功能怎样测试网速
怎样测试网速 时间:2021-05-18 阅读:()
200"序号","指标","参数","评分"1,"主要技术和性能参数",1.
1,"每小时测试速度(恒速)","≥200Test/小时(不含ISE)",3,,"≥300Test/小时(不含ISE)",5,1.
2,"离子电极寿命","≥6个月或≥30000测试",51.
3,"光学系统",,"1.
3.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
3.
2","光度计构造(光栅性能)","光栅",3,,"滤光片",1"1.
3.
3","检测波长范围(nm)","覆盖340-800nm,≥12固定波长",3"1.
3.
4","吸光度线性范围(Abs)","0-3.
00Abs",1"1.
3.
5","反应时间","3-15分钟",3"1.
3.
6","检测项目数","≥20个",1,,"≥40个",2"1.
4","试剂单元",,"1.
4.
1","试剂位","≥40位",2,,"≥60位",4"1.
4.
2","试剂针","最小吸样量10μL",2,,"最小吸样量20μL",1"1.
4.
3","试剂仓冷藏功能","有/无","一票否决""1.
4.
4","试剂针液面检测","有/无","一票否决""1.
4.
5","试剂量检测及提示功能","有/无","一票否决""1.
5","样品单元",,"1.
5.
1","自动连续进样","有",1"1.
5.
2","样本位","≥40",1,,"≥60",2"1.
5.
3","样品自动稀释功能","有",2"1.
5.
4","最小样品量","≤3ul",2"1.
5.
5","样品针液面检测","有/无","一票否决""1.
5.
6","急诊样品插入功能情况","有/无","一票否决""1.
5.
7","凝块监测功能","有/无","一票否决""1.
5.
8","自动重检功能","有/无","一票否决""1.
6","比色杯",,"1.
6.
1","比色杯检测功能","有/无","一票否决""1.
6.
2","光径精度","正负0.
1mm",1"1.
6.
3","比色杯空白吸光度变异及报警功能","≤0.
02A",1"2","其他功能",,"2.
1","自动冲洗功能","有/无","一票否决""2.
2","特殊清洗功能","有/无",1"2.
3","恒温系统","有/无","一票否决""2.
4","恒温装置",,"2.
4.
1","恒温准确度","正负0.
1度",1"2.
4.
2","恒温波动度","正负0.
1度",1"2.
5","孵育槽温度检测及报警功能","有","一票否决""2.
6","最小反应液量","≤120μl",2,,"≤100μl",3"2.
7","携带污染率","≤0.
05%",2,,"≤0.
08%",1"2.
8","搅拌系统功能独立","有/无","一票否决""2.
9","样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决""2.
10","软件功能监测和打印","有/无","一票否决""2.
11","反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
15","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
16","自动报警提示功能","有/无","一票否决""2.
17","底物耗竭报警","有/无",1"2.
18","探针防撞保护","有/无",1"2.
19","比色杯脏损提示功能","有/无",1"2.
20","废液满溢提示功能","有/无",1"2.
21","校准监控功能","有/无","一票否决""2.
22","样本条码扫描","有/无","一票否决""2.
23","系统外部标准接口","有/无","一票否决""2.
24","配套试剂、质控物、校准物","有/无",1"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",10,,,,400,"指标","参数","评分"1,"主要技术和性能参数",,1.
1,"每小时测试速度(恒速)","≥400Test/小时",3,,"≥600Test/小时",51.
2,"离子","≥200Test/小时",51.
3,"离子电极寿命","≥6个月或≥30000测试",51.
4,"光学系统",,"1.
4.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
4.
2","光度计构造(光栅性能)","光栅,后分光",3,,"滤光片",11.
5,"检测波长范围(nm)","覆盖340-800nm,≥12固定波长",31.
6,"吸光度线性范围(Abs)","0-3.
00Abs",1,,"0-3.
50Abs",21.
7,"反应时间","3-15分钟",31.
8,"检测项目数","≥40个",2,,"≥80个",4"1.
9","试剂单元",,"1.
9.
