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医用针具的质量检测——实验室与实际应用

Quality testing of medical needles--laboratory and practice.

作者信息

Kinast P

机构信息

Melab GmbH, Friolzheim, FRG.

出版信息

Med Device Technol. 1992 Aug-Sep;3(6):46-9.

Abstract

Tip deformities as small as 10 mum on cannulae can cause unnecessary pain to patients. The only way of preventing these deformed cannulae from reaching patients is to test every cannula at the manufacturing stage. Clinical and laboratory tests carried out by the company compare handling and trauma caused by medical cannulae with technical parameters for manufacturing and testing. This article discusses the results of these tests, which the author found verified that the properties of medical cannulae can be evaluated by measuring the penetration load piercing a skin substitute. The discovery of tip deformities with clinical significance led to the development of specially designed equipment that detects the presence of deformities by using the noise made by a deformed cannula penetrating a foil.

摘要

插管尖端小至10微米的变形都可能给患者带来不必要的痛苦。防止这些变形插管进入患者体内的唯一方法是在制造阶段对每个插管进行测试。该公司进行的临床和实验室测试将医用插管造成的操作和创伤与制造和测试的技术参数进行了比较。本文讨论了这些测试的结果,作者发现这些结果证实了医用插管的性能可以通过测量穿透皮肤替代物的刺入负荷来评估。具有临床意义的尖端变形的发现促使开发了专门设计的设备,该设备通过使用变形插管穿透箔片时产生的噪音来检测变形的存在。

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