J9九游会AG

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J9九游会AG产品

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医用棉垫

2022-06-28 10:25:03
医用棉垫
详(xiang)细介绍:

【产品名称】医用棉垫


【规(gui)格(ge)(ge)型(xing)号(hao)】长(1cm-300cm)×宽(1cm-300cm)-层(1P-10P),具(ju)体(ti)规(gui)格(ge)(ge)详(xiang)见产品小包装。


【注册人名称】河南省J9九游会AG医疗器械有限公司


【住(zhu)    所】河南长垣市丁栾工业(ye)区

【联(lian)系电话】0373-8690789


【售(shou)后服务单位】河(he)南(nan)省J9九游会AG医疗器械销售(shou)有限(xian)公(gong)司


【生产(chan)企业名称】河南省J9九游会AG医(yi)疗(liao)器械(xie)有限(xian)公司


【住    所】河(he)南长垣市丁栾(luan)工业(ye)区


【生产地址(zhi)】河南长(zhang)垣(yuan)市丁栾(luan)工业区


【联(lian)系方式】0373-8690789


【生(sheng)产许可证】豫食药监械生(sheng)产许20080036号(hao)


【注册证编号】豫械注准20172640054


【技术要求编号】豫械注准20172640054


医用棉垫.jpg

【结构与组成】本产品由医用脱脂纱布或薄型粘合法非织造布和医用脱脂棉加工制成。


【产品性能】1.脱(tuo)(tuo)脂(zhi)(zhi)棉(mian)(mian)薄厚应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)均匀一致;棉(mian)(mian)垫应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)无霉斑、杂(za)质、破洞、异(yi)味缺陷。2.实际(ji)值与标(biao)称值允差±10%。3.脱(tuo)(tuo)脂(zhi)(zhi)棉(mian)(mian)纱(sha)布棉(mian)(mian)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)呈扁平(ping)带状、宽10μm至(zhi)(zhi)40μm、端(duan)部(bu)增粗(cu)并具有形状不(bu)(bu)(bu)(bu)规则(ze)的(de)(de)(de)(de)内腔;纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显紫色(se)(se)(se);纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)溶(rong)(rong)(rong)(rong)(rong)解;不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)有溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)显粉(fen)红色(se)(se)(se);经纱(sha)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)全(quan)部(bu)或几(ji)乎全(quan)部(bu)是棉(mian)(mian)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei),纬纱(sha)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)全(quan)部(bu)或几(ji)乎全(quan)部(bu)是典(dian)型的(de)(de)(de)(de)棉(mian)(mian)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)。检查经纱(sha)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)和纬纱(sha)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)时(shi)(shi)(shi),可(ke)以(yi)(yi)偶(ou)(ou)尔有少(shao)量(liang)孤立的(de)(de)(de)(de)外来纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)存在;只(zhi)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显微(wei)棕紫色(se)(se)(se)荧(ying)光(guang)和少(shao)量(liang)黄色(se)(se)(se)颗(ke)(ke)粒(li)。除(chu)少(shao)量(liang)孤立的(de)(de)(de)(de)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)外,不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显强(qiang)蓝(lan)色(se)(se)(se)荧(ying)光(guang);每100mm的(de)(de)(de)(de)纱(sha)线(xian)数应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)符合(he)表(biao)(biao)(biao)1的(de)(de)(de)(de)要(yao)(yao)求(qiu);每平(ping)方米质量(liang)(以(yi)(yi)克为单(dan)位)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)符合(he)表(biao)(biao)(biao)1的(de)(de)(de)(de)要(yao)(yao)求(qiu);每50mm的(de)(de)(de)(de)最小断裂(lie)力(以(yi)(yi)牛顿为单(dan)位)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)符合(he)表(biao)(biao)(biao)1的(de)(de)(de)(de)要(yao)(yao)求(qiu);下(xia)(xia)(xia)沉时(shi)(shi)(shi)间应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)超过(guo)10S;醚中(zhong)可(ke)溶(rong)(rong)(rong)(rong)(rong)物(wu)的(de)(de)(de)(de)总(zong)(zong)量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)0.50%;300S后供试(shi)(shi)液(ye)(ye)(ye)(ye)表(biao)(biao)(biao)面活性物(wu)质泡沫(mo)的(de)(de)(de)(de)高度(du)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)超2mm;水中(zhong)可(ke)溶(rong)(rong)(rong)(rong)(rong)物(wu)的(de)(de)(de)(de)总(zong)(zong)量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)0.50%;溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显蓝(lan)色(se)(se)(se)、紫色(se)(se)(se)、淡红色(se)(se)(se)或淡棕色(se)(se)(se);获得的(de)(de)(de)(de)液(ye)(ye)(ye)(ye)体(ti)的(de)(de)(de)(de)颜(yan)色(se)(se)(se)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)深于(yu)(yu)(yu)(yu)附录(lu)A规定(ding)(ding)的(de)(de)(de)(de)对(dui)照(zhao)液(ye)(ye)(ye)(ye)Y5、GY6或按(an)(an)以(yi)(yi)下(xia)(xia)(xia)方法配制的(de)(de)(de)(de)对(dui)照(zhao)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye):向3.0mL初级(ji)蓝(lan)色(se)(se)(se)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)中(zhong)加入(ru)7.0mL的(de)(de)(de)(de)盐(yan)(yan)酸(suan)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)(质量(liang)浓度(du)为10g/L的(de)(de)(de)(de)盐(yan)(yan)酸(suan)),并用(yong)盐(yan)(yan)酸(suan)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)(质量(liang)浓度(du)为10g/L的(de)(de)(de)(de)盐(yan)(yan)酸(suan))将0.5mL的(de)(de)(de)(de)上(shang)述溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)稀释至(zhi)(zhi)10.0mL;脱(tuo)(tuo)脂(zhi)(zhi)棉(mian)(mian)纱(sha)布质量(liang)损失(shi)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)8.0%;硫(liu)酸(suan)盐(yan)(yan)灰分(fen)的(de)(de)(de)(de)总(zong)(zong)量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)符合(he)表(biao)(biao)(biao)2的(de)(de)(de)(de)要(yao)(yao)求(qiu)。