研究所（NIOSH）报告的数字头模的人体测量尺寸开发的，具有具有特定局部组织厚度的硅聚合物皮肤。对七种不同尺寸和设计的 N95 FFR 模型进行了定量贴合因子评估。测试时分别采用和不采用预测试泄漏检查方法进行佩戴。对于每种方法，每个模型的四个重复 FFR 样本进行两次重复佩戴测试，每次佩戴测试各进行四个重复，每种佩戴方法共进行 56 次测试。每次贴合因子评估均包括三个 86 秒的测试：“正常呼吸”（NB，11.2 升/分钟（lpm））、“深呼吸”（DB，20.4 lpm），然后再次进行 NB。获得了每个练习的贴合因子和总体测试贴合因子。方差分析方法用于识别不同 FFR 模型、练习和测试方法之间贴合因子（对数分析）的统计学差异。对于每个 FFR 模型，对于每个测试方法，NB 和 DB 贴合因子数据没有显著差异（P > 0.05）。在所有 FFR 模型（汇总数据）的两种佩戴方法之间的整体运动贴合因子数据以及在某些模型中两种测试方法的整体运动贴合因子数据中观察到显著差异。使用泄漏检查方法提高了获得整体运动贴合因子≥100 的总体比例。预计在人体研究中整体贴合因子≥100 的 FFR 模型，在 StAH 上也达到了整体运动贴合因子≥100。需要进一步研究以评估在 StAH 上适配的 FFR 与在人身上适配的 FFR 的相关性。[本文提供了补充材料。请访问《职业与环境卫生杂志》的出版商在线版本，获取以下免费补充资源：一份提供高级头模设计和制造过程详细信息的文件。]。