1","试剂位","≥60位",3,,"≥80位",4"1.
9.
2","试剂仓冷藏功能","有/无","一票否决""1.
9.
3","试剂针液面检测","有/无","一票否决""1.
9.
4","试剂量检测及提示功能","有/无","一票否决""1.
10","样品单元",,"1.
10.
1","自动连续进样","有",1"1.
10.
2","样本位","≥80",1,,"≥100",2"1.
10.
3","样品自动稀释功能","有/无",2"1.
10.
4","最小样品量","≤3ul",2,,"≤2ul",4"1.
10.
5","样品针液面检测","有/无","一票否决""1.
10.
6","急诊样品插入功能情况","有/无","一票否决""1.
10.
7","凝块监测功能","有/无","一票否决""1.
10.
8","自动重检功能","有/无","一票否决""1.
11","比色杯",,"1.
11.
1","比色杯检测功能","有/无","一票否决""1.
11.
2","光径精度","正负0.
1mm",1"1.
11.
3","比色杯空白吸光度变异及报警功能","≤0.
01A",1"2","其他功能",,"2.
1","自动冲洗功能","有/无","一票否决""2.
2","特殊清洗功能","有/无",1"2.
3","恒温系统","有/无","一票否决""2.
4","恒温装置",,"2.
4.
1","恒温波动度","正负0.
1度",1"2.
4.
2","恒温准确度","正负0.
1度",1"2.
5","孵育槽温度检测及报警功能","有","一票否决""2.
6","最小反应液量","≤120μl",2,,"≤100μl",3"2.
7","搅拌系统功能独立","有/无","一票否决""2.
8","样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决""2.
9","软件功能监测和打印","有/无","一票否决""2.
10","反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
11","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
15","自动报警提示功能","有/无","一票否决""2.
16","底物耗竭报警","有/无",1"2.
17","探针防撞保护","有/无",1"2.
18","比色杯脏损提示功能","有/无",1"2.
19","废液满溢提示功能","有/无",1"2.
20","校准监控功能","有/无","一票否决""2.
21","样本条码扫描","有/无","一票否决""2.
22","系统外部标准接口","有/无","一票否决""2.
23","配套试剂、质控物、校准物","有/无",1"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",10800"序号","指标","参数","评分"1,"主要技术和性能参数",,1.
1,"每小时测试速度(恒速)","≥800Test/小时(不含ISE)",31.
2,"离子","≥400Test/小时",21.
3,"离子电极寿命","≥6个月或≥30000测试",51.
4,"光学系统",,"1.
4.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
4.
2","光度计构造(光栅性能)","光栅,后分光",3"1.
4.
3","检测波长范围(nm)","覆盖340-800nm,≥12固定波长",3"1.
4.
4","吸光度线性范围(Abs)","0-3.
00Abs",1,,"0-3.
50Abs",2"1.
4.
5","反应时间","3-15分钟",3"1.
4.
6","检测项目数","≥60个",41.
5,"试剂单元",,"1.
5.
1","试剂位","≥80位",2,,"≥120位",4"1.
5.
2","试剂仓冷藏功能","有/无","一票否决""1.
5.
3","试剂针液面检测","有/无","一票否决""1.
5.
4","试剂量检测及提示功能","有/无","一票否决"1.
6,"样品单元",,"1.
6.
1","自动连续进样","轨道",4"1.
6.
2","盘式样本位","≥100",1,,"≥140",2"1.
6.
3","样品自动稀释功能","有/无",2"1.
6.
4","最小样品量","≤3ul",2,,"≤2ul",4"1.
6.
5","样品针液面检测","有/无","一票否决""1.
6.
6","急诊样品插入功能情况","有/无","一票否决""1.
6.
7","凝块监测功能","有/无","一票否决""1.
6.
8","自动重检功能","有/无","一票否决"1.
7,"比色杯",,"1.
7.
1","比色杯检测功能","有/无","一票否决""1.
7.
2","光径精度","正负0.
1mm",1"1.
7.
3","比色杯空白吸光度变异及报警功能","≤0.