4.缝制的(de)(de)(de)(de)棉(mian)(mian)垫针距(ju)为每10cm内不(bu)(bu)(bu)(bu)少(shao)于(yu)(yu)(yu)(yu)24针。5.外观应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)无叶片(pian)、果皮(pi)、种皮(pi)、残(can)留或其他杂(za)质,拉伸时(shi)(shi)(shi)有一定(ding)(ding)阻力,轻摇时(shi)(shi)(shi)不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)有任何粉(fen)尘脱(tuo)(tuo)落;鉴别应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)符合(he)YY/T 0330-2015标(biao)准(zhun)中(zhong)4.3的(de)(de)(de)(de)要(yao)(yao)求(qiu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)只(zhi)含(han)典(dian)型的(de)(de)(de)(de)棉(mian)(mian)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei),允许(xu)偶(ou)(ou)尔有少(shao)量(liang)孤立的(de)(de)(de)(de)外来纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)存在;棉(mian)(mian)结应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)满足3.5.5的(de)(de)(de)(de)要(yao)(yao)求(qiu);水中(zhong)可(ke)溶(rong)(rong)(rong)(rong)(rong)物(wu)总(zong)(zong)量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)0.50%;不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)有溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)显粉(fen)红色(se)(se)(se);下(xia)(xia)(xia)沉时(shi)(shi)(shi)间应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)超过(guo)10S;每克医用(yong)脱(tuo)(tuo)脂(zhi)(zhi)棉(mian)(mian)的(de)(de)(de)(de)吸水量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)小于(yu)(yu)(yu)(yu)23.0g;醚中(zhong)可(ke)溶(rong)(rong)(rong)(rong)(rong)物(wu)总(zong)(zong)量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)0.50%;医用(yong)脱(tuo)(tuo)脂(zhi)(zhi)棉(mian)(mian)只(zhi)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显微(wei)棕紫色(se)(se)(se)荧(ying)光(guang)和少(shao)量(liang)黄色(se)(se)(se)颗(ke)(ke)粒(li);除(chu)少(shao)量(liang)孤立的(de)(de)(de)(de)纤(xian)(xian)(xian)(xian)维(wei)(wei)(wei)外,不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显强(qiang)蓝(lan)色(se)(se)(se)荧(ying)光(guang);减失(shi)质量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)8.0%;硫(liu)酸(suan)盐(yan)(yan)灰分(fen)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)大(da)(da)于(yu)(yu)(yu)(yu)0.40%;表(biao)(biao)(biao)面活性物(wu)质泡沫(mo)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)覆盖(gai)整个(ge)液(ye)(ye)(ye)(ye)体(ti)表(biao)(biao)(biao)面;获得的(de)(de)(de)(de)液(ye)(ye)(ye)(ye)体(ti)的(de)(de)(de)(de)颜(yan)色(se)(se)(se)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)深于(yu)(yu)(yu)(yu)附录(lu)A规定(ding)(ding)的(de)(de)(de)(de)对(dui)照(zhao)液(ye)(ye)(ye)(ye)Y5、GY6或按(an)(an)以(yi)(yi)下(xia)(xia)(xia)方法配制的(de)(de)(de)(de)对(dui)照(zhao)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye):向3.0mL初级(ji)蓝(lan)色(se)(se)(se)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)中(zhong)加入(ru)7.0mL的(de)(de)(de)(de)盐(yan)(yan)酸(suan)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)(质量(liang)浓度(du)为10g/L的(de)(de)(de)(de)盐(yan)(yan)酸(suan)),并用(yong)盐(yan)(yan)酸(suan)溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)(质量(liang)浓度(du)为10g/L的(de)(de)(de)(de)盐(yan)(yan)酸(suan))将0.5mL的(de)(de)(de)(de)上(shang)述溶(rong)(rong)(rong)(rong)(rong)液(ye)(ye)(ye)(ye)稀释至(zhi)(zhi)10.0mL。6.缝线(xian)荧(ying)光(guang)物(wu)按(an)(an)YY 0594-2006标(biao)准(zhun)中(zhong)附录(lu)D中(zhong)试(shi)(shi)验(yan)A试(shi)(shi)验(yan)时(shi)(shi)(shi),缝线(xian)不(bu)(bu)(bu)(bu)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)显强(qiang)蓝(lan)色(se)(se)(se)荧(ying)光(guang);水中(zhong)可(ke)溶(rong)(rong)(rong)(rong)(rong)物(wu)水中(zhong)可(ke)溶(rong)(rong)(rong)(rong)(rong)物(wu)的(de)(de)(de)(de)总(zong)(zong)量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)超过(guo)0.50%。7.所(suo)用(yong)非织(zhi)造(zao)布克重应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)低于(yu)(yu)(yu)(yu)20g/m2;纵(zong)向断裂(lie)强(qiang)力应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)大(da)(da)于(yu)(yu)(yu)(yu)等于(yu)(yu)(yu)(yu)13N,横向断裂(lie)强(qiang)力应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)大(da)(da)于(yu)(yu)(yu)(yu)等于(yu)(yu)(yu)(yu)8N。8. 棉(mian)(mian)垫应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)无菌。9.棉(mian)(mian)垫经环氧(yang)(yang)乙烷灭菌,其环氧(yang)(yang)乙烷残(can)留量(liang)应(ying)(ying)(ying)(ying)(ying)(ying)(ying)(ying)不(bu)(bu)(bu)(bu)超过(guo)10μg/g。


