医疗器械环氧乙烷残留专用气相色谱�?参数-价格-中国粉体罐�/title>

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<p><strong><span><strong>医疗器械环氧乙烷残留专用气相色谱�?/strong></span></strong></p><p><span>口罩</span><span>�?/span><span>环氧乙烷灭菌，为何还要检测环氧乙烷残留量达标情况＞�/span><span>　　</span><span>是因为环氧乙烷是一种有机化合物，化学式�?/span>C2H4O，是一种有毒的物质，被用来制造杀菌剂。环氧乙烷易燃易爆，不易长途运输，因此有强烈的地域性。被广泛地应用于洗涤，制药，印染等行业。在化工相关产业可作为清洁剂的起始剂、�/span><span>　　</span><span>然而，使用环氧乙烷灭菌是因为它是广谱、高效的气体杀菌消毒剂。对消毒物品的穿透力强，可达到物品深部，可以杀灭数病原微生物，包括细菌繁殖体、芽孢、病毒和真菌。气体和液体均有较强杀微生物作用，以气体作用强，故多用其气体。在医学消毒和工业灭菌上用途广泛、�/span><span>使用环氧乙烷对一次性医用口罩消毒后，还需要经过一系列程序处理，而一次性医用口罩在出厂前也是必须要严格经过检测口罩内环氧乙烷含量达标后才可出厂，所以对人体呼吸是没有危害的、�/span></p><p><span>关于医用口罩环氧乙烷残留含量检测仪器解决方案，</span><span>北京</span><span>北分三谱</span><span>推荐以下解决方案、�/span></p><p><span>参考国家标准：</span></p><p><span>1、《GB/T16886.7-2015医疗器械生物学评价第七部分：环氧乙wan灭菌残留量《�/span></p><p><span>顶空</span>-色谱法检测口罩中残留的环氧乙wan含量：�/span></p><p><span>2�?/span><span>〉�/span>GB/T14233.1-2008医用输液、输血、注射器具检验方� di一部分：化学分析方法》、�/span></p><table cellspacing="0" cellpadding="2" border="1" bordercolor="#f2f2f2" width="100%"><tbody><tr><td><p><strong><span>序号</span></strong><strong></strong></p></td><td><p><strong><span>名称</span></strong><strong></strong></p></td><td><p><strong><span>型号</span></strong><strong></strong></p></td><td><p><strong><span>数量</span></strong><strong></strong></p></td><td><p><strong><span>单位</span></strong><strong></strong></p></td></tr><tr><td><p><strong><span>1</span></strong><strong></strong></p></td><td><p><strong><span>气相色谱�?/span></strong><strong></strong></p></td><td><p><strong><span>GC-9860</span></strong><strong></strong></p></td><td><p><strong><span>1</span></strong><strong></strong></p></td><td><p><strong><span>�?/span></strong><strong></strong></p></td></tr><tr><td><p><span>2</span></p></td><td><p><span>全自动顶空进样器</span></p></td><td><p><span>AHS-20A plus</span></p></td><td><p><span>1</span></p></td><td><p><span>�?/span></p></td></tr><tr><td><p><span>3</span></p></td><td><p><span>氢气发生�?/span></p></td><td><p><span>BF-300E</span></p></td><td><p><span>1</span></p></td><td><p><span>�?/span></p></td></tr><tr><td><p><span>4</span></p></td><td><p><span>空气发生�?/span></p></td><td><p><span>BF-2L</span></p></td><td><p><span>1</span></p></td><td><p><span>�?/span></p></td></tr><tr><td><p><span>5</span></p></td><td><p><span>氮气发生�?/span></p></td><td><p><span>BF-300N</span></p></td><td><p><span>1</span></p></td><td><p><span>�?/span></p></td></tr><tr><td><p><span>6</span></p></td><td><p><span>SE-54色谱柰�/span></p></td><td><p><span>30m��0.32mm��0.5um</span></p></td><td><p><span>1</span></p></td><td><p><span>核�/span></p></td></tr></tbody></table><p><strong><span>环氧乙烷残留量检验方法：</span></strong></p><p><strong><span>1.</span></strong><strong><span>环氧乙烷残留量检验原琅�/span></strong></p><p><span>在一定温度下，用水萃取样品中所含环氧乙烷，用顶空气相色谱法测定环氧乙烷含量、�/span></p><p><strong><span>2.</span></strong><strong><span>环氧乙烷残留量检验气相色谱仪条件</span></strong></p><p><span>氢焰鉴定�?/span><span>:</span><span>灵敏度不小于</span><span>2X 1 0-11g/s</span><span>(苯，二硫化碳</span><span>(CS2)</span><span>〔�/span></p><p><span>色谱柰�/span><span>:</span><span>所用色谱柱应能使试样中杂质和环氧乙烷完全分开，并有一定的耐水性。色谱柱可逈�/span></p><table cellspacing="0" cellpadding="2" border="1" bordercolor="#f2f2f2" width="100%"><tbody><tr><td><p><span>柱长</span></p></td><td><p><span>内径</span></p></td><td><p><span>担体</span></p></td><td><p><span>柱温</span></p></td></tr><tr><td><p><span>30m</span></p></td><td><p><span>0.53mm</span></p></td><td><p><span>30QC5/AC10-1.0</span></p></td><td><p><span>40</span><span>摄氏�?/span></p></td></tr><tr><td rowspan="2"><p><span>1m-2m</span></p></td><td rowspan="2"><p><span>2mm-3mm</span></p></td><td><p><span>GDX-407 80</span><span>�?/span><span>~100</span><span>�?/span></p></td><td><p><span>�?/span><span>130</span><span>摄氏�?/span></p></td></tr><tr><td><p><span>P.-PA Q- 80</span><span>�?/span><span>~100</span><span>�?/span></p></td><td><p><span>�?/span><span>120</span><span>摄氏�?/span></p></td></tr></tbody></table><p><span>仪器各部位温度：</span></p><p><span>a)</span><span>气化宣�/span><span>200</span><span>摄氏度；</span></p><p><span>b)</span><span>检测室</span><span>250</span><span>摄氏度、�/span></p><p><span>气流野�/span><span>:</span></p><p><span>a)</span><span>氮气</span><span>15m L/min-30m l-/min;</span></p><p><span>b)</span><span>氢气</span><span>30m L/min;</span></p><p><span>c)</span><span>空气</span><span>300 mL/mina</span></p><p><strong><span>3.</span></strong><strong><span>环氧乙烷残留量检验标准贮备液的配刵�/span></strong></p><p><span>取外部干燥的</span><span>50m</span><span>工容量瓶，加人约</span><span>30m 1</span><span>水，加瓶塞，称重＋�/span>**到、�/span><span>0.1 m g</span><span>。用注射器注入约</span><span>0. 6 mL</span><span>环氧乙烷，不加瓶塞，轻轻摇匀，盖好瓶塞，称重，前后两次称重之差，即为溶液中所含环氧乙烷重量。加水至刻度再将此溶液稀释成</span><span>1 X 10-' g/L</span><span>作为标准贮备液、�/span></p><p><strong><span>4.</span></strong><strong><span>环氧乙烷残留量检验制夆�/span></strong></p><p><span>4.1</span><span>试验样制备应在取样后立即进行，否则应将供试样品封于由聚四氟乙烯密封的金属容器中保存、�/span></p><p><span>4.2</span><span>将样品截丹�/span><span>5 mm</span><span>长碎块，叕�/span><span>2. 0 g</span><span>放人萃取容器中，功�/span><span>10 mL</span><span>水，顶端空间</span><span>2</span><span>0 mL</span><span>，容器内压力为常压，</span><span>�?/span>AHS-20A全自动顶空进样器恒温</span><span>60 </span><span>�?/span><span>中放�?/span><span>20 min.</span><span>、�/span></p><p><strong><span>5.</span></strong><strong><span>环氧乙烷残留量检验步骣�/span></strong></p><p><span>5 .1</span><span>用贮备液配制</span><span>1X10</span><span>-3</span><span>g/L�?X10</span><span>2</span><span>g/L</span><span>六个系列浓度的标准溶液。各叕�/span><span>10mL</span><span>挈�/span><span>4 .2</span><span>方法处理、�/span></p><p><span>每个样品</span><span>(</span><span>包括标样</span><span>)</span><span>在尽可能短的时间内分析三次，三次分析中必须有两次结果相差不大亍�/span><span>5%</span><span>，否则此样品应重新进行分析、�/span></p><p><span>5.2</span><span>用标准样所测数据，绘出标准曲线</span><span>(X:EO</span><span>浓度</span><span>/(g/L);Y:</span><span>峰高或面�?/span><span>)</span><span>、�/span></p><p><span>5 .3</span><span>从标准曲线上找出样品相应的浓度。如果所测样品结果不在标准曲线范围内，应改变标准溶液的浓度重新作标准曲线、�/span></p><p><strong><span>6</span></strong><strong><span>．环氧乙烷残留量检验结果计箖�/span></strong></p><p><span>环氧乙烷残留量用</span>**含量或相对含量表示、�/span></p><p><span>按式</span><span>(H.1 )</span><span>计算样品中环氧乙烶�/span>**含量</span><span>:</span></p><p><span>W</span><span>EO</span><span>= 5c</span><span>1</span><span>��</span><span>G</span></p><p><span>式中</span><span>:</span></p><p><span>W</span><span>EO</span><span>—单位产品中环氧乙烷**含量，单位为毫克</span><span>(mg);</span></p><p><span>5c</span><span>1</span><span>—标准曲线上找出的试液相应的浓度，单位为克每卆�/span><span>(g/L);</span></p><p><span>G</span><span>—单位产品的质量，单位为兊�/span><span>(9)</span><span>、�/span></p><p><span>2</span><span>按式</span><span>(H.2)</span><span>计算样品中环氧乙烷相对含野�/span><span>:</span></p><p><span>C</span><span>EO</span><span>= 5c</span><span>1*</span><span>1 0 00</span></p><p><span>式中</span><span>:</span></p><p><span>C</span><span>EO–�/span><span>产品中环氧乙烷相对含量，单位为毫克每千克</span><span>(mg/kg);</span></p><p><span>c</span><span>1–�/span><span>标准曲线上找出的试液相应的浓度，单位为克每升</span><span>(g/L)</span><strong></strong></p><p></p> </div>  <div class="cxd"> <div class="cxd_tit"><span></span>创新炸�/div> <p style=" color: #333; font-size: 14px; margin: 10px 0 0; line-height: 26px;"> 暂无数据� </p> </div>  <div class="xgfa"> <div class="xgfa_tit"> <div> 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