01A",12,"其他功能",,2.
1,"自动冲洗功能","有/无","一票否决"2.
2,"特殊清洗功能","有/无",12.
3,"恒温系统","有/无","一票否决"2.
4,"恒温装置",,"2.
4.
1","恒温波动度","正负0.
1度",1"2.
4.
2","恒温准确度","正负0.
1度",1"2.
4.
3","孵育槽温度检测及报警功能","有","一票否决"2.
5,"最小反应液量","≤150μl",2,,"≤120μl",3,,"≤90μl",42.
6,"搅拌系统功能独立","有/无","一票否决"2.
7,"样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决"2.
8,"软件功能监测和打印","有/无","一票否决"2.
9,"反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
10","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",12.
11,"定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","自动报警提示功能","有/无","一票否决""2.
15","底物耗竭报警","有/无",1"2.
16","探针防撞保护","有/无",1"2.
17","比色杯脏损提示功能","有/无",1"2.
18","废液满溢提示功能","有/无",1"2.
19","校准监控功能","有/无","一票否决""2.
20","样本条码扫描","有/无","一票否决""2.
21","系统外部标准接口","有/无","一票否决""2.
22","配套试剂、质控物、校准物","有/无",1"2.
23","生化免疫联机","有/无",2"2.
24","生化双模块","有/无",1"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",101600"序号","指标","参数","评分"1,"主要技术和性能参数",,1.
1,"每小时测试速度(恒速)","≥1600Test/小时(不含ISE)",3,,"≥2000Test/小时(不含ISE)",51.
2,"离子","≥600Test/小时",31.
3,"离子电极寿命","≥6个月或≥30000测试",51.
4,"光学系统",,"1.
4.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
4.
2","光度计构造(光栅性能)","光栅,后分光",3"1.
4.
3","检测波长范围(nm)","覆盖340-800nm,≥12固定波长",3,,"覆盖340-800nm,≥16固定波长",5"1.
4.
4","吸光度线性范围(Abs)","0-3.
00Abs",1,,"0-3.
50Abs",2"1.
4.
5","反应时间","3-15分钟",3"1.
4.
6","检测项目数","≥80个",41.
5,"试剂单元",,"1.
5.
1","试剂位","≥100位",3,,"≥140位",4"1.
5.
2","试剂仓冷藏功能","有/无","一票否决""1.
5.
3","试剂针液面检测","有/无","一票否决""1.
5.
4","试剂量检测及提示功能","有/无","一票否决"1.
6,"样品单元",,2"1.
6.
1","自动连续进样","轨道",4"1.
6.
2","样品自动稀释功能","有",2"1.
6.
3","最小样品量","≤3ul",2,,"≤1.
5ul",4"1.
6.
4","样品针液面检测","有/无","一票否决""1.
6.
5","急诊样品插入功能情况","有/无","一票否决""1.
6.
6","凝块监测功能","有/无","一票否决""1.
6.
7","自动重检功能","有/无","一票否决"1.
7,"比色杯",,"1.
7.
1","比色杯检测功能","有","一票否决""1.
7.
2","光径精度","±0.
1mm",1"1.
7.
3","比色杯空白吸光度变异及报警功能","≤0.
01A",12,"其他功能",,2.
1,"自动冲洗功能","有/无","一票否决"2.
2,"特殊清洗功能","有/无",12.
3,"恒温系统","有/无","一票否决"2.
4,"恒温装置",,"2.
4.
1","恒温波动度","±0.
1°",1"2.
4.
2","恒温准确度","±0.
1°",1"2.
4.
3","孵育槽温度检测及报警功能","有","一票否决"2.
5,"最小反应液量","≤150μl",2,,"≤100μl",3,,"≤80μl",42.
6,"搅拌系统功能独立","有/无","一票否决"2.
7,"样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决"2.
8,"软件功能监测和打印","有/无","一票否决"2.
9,"反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
10","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
11","定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","自动报警提示功能","有/无","一票否决""2.
15","底物耗竭报警","有/无",1"2.
