欧盟OMCL仪器确认附件8：天平的确认

201312 PA/PH/OMCL (12) 77 7R 欧盟OMCL仪器确认附件8：天平的确认 1/2

OMCL Network of the Council of Europe

QUALITY MANAGEMENT DOCUMENT

PA/PH/OMCL (12) 77 7R

QUALIFICATION OF EQUIPMENT

ANNEX 8: QUALIFICATION OF BALANCES

OMCL网络质量管理文件

PA/PH/OMCL (12) 77 7R

仪器确认附件8：天平的确认

Full document title and reference	Qualification of Balances Annex 8 to the OMCL Network Guideline “Qualification of Equipment” PA/PH/OMCL (12) 77 7R
文件全名和索引号	天平的确认 OMCL网络指南“仪器确认”附件8 PA/PH/OMCL (12) 77 7R
Document type	Guideline
文件类型	指南
Legislative basis
法规依据
Date of first adoption	August 2013
首次采纳日期	2013年8月
Date of original entry into force	December 2013
首次生效日期	2013年12月
Date of entry into force of revised document	n/a
修订后文件生效日期	不适用
Previous titles/other references / last valid version	n/a
旧文件标题/其它索引号/最后有效版本	不适用
Custodian Organisation	The present document was elaborated by the OMCL Network / EDQM of the Council of Europe
托管组织	现行文件由OMCL网络/EDQM起草
Concerned Network	GEON
相关网络	GEON

ANNEX 8 OF THE OMCL NETWORK GUIