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1、Good is good, but better carries it.精益求精,善益求善。SYZ03-028蒸汽灭菌柜验证528-目录:1、确认概述.22、确认目的.23、确认范围.24、确认职责.25、风险评估.36、确认正文.37、确认结果报告书.118、确认记录.129、确认证书.39验证小组组长:宋伶香验证小组组员:郭凤华、关建萍、张航、施振伟、李林、杨硕编审批过程:起草人审核人批准人部门质控处质保处质量部总工程师签名日期验证概述DYML-S50LA高压蒸汽灭菌器(120406-ZK-01)位于质控处无菌室,生产厂家为盛达(北京)生物电子设备有限公司。该设备灭菌工艺参数及用途见下表:

2、灭菌工艺参数用途115/30min缓冲液、纯化水及生理盐水121/15min培养基121/30min无菌衣、过滤器、滤膜及取样钎等为保证该设备能够达到设定的灭菌工艺要求,对该设备进行满载和热穿透温度分布均一性验证。本次验证选择的工艺参数为115/30min和121/30min。2、验证目的:确认DYML-S50LA高压蒸汽灭菌器(120406-ZK-01)在设定的灭菌工艺下能够达到灭菌效果。3、验证范围:DYML-S50LA高压蒸汽灭菌器(120406-ZK-01)4、验证职责:验证小组成员部门及职位职责组长宋伶香质控处处长负责高压蒸汽灭菌锅再验证方案及报告的审核,并对验证结果及过程进行评价。

3、组员郭凤华质控处QC负责高压灭菌锅再验证方案及报告的起草。关建萍质控处QC按照批准的方案实施验证,收集数据,确保验证过程中的数据准确。张航质控处QC施振伟质控处设备员确保验证过程中涉及的仪器、仪表、器具等在校验期内。李林质控处设备员杨硕质保处QA监督验证过程的实施,负责验证过程中的协调工作,对验证过程中的变更和偏差进行评价。王连荣质量部长验证方案及验证报告的批准。邱桂侠总工程师验证方案及验证报告的批准、发放验证证书、确认再验证周期。5、风险评估该高压蒸汽灭菌锅用于培养基及缓冲液等物品的灭菌,影响灭菌效果的指标是温度和时间,故需对高压蒸汽灭菌锅的灭菌温度和时间进行确认,同时为考察灭菌效果,还要进

4、行微生物挑战试验。由于该设备一直处于良好的运行状态,本次确认是在继上次确认(确认时间2012年11月7日)结束后,无任何偏差、变更情况下对设备性能进行的再确认,故在灭菌效果确认时,无需考察空载状态,如满载及热穿透温度分布均一性能够达到验证可接受标准,即可证明设备性能稳定。6、验证正文6.1、相关条件确认6.1.1文件确认文件名称份数存放处DYML-S50LA电脑压力蒸汽灭菌器说明书1质控处办公室确认人/日期:复核人/日期:6.1.2相关SOP文件名称编号是否接受备注DYML-S50LA电脑压力蒸汽灭菌器操作规程ZL222是否确认人/日期:复核人/日期:6.1.3相关培训高压蒸汽灭菌锅再确认方案

5、培训出席、评估表复印件6.1.4设备基本参数项目参数工作温度115132灭菌时间060分钟可调工作电压220V,300W额定压力0.25Mpa内桶容积50L外型尺寸480480840mm6.1.5校验仪器序号仪器仪表名称型号编号范围校正日期有效期1热电偶HSB-600RTI10-15-1-103002013-03-26一年2热电偶HSB-600RTI10-15-1-203002013-03-26一年3热电偶HSB-600RTI10-15-1-303002013-03-26一年4热电偶HSB-600RTI10-15-1-403002013-03-26一年5热电偶HSB-600RTI10-15-1

