生物安全性评价方法在智能穿戴设备中的应用分析  

Analysis of the Application of Biological Safety Evaluation Methods in Smart Wearable Devices

作　　者：陈强 高燕安 郭锦添 邵华东 刘岩 

机构地区：[1]威凯检测技术有限公司,广州510663

出　　处：《日用电器》2024年第12期141-144,共4页ELECTRICAL APPLIANCES

摘　　要：智能穿戴产品如电话手表、智能手/脚环、智能眼镜、耳机、腰带等越来越多的应用于人民的日常生活中,为人民生活、通讯、健康监测带来便捷。这类产品几乎都要与人体皮肤接触,在医疗器械领域,与人体接触的医疗器械需要对产品进行生物安全性评价,用于判断产品是否会对人体产生异常刺激。鉴于目前经常会有消费者反映使用智能穿戴产品后接触部位皮肤不舒服,为了解决这个问题,本文借鉴医疗器械生物安全性评价的方法,通过皮肤刺激、致敏和体外细胞毒性实验等方法,为智能穿戴产品接触人体皮肤时可能产生异常刺激建立一种评价方法。根据现有研究结果,我们可以确定目前智能穿戴产品部分零部件确实存在对人体的异常作用。Smart wearable products,such as smartwatches,smart wristbands/anklets,smart glasses,headphones,and waistbands,increasingly being used in daily life,bringing convenience to people’s lives,communications,and health monitoring.These products almost all come into contact with human skin.In medical field,medical devices that come into contact with the human body need to undergo biological safety evaluations to determine whether they cause abnormal irritation tothe body.Given that often report discomfort in the contact area after using smart wearable products,this article aims to use the methods of medical device biological safety evaluation.By using methods such as irritation,sensitization,and in vitro cell toxicity tests,we aimto establish an inspection and evaluation method for potential abnormal irritation caused by smart wearable products when they intocontact with human skin.Based on existing research results,

关 键 词：智能穿戴设备 生物安全性试验 生物安全性评价 

分 类 号：F42[经济管理—产业经济]