90度剥离粘附基材的评估——一项合作研究。I. 医用胶带。
Evaluation of substrates for 90 degrees peel adhesion--a collaborative study. I. Medical tapes.
作者信息
Wokovich Anna M, Brown Stanley A, McMaster Fraser J, Doub William H, Cai Bing, Sadrieh Nakissa, Chen Mei Ling, Machado Stella, Shen Meiyu, Buhse Lucinda F
机构信息
Center for Drug Evaluation and Research, Food and Drug Administration, St. Louis, Missouri, USA.
出版信息
J Biomed Mater Res B Appl Biomater. 2008 Oct;87(1):105-13. doi: 10.1002/jbm.b.31075.
As part of a method development for peel testing, an interlaboratory comparison among Food and Drug Administration-Center for Drug Evaluation and Research, Food and Drug Administration-Center for Devices and Radiological Health and Southwest Research Institute was conducted using medical tapes. The aim was to determine which readily available substrate [stainless steel (SS), high density polyethylene (HDPE) or Vitro-Skin(R)] would best distinguish among various medical tapes. Five medical tapes (3M 1523, 3M 1525L, 3M 1776, Mepiform(R) and Mediderm(R) 3505) were evaluated on four different substrates (SS, HDPE, Vitro-Skin, and human cadaver skin) using the following peel parameters: approximately 3 min dwell time, 90 degrees peel angle, and 300 mm/min peel rate. No substrate mimics cadaver skin for all five tapes. SS had the best ability to distinguish among the medical tapes. Overall, for quality control purposes (yielding good discrimination and precision), SS would be the optimal substrate.
作为一项用于剥离测试的方法开发的一部分，美国食品药品监督管理局药品评价和研究中心、美国食品药品监督管理局器械和放射健康中心与西南研究院之间使用医用胶带进行了一项实验室间比对。目的是确定哪种现成的基材（不锈钢（SS）、高密度聚乙烯（HDPE）或体外皮肤（Vitro-Skin®））能最好地区分各种医用胶带。使用以下剥离参数，在四种不同基材（SS、HDPE、体外皮肤和人体尸体皮肤）上对五种医用胶带（3M 1523、3M 1525L、3M 1776、美皮护（Mepiform®）和美德肤（Mediderm®）3505）进行了评估：约3分钟的停留时间、90度的剥离角度和300毫米/分钟的剥离速率。没有一种基材能对所有五种胶带模拟尸体皮肤的情况。SS区分医用胶带的能力最佳。总体而言，出于质量控制目的（实现良好的区分度和精密度），SS将是最佳基材。
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