詞條概要
預(yù)灌封注射器適配器卡圈牢固度測(cè)定法是依據(jù)《中華人民共和國(guó)藥典》2025年版規(guī)定的檢測(cè)方法（章節(jié)號(hào)4000/4043），用于量化預(yù)灌封注射器魯爾鎖定適配器卡圈抗扭力與拔出力的標(biāo)準(zhǔn)技術(shù)。該方法通過(guò)測(cè)量卡圈初始旋動(dòng)扭矩及軸向脫離負(fù)荷，評(píng)價(jià)適配器與錐頭接口的連接可靠性，是確保注射器組件安全性的關(guān)鍵指標(biāo)。
核心原理
抗扭力：魯爾鎖定卡圈在注射器上開(kāi)始旋轉(zhuǎn)所需的最大扭矩（N·cm），反映卡圈與錐頭的嚙合強(qiáng)度
拔出力：卡圈從錐頭脫離所需的最大軸向負(fù)荷（N），評(píng)價(jià)卡圈的軸向固定能力
儀器裝置
抗扭力測(cè)定
扭矩儀：示值誤差≤±5%，轉(zhuǎn)速20r/min（可調(diào)），帶旋轉(zhuǎn)夾具（圖1）
夾持器：專用設(shè)計(jì)，固定卡圈時(shí)避免施加預(yù)扭矩
注射器夾具：旋轉(zhuǎn)式底板，適配套筒法蘭固定
拔出力測(cè)定
材料試驗(yàn)機(jī)：示值誤差≤±1%，試驗(yàn)速率20mm/min（可調(diào)）
拉拔裝置：垂直軸向施力，與卡圈接觸面平行（圖2）
注射器夾具/底板：固定套筒法蘭，確保軸向受力不偏移
操作規(guī)范
抗扭力測(cè)定
樣品準(zhǔn)備
適配器卡圈與套筒裝配后靜置≥12小時(shí)
去除錐頭護(hù)帽，清潔接口表面
測(cè)定步驟
固定注射器：套筒垂直置于旋轉(zhuǎn)夾具（圖1）
夾持卡圈：專用夾持器固定卡圈，避免預(yù)應(yīng)力
扭矩施加：以20r/min速度旋開(kāi)卡圈90°（或指定角度）
數(shù)據(jù)采集：記錄初始旋動(dòng)時(shí)的峰值扭矩
拔出力測(cè)定
樣品準(zhǔn)備
適配器卡圈與套筒裝配后靜置≥12小時(shí)
確保拉拔裝置與卡圈接觸面平行
測(cè)定步驟
固定注射器：套筒法蘭置于夾具/底板，卡圈朝上
拉拔裝置對(duì)接：垂直夾持卡圈，避免側(cè)向力
軸向拉伸：材料試驗(yàn)機(jī)以20mm/min速度垂直拉拔
數(shù)據(jù)采集：記錄力-位移曲線，卡圈脫離時(shí)停止
結(jié)果判定
檢查項(xiàng)目 判定標(biāo)準(zhǔn)
抗扭力 峰值扭矩（N·cm），符合品種規(guī)定范圍
拔出力 力-位移曲線峰值力（N），符合品種規(guī)定范圍
通用要求 試驗(yàn)后卡圈無(wú)破損，錐頭接口功能正常
質(zhì)量控制
設(shè)備校準(zhǔn)：
扭矩儀誤差≤±5%，定期驗(yàn)證
材料試驗(yàn)機(jī)力值誤差≤±1%，速度精度≤±1mm/min
環(huán)境控制：
實(shí)驗(yàn)室溫濕度23℃±2℃/50%±5%
避免振動(dòng)干擾測(cè)量精度
異常處理：
卡圈滑動(dòng)需調(diào)整夾持力后復(fù)測(cè)
扭矩/力值超量程時(shí)更換適配夾具
附注
旋轉(zhuǎn)角度：90°為通用值，特殊規(guī)格按品種項(xiàng)下規(guī)定執(zhí)行
夾持器設(shè)計(jì)：避免對(duì)卡圈施加彎曲應(yīng)力，防止測(cè)試偏差
預(yù)扭矩避免：扭矩儀歸零后緩慢施力，防止初始力值干擾
規(guī)范依據(jù)
《中華人民共和國(guó)藥典》2025年版 四部 4000藥包材檢測(cè)方法 4043預(yù)灌封注射器適配器卡圈牢固度測(cè)定法
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無(wú)菌針灸針?shù)h利度針刺測(cè)試儀????專用于醫(yī)用針、注射針、穿刺針等的穿刺力測(cè)定，精準(zhǔn)評(píng)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(cè)穿刺性能的單位。
MST-01 藥品包裝用預(yù)灌封注射器檢測(cè)儀適用于測(cè)試注射器/預(yù)灌封注射器等產(chǎn)品的各種性能。測(cè)試項(xiàng)目包含:活塞與推桿的配合性，活塞潤(rùn)滑性、活塞滑動(dòng)性能、器身密合性、針尖穿刺力、針與針座的連接力、針頭護(hù)帽的拔出力等。
