天平验证

美泰科技（青岛）有限公司

MEITEK TECHNOLOGY (QINGDAO)CO. ,LTD.

十万分之一电子天平再验证方案

One hundred thousandth electronic balance Validation Protocol

目录

Table of Contents

1 概述Overview (3)

2 再验证目的Validation Purpose s (3)

3 再验证要求Validation Conditions... (3)

4 再验证合格标准Validation Criterion ......... (3)

5 方案实施Implementation of the protocol (3)

6 采用文件Reference Documents (3)

7 再验证内容与方法Contents and Methods of Validation (3)

8 再验证数据分析The analysis of validation dat a (4)

9 验证结果与结论Result and conclusion of validation (5)

10 附件Appendix (5)

1.概述Overview

1.1电子天平型号Electronic Balance Model：BT25S 设备编号Equipment No.：QC62Y011

1.2该设备由德国赛多利斯股份公司制造，安装在天平室。

This equipment which Installed in the balance room is produced by Germany Sartorius AG

2.再验证目的Validation Purposes

确认该仪器的称量示值误差、重复性、及其自动校准功能等技术指标经过一年的使用后仍旧能够符合要求。

Confirm that the largest weighing range, repeatability, error range of the equipment meet the required technical specifications and in accordance with the inspection requirements.

3.再验证要求Validation requirements

3.1验证前检查该设备的使用记录及其日常维护保养测试记录。

Before the validation,Confirm the equipment documents and spare parts are complete.

3.2验证前必须对BT25S型电子天平进行每年一次的校验。

Before the validation, Confirm the installation, operation of BT25S-type electronic balance and in accordance with the requirements of inspection weighing .

3.3验证前必须对所用的校准砝码确定有效。

Before the validation, Confirm the process of calibration weight of the trial used to effective

4.再验证合格标准The validation Criterion

4.1BT25S型电子天平的称量示值误差范围为20.0000g±1mg。

BT25S-type electronic balance sensitivity test weight is 20.0000g ± 1mg.

4.2BT25S型电子天平的重复性实验合格标准：标准偏差≤0.02mg

BT25S-type electronic balance's eligibility criteria of reproducibility experimental: standard deviation is not more than 0.02mg.

4.3BT25S型电子天平的自动校准功能正常。

5.方案实施Implementation of the protocol

本验证方案计划于2010年01月04日－01月 05日进行验证

The validation program is planned for verifying in December 21, 2008 to December 24 由验证小组：杨平、钟迪仕、李霄、吴晓飞负责实施。

By the validation team: Yang Ping, Liu Qiang,Liu Xiangwen,WuXiaofei, is responsible to implement.

6.采用文件Reference Documents

SOP-SB-QC022

7.再验证内容与方法Contents and Methods of Validation

7.1日常使用记录检查及运行测试。

7.1.1目的：根据设备SOP-SB-QC022进行操作，确认该设备运行正常。

Objective: operate the equipment in accordance with the equipment SOP-SB-QC022 。

7.1.2检查项目（检查结果在□划“√”）Check the item (the results in the □ zoned "√")

7.1.2.1按键功能、显示器Button functions, display