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醫(yī)療器械密封測試儀:守護醫(yī)療包裝安全的科技利器

更新時間:2025-08-20      點擊次數(shù):2028
  阿美特克商貿(上海)有限公司專注于為各行業(yè)提供先進的測試與檢測解決方案,其醫(yī)療器械密封測試儀在醫(yī)療領域應用廣泛。這款測試儀專為醫(yī)療包裝完整性驗證設計,旨在確保無菌醫(yī)療器械,如手術器械、導管、藥品泡罩等的包裝,在運輸、儲存及使用前始終維持良好的密封性,有效防止微生物侵入或氣體泄漏。
 
  核心功能,精準檢測
 
  1.泄漏檢測:測試儀運用高精度的壓力傳感器和先進的算法,能夠精準探測到極其微小的泄漏。無論是采用正壓還是負壓檢測方法,都可依據(jù)不同醫(yī)療器械包裝的特性進行靈活設定。在正壓檢測時,將測試氣體(通常為空氣)充入包裝內部,通過監(jiān)測壓力變化來判斷是否存在泄漏;負壓檢測則是在抽真空環(huán)境下,觀察包裝外部與內部的壓力差變化情況。例如,對于滅菌袋,可確保環(huán)氧乙烷(EO)或輻照滅菌后不會出現(xiàn)微孔滲漏,保障袋內器械的無菌狀態(tài)。
 
  2.爆破壓力測試:通過逐步增加包裝內部的壓力,直至包裝破裂,從而準確測定包裝所能承受的最大壓力值。這一功能對于評估包裝在運輸過程中遭受意外擠壓或極端環(huán)境時的耐受能力至關重要。以心臟支架封裝為例,需模擬運輸振動后的爆破壓力,要求達到≥300 kPa,確保支架在復雜運輸條件下包裝依然完好,不影響產品質量。
 
  3.蠕變測試:長時間對包裝施加一定壓力,觀察包裝材料是否會發(fā)生緩慢變形,即蠕變現(xiàn)象。此測試可有效評估包裝在長期儲存過程中的穩(wěn)定性。像人工關節(jié)保護套,需要進行 72 小時持續(xù)加壓的長期蠕變測試,以保證保護套在儲存期間始終維持良好的密封性能。
 
  嚴格標準,全球認可
 
  阿美特克醫(yī)療器械密封測試儀嚴格遵循 ISO 11607、ASTM F2096、GB/T 19633 等全球醫(yī)療器械包裝標準進行設計與制造。這些標準對醫(yī)療器械包裝的密封完整性、材料性能等方面提出了嚴格要求,測試儀通過精準的測試結果,助力醫(yī)療器械生產企業(yè)滿足法規(guī)標準,順利通過各類認證審核,確保產品在全球市場的合規(guī)性與流通性。

 

 


 
  典型應用,全面覆蓋
 
  1.無菌醫(yī)療器械包裝:除了上述滅菌袋密封性驗證,還可進行呼吸管路連接測試,精準檢測接頭處泄漏率,目標可控制在≤0.5 mL/min,確保呼吸管路在使用過程中無氣體泄漏,保障患者的呼吸安全。
 
  2.藥品與生物制劑包裝:對于預灌封注射器,依據(jù) ASTM F2338 標準,測試儀能夠精確檢測針頭與管壁的密封完整性;針對凍干粉西林瓶,按照 USP<1207> 標準,對膠塞與瓶口的密封性進行精準評估,保證藥品在儲存和使用過程中的質量穩(wěn)定。
 
  3.植入器械與高值耗材:測試儀在植入器械與高值耗材的包裝檢測中發(fā)揮著關鍵作用。如對心臟支架封裝進行模擬運輸振動后的爆破壓力測試,確保支架在運輸過程中的安全性;對人工關節(jié)保護套進行長期蠕變測試,保證保護套在儲存期間的密封性能,從而確保植入器械和高值耗材在使用前的質量不受影響。
 
  阿美特克商貿(上海)有限公司的醫(yī)療器械密封測試儀,以其強大的功能、嚴格的標準遵循以及廣泛的應用場景,為醫(yī)療器械包裝的質量與安全提供了堅實保障,助力醫(yī)療器械行業(yè)不斷發(fā)展,為患者的健康保駕護航。
 
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