Serological Pipets Quality Final Check List xxx最终质量检查表 | |||||||||||
送检单号 Application Inspection Number | 20210321-001 | 检验日期 Inspection Date | 2021-03-21 | ||||||||
目录号/规格 Cat# or Part# | /50ml | 检验编号 Inspection Number | |||||||||
批号 Lot Number | 数量 Quantity(CS/PCS) | 190cs / 19000pcs | |||||||||
检验项目及结果 Inspection Item and Result | |||||||||||
检验项目及标准 Inspection Item and Standard | 接收水平 Acceptance Level | 检验结果 Inspection Result | |||||||||
检验水平 Quality Level | 样品数 Sample Size |
收：退 Ac:Re |
结果 Result |
判断 Judgement | |||||||
外观 Appearance |
产品 Products | Level II | C=0 | 315 | 0:1 | 符合/Meet criteria |
PASS | ||||
MI 1.5 | 315 | 10:11 | 符合/Meet criteria | ||||||||
内包装 Inner-package | Level II | C=0 | 315 | 0:1 | 符合/Meet criteria |
PASS | |||||
MI 1.5 | 315 | 10:11 | 符合/Meet criteria | ||||||||
外包装 Outer-package | Level II | C=0 | 32 | 0:1 | 符合/Meet criteria |
PASS | |||||
MI 1.5 | 32 | 1:2 | 符合/Meet criteria | ||||||||
性能 Function | 容 量 ： 允 差 ：±2% Capacity: Graduation are calibrated for accurate dispensing to within ±2% |
C=0 |
10 |
0：1 |
最大值 Max：51.0ml 最小值Mix：49.0ml 平均值 Mean：50.0ml |
PASS | |||||
密封性 Sealing property | C=0 | 10 | 0：1 | 符合/Meet criteria | PASS | ||||||
油墨牢固度 Ink Fastness | C=0 | 10 | 0：1 | 符合/Meet criteria | PASS | ||||||
管头超声强度 Ultrasonic intensity of top end |
C=0 |
10 |
0：1 |
符合/Meet criteria |
PASS | ||||||
流出时间 Outflow | C=0 | 10 | 0：1 | 符合/Meet criteria | PASS | ||||||
生物性能Biological Performance |
无菌 Sterilized(SAL=10-6) |
C=0 |
3 |
0：1 | 样品 Samples：- - - 阳性对照 Positive：+ + + 阴性对照 Negative：- - - |
PASS | |||||
热原≤0.5EU/ML Non-Pyrogenic (≤0.5EU/ML) |
C=0 |
3 |
0：1 | 样品 Samples：- - - 阳性对照 Positive：+ + + 阴性对照 Negative：- - - |
PASS | ||||||
细胞毒性 Cytotoxicity |
C=0 |
3 |
0：1 | 样品 Samples：- - - 阳性对照 Positive：+ + + 阴性对照 Negative：- - - |
PASS | ||||||
最终判断 Final Judgement | 接收 Accept | √ | 拒收 Reject | ||||||||
签名 Signature | |||||||||||
检验员Inspector | 审核人 Approval | ||||||||||