6、-503002013-03-26一年6热电偶HSB-600RTI10-15-1-603002013-03-26一年7热电偶HSB-600RTI10-15-1-703002013-03-26一年8热电偶HSB-600RTI10-15-1-803002013-03-26一年9热电偶HSB-600RTI10-15-1-903002013-03-26一年10热电偶HSB-600RTI10-15-1-1003002013-03-26一年11真空表Y-10P10-07-200.25Mpa2013-7-9半年12秒表SJ9-1A538932013-4-181年确认人/日期:复核人/日期:6.1.6运行确认按

7、DYML-S50LA电脑压力蒸汽灭菌器操作规程要求运行,对高压蒸汽灭菌锅的各项功能进行检查。具体检查项如下:1)对设备外观进行检查,高压灭菌锅内外表面应无腐蚀或破损。2)与四周、建筑物距离在0.20米以上有足够的空间维护保养。3)上盖密封圈应完好无撕裂或老化现象。4)灭菌时间应可以设定,设定范围060分钟。5)有水位限度信号,超出警戒水位,水位指示灯亮起。6)设备加热时,加热指示灯应亮起。7)管路应密封无泄漏。确认结果:确认人/日期:6.2性能确认6.2.1热电偶放置方式的确认将12支热电偶放到灭菌锅内不同位置,测温点不得接触金属表面和其它表面,具体放置位置见如下示意图:注:第1、3、4层,从

8、左右,为13,第2层,从上到下,为13图一取样点分层取样点位置热电偶编号取样点位置热电偶编号取样点位置热电偶编号第一层1-1011-2021-303第二层2-1042-2052-306第三层3-1073-2083-309第四层4-1104-2114-312满载及热穿透取样点编号见附表16.2.2满载热温度分布均一性确认在高压灭菌锅满载状态下进行温度均一性确认,灭菌工艺为115/30min和121/30min。验证仪每分钟记录一次数据,每个工艺参数条件下连续进行三次确认。可接受标准:达到灭菌状态后,各测试点温度与设定值温差2灭菌温度为115时,各测试点温度范围113117;灭菌温度为121时,各

9、测试点温度范围119123。6.2.3热穿透温度分布均一性确认热穿透温度均一性确认在满载状态下进行,将温度验证仪探头放在被灭菌的物品内部,以考察灭菌效果。该项确认同样在115/30min和121/30min每个工艺参数条件下连续进行三次。可接受标准:达到灭菌状态后,各测试点温度与设定值温差2灭菌温度为115时,各测试点温度范围113117;灭菌温度为121时,各测试点温度范围119123,温度最低点F0值8。6.2.4生物指示剂灭菌效果考察取4支湿热灭菌指示剂分别放在图一中的1、2、3、4层,每层放置一个,与热穿透确认过程同步进行,每个工艺条件下连续进行三次,灭菌结束后,取出指示剂后,折断塑料

10、外壳内的玻璃内壳,使培养基流出与菌片接触,在55温度下培养48小时,同时取一只未灭菌的指示剂进行阳性对照。每天观察结果并将结果记录在记录4。6.2.4.1生物指示剂信息名称生产厂家含菌量有效期至四环牌ME-压力蒸汽灭菌生物指示剂北京四环卫生药械厂有限公司51055106cfu/片2014年1月3日6.2.4.2生物指示剂编号指示剂放置位置试验次数1层2层3层4层阳性11-11-21-31-41-Y22-12-22-32-42-Y33-13-23-33-43-Y注:121灭菌工艺在指示剂编号前加1,115灭菌工艺在指示剂编号前加2。6.2.4.3可接受标准:灭菌后指示剂应无菌生长,阳性对照应有菌

11、生长。6.3数据统计及分析分别统计满载及热穿透温度分布确认结果,统计生物指示剂灭菌结果。121满载温度分布统计结果单位:试验次数项目热电偶编号温差0102030405060708091011121最大值121.3121.7121.2122.3121.6121.4121.7122.7120.3122.8121.7121.62.9最小值120.6121.0120.6121.7120.8120.9121.1122.2119.3121.8120.7121.02.42最大值121.0121.5120.9121.9121.0120.9121.1122.2120.0122.3121.7121.52.6最小值

