信装机配件
数字家电厨卫家电生活电器办公外设办公软件网络设备服 务 器无线网络网络存储安防监控
NEC NP-M260XS+( NECNP-M260XS+
NEC NP-M260XS+图片(共120张)
图片分类：
NEC NP-M260XS+整体外观（2）
NEC NP-M260XS+产品实拍图（4）
NEC NP-M260XS+机身细节（10）
NEC NP-M260XS+模特图（94）
NEC NP-M260XS+评测图（9）
NEC NP-M260XS+配件图（1）
NEC NP-M260XS+ 推荐精品图
接下来您可以
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国家食品药品监督管理局关于认可天津医疗器械质量监督检验中心对外科植入物用β―磷酸三钙等160个产品和项目检测资格的通知
国家食品药品监督管理局关于认可天津医疗器械质量监督检验中心对外科植入物用β-磷酸三钙等160个产品和项目检测资格的通知（国食药监械[号）
天津市食品药品监督管理局：
根据《医疗器械监督管理条例》及《医疗器械检测机构资格认可办法（试行）》（国药监械〔号）的规定，日至29日，国家局组织专家组对天津医疗器械质量监督检验中心的医疗器械检测能力进行了现场评审。经审查，认可该中心对外科植入物用β-磷酸三钙等160个医疗器械产品和项目进行检测的资格（见附件）。有效期5年。
附件：认可的医疗器械受检目录?
国家食品药品监督管理局二○○八年十二月三日
附件：　　认可的医疗器械受检目录
序号&产品/项目名 称&项目/参数&检测标准（方法）名称及编号（含年号）&说 明&序号&名称&1&外科植入物用β-磷酸三钙&& 全部项目&外科植入物用β-磷酸三钙ASTM F&&2&腔静脉滤器系统&&全部项目&无源外科植入物--心脏和血管植入物的特殊要求.第3部分： 血管内装置EN8&&3&人工血管&&部分项目&心血管植入物 人工血管YY &水渗透压、扩张内径和顺应性不能测&4&缝合及其它外科用金属丝&&全部项目&外科植入物-缝合及其它外科用金属丝ISO &&5&颅骨盖板&&全部项目&可预塑颅骨盖板的标准要求ASTM F452-76　　可变形预塑颅骨盖板的标准要求ASTM F622-79&&6&消化道吻合器&&全部项目&吻（缝）合器通用技术条件YY/T&&7&医用缝合针&&全部项目&医用缝合针YY &&8&金属夹&&全部项目&外科植入物 金属夹 YY/T &&9&一次性使用血路产品&&全部项目&一次性使用血路产品通用技术条件GB1&&10&医用超声耦合剂&&部分项目&医用超声耦合剂YY &声速、声阻抗率和声衰减不能测&11&一次性使用无菌导尿管&&全部项目&一次性使用无菌导尿管YY &&12&软组织扩张器&&全部项目&软组织扩张器YY &&13&手术刀片&&全部项目&手术刀片 YY&&14&非血管内导管&&全部项目&非血管内导管 第1部分：一般性能试验方法GB/T 5&&15&接骨螺钉最大断裂扭矩和断裂扭转角的测定&&全部项目&外科植入物 不对称螺纹和球形下表面的金属接骨螺钉机械性能要求和试验方法YY/T &&16&接骨板弯曲强度和刚度的测定&&全部项目&外科植入物 接骨板弯曲强度和刚度的测定YY/T &&17&动脉支架&&部分项目&无源外科植入物--心脏和血管植入物的特殊要求--动脉支架的专用要求YY/T &支架磁共振成像（MRI）相容性评价不能测&18&外周血管支架系统&&部分项目&19&球囊扩张式胆道支架系统&&部分项目&20&一次性使用穿刺针&&全部项目&一次性使用动静脉穿刺针YZB/国&&21&外固定器&&全部项目&外固定器YZB/闽 &&22&生物陶瓷听小骨置换假体&&全部项目&生物陶瓷听小骨置换假体YZB/国 4-46-2004&&23&环抱式接骨器&&全部项目&TYNH型 TiNi环抱式接骨器YZB/国 4&&24&可吸收板、螺钉&&全部项目&内固定植入物用可吸收板、钉的标准要求及试验方法ASTM F &&25&手术工具&&全部项目&手术工具YZB/USA &&26&脊柱及躯干矫形器&&全部项目&脊柱及躯干矫形器YZB/GEM &&27&髋关节矫形器&&全部项目&髋关节矫形器YZB/GEM &&28&脊柱内固定系统&&全部项目&骨接合植入物 金属矫形用钉YY 　　骨接合植入物 金属矫形用棒YY &标准变更&29&陶瓷球头&&全部项目&髋关节假体YY &标准变更&30&套针外周导管&&全部项目&一次性使用无菌血管内导管第5部分：套针外周导管YY 4&标准变更&31&一次性使用人体静脉血样采集容器&&全部项目&一次性使用人体静脉血样采集容器YY&标准变更&32&动脉瘤夹&&全部项目&神经外科植入物－自闭合颅内动脉瘤夹YY/T&标准变更
33&脱脂棉纱布、脱脂棉粘胶混纺纱布&& 全部项目&脱脂棉纱布、脱脂棉粘胶混纺纱布的性能要求和试验方法YY &标准变更&34&与体表或创面接触的医用胶带&&全部项目&医用胶带 通用要求YY/T &标准变更&35&血液透析及血液过滤用浓缩液（粉）&&全部项目&血液透析及相关治疗用浓缩物YY&标准变更&36&OCu宫内节育器&&全部项目&OCu宫内节育器GB &标准变更&37&VCu宫内节育器&&全部项目&VCu宫内节育器GB &标准变更&38&TCu宫内节育器&&全部项目&TCu宫内节育器GB &标准变更&39&宫腔形宫内节育器&&全部项目&宫腔形宫内节育器GB &标准变更&40&可编程的医用电气系统&&全部项目&医用电气设备 第1-4部分：安全通用要求-并列标准：可编程的医用电气系统IEC ：2000&&41&短波治疗设备&&部分项目&医用电气设备 第2部分：短波治疗设备安全专用要求IEC ：1991＋A1：1998&AP/APG不能测&42&脑电图机&&部分项目&医用电气设备 第2-26部分：脑电图机安全专用要求GB 5&X射线辐射和AP/APG不能测&43&呼吸治疗设备&&部分项目&睡眠鼾症呼吸治疗--第一部分：睡眠鼾症呼吸治疗设备ISO 02&AP/APG不能测&44&医用湿化系统&&部分项目&医用湿化系统基本要求
ISO &AP/APG不能测&45&测量、控制和试验室用电气设备&&部分项目&测量、控制和试验室用电气设备的安全要求　第1部分：通用要求GB 7&超声压力不能测&46&超声治疗设备&&部分项目&医用电气设备　超声治疗设备专用安全要求GB &声能不能测&47&医用超声诊断和监护设备&&全部项目&医用电气设备 医用超声诊断和监护设备专用安全要求GB 7&&48&治疗呼吸机&&部分项目&医用电气设备 第2部分：呼吸机安全专用要求 治疗呼吸机GB 6&X射线辐射和AP/APG不能测&49&麻醉系统&&部分项目&医用电气设备 第2部分：麻醉系统的安全和基本性能专用要求GB 6&X射线辐射和AP/APG不能测&50&医用软件&&全部项目&软件工程 产品质量 第1部分：质量模型GB/T 6　　软件工程 产品质量 第2部分：外部度量GB/T 6　　软件工程 产品质量 第3部分：内部度量GB/T 6　　软件工程 产品质量 第4部分：使用质量的度量GB/T 6　　信息技术 软件包 质量要求和测试GB/T YNT500内窥镜图文工作站
