Eric Linvill, Chung Tsai, Paolo Ravaynia, Chun Chang, Karin Brolin, Victor Alvarez, Sofia Jonasson
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引用次数: 0
摘要
根据 ISO 11608-1 标准,在坚硬表面上的激活并不总能代表设备在柔软注射部位的使用情况。较软的注射部位(肥胖患者的人体测量特性)具有明显的粘弹性,可导致更大的自动注射器激活力,而标准化的激活测试方法无法捕捉到这种激活力。为了推进自动注射器的开发,SHL 开发了软组织模拟和物理测试,允许在涉及最柔软注射部位的情况下进行严格的测试和挑战。
Rethinking Human Factors in Obesity: Development of Simulation and Physical Test Models of Human Soft Tissue to Study Autoinjector Activation Performance.
Activation against a hard surface according to ISO 11608-1 is not always representative of device use on a soft injection site. A softer injection site - which is an anthropometric property found in obese patients - presents a distinct viscoelastic property which can lead to greater autoinjector activation forces that are not captured in standardized activation testing methodology. Soft tissue simulation and physical testing were developed at SHL to advance the development of autoinjectors, allowing for rigorous testing and challenging these in scenarios involving even the softest injection sites.