12、120.4120.9120.4121.5120.6120.6120.9121.9119.5121.8121.1121.02.33最大值121.1121.4120.9122.0121.2121.0121.1122.4120.0122.6121.2121.43.4最小值120.5120.9120.5121.5120.6120.6120.7122.0119.2122.0120.7120.82.2121热穿透温度分布统计结果单位:试验次数项目热电偶编号温差0102030405060708091011121最大值121.9121.9121.2122.5122.4121.9121.6121.7120.81

13、22.6122.2121.92.2最小值120.6120.8120.1121.3121.3120.7120.5120.4119.6121.5121.1120.81.7F029.731.126.435.035.031.630.028.923.837.834.531.02最大值121.6121.0120.7121.5122.0121.0121.0121.2120.2122.9121.5121.33.1最小值120.4120.2119.8120.6121.2120.4120.2120.2119.3121.7120.7120.41.7F030.127.725.031.033.927.727.228.3

14、22.838.831.129.43最大值121.3121.8121.2122.5122.4121.5121.6121.4121.6120.3122.7121.52.7最小值120.9121.4120.9122.1121.9121.1121.0120.9121.3119.8122.1121.02.1F030.634.430.140.238.731.532.330.532.924.141.631.7121灭菌条件生物指示剂灭菌结果第1次第2次第3次编号结果编号结果编号结果1-1-1合格1-2-1合格1-3-1合格1-1-2合格1-2-2合格1-3-2合格1-1-3合格1-2-3合格1-3-3合格1

15、-1-4合格1-2-4合格1-3-4合格1-1-Y合格1-2-Y合格1-3-Y合格115满载温度分布统计结果单位:试验次数项目热电偶编号温差0102030405060708091011121最大值115.4116.2115.4116.6116.1116.5115.7115.6115.6116.0114.5116.92.6最小值115.0115.7114.9116.3115.8116.1115.4115.1115.1115.5114.1116.42.12最大值115.7116.4115.5116.8116.6115.8115.8116.2115.7116.0114.5117.13.0最小值114

16、.8115.7114.6116.3116.0115.4115.3115.6115.1115.1113.7116.52.13最大值115.4116.4115.7116.6116.5116.0116.0115.5115.7115.8114.9116.72.0最小值115.1116.1115.4116.4116.2115.8115.6115.3115.5115.5114.6116.51.7115热穿透温度分布统计结果单位:试验次数项目热电偶编号温差0102030405060708091011121最大值115.4115.2115.8115.0116.2116.1115.4115.2115.7114.

17、3116.4114.82.4最小值115.1114.8115.4114.8115.9115.8115.0114.9115.4113.8116.0114.31.82最大值115.0115.8115.0116.3116.2115.4115.2115.8114.1116.5115.8115.82.6最小值114.5115.5114.6115.8115.8115.2114.9115.4113.9116.2115.4115.52.23最大值115.8115.4116.2115.5116.8115.1116.5115.8115.5115.8114.4116.93.0最小值114.8114.6115.211

18、4.7116.0114.2115.9115.1114.9115.0113.5116.32.2115灭菌条件生物指示剂灭菌结果第1次第2次第3次编号结果编号结果编号结果2-1-1合格2-2-1合格2-3-1合格2-1-2合格2-2-2合格2-3-2合格2-1-3合格2-2-3合格2-3-3合格2-1-4合格2-2-4合格2-3-4合格2-1-Y合格2-2-Y合格2-3-Y合格小结:确认人/日期:6.4计算公式:F0=t10(T1-T2)/10t灭菌时间;T1实际测得温度;T21216.5验证合格标准6.5.1该设备在满载及热穿透温度均一性能达到相应的可接受标准。6.5.2生物指示剂灭菌结果合格。

19、6.6变更与偏差处理确认过程中如果出现偏差和/或变更,应立即通知质保处,按照偏差处理程序和/或变更控制程序对其处理。所有偏差和变更按照相应规程得到有效处理后,确认方可进入下一步骤。原始的偏差表或变更表经过批准后,其复印件必须附在最终的确认报告中。确认过程无变更与偏差。评价人/日期:6.7确认结果评定与结论验证工作小组组长对确认结果进行综合评审,做出确认结论。验证领导小组组长发放验证证书,对确认结果的评审应包括:(1)验证结果是否有遗漏?验证结果无遗漏(2)验证过程中的偏差、变更是否关闭?验证过程无偏差及变更(3)验证实施过程中对验证方案有无修改,修改原因、依据、是否经过批准?验证实施过程对方案

20、无修改(4)验证记录是否完整?验证记录完整、真实(5)验证结果是否符合标准要求?验证结果能够达到验证合格标准。评价人/日期:7、确认结果报告书8、记录附表1设备运行确认记录附表2121满载及热穿透温度分布确认记录附表3115满载及热穿透温度分布确认记录附表4生物指示剂培养记录9、验证证书确认结果报告书题目高压蒸汽灭菌锅再确认目的确认DYML-S50LA高压蒸汽灭菌器(120406-ZK-01)在设定的灭菌工艺下能够达到灭菌效果。对象DYML-S50LA高压蒸汽灭菌器(120406-ZK-01)验证结果建议与评价DYML-S50LA高压蒸汽灭菌器(120406-ZK-01)经确认能够符合验证合格

21、标准,在121、115满载及热穿透状态下箱体内温度分布均匀,生物指示剂灭菌完全,可以继续投入使用。验证实施时间2013年10月负责者(部门)质控处再验证周期正常状态下再确认周期为一年;2、若仪器发生重大变更、更改灭菌工艺条件或改变灭菌物品则应立即组织再验证。确认:起草人复核人验证小组组长签名日期附表1:设备运行确认表项目可接受标准结果结论设备情况高压灭菌锅内外表面应无腐蚀或破损。位置与四周、建筑物距离在0.20米以上有足够的空间维护保养密封圈上盖密封圈应完好无撕裂或老化现象灭菌时间应可以设定,设定范围060分钟水位限度信号超出警戒水位,水位指示灯亮起。指示灯设备加热时,加热指示灯应亮起管路管路

22、应密封无泄漏附表2:121满载热分布测试记录(第1次)设备编号:120406-ZK-01温度:位置时间123456789101112T2013-11-17:48121.2121.7121.1122.3121.6121.4121.7122.7120.3122.8121.7121.52.52013-11-17:49121.0121.7121.1122.3121.4121.3121.5122.5120.2122.7121.6121.52.52013-11-17:50121.2121.7121.1122.1121.4121.2121.5122.7120.1122.6121.5121.52.62013-

23、11-17:51121.3121.7121.2122.3121.5121.4121.6122.7120.3122.6121.5121.62.42013-11-17:52121.0121.5121.1122.2121.2121.2121.5122.6119.9122.5121.4121.52.72013-11-17:53121.2121.7121.0122.2121.2121.2121.5122.6120.1122.5121.4121.42.52013-11-17:54120.9121.5121.0122.1121.2121.1121.4122.5119.9122.3121.2121.42.62

24、013-11-17:55121.0121.4120.6122.1121.1121.1121.3122.4119.9122.3121.2121.02.52013-11-17:56121.2121.6120.9122.1121.2121.1121.5122.7120.1122.5121.4121.32.62013-11-17:57120.9121.5121.0122.0121.1121.1121.4122.4120.0122.4121.3121.42.42013-11-17:58120.7121.4120.7121.7120.9121.0121.3122.5119.8122.3121.2121.1

25、2.72013-11-17:59120.7121.6120.9121.9121.1121.1121.4122.6120.0122.3121.2121.32.62013-11-18:00120.9121.5120.8122.0121.1120.9121.3122.5119.8122.2121.1121.22.72013-11-18:01120.8121.4120.9122.0121.1121.0121.4122.6119.9122.2121.1121.32.72013-11-18:02120.9121.7120.8122.0121.1121.0121.5122.4119.9122.3121.21