【适用范围(wei)】供临床护创、吸湿用。


【禁(jin) 忌(ji) 症】无禁(jin)忌(ji)症。


【注意事(shi)项】1、本(ben)品属一次性用品,包装破损(sun),严禁使用,用后(hou)销毁。


            2、生产批号见(jian)包装(zhuang)封口(kou)处(chu)或标签,灭菌日期见(jian)外包装(zhuang)箱(xiang)。


            3、本品经(jing)环氧乙烷灭菌。  


【使用(yong)(yong)方法】1、选择适用(yong)(yong)的规格型(xing)号,确定外包装(zhuang)完好后打(da)开包装(zhuang)。


            2、保护(hu)创面或铺垫患者体下。


            3、产品结束使(shi)用后按医疗垃(la)圾处理(li),以免造成污染。


【贮(zhu)存方法】1、本产(chan)品应用有遮蓬(peng)的车厢、船舱装载运输,并保持(chi)清洁,不得重(zhong)压(ya)、阳光直晒(shai)和雨雪浸淋。


            2、搬(ban)运过程中应轻拿轻放(fang),避(bi)免剧烈(lie)碰(peng)撞;


            3、本品应贮存在远离火源,相对(dui)湿度不超过80%,无腐蚀性气体和通风良好、清(qing)洁(jie)的环境内。



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