16","探针防撞保护","有/无",1"2.
17","比色杯脏损提示功能","有/无",1"2.
18","废液满溢提示功能","有/无",1"2.
19","校准监控功能","有/无","一票否决""2.
20","样本条码扫描","有/无","一票否决""2.
21","系统外部标准接口","有/无","一票否决""2.
22","配套试剂、质控物、校准物","有/无",1"2.
23","生化免疫联机","有/无",2"2.
24","生化双模块","有/无",2"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",10企业情况"企业基本情况表",,,,"序号","指标","评分标准","得分","备注"1,"员工总数","≥500人",4,"企业整体数据"2,"注册资本","≥3000万",4,3,"配件库","≥30个",4,,,"≥20个",3,,,"≥10个",1,4,"维修站","≥35个",4,,,"≥20个",3,,,"≥10个",1,5,"维修队伍","≥100人",4,,,"≥80人",3,,,"≥50人",1,6,"培训队伍","≥50人",4,,,"≥30人",3,,,"≥20人",1,7,"生化仪研发人员、生产人员","≥200人",4,,,"≥100人",3,,,"≥50人",1,8,"高新企业、获奖证书","省部级以上",5,"生产线整体数据"9,"进入生化仪市场时间","≥8年",8,,,"≥5年",5,,,"≥2年",2,10,"近三年国内总装机量","≥2000台",8,,,"≥1500台",5,,,"≥1000台",2,11,"2019年销量","≥1000台",10,,,"≥500台",5,,,"≥300台",3,12,"溯源体系","具有原厂参考实验室",2,13,"认证情况","CE、FDA认证每项一分",2,14,"国外销售","有",3,临床应用评价"专家评价表(全自动生化分析仪)",,,,"生产厂家:",,,"型号:",,"指标",,"评分标准","评分""产品基本情况","外观和工艺","外观是否精美","精美3分、一般2分、欠缺0分",,,"整机和部件的工艺水平","工艺水平好5分、一般3分、欠缺0分",,"技术水准","物理结构的先进性的综合评价(如加样系统、光学系统、恒温系统、软件系统等)","先进10分、一般6分、欠缺0分",,,"与相应进口机综合比较的情况","相当3分、接近2分、差距较大1分",,,"该机的技术档次","高3分、中2分、低1分",,"性价比","性能与价格比是否合理","合理6分、一般4分、不合理0分","临床使用情况","临床应用适宜性","功能是否齐全,在临床应用的适宜性(如校准和反应方式、条码系统、室内质控数据管理、LIS接口,等)","适宜性好10分、一般6分、差3分",,,"适合使用的医院等级","三级以上4分、二级甲等2分、社区1分",,"系统性能","系统性能是否满足临床分析要求(与商品试剂的配套性、正确度、精密度、测量范围、携带污染率等)","完全满足10分、基本满足6分、欠缺0分",,"方便性","操作是否简单、人机工程学设计是否合理","操作简单、设计合理3分、一般2分、欠缺0分",,"故障率","每年故障次数","0-3次5分、3-10次3分、10次以上1分",,"使用寿命","整机正常使用寿命","6年以上5分、4年3分、2年左右1分",,"安全性","包括电气安全和设备防护安全","很安全3分、安全2分、有风险0分",,"不良事件","有无引发不良事件的情况","无5分、个别3分、多次1分","售后服务情况","维修站设置","维修站区域设置是否合理、有无配件库","本地有维修站,配件齐全5分、本区域有维修站,配件基本有保障3、不足2分",,"安装培训","是否有安装培训","效果好5分,一般3分,不好1分",,"响应时间","收到要求维修/维护信息时限","当天响应5分、3日内响应3分、3日后响应1分",,"服务费用","维修/维护费用是否合理","合理5分、一般3分、不合理1分",,"服务质量","常规维修/维护解决相应问题的能力","当日解决问题5分、3日内解决3分、一周以上解决1分",
1,"每小时测试速度(恒速)","≥200Test/小时(不含ISE)",3,,"≥300Test/小时(不含ISE)",5,1.