26、21.22.52013-11-18:03120.6121.0120.6121.7120.8120.9121.1122.2119.3121.8120.7121.02.92013-11-18:04121.0121.7121.1122.3121.4121.3121.5122.5120.2122.7121.6121.52.52013-11-18:05121.2121.7121.1122.1121.4121.2121.5122.7120.1122.6121.5121.52.62013-11-18:06121.3121.7121.2122.3121.5121.4121.6122.7120.3122.612

27、1.5121.62.42013-11-18:07121.0121.5121.1122.2121.2121.2121.5122.6119.9122.5121.4121.52.72013-11-18:08121.2121.7121.0122.2121.2121.2121.5122.6120.1122.5121.4121.42.52013-11-18:09120.9121.5121.0122.1121.2121.1121.4122.5119.9122.3121.2121.42.62013-11-18:10120.7121.4120.7121.7120.9121.0121.3122.5119.8122

28、.3121.2121.12.72013-11-18:11120.7121.6120.9121.9121.1121.1121.4122.6120.0122.3121.2121.32.62013-11-18:12120.9121.5120.8122.0121.1120.9121.3122.5119.8122.2121.1121.22.72013-11-18:13120.8121.4120.9122.0121.1121.0121.4122.6119.9122.2121.1121.32.72013-11-18:14120.9121.7120.8122.0121.1121.0121.5122.4119.

29、9122.3121.2121.22.52013-11-18:15120.6121.0120.6121.7120.8120.9121.1122.2119.3121.8120.7121.02.92013-11-18:16121.0121.7121.1122.3121.4121.3121.5122.5120.2122.7121.6121.52.52013-11-18:17121.2121.7121.1122.1121.4121.2121.5122.7120.1122.6121.5121.52.62013-11-18:18121.3121.7121.2122.3121.5121.4121.6122.7

30、120.3122.6121.5121.62.4最大值121.3121.7121.2122.3121.6121.4121.7122.7120.3122.8121.7121.6最小值120.6121.0120.6121.7120.8120.9121.1122.2119.3121.8120.7121.0测试人/日期:复核人/日期:附表2:121满载热分布测试记录(第2次)设备编号:120406-ZK-01温度:位置时间123456789101112T2013-11-113:55120.9121.3120.9121.8121.0120.8120.9122.2119.8122.2121.6121.32.

31、42013-11-113:56121.0121.5120.9121.9121.0120.9121.1122.2120.0122.3121.7121.52.32013-11-113:57120.9121.2120.9121.8121.0120.9121.1122.1119.8122.1121.6121.32.32013-11-113:58120.7121.3120.8121.7121.0120.7120.9122.1119.8122.1121.4121.32.32013-11-113:59120.7121.2120.5121.6120.9120.7120.9122.0119.7122.1121.

32、4121.22.42013-11-114:00120.7121.3120.6121.6120.9120.7121.0122.2119.8122.0121.4121.32.42013-11-114:01121.0121.3120.8121.8121.0120.8121.1122.1119.6122.2121.7121.12.62013-11-114:02120.8121.1120.8121.8120.9120.7121.1122.1119.7122.0121.5121.22.42013-11-114:03120.7121.2120.7121.7120.8120.7121.1122.1119.71

33、22.1121.4121.22.42013-11-114:04120.8121.3120.7121.7120.9120.9121.1122.1119.8122.1121.5121.32.32013-11-114:05120.7121.1120.7121.9120.9120.7121.0122.0119.7122.1121.4121.22.42013-11-114:06120.6121.0120.5121.6120.9120.7120.9122.1119.7122.0121.3121.22.42013-11-114:07120.7121.0120.5121.6120.8120.6121.0122

34、.2119.7121.9121.4121.22.52013-11-114:08120.4120.9120.4121.5120.6120.6120.9121.9119.5121.8121.1121.02.42013-11-114:09120.7121.2120.6121.7120.9120.7121.1122.2119.9121.8121.4121.42.32013-11-114:10120.7121.3120.8121.7121.0120.8121.1122.2119.9121.9121.4121.42.32013-11-114:11120.7121.2120.5121.6120.9120.7

