EDQM附件天平确认中英.docx

Table 3Parameter to be checked待检查参数Frequency频次Typical tolerance limit可接受标准Levelling 找平every day beforeweighing begins每天称量前Acceptance limits of the balance 天平的可接受限度Internal calibration (adjustment)(automatic or manual) 内校（自动或手动）every day beforeweighing begins每天称量前Automatic acceptance limits of the balance天平的自动接受限度Verification (in usecontrol)验证（使用时控制）At least once a week每周至少一次OMCLs shall define their ownacceptance criteria需制订专门的接受标准Accuracy准确度Frequency to be definedby OMCL, typically oncea year 典型1年1次OMCLs shall define their ownacceptance criteria需制订专门的接受标准Linearity线性Frequency to be definedby OMCL, typically oncea year典型1年1次OMCLs shall define their ownacceptance criteria需制订专门的接受标准(k = 10.0001)Precision精密度Frequency to be definedby OMCL, typically oncea year典型1年1次OMCLs shall define their ownacceptance criteria需制订专门的接受标准(SD = maximum 5*d)Eccentricity偏心率Frequency to be definedby OMCL, typically oncea year典型1年1次OMCLs shall define their ownacceptance criteria需制订专门的接受标准(RSD = 0.05%)k = correlation coefficient 相关系数SD = standard deviation 标准偏差RSD = relative standard deviation相对标准偏差The following qualification tests may also be performed in addition to those described inTable 3 (recommended, not obligatory): 表3中可能还需有以下确认内容（推荐，非强制）：Parameter to be checked待检查参数Frequency (recommended)频次（推荐）Typical tolerance limit可接受标准Linearity error线性误差once every six months每6个月1次OMCLs shall define their ownacceptance criteria (accuracy of the balances) 需制订专门的接受标准（天平的准确度）Drift test 漂移测试once every six months每6个月1次OMCLs shall define their ownacceptance criteria需制订专门的接受标准(RSD = 0.05%)Minimum weight 最小称样量once a year每年一次OMCLs shall define their ownacceptance criteria depending on the type of the balance根据天平类型制订专门的接受标准Measurement uncertainty称量不确定度once a year每年一次OMCLs shall define their ownacceptance criteria depending on the type of the balance根据天平类型制订专门的接受标准7. QUALIFICATION PROCEDURE 确认程序Verification 验证Verification of the balance is performed by placing a suitable weight (depending on the typeof balance) in the centre of the weighing pan once and comparing the result with pre-definedacceptance criteria. The same weight should always be used in these verifications.天平的验证是通过将适当的砝码（根据天平的类型选择）放置在秤盘中心测定，结果与预先设定的标准进行比较。在验证中应一直使用相同的砝码。The acceptance criteria shall be defined by each individual OMCL.每个实验室自行制订可接受标准。Accuracy准确度The accuracy of the balance is checked by weighing at least three different certified weightsthat cover the usual weighing range of the balance. It is recommended that the weights haveapproximately 5%, 50% and 100% of the maximum capacity of the balance (or of themaximum weight used on the balance), depending on the type of balance. It is recommendedthat the weighing is repeated at least 5 times for every weight, particularly, when the resultsshall also be used in the test for precision.天平的准确度应至少由三个不同的标准砝码进行检查，应涵盖天平的通常称量范围。建议使用的砝码为天平最大称量量（或天平正常使用的最大重量）的约5，50，100，这取决于天平的类型。建议每个砝码至少重复称量5次，称量结果还可在精度检查中使用。The acceptance criteria shall be defined by each individual OMCL.每个实验室自行制订可接受标准。Linearity线性The results obtained from a series of accuracy checks can be used to calculate the correlationcoefficient and to check for linearity. The correlation coefficient is calculated by comparingthe nominal and measured masses of the weights.从准确度检查中获得的一系列结果可以用于计算相关系数，并检查线性。相关系数是通过砝码名义值和测量值的比较得出。The acceptance criteria for the correlation coefficient shall be defined by each individualOMCL. (Proposed criterion: k = 10.0001).相关系数的可接受标准由每个实验室自行制订。（建议标准：k = 10.0001）Precision精度The precision of the balance should be verified by weighing at least 5 times a weight that isequivalent to approximately 50% of the maximum capacity of the balance. It is recommendedto repeat the test with a weight that is equivalent to approximately 5% of the maximumcapacity of the balance, if the balance is used at the lower range.天平的精度验证是通过将相当或约天平最大称量量50%的砝码至少重复测定5次。如果天平使用较低的称量范围，此项测试建议用相当或接近于天平最大称量量5%的砝码进行。The acceptance criteria shall be defined by each individual OMCL.(Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. d=0.1 mg).每个实验室自行制订可接受标准。（建议标准：SD = max 5*d, d = (实际)分度值 (例如 d=0.1 mg)）Eccentricity偏载The eccentricity test should be carried out using a weight equivalent to at least 30% of themaximum capacity of the balance (or of the maximum weight used on the balance). Theweight should be placed between halfway to of the distance from the centre of the pan to itsedge and be measured at each location in the following sequence: centre, front left, back left,back right, front right, and (optional) again centre.偏载测试应使用至少相当于天平最大称量量（或天平正常使用的最大重量）30的砝码进行。砝码放置的位置应在秤盘中心到边缘的1/2到3/4处，在每个位置按如下顺序进行测量：中心，前左，后左，右后，右前，和（可选）中心。The acceptance criteria shall be defined by each individual OMCL.(Proposed criterion: RSD not more than 0.05%, calculated from all weighings at differentlocations on the pan).每个实验室自行制订可接受标准。（建议标准：RSD0.05%，通过秤盘不同位置的称量值计算）Linearity error线性误差Linearity error is tested at least 3 times using four weights of defined masses whose aggregatetotal mass is approximately equal to half of the maximum capacity, depending on the type ofbalance.线性误差是使用4只标准砝码至少测试3次。砝码的总质量应约等于天平最大称量量的一半，取决于天平类型。First, the combined mass of all four weights is weighed and recorded. Then, two sub-sets ofweights are made and their masses are recorded. 首先，将4只砝码分别测定，记录。然后确定两个子集砝码，记录质量。The linearity error of the balance is an absolute value calculated by the difference between thecombined mass of all four weights and the sum of the masses from the two sub-sets ofweights, divided by 2.天平的线性误差的计算：4个砝码的总质量与2个子砝码质量和的差值绝对值，再除以2。The acceptance criteria shall be defined by each individual OMCL.(Proposed criterion: linearity error accuracy of the balances).每个实验室自行制订可接受标准。（建议标准：线性误差天平的准确度）Drift testA drift test is only performed on 5, 6 or 7 decimal scale balances. It is carried out by repeatedmeasurements (every 5 minutes for 30 minutes) of a control weight (depending on the type ofbalance) in the morning and afternoon.仅5，6或7十进制规模的天平进行漂移测试。采用特定质量的砝码（取决于天平类型）在上午和下午重复测量（30分钟内每5分钟测定）。The mean measurement, standard deviation and relative standard deviation can be calculatedfrom the resulting data. The drift can also be extracted from the trend analysis of theverification test (Table 3).根据测量结果可以计算平均值，标准偏差和相对标准偏差。漂移也可以从验证测试的趋势分析中得出（表3）。The acceptance criteria shall be defined by each individual OMCL.(Proposed criterion: RSD = 0.05%).每个实验室自行制订可接受标准。（建议标准：RSD = 0.05%）Minimum weight最小称量The minimum weight value depends on the type of balance. It is determined from technicaldata and the external calibration certificate.最小重量值取决于天平的类型。需要有技术支持数据和外部校准证书。The acceptance criteria shall be defined by each individual OMCL.(Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and IIIbalances).每个实验室自行制订可接受标准。（建议标准：允差0.5，K=3（I级天平），允差1，K=3，（适用于II级和III天平）Measurement uncertainty测量不确定度The measurement uncertainty can be calculated according to GUM or other relevantdocuments or can be determined from the external calibration certificate.测量不确定度可根据GUM或其他相关文件计算得出或可以根据外部校准证书来确定。A simplified procedure is proposed as follows:A weight of approximately 50% of the maximum capacity of the balance (depending on thetype of balance) is weighed at least 10 times and the mean measurement, standard deviationand relative standard deviation are calculated.简化验证程序建议如下：用约50%天平最大称量量的砝码（取决于天平类型）进行称重，至少10倍，计算平均值，标准偏差和相对标准偏差。