2,"离子电极寿命","≥6个月或≥30000测试",51.
3,"光学系统",,"1.
3.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
3.
2","光度计构造(光栅性能)","光栅",3,,"滤光片",1"1.
3.
3","检测波长范围(nm)","覆盖340-800nm,≥12固定波长",3"1.
3.
4","吸光度线性范围(Abs)","0-3.
00Abs",1"1.
3.
5","反应时间","3-15分钟",3"1.
3.
6","检测项目数","≥20个",1,,"≥40个",2"1.
4","试剂单元",,"1.
4.
1","试剂位","≥40位",2,,"≥60位",4"1.
4.
2","试剂针","最小吸样量10μL",2,,"最小吸样量20μL",1"1.
4.
3","试剂仓冷藏功能","有/无","一票否决""1.
4.
4","试剂针液面检测","有/无","一票否决""1.
4.
5","试剂量检测及提示功能","有/无","一票否决""1.
5","样品单元",,"1.
5.
1","自动连续进样","有",1"1.
5.
2","样本位","≥40",1,,"≥60",2"1.
5.
3","样品自动稀释功能","有",2"1.
5.
4","最小样品量","≤3ul",2"1.
5.
5","样品针液面检测","有/无","一票否决""1.
5.
6","急诊样品插入功能情况","有/无","一票否决""1.
5.
7","凝块监测功能","有/无","一票否决""1.
5.
8","自动重检功能","有/无","一票否决""1.
6","比色杯",,"1.
6.
1","比色杯检测功能","有/无","一票否决""1.
6.
2","光径精度","正负0.
1mm",1"1.
6.
3","比色杯空白吸光度变异及报警功能","≤0.
02A",1"2","其他功能",,"2.
1","自动冲洗功能","有/无","一票否决""2.
2","特殊清洗功能","有/无",1"2.
3","恒温系统","有/无","一票否决""2.
4","恒温装置",,"2.
4.
1","恒温准确度","正负0.
1度",1"2.
4.
2","恒温波动度","正负0.
1度",1"2.
5","孵育槽温度检测及报警功能","有","一票否决""2.
6","最小反应液量","≤120μl",2,,"≤100μl",3"2.
7","携带污染率","≤0.
05%",2,,"≤0.
08%",1"2.
8","搅拌系统功能独立","有/无","一票否决""2.
9","样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决""2.
10","软件功能监测和打印","有/无","一票否决""2.
11","反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
15","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
16","自动报警提示功能","有/无","一票否决""2.
17","底物耗竭报警","有/无",1"2.
18","探针防撞保护","有/无",1"2.
19","比色杯脏损提示功能","有/无",1"2.
20","废液满溢提示功能","有/无",1"2.
21","校准监控功能","有/无","一票否决""2.
22","样本条码扫描","有/无","一票否决""2.
23","系统外部标准接口","有/无","一票否决""2.
24","配套试剂、质控物、校准物","有/无",1"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",10,,,,400,"指标","参数","评分"1,"主要技术和性能参数",,1.
1,"每小时测试速度(恒速)","≥400Test/小时",3,,"≥600Test/小时",51.
2,"离子","≥200Test/小时",51.
3,"离子电极寿命","≥6个月或≥30000测试",51.
4,"光学系统",,"1.
4.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
4.
2","光度计构造(光栅性能)","光栅,后分光",3,,"滤光片",11.
5,"检测波长范围(nm)","覆盖340-800nm,≥12固定波长",31.
6,"吸光度线性范围(Abs)","0-3.
00Abs",1,,"0-3.
50Abs",21.
7,"反应时间","3-15分钟",31.
8,"检测项目数","≥40个",2,,"≥80个",4"1.
9","试剂单元",,"1.
9.
1","试剂位","≥60位",3,,"≥80位",4"1.
9.
2","试剂仓冷藏功能","有/无","一票否决""1.
9.
3","试剂针液面检测","有/无","一票否决""1.
9.
4","试剂量检测及提示功能","有/无","一票否决""1.