35、120.9122.0119.7122.1121.4121.22.42013-11-114:12120.7121.3120.6121.6120.9120.7121.0122.2119.8122.0121.4121.32.42013-11-114:13121.0121.3120.8121.8121.0120.8121.1122.1119.6122.2121.7121.12.62013-11-114:14120.8121.1120.8121.8120.9120.7121.1122.1119.7122.0121.5121.22.42013-11-114:15120.7121.2120.7121.712

36、0.8120.7121.1122.1119.7122.1121.4121.22.42013-11-114:16120.8121.3120.7121.7120.9120.9121.1122.1119.8122.1121.5121.32.32013-11-114:17120.7121.1120.7121.9120.9120.7121.0122.0119.7122.1121.4121.22.42013-11-114:18120.6121.0120.5121.6120.9120.7120.9122.1119.7122.0121.3121.22.42013-11-114:19120.7121.0120.

37、5121.6120.8120.6121.0122.2119.7121.9121.4121.22.52013-11-114:20120.4120.9120.4121.5120.6120.6120.9121.9119.5121.8121.1121.02.42013-11-114:21120.7121.2120.6121.7120.9120.7121.1122.2119.9121.8121.4121.42.32013-11-114:22121.0121.3120.8121.8121.0120.8121.1122.1119.6122.2121.7121.12.62013-11-114:23120.81

38、21.1120.8121.8120.9120.7121.1122.1119.7122.0121.5121.22.42013-11-114:24120.7121.2120.7121.7120.8120.7121.1122.1119.7122.1121.4121.22.42013-11-114:25120.8121.3120.7121.7120.9120.9121.1122.1119.8122.1121.5121.32.3最大值121.0121.5120.9121.9121.0120.9121.1122.2120.0122.3121.7121.5最小值120.4120.9120.4121.5120

39、.6120.6120.9121.9119.5121.8121.1121.0测试人/日期:复核人/日期:附表2:121满载热分布测试记录(第3次)设备编号:120406-ZK-01温度:位置时间123456789101112T2013-11-27:54120.8121.0120.5121.9121.0120.7120.7122.1119.2122.6121.1121.43.42013-11-27:55121.0121.4120.8121.9121.1120.9120.9122.2120.0122.3121.1121.12.32013-11-27:56121.1121.4120.9122.0121

40、.2121.0121.1122.4120.0122.6121.2121.42.62013-11-27:57120.9121.4120.9122.0121.0121.0120.9122.2119.9122.5121.2121.32.62013-11-27:58120.8121.3120.7121.8121.0120.9120.9122.2119.9122.2121.0121.02.32013-11-27:59121.0121.4120.9121.9121.0120.9121.0122.2120.0122.2121.1121.02.22013-11-28:00120.7121.2120.7121.

41、9121.0120.8121.0122.1119.8122.3121.1121.12.52013-11-28:01120.6121.1120.6121.7120.9120.6120.9122.0119.7122.1120.9120.92.42013-11-28:02120.7121.2120.8121.7120.9120.7121.0122.2119.7122.1120.9120.92.52013-11-28:03120.6121.0120.5121.6120.8120.7120.9122.0119.7122.1120.8120.92.42013-11-28:04120.6121.2120.6

42、121.6120.9120.7120.8122.1119.8122.1120.8120.92.32013-11-28:05120.7121.1120.6121.7120.9120.7120.9122.0119.8122.1120.9120.92.32013-11-28:06120.7120.9120.5121.5120.9120.6120.9122.0119.7122.0120.7120.82.32013-11-28:07120.9121.2120.8121.7120.8120.7121.1122.1119.9122.1120.9120.92.22013-11-28:08120.8121.11

43、20.8121.7120.9120.7121.1122.1119.8122.0120.9120.82.32013-11-28:09120.5121.0120.5121.6120.6120.6120.9122.0119.6122.1120.8120.92.52013-11-28:10120.7121.2120.8121.7120.9120.7121.0122.2119.7122.1120.9120.92.52013-11-28:11120.6121.0120.5121.6120.8120.7120.9122.0119.7122.1120.8120.92.42013-11-28:12120.612