YZB/京 &&51&手术显微镜&&全部项目&手术显微镜 第1部分：要求和试验方法GB 5&&52&人工心肺机 热交换水箱&&全部项目&人工心肺机 热交换水箱GB &&53&气囊式体外反搏装置&&全部项目&气囊式体外反搏装置GB &&54&电动轮椅车&&全部项目&电动轮椅车GB &手动轮椅车&&部分项目&手动轮椅车GB/T 13800-92&耐疲劳性不能测&56&高频喷射呼吸机&&全部项目&高频喷射呼吸机YY &&57&家用呼吸支持设备&&部分项目&医用呼吸机 基本安全和主要性能专用要求 第1部分：家用呼吸支持设备YY 7&X射线辐射和AP/APG不能测&58&依赖呼吸机患者使用的家用呼吸机&&部分项目&医用呼吸机 基本安全和主要性能专用要求 第2部分：依赖呼吸机患者使用的家用呼吸机YY 7&X射线辐射和AP/APG不能测&59&急救和转运用呼吸机&&部分项目&医用呼吸机 基本安全和主要性能专用要求 第3部分：急救和转运用呼吸机YY 7&AP/APG不能测&60&麻醉气体监护仪&&部分项目&麻醉气体监护仪YY &X射线辐射和AP/APG不能测&61&婴儿辐射保暖台&&部分项目&医用电气设备 第2部分：婴儿辐射保暖台安全专用要求YY &X射线辐射不能测&62&医用硬管内窥镜&&全部项目&医用硬管内窥镜通用技术条件YY &&63&硬性电凝切割内窥镜&&全部项目&硬性电凝切割内窥镜YY &&64&硬性宫腔内窥镜&&全部项目&硬性宫腔内窥镜YY
65&硬性关节内窥镜&& 全部项目&硬性关节内窥镜YY &&66&超声理疗设备&&部分项目&超声理疗设备YY/T &绝对最大波束不均匀性系数和最大圆柱不对称参数不能测&67&超声多普勒胎儿心率仪&&部分项目&超声多普勒胎儿心率仪YY &综合灵敏度和声输出参数的公布要求不能测&68&医用超声雾化器&&全部项目&医用超声雾化器YY &&69&超声洁牙设备&&全部项目&超声洁牙设备YY &&70&环氧乙烷灭菌器&&全部项目&环氧乙烷灭菌器YY &&71&医用脚踏开关&&部分项目&医用脚踏开关通用技术条件YY &导线压紧不能测&72&手提式压力蒸汽灭菌器&&部分项目&手提式压力蒸汽灭菌器YY &灭菌效果不能测&73&医院电动床&&部分项目&医用电气设备 第2部分：医院电动床安全专用要求YY &X射线辐射和AP/APG不能测&74&普通产床&&全部项目&普通产床YY &脚踏吸引器&&全部项目&脚踏吸引器YY &电动牙钻&&全部项目&电动牙钻通用技术条件YY/T &&77&牙科手机&&全部项目&牙科手机YY 0059.1～.3-91&&78&立式压力蒸汽灭菌器&&全部项目&立式压力蒸汽灭菌器YY &灭菌效果不能测&79&医用分子筛制氧设备&&部分项目&医用分子筛制氧设备通用技术规范YY/T &CO和气态酸、碱含量不能测&80&医用中心吸引系统&&部分项目&医用中心吸引系统通用技术条件YY/T 0186-94&排出空气细菌含量不能测&81&医用中心供氧系统&&全部项目&医用中心供氧系统通用技术条件YY/T &听诊器&&部分项目&听诊器YY &传音清晰试验不能测&83&麻醉机&&全部项目&麻醉和呼吸护理报警信号 第1部分：视觉报警信号YY 5　　麻醉和呼吸护理报警信号 第2部分：听觉报警信号YY 5　　麻醉和呼吸护理报警信号 第3部分：报警应用指南YY 5&&84&手术照明灯和诊断照明灯&&部分项目&医用电气设备 第2部分：手术照明灯和诊断照明灯安全专用要求YY &AP/APG不能测&85&超声经颅多普勒血流分析仪&&部分项目&超声经颅多普勒血流分析仪YY &声输出公布要求不能测&86&微循环显微镜&&全部项目&微循环显微镜YY &&87&麻醉机和呼吸机用呼吸管路&&部分项目&麻醉机和呼吸机用呼吸管路YY &静电预防不能测&88&麻醉喉镜&&全部项目&麻醉喉镜通用技术条件YY &&89&臭氧消毒柜&&部分项目&臭氧消毒柜安全、消毒效果通用技术条件YY 5&消毒效果不能测&90&电热恒温水浴锅&&全部项目&电热恒温水浴锅YY &&91&恒温水槽&&全部项目&恒温水槽YY &&92&医用低速离心机&&全部项目&医用低速离心机YY &&93&血液冷藏箱&&全部项目&血液冷藏箱YY/T &&94&药品冷藏箱&&全部项目&药品冷藏箱YY/T &&95&孔式手术无影灯&&全部项目&孔式手术无影灯YY &&96&冷光单孔手术灯&&全部项目&冷光单孔手术灯YY &&97&微量进样器&&全部项目&微量进样器YY&&98&脉动真空压力蒸汽灭菌器&&全部项目&脉动真空压力蒸汽灭菌器YY2&&99&预真空压力蒸汽灭菌器&&全部项目&预真空压力蒸汽灭菌器YY2&&100&浮标式氧气吸入器&&全部项目&浮标式氧气吸入器YY &&101&亚低温治疗仪&&全部项目&亚低温治疗仪YZB/粤 &&102&中频静电治疗仪&&全部项目&中频静电治疗仪YZB/粤 &&103&全身热疗系统&&全部项目&SRI全身热疗系统YZB/国 &&104&射频皮肤治疗仪&&全部项目&XL-射频皮肤治疗仪YZB/京
105&调序治疗仪&& 全部项目&TX-II型调序治疗仪YZB/津 &&106&红外磁脉冲治疗仪&&部分项目&LD-20B型红外磁脉冲治疗仪YZB/津 &放射性能不能测&107&医疗电解制水机&&部分项目&SY－01－B型医疗电解制水机YZB/津 &卫生指标不能测&108&耳鼻喉科综合治疗台&&全部项目&RTHAO-101型耳鼻喉科综合治疗台YZB/京 &&109&离子导入治疗仪&&全部项目&FBG-1型离子导入治疗仪
YZB/京 &&110&针灸治疗仪&&全部项目&WHZ-Ⅱ型针灸治疗仪YZB/陕 &&111&电离子治疗机&&全部项目&QL/DL-ⅢD电离子治疗机YZB/川 &&112&高频电刀&&全部项目&ACG系列高频电刀YZB/国 &&113&强心卡&&部分项目&强心卡YZB/津 &比辐射率、皮肤刺激性和放射性不能测&114&低温手术系统&&全部项目&CRYOCARE？低温手术系统YZB/USA &&115&微振治疗仪&&全部项目&JB微振治疗仪YZB/津 &&116&全自动结肠水疗仪&&全部项目&全自动结肠水疗仪YZB/津 &&117&微波电刀两用治疗仪&&全部项目&微波电刀两用治疗仪YZB/国 41-25-&电脑扁桃体切除仪&&全部项目&DBQ-1型电脑扁桃体切除仪YZB/国 &&119&男性康复调节器&&全部项目&男性康复调节器YZB/宁 &&120&气腹机&&全部项目&气腹机YZB/GEM &&121&睡眠监测和诊断系统&&全部项目&睡眠监测和诊断系统YZB/GEM &&122&视野仪&&全部项目&视野仪YZB/USA 423-22-&自动锥板式粘度计&&全部项目&自动锥板式粘度计YZB/津 &&124&角膜电子曲率仪&&全部项目&角膜电子曲率仪YZB/津 &&125&电动自停开颅钻&&全部项目&电动自停开颅钻YZB/津 &&126&非接触眼压计&&全部项目&非接触眼压计YZB/津 &&127&三维脑电地形图仪&&全部项目&三维脑电地形图仪YZB/京&&128&血液混匀仪&&全部项目&血液混匀仪YZB/京&&129&吸氧仪&&全部项目&吸氧仪YZB/京&&130&医学影像工作站&&全部项目&医学影像工作站YZB/津&&131&微量元素分析仪&&全部项目&微量元素分析仪YZB/津 &&132&头部操纵式全液压综合手术台&&全部项目&头部操纵式全液压综合手术台
YZB/津 &&133&伤口愈合负压机&&全部项目&伤口愈合负压机YZB/津 &&134&潜视力检查仪&&全部项目&潜视力检查仪YZB/津 &&135&刨削手机&&全部项目&刨削手机YZB/USA &&136&基因扩增热循环仪&&全部项目&基因扩增热循环仪YZB/陕 &&137&光谱治疗仪&&全部项目&光谱治疗仪YZB/津 &&138&电动吸痰器&&全部项目&电动吸痰器YZB/津 &&139&半自动血凝仪&&全部项目&半自动血凝仪YZB/津 &&140&自动升降温水箱&&全部项目&自动升降温水箱YZB/津 &&141&激光光动力治疗仪&&全部项目&LH系列激光光动力治疗仪YZB/津&&142&眼震电图分析仪&&全部项目&CHARTR VNG/ENG眼震电图分析仪YZB/USA &&143&视力灯箱&&全部项目&视力灯箱YZB/KOR 4&&144&视力表投影仪&&全部项目&视力表投影仪YZB/KOR 4&&145&悬吊式腹腔镜手术器械&&全部项目&悬吊式腹腔镜手术器械YZB/JAP &&146&注射泵&&全部项目&CP系列注射泵YZB/京&&147&前列腺场效应消融仪&&全部项目&HA100前列腺场效应消融仪
148&电化学介入治疗仪&& 全部项目&电化学介入治疗仪YZB/国 4&&149&石墨炉原子吸收光谱仪&&全部项目&BH系列石墨炉原子吸收光谱仪YZB/京 &&150&手术无影灯和诊断用照明灯&&全部项目&医用电气设备 第2部分：手术无影灯和诊断用照明灯安全专用要求YY 　　医用电气设备 第2部分：手术照明灯和诊断照明灯安全专用要求YY 　　孔式手术无影灯YY 　　冷光单孔手术灯YY &&151&医用离心机&&全部项目&医用离心机YY/T 　　医用低速离心机YY &&152&人工驱动吸引设备&&全部项目&医用吸引设备 第2部分：人工驱动吸引设备YY 8　　脚踏吸引器YY 3&微波治疗设备&&部分项目&医用电气设备 第二部分：微波治疗设备安全专用要求GB 7&AP/APG不能测标准变更&154&一次性使用心电电极&&全部项目&一次性使用心电电极YY/T &标准变更&155&半自动生化分析仪&&全部项目&半自动生化分析仪YY/T &标准变更&156&热垫式治疗仪&&全部项目&热垫式治疗仪YY/T &标准变更&157&特定电磁波治疗器&&部分项目&特定电磁波治疗器YY/T &有害射线不能测、标准变更&158&肌电生物反馈仪&&全部项目&肌电生物反馈仪YY/T &标准变更&159&温度生物反馈仪&&全部项目&温度生物反馈仪YY/T &标准变更&160&医用电气设备&&全部项目&医用电气设备 第1-2部分：安全通用要求并列标准：电磁兼容 要求和试验
YY &&1&传导骚扰&电磁兼容 家用电器、电动工具和类似器具的要求 第1部分：发射GB 3　　工业、科学和医疗（ISM）射频设备 电磁骚扰特性 限值和测量方法GB 　　信息技术设备的无线电骚扰限值和测量方法GB 　　电气照明和类似设备的无线电骚扰特性的限值和测量方法GB &&2&辐射骚扰&3&谐波电流发射&电磁兼容 限值 谐波电流发射限值（设备每相输入电流≤16A）GB 3&三相设备不能测&4&电压波动/闪烁发射&电磁兼容 限值 限值对额定电流不大于16A的设备在低压供电系统中产生的电压波动和闪烁的限制GB 9&5&静电放电（ESD）抗扰度&电磁兼容 试验和测量技术 静电放电抗扰度试验GB/T 8
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