10","样品单元",,"1.
10.
1","自动连续进样","有",1"1.
10.
2","样本位","≥80",1,,"≥100",2"1.
10.
3","样品自动稀释功能","有/无",2"1.
10.
4","最小样品量","≤3ul",2,,"≤2ul",4"1.
10.
5","样品针液面检测","有/无","一票否决""1.
10.
6","急诊样品插入功能情况","有/无","一票否决""1.
10.
7","凝块监测功能","有/无","一票否决""1.
10.
8","自动重检功能","有/无","一票否决""1.
11","比色杯",,"1.
11.
1","比色杯检测功能","有/无","一票否决""1.
11.
2","光径精度","正负0.
1mm",1"1.
11.
3","比色杯空白吸光度变异及报警功能","≤0.
01A",1"2","其他功能",,"2.
1","自动冲洗功能","有/无","一票否决""2.
2","特殊清洗功能","有/无",1"2.
3","恒温系统","有/无","一票否决""2.
4","恒温装置",,"2.
4.
1","恒温波动度","正负0.
1度",1"2.
4.
2","恒温准确度","正负0.
1度",1"2.
5","孵育槽温度检测及报警功能","有","一票否决""2.
6","最小反应液量","≤120μl",2,,"≤100μl",3"2.
7","搅拌系统功能独立","有/无","一票否决""2.
8","样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决""2.
9","软件功能监测和打印","有/无","一票否决""2.
10","反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
11","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
15","自动报警提示功能","有/无","一票否决""2.
16","底物耗竭报警","有/无",1"2.
17","探针防撞保护","有/无",1"2.
18","比色杯脏损提示功能","有/无",1"2.
19","废液满溢提示功能","有/无",1"2.
20","校准监控功能","有/无","一票否决""2.
21","样本条码扫描","有/无","一票否决""2.
22","系统外部标准接口","有/无","一票否决""2.
23","配套试剂、质控物、校准物","有/无",1"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",10800"序号","指标","参数","评分"1,"主要技术和性能参数",,1.
1,"每小时测试速度(恒速)","≥800Test/小时(不含ISE)",31.
2,"离子","≥400Test/小时",21.
3,"离子电极寿命","≥6个月或≥30000测试",51.
4,"光学系统",,"1.
4.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
4.
2","光度计构造(光栅性能)","光栅,后分光",3"1.
4.
3","检测波长范围(nm)","覆盖340-800nm,≥12固定波长",3"1.
4.
4","吸光度线性范围(Abs)","0-3.
00Abs",1,,"0-3.
50Abs",2"1.
4.
5","反应时间","3-15分钟",3"1.
4.
6","检测项目数","≥60个",41.
5,"试剂单元",,"1.
5.
1","试剂位","≥80位",2,,"≥120位",4"1.
5.
2","试剂仓冷藏功能","有/无","一票否决""1.
5.
3","试剂针液面检测","有/无","一票否决""1.
5.
4","试剂量检测及提示功能","有/无","一票否决"1.
6,"样品单元",,"1.
6.
1","自动连续进样","轨道",4"1.
6.
2","盘式样本位","≥100",1,,"≥140",2"1.
6.
3","样品自动稀释功能","有/无",2"1.
6.
4","最小样品量","≤3ul",2,,"≤2ul",4"1.
6.
5","样品针液面检测","有/无","一票否决""1.
6.
6","急诊样品插入功能情况","有/无","一票否决""1.
6.
7","凝块监测功能","有/无","一票否决""1.
6.
8","自动重检功能","有/无","一票否决"1.
7,"比色杯",,"1.
7.
1","比色杯检测功能","有/无","一票否决""1.
7.
2","光径精度","正负0.
1mm",1"1.
7.
3","比色杯空白吸光度变异及报警功能","≤0.
01A",12,"其他功能",,2.
1,"自动冲洗功能","有/无","一票否决"2.
2,"特殊清洗功能","有/无",12.
3,"恒温系统","有/无","一票否决"2.
4,"恒温装置",,"2.
4.
1","恒温波动度","正负0.
1度",1"2.
4.
2","恒温准确度","正负0.
1度",1"2.
4.
3","孵育槽温度检测及报警功能","有","一票否决"2.
5,"最小反应液量","≤150μl",2,,"≤120μl",3,,"≤90μl",42.
6,"搅拌系统功能独立","有/无","一票否决"2.
7,"样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决"2.
8,"软件功能监测和打印","有/无","一票否决"2.
9,"反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
10","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",12.
11,"定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","自动报警提示功能","有/无","一票否决""2.
15","底物耗竭报警","有/无",1"2.
16","探针防撞保护","有/无",1"2.
17","比色杯脏损提示功能","有/无",1"2.
18","废液满溢提示功能","有/无",1"2.
19","校准监控功能","有/无","一票否决""2.
20","样本条码扫描","有/无","一票否决""2.
21","系统外部标准接口","有/无","一票否决""2.
22","配套试剂、质控物、校准物","有/无",1"2.
23","生化免疫联机","有/无",2"2.
24","生化双模块","有/无",1"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",101600"序号","指标","参数","评分"1,"主要技术和性能参数",,1.
1,"每小时测试速度(恒速)","≥1600Test/小时(不含ISE)",3,,"≥2000Test/小时(不含ISE)",51.
2,"离子","≥600Test/小时",31.
3,"离子电极寿命","≥6个月或≥30000测试",51.
4,"光学系统",,"1.
4.
1","光源灯有效寿命(小时)","≥2000小时",4"1.
4.
2","光度计构造(光栅性能)","光栅,后分光",3"1.
4.
3","检测波长范围(nm)","覆盖340-800nm,≥12固定波长",3,,"覆盖340-800nm,≥16固定波长",5"1.
4.
4","吸光度线性范围(Abs)","0-3.
00Abs",1,,"0-3.
50Abs",2"1.
4.
5","反应时间","3-15分钟",3"1.
4.
6","检测项目数","≥80个",41.
5,"试剂单元",,"1.
5.
1","试剂位","≥100位",3,,"≥140位",4"1.
5.
2","试剂仓冷藏功能","有/无","一票否决""1.
5.
3","试剂针液面检测","有/无","一票否决""1.
5.
4","试剂量检测及提示功能","有/无","一票否决"1.
6,"样品单元",,2"1.
6.
1","自动连续进样","轨道",4"1.
6.
2","样品自动稀释功能","有",2"1.
6.
3","最小样品量","≤3ul",2,,"≤1.
5ul",4"1.
6.
4","样品针液面检测","有/无","一票否决""1.
6.
5","急诊样品插入功能情况","有/无","一票否决""1.
6.
6","凝块监测功能","有/无","一票否决""1.
6.
7","自动重检功能","有/无","一票否决"1.
7,"比色杯",,"1.
7.
1","比色杯检测功能","有","一票否决""1.
7.
2","光径精度","±0.
1mm",1"1.
7.
3","比色杯空白吸光度变异及报警功能","≤0.
01A",12,"其他功能",,2.
1,"自动冲洗功能","有/无","一票否决"2.
2,"特殊清洗功能","有/无",12.
3,"恒温系统","有/无","一票否决"2.
4,"恒温装置",,"2.
4.
1","恒温波动度","±0.
1°",1"2.
4.
2","恒温准确度","±0.
1°",1"2.
4.
3","孵育槽温度检测及报警功能","有","一票否决"2.
5,"最小反应液量","≤150μl",2,,"≤100μl",3,,"≤80μl",42.
6,"搅拌系统功能独立","有/无","一票否决"2.
7,"样本测试结果储存","符合HL7、IHE标准和LOINC标准","一票否决"2.
8,"软件功能监测和打印","有/无","一票否决"2.
9,"反应进程曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
10","反应吸光度监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
11","定标曲线监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
12","质控图监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
13","参数计算功能监测和打印","符合HL7、IHE标准和LOINC标准",1"2.
14","自动报警提示功能","有/无","一票否决""2.