44、1.2120.6121.6120.9120.7120.8122.1119.8122.1120.8120.92.32013-11-28:13120.7121.1120.6121.7120.9120.7120.9122.0119.8122.1120.9120.92.32013-11-28:14120.7120.9120.5121.5120.9120.6120.9122.0119.7122.0120.7120.82.32013-11-28:15120.9121.2120.8121.7120.8120.7121.1122.1119.9122.1120.9120.92.22013-11-28:16120

45、.8121.1120.8121.7120.9120.7121.1122.1119.8122.0120.9120.82.32013-11-28:17120.5121.0120.5121.6120.6120.6120.9122.0119.6122.1120.8120.92.52013-11-28:18120.9121.4120.9122.0121.0121.0120.9122.2119.9122.5121.2121.32.62013-11-28:19120.8121.3120.7121.8121.0120.9120.9122.2119.9122.2121.0121.02.32013-11-28:2

46、0121.0121.4120.9121.9121.0120.9121.0122.2120.0122.2121.1121.02.22013-11-28:21120.7121.2120.7121.9121.0120.8121.0122.1119.8122.3121.1121.12.52013-11-28:22120.6121.1120.6121.7120.9120.6120.9122.0119.7122.1120.9120.92.42013-11-28:23120.7121.2120.8121.7120.9120.7121.0122.2119.7122.1120.9120.92.52013-11-

47、28:24120.6121.0120.5121.6120.8120.7120.9122.0119.7122.1120.8120.92.4最大值121.1121.4120.9122.0121.2121.0121.1122.4120.0122.6121.2121.4最小值120.5120.9120.5121.5120.6120.6120.7122.0119.2122.0120.7120.8测试人/日期:复核人/日期:附表2:121热穿透分布测试记录(第1次)设备编号:120406-ZK-01温度:位置时间123456789101112T2013-11-213:57121.3121.1120.512

48、1.7121.9121.1121.0121.0120.3122.2121.8121.21.92013-11-213:58121.5121.1120.7121.7122.0121.2121.0121.2120.4122.2121.8121.41.82013-11-213:59121.1121.1120.7121.5122.0121.1120.9121.0120.3122.3121.9121.42.02013-11-214:00120.9120.9120.4121.4121.7121.0120.7120.7120.1122.0121.6121.11.92013-11-214:01121.4121.

49、4120.6122.0122.0121.5121.0121.2120.5122.2121.8121.31.72013-11-214:02121.9121.9121.1122.4122.4121.9121.4121.6120.8122.5122.1121.81.72013-11-214:03121.8121.9121.2122.5122.4121.9121.6121.7120.8122.6122.2121.91.82013-11-214:04121.5121.7121.1122.3122.4121.7121.5121.5120.6122.6122.2121.82.02013-11-214:051

50、21.1121.4120.8121.8121.9121.6121.2121.0120.2122.3121.9121.52.12013-11-214:06120.6120.8120.4121.4121.5121.1120.8120.7119.8122.0121.6121.12.22013-11-214:07120.7121.0120.2121.4121.5121.0120.7120.6119.9122.1121.7120.92.22013-11-214:08120.7120.9120.1121.3121.3120.7120.7120.6119.6121.7121.3120.82.12013-11

51、-214:09120.8121.1120.1121.7121.4121.1120.6120.9119.8121.7121.3120.81.92013-11-214:10120.9121.3120.4121.8121.5121.4120.7120.7119.9121.9121.5121.12.02013-11-214:11120.7121.0120.2121.6121.5121.0120.6120.6119.6121.5121.1120.92.02013-11-214:12120.6120.9120.1121.4121.3121.1120.5120.4119.6121.7121.3120.82.

