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針刺穿測試儀是用于評估醫用針、注射針等穿刺器械針尖鋒利度的專業檢測設備,通過量化穿刺過程中的最大力值,確保醫療器械的安全性和有效性。該設備廣泛應用于藥品質檢機構、醫療器械生產企業及科研單位,為產品性能驗證提供關鍵數據支持。
概述
針刺穿測試儀是針對醫療器械行業研發的高精度檢測儀器,核心功能為測定各類注射針、穿刺針等樣品的穿刺力值。設備采用模塊化設計,結合工業級控制系統與人性化操作界面,可滿足基礎穿刺力測試及藥用包裝材料物理性能擴展檢測需求。其測試結果直接影響醫療器械的臨床使用體驗和安全性,是醫療器械質量控制的核心設備之一。
測試原理
設備通過以下步驟實現精準測試:
1. 樣品固定:將待測針具與高精度力值傳感器連接,并將被穿刺材料(如橡膠塞、復合膜等)固定于專用夾具;
2. 恒速穿刺:驅動裝置以設定速度(1-500mm/min無極可調)推動針具垂直穿刺樣品;
3. 數據采集:傳感器實時記錄穿刺過程中的力值變化,自動捕獲最大力值作為穿刺力指標;
4. 自動復位:測試完成后測試頭自動回位,支持連續高效檢測。
符合標準
● 國家標準:GB 15811(一次性使用無菌注射針)、GB/T 10004(包裝用塑料復合膜)
● 醫藥行業標準:YY/T 0616.4(一次性使用無菌注射器)、YBB系列標準(藥用包裝材料)
● 國際標準:ISO 7864(醫用注射針規格)、ASTM F2878(醫用針具穿刺力測試方法)
測試應用
● 注射針、采血針的銳利度檢測
● 預灌封注射器針頭穿刺性能驗證
● 安全注射器自毀機構觸發力測試
● 留置針、穿刺針等針具的鋒利度評估
● 輸液器、輸血器等管路類產品的穿刺性能驗證
技術特征
1. 控制系統:采用PLC工業級控制模塊,確保測試過程穩定性與數據重復性;
2. 操作界面:7英寸HMI彩色觸摸屏,支持中英文切換及多級權限管理;
3. 速度調節:1-500mm/min無極變速,覆蓋從慢速精密測試到高速質檢場景;
4. 擴展功能:可定制化夾具適配不同規格樣品,支持拉壓力、剝離力等多項目測試;
5. 數據輸出:內置微型打印機實時輸出測試結果,支持USB數據導出;
6. 安全設計:緊急制動按鈕與過載保護裝置,保障操作人員與設備安全。
總結
針刺穿測試儀以高精度傳感器、模塊化設計及符合性標準為核心優勢,不僅滿足醫療器械行業對針具鋒利度的嚴苛檢測需求,更通過可擴展架構成為藥用包裝材料質量控制的綜合性解決方案,助力企業提升產品競爭力并符合國內外監管要求。
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