有毒还是无毒?标准ISO 10993-5的规范不够明确,无法在相同医疗器械的细胞毒性评估中产生可比较的结果。

Frontiers in Medical Technology Pub Date : 2023-06-14 eCollection Date: 2023-01-01 DOI:10.3389/fmedt.2023.1195529
Sarah Gruber, Angela Nickel
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摘要

背景:医疗器械制造商有义务证明其产品与人体接触时的生物相容性。国际标准系列ISO 10993规定了医疗器械生物学评估的要求。本系列的第五部分介绍了体外细胞毒性试验的性能。该测试评估医疗器械使用对细胞健康的影响。具体标准的存在表明,测试将产生可靠和可比的结果。然而,ISO 10993-5在测试规范中提供了广泛的自由度。过去,我们注意到不同实验室的结果不一致。目的:确定ISO 10993-5标准的规范是否明确,以确保测试结果的可比性,如果没有,则确定潜在的影响因素。方法:根据ISO 10993-5进行体外细胞毒性试验的实验室间比较。52个国际实验室评估了两个未知样品的细胞毒性。一种是聚乙烯(PE)管,预计其无细胞毒性,另一种是聚氯乙烯(PVC)管,推测其具有细胞毒性潜力。要求所有实验室按照预先确定的提取规格进行洗脱试验。其他测试参数由实验室根据标准制定的指南自由选择。结果:令我们惊讶的是,只有58%的参与实验室确定了这两种材料的细胞毒性潜力。特别是对于聚氯乙烯,观察到实验室之间的结果有相当大的差异[平均值 = 43 ± 30(SD),最小 = 0,最大值 = 100]。我们发现,在提取培养基中添加10%的血清,以及用提取物培养细胞的时间更长,大大提高了PVC的检测灵敏度。结论:结果清楚地表明,ISO 10993-5规定的规范不够明确,无法获得相同医疗器械的可比结果。为了制定确保可靠的细胞毒性评估的要求,有必要进行进一步研究,以确定特定材料和/或装置的最佳测试条件,并需要对标准进行相应修订。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Toxic or not toxic? The specifications of the standard ISO 10993-5 are not explicit enough to yield comparable results in the cytotoxicity assessment of an identical medical device.

Background: Medical device manufacturers are obliged to prove the biocompatibility of their products when they come into contact with the human body. The requirements for the biological evaluation of medical devices are specified by the international standard series ISO 10993. Part five of this series describes the performance of in vitro cytotoxicity tests. This test evaluates the effects of medical device use on cell health. The existence of the specific standard suggests that the tests will produce reliable and comparable results. However, the ISO 10993-5 offers wide latitude in the test specifications. In the past, we noticed inconsistencies of the results from different laboratories.

Objective: To determine if the specifications of the standard ISO 10993-5 are explicit to ensure the comparability of test results and, if not, identify potential influencing factors.

Methods: An interlaboratory comparison was conducted for the in vitro cytotoxicity test according to ISO 10993-5. Fifty-two international laboratories evaluated the cytotoxicity for two unknown samples. One was polyethylene (PE) tubing, which is expected to be non-cytotoxic and the other was polyvinyl chloride (PVC) tubing, for which a cytotoxic potential was presumed. All laboratories were asked to perform an elution test with predefined extraction specifications. The other test parameters were freely chosen by the laboratories according to the guidelines set by the standard.

Results: To our surprise only 58 percent of the participating laboratories identified the cytotoxic potential of both materials as expected. Particularly for PVC a considerable variation of the results between the laboratories was observed [mean = 43 ± 30 (SD), min = 0, max = 100]. We showed that ten percent serum supplementation to the extraction medium, as well as longer incubation of the cells with the extract, greatly increased the test sensitivity for PVC.

Conclusion: The results clearly show that the specifications set by the ISO 10993-5 are not explicit enough to obtain comparable results for an identical medical device. To set requirements that ensure reliable cytotoxicity assessments, further research will be necessary to identify the best test conditions for specific materials and/or devices and the standard needs to be revised accordingly.

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