Recommended test methods and pass/fail criteria for a respirator fit capability test of half-mask air-purifying respirators
Recommended test methods and pass/fail criteria for a respirator fit capability test of half-mask air-purifying respirators
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DOI：
10.1080/15459624.2017.1296233
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发表时间：
2017-01-01
影响因子：
2
通讯作者：
Shaffer, Ronald
中科院分区：
文献类型：
--
作者：
Zhuang, Ziqing;Bergman, Michael;Shaffer, Ronald
这项研究评估了为半面罩空气净化微粒呼吸器开发呼吸器适配能力(RFC)测试的关键测试参数和合格/不合格标准选项。使用一个由25名受试者组成的测试小组，收集了101个国家职业安全与健康研究所认证的呼吸器型号的基准RFC数据。这些模特被进一步分成61个一号、两号或三号的家庭。适合度测试使用PortaCount(R)Plus和N95-Companion附件以及职业安全与健康管理局认可的定量适合度测试协议进行。每个受试者/呼吸器模型组合进行三次重复测试(DONING)。每个模型的小组通过率(PPR)(25名受试者小组达到可接受适合度的数量或百分比)是使用五种不同的确定可接受适配性的替代标准来确定的。当单独评估101个模型时(即，不按家庭分组)，对于前两个配合度中至少一个和至少三个配合度中的至少一个，能够拟合小组的75%(19/25个受试者)的模型的百分比分别为29%和32%。当模型按家庭分组进行评估时，使用75%的小组受试者在两个唐纳中至少有一个的拟合系数>；=100作为PPR通过/不通过的标准，所有模型中有48%可以通过。当50%(13/25名受试者)为PPR标准时，合格模型的百分比增加到70%。按家族分组测试口罩并评估两种口罩大小的前两个口罩尺寸提供了满足最终用户期望和为制造商创造性能标准之间的最佳平衡。将受试者获得可接受的适合度的测试标准指定为在两种设计中至少一种上达到适配系数>；=100是合理的，因为大多数现有的口罩家族可以使用该标准实现>；50%的PPR。标准开发组织在开发标准时可以考虑不同的测试标准。
This study assessed key test parameters and pass/fail criteria options for developing a respirator fit capability (RFC) test for half-mask air-purifying particulate respirators. Using a 25-subject test panel, benchmark RFC data were collected for 101 National Institute for Occupational Safety and Health-certified respirator models. These models were further grouped into 61 one-, two-, or three-size families. Fit testing was done using a PortaCount (R) Plus with N95-Companion accessory and an Occupational Safety and Health Administration-accepted quantitative fit test protocol. Three repeated tests (donnings) per subject/respirator model combination were performed. The panel passing rate (PPR) (number or percentage of the 25-subject panel achieving acceptable fit) was determined for each model using five different alternative criteria for determining acceptable fit.When the 101 models are evaluated individually (i.e., not grouped by families), the percentages of models capable of fitting >75% (19/25 subjects) of the panel were 29% and 32% for subjects achieving a fit factor >= 100 for at least one of the first two donnings and at least one of three donnings, respectively. When the models are evaluated grouped into families and using >75% of panel subjects achieving a fit factor >= 100 for at least one of two donnings as the PPR pass/fail criterion, 48% of all models can pass. When >50% (13/25 subjects) of panel subjects was the PPR criterion, the percentage of passing models increased to 70%.Testing respirators grouped into families and evaluating the first two donnings for each of two respirator sizes provided the best balance between meeting end user expectations and creating a performance bar for manufacturers. Specifying the test criterion for a subject obtaining acceptable fit as achieving a fit factor >= 100 on at least one out of the two donnings is reasonable because a majority of existing respirator families can achieve an PPR of >50% using this criterion. The different test criteria can be considered by standards development organizations when developing standards.