The acceptance criteria shall be defined by each individual OMCL.Proposed criterion: measurement uncertainty is satisfactory if three times the standarddeviation of not less than ten replicate weight measurements, divided by the amount weighed(approximately 50 % of the maximum capacity of the balance), does not exceed 0.001.每个实验室自行制订可接受标准。（建议标准：如3倍的不少于10次测量值的标准偏差除以砝码质量（约为天平最大称量量50），值不超过0.001）Alternatively to the above described qualification procedures the OMCL may use the guideOIML R76-1 from the International Organisation of Legal Metrology (current edition, seepoint 10. References). 实验室操作中，以上确认程序可根据国际计量组织R76-1 OIML指南（最新版本，请参阅参考资料10）进行替代测试。8. QUALIFICATION REPORT确认报告After the qualification procedure, OMCLs should appropriately record the results.The following minimum information should be included:- Title of the report- Identification of the report- Version number of the master copy.- Entity that performed the qualification.- Page numbering.- Date.- Unique identification of the weights used and their qualifications (unless specified inanother quality document). Traceability to certificates must be provided.- Unique identification of the balances.- Qualification results and acceptance criteria.- Conclusion (e.g. PASS/FAIL).- Name and signature of the operator who performed the qualification.- Name and signature of the person responsible for the release for use of the balances(preferably a different person from the operator who performed the qualification).确认程序完成后，OMCLs应该适当地记录结果。信息应至少包括一下：- 报告标题- 报告类型- 主副本的版本号。- 已执行的确认内容。- 页码。- 日期。- 标准砝码的唯一标识和其确认证明（除非用另一种质量文件表示）。必须提供可追溯的证书。- 天平的唯一标识。- 确认结果和验收标准。- 结论（例如：通过/ 失败）。- 操作人及签名。- 放行人及签名（最好与确认执行人不是同一人）。Note:If an OMCL requests qualification/calibration from an external company, it must be ensuredthat this minimal information is contained in the external calibration report/certificate. Theresponsible person in the OMCL should evaluate and approve this report/certificate as arelease for use of the balances.注意：如果实验室请外部公司进行确认/校准，必须确保报告中的最少信息包含在外部校准报告/证书中。实验室负责人应评估和批准本报告/证书作为天平使用的放行证明。9. GLOSSARY 结语Terms and definitions: 术语和定义：Accuracy准确度Accuracy is the degree of closeness of a measurement to the true value of the quantity beingmeasured.准确度是测量值与质量真值的接近度。Calibration校准Calibration is a demonstration that an instrument or a device produces results within specifiedlimits when compared to those produced by a standard (or a reference standard that istraceable to a national or international standard) over an appropriate range of measurements.Calibration is a determination of the deviation between measurements and the true valueunder specified measuring conditions.校准是在适当的量程范围内，与一参比标准（或可追溯的国家或国际标准）比较产生的结果证明某一特定的仪器或设备产生的结果在规定的限度范围内的过程。校准是在规定的测量条件下测量值和真值之间的偏差判定。Drift (Sensitivity Drift ) 漂移（灵敏度漂移）Drift is a progressive (continuously upward or continuously downward) change in the displayof the digital readouts of balances, which means that weight readings are not stable.Environmental factors affect instrument stability (drift): e. g. temperature, static electricity, airflow and vibrations.漂移是天平读数显示一个渐进的（连续向上或向下）改变，这意味着重量读数是不稳定的。环境因素对仪器稳定性的影响（漂移）：如温度，静电，空气流动和振动。Eccentricity偏载Eccentricity is an error relating to variations in the positioning of weights on the weighingpan.偏载是与砝码在秤盘不同位置产生的测量误差。Levelling找平Levelling is a procedure to ensure the balance is in the horizontal position.找平是指确保天平处于水平位置的操作。Linearity线性Linearity refers to the ability to deliver identical sensitivity throughout the weighing capacityof a balance.线性是指天平在称量范围内提供相同灵敏度的能力。Linearity error线性误差Linearity error is the difference between the digital display for a weight that w