針刺穿測試儀是用于評估醫(yī)用針、注射針等穿刺器械針尖鋒利度的專業(yè)檢測設(shè)備，通過量化穿刺過程中的最大力值，確保醫(yī)療器械的安全性和有效性。該設(shè)備廣泛應(yīng)用于藥品質(zhì)檢機(jī)構(gòu)、醫(yī)療器械生產(chǎn)企業(yè)及科研單位，為產(chǎn)品性能驗證提供關(guān)鍵數(shù)據(jù)支持。
概述
針刺穿測試儀是針對醫(yī)療器械行業(yè)研發(fā)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(shè)備采用模塊化設(shè)計，結(jié)合工業(yè)級控制系統(tǒng)與人性化操作界面，可滿足基礎(chǔ)穿刺力測試及藥用包裝材料物理性能擴(kuò)展檢測需求。其測試結(jié)果直接影響醫(yī)療器械的臨床使用體驗和安全性，是醫(yī)療器械質(zhì)量控制的核心設(shè)備之一。
測試原理
設(shè)備通過以下步驟實(shí)現(xiàn)精準(zhǔn)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(fù)合膜等）固定于專用夾具；
2. 恒速穿刺：驅(qū)動裝置以設(shè)定速度（1-500mm/min無極可調(diào)）推動針具垂直穿刺樣品；
3. 數(shù)據(jù)采集：傳感器實(shí)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(biāo)；
4. 自動復(fù)位：測試完成后測試頭自動回位，支持連續(xù)高效檢測。
符合標(biāo)準(zhǔn)
● 國家標(biāo)準(zhǔn)：GB 15811（一次性使用無菌注射針）、GB/T 10004（包裝用塑料復(fù)合膜）
● 醫(yī)藥行業(yè)標(biāo)準(zhǔn)：YY/T 0616.4（一次性使用無菌注射器）、YBB系列標(biāo)準(zhǔn)（藥用包裝材料）
● 國際標(biāo)準(zhǔn)：ISO 7864（醫(yī)用注射針規(guī)格）、ASTM F2878（醫(yī)用針具穿刺力測試方法）
測試應(yīng)用
● 注射針、采血針的銳利度檢測
● 預(yù)灌封注射器針頭穿刺性能驗證
● 安全注射器自毀機(jī)構(gòu)觸發(fā)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(chǎn)品的穿刺性能驗證
技術(shù)特征
1. 控制系統(tǒng)：采用PLC工業(yè)級控制模塊，確保測試過程穩(wěn)定性與數(shù)據(jù)重復(fù)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(quán)限管理；
3. 速度調(diào)節(jié)：1-500mm/min無極變速，覆蓋從慢速精密測試到高速質(zhì)檢場景；
4. 擴(kuò)展功能：可定制化夾具適配不同規(guī)格樣品，支持拉壓力、剝離力等多項目測試；
5. 數(shù)據(jù)輸出：內(nèi)置微型打印機(jī)實(shí)時輸出測試結(jié)果，支持USB數(shù)據(jù)導(dǎo)出；
6. 安全設(shè)計：緊急制動按鈕與過載保護(hù)裝置，保障操作人員與設(shè)備安全。
總結(jié)
針刺穿測試儀以高精度傳感器、模塊化設(shè)計及符合性標(biāo)準(zhǔn)為核心優(yōu)勢，不僅滿足醫(yī)療器械行業(yè)對針具鋒利度的嚴(yán)苛檢測需求，更通過可擴(kuò)展架構(gòu)成為藥用包裝材料質(zhì)量控制的綜合性解決方案，助力企業(yè)提升產(chǎn)品競爭力并符合國內(nèi)外監(jiān)管要求。
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多層共擠輸液用袋穿刺力測試儀TST-01應(yīng)用于對各種材料進(jìn)行拉伸，壓縮，撕裂，剝離，形變等力學(xué)性能項目的測試，適用于塑料薄膜，薄片，復(fù)合材料，紙張，橡膠紡織，醫(yī)藥包裝等領(lǐng)域的物理機(jī)械性能測試，是各材料生產(chǎn)廠家，研究機(jī)構(gòu)進(jìn)行物性試驗、研究及質(zhì)量控制重要的工具。
醫(yī)用導(dǎo)管穿刺力測試儀專用于醫(yī)用針、注射針、穿刺針等的穿刺力測定，精準(zhǔn)評估針尖鋒利度，確保醫(yī)療器械的安全性和有效性。廣泛應(yīng)用于藥檢中心、質(zhì)檢機(jī)構(gòu)、藥廠、食品廠等需要嚴(yán)格檢測穿刺性能的單位。
聚丙烯組合蓋穿刺力測試是評估輸液容器用聚丙烯組合蓋性能的重要一環(huán)。該測試旨在確定組合蓋在受到穿刺時所能承受的最大力量，以確保在實(shí)際使用過程中不會發(fā)生意外破裂或泄漏，保障患者的安全。
