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爬梯機之機械安全性檢驗項目評估研究

Mechanical Safety Risk Assessment of Tracked Stair-Climbing Device Relative to National Standards

摘要


台灣隨著人口老化及長期照護需要所衍生的輔助科技需求,反映出輔具服務的重要,在輔具多元發展的情況下,透過標準訂定來保護使用者的安全及產品品質為必要的工作。據營建署統計,台灣屋齡超過20年的老舊住宅約470萬宅,身障及銀髮族居住於老舊公寓,無法自行上下樓之困境,使得爬梯機成了出借率最高的輔具之一(中央社,2014)。輪椅爬梯機主要對象為行動不方便之患者及老年人,產品安全性相對重要。因此在美國列為第二級的醫療器材,屬於高風險性的醫療器材。美國FDA規定此類產品需要評估不穩定、使用錯誤、摔倒及相關傷害等風險,其中這些風險藉由標準性能測試來評估。本研究之進行主要在於透過爬梯機品質安全評估與檢驗方法來檢視行動輔具之安全性及功能性,依據資料之蒐集與分析比較國內與國外使用環境的差別,並依據國內多為老舊公寓使用上的困境,特別加入標準中缺少的迴轉半徑列為評估項目之一,依據結果建立安全性評估測試項目並針對現行標準的不足依現況增加符合國內使用的測試項目,避免使用上造成嚴重的傷害,其意義在於能符合國內使用環境下安全地使用爬梯機。

關鍵字

爬梯機 安全性 行動輔具

並列摘要


The demand for assistive technology derived from the ageing population and the need for long-term care in Taiwan reflect the importance of assistive services. As assistive technology and devices continue to develop, it is necessary to ensure user safety and product quality through the setting of standards. There are about 4.7 million apartments in Taiwan that are over 20 years old. More often than not, disabled people and the elderly who live in such old apartments cannot go up and down the stairs by themselves. This makes climbing devices an important class of assistive equipment. Climbing devices for wheelchairs are suitable for the elderly and those who have difficulty moving from one place to another, making the safety of the products they use very important. Therefore, the second-grade medical equipment in the United States is a high-risk medical device. The US FDA requires such products to be assessed for risks such as stability, misuse, falls, and fall-related injuries. Such risks are assessed by standard performance tests. The main purpose of this research is to examine the safety and functionality of mobility aids through the ladder safety quality assessment and inspection methods. Based on the data collection and analysis, the safety assessment test project is established and the current standard was found to be insufficient to meet the current situation.

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