15","底物耗竭报警","有/无",1"2.
16","探针防撞保护","有/无",1"2.
17","比色杯脏损提示功能","有/无",1"2.
18","废液满溢提示功能","有/无",1"2.
19","校准监控功能","有/无","一票否决""2.
20","样本条码扫描","有/无","一票否决""2.
21","系统外部标准接口","有/无","一票否决""2.
22","配套试剂、质控物、校准物","有/无",1"2.
23","生化免疫联机","有/无",2"2.
24","生化双模块","有/无",2"3","自主知识产权","发明专利(核心技术、关键零部件等)(每项2分,最多10分)",10企业情况"企业基本情况表",,,,"序号","指标","评分标准","得分","备注"1,"员工总数","≥500人",4,"企业整体数据"2,"注册资本","≥3000万",4,3,"配件库","≥30个",4,,,"≥20个",3,,,"≥10个",1,4,"维修站","≥35个",4,,,"≥20个",3,,,"≥10个",1,5,"维修队伍","≥100人",4,,,"≥80人",3,,,"≥50人",1,6,"培训队伍","≥50人",4,,,"≥30人",3,,,"≥20人",1,7,"生化仪研发人员、生产人员","≥200人",4,,,"≥100人",3,,,"≥50人",1,8,"高新企业、获奖证书","省部级以上",5,"生产线整体数据"9,"进入生化仪市场时间","≥8年",8,,,"≥5年",5,,,"≥2年",2,10,"近三年国内总装机量","≥2000台",8,,,"≥1500台",5,,,"≥1000台",2,11,"2019年销量","≥1000台",10,,,"≥500台",5,,,"≥300台",3,12,"溯源体系","具有原厂参考实验室",2,13,"认证情况","CE、FDA认证每项一分",2,14,"国外销售","有",3,临床应用评价"专家评价表(全自动生化分析仪)",,,,"生产厂家:",,,"型号:",,"指标",,"评分标准","评分""产品基本情况","外观和工艺","外观是否精美","精美3分、一般2分、欠缺0分",,,"整机和部件的工艺水平","工艺水平好5分、一般3分、欠缺0分",,"技术水准","物理结构的先进性的综合评价(如加样系统、光学系统、恒温系统、软件系统等)","先进10分、一般6分、欠缺0分",,,"与相应进口机综合比较的情况","相当3分、接近2分、差距较大1分",,,"该机的技术档次","高3分、中2分、低1分",,"性价比","性能与价格比是否合理","合理6分、一般4分、不合理0分","临床使用情况","临床应用适宜性","功能是否齐全,在临床应用的适宜性(如校准和反应方式、条码系统、室内质控数据管理、LIS接口,等)","适宜性好10分、一般6分、差3分",,,"适合使用的医院等级","三级以上4分、二级甲等2分、社区1分",,"系统性能","系统性能是否满足临床分析要求(与商品试剂的配套性、正确度、精密度、测量范围、携带污染率等)","完全满足10分、基本满足6分、欠缺0分",,"方便性","操作是否简单、人机工程学设计是否合理","操作简单、设计合理3分、一般2分、欠缺0分",,"故障率","每年故障次数","0-3次5分、3-10次3分、10次以上1分",,"使用寿命","整机正常使用寿命","6年以上5分、4年3分、2年左右1分",,"安全性","包括电气安全和设备防护安全","很安全3分、安全2分、有风险0分",,"不良事件","有无引发不良事件的情况","无5分、个别3分、多次1分","售后服务情况","维修站设置","维修站区域设置是否合理、有无配件库","本地有维修站,配件齐全5分、本区域有维修站,配件基本有保障3、不足2分",,"安装培训","是否有安装培训","效果好5分,一般3分,不好1分",,"响应时间","收到要求维修/维护信息时限","当天响应5分、3日内响应3分、3日后响应1分",,"服务费用","维修/维护费用是否合理","合理5分、一般3分、不合理1分",,"服务质量","常规维修/维护解决相应问题的能力","当日解决问题5分、3日内解决3分、一周以上解决1分",
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