52、12013-11-214:13121.1121.4120.8121.8121.9121.6121.2121.0120.2122.3121.9121.52.12013-11-214:14120.6120.8120.4121.4121.5121.1120.8120.7119.8122.0121.6121.12.22013-11-214:15120.7121.0120.2121.4121.5121.0120.7120.6119.9122.1121.7120.92.22013-11-214:16120.7120.9120.1121.3121.3120.7120.7120.6119.6121.7121.

53、3120.82.12013-11-214:17120.8121.1120.1121.7121.4121.1120.6120.9119.8121.7121.3120.81.92013-11-214:18120.9121.3120.4121.8121.5121.4120.7120.7119.9121.9121.5121.12.02013-11-214:19120.7121.0120.2121.6121.5121.0120.6120.6119.6121.5121.1120.92.02013-11-214:20120.6120.9120.1121.4121.3121.1120.5120.4119.61

54、21.7121.3120.82.12013-11-214:21120.9121.3120.4121.8121.5121.4120.7120.7119.9121.9121.5121.12.02013-11-214:22120.7121.0120.2121.6121.5121.0120.6120.6119.6121.5121.1120.92.02013-11-214:23120.6120.9120.1121.4121.3121.1120.5120.4119.6121.7121.3120.82.12013-11-214:24121.1121.4120.8121.8121.9121.6121.2121

55、.0120.2122.3121.9121.52.12013-11-214:25120.6120.8120.4121.4121.5121.1120.8120.7119.8122.0121.6121.12.22013-11-214:26120.7121.0120.2121.4121.5121.0120.7120.6119.9122.1121.7120.92.22013-11-214:27120.7120.9120.1121.3121.3120.7120.7120.6119.6121.7121.3120.82.1最大值121.9121.9121.2122.5122.4121.9121.6121.71

56、20.8122.6122.2121.9最小值120.6120.8120.1121.3121.3120.7120.5120.4119.6121.5121.1120.8F0值29.731.126.435.035.031.630.028.923.837.834.531.0测试人/日期:复核人/日期:附表2:121热穿透分布测试记录(第2次)设备编号:120406-ZK-01温度:位置时间123456789101112T2013-11-37:58120.9120.8120.0121.3121.2120.7120.5120.5119.8122.9121.3120.93.12013-11-37:59121

57、.0120.9120.1121.3121.6120.7120.5120.9120.0122.9121.4121.12.92013-11-38:00120.9120.6120.1121.0121.5120.5120.5120.6119.6122.7121.1120.73.12013-11-38:01120.4120.2119.8120.6121.2120.4120.3120.2119.3122.2120.7120.42.92013-11-38:02120.6120.3119.8120.9121.3120.4120.2120.5119.5122.2120.8120.62.72013-11-38:0

58、3120.9120.4120.0120.8121.4120.5120.3120.5119.5122.0120.9120.62.52013-11-38:04121.4121.0120.4121.5121.6120.7120.7121.2120.1122.2121.5121.22.12013-11-38:05121.6121.0120.6121.5122.0120.7121.0121.2120.2122.4121.5121.32.22013-11-38:06121.4121.0120.7121.4121.9121.0120.9121.0120.1122.3121.5121.22.22013-11-

59、38:07120.9120.5120.2121.1121.5120.7120.7120.6119.7122.0121.0120.82.32013-11-38:08120.6120.4119.9120.8121.3120.6120.4120.3119.5121.7120.9120.62.22013-11-38:09120.6120.3120.0121.0121.4120.5120.5120.6119.6121.7120.8120.72.12013-11-38:10121.2120.9120.1121.3121.6120.6120.5120.9120.0121.7121.4121.11.72013

60、-11-38:11121.4120.9120.5121.3121.8120.9120.7121.1120.1122.1121.4121.22.02013-11-38:12121.2120.7120.5121.3121.6120.8120.7120.9120.0122.0121.2121.12.02013-11-38:13120.6120.5120.1121.0121.4120.7120.6120.5119.6121.7121.0120.72.12013-11-38:14121.4121.0120.4121.5121.6120.7120.7121.2120.1122.2121.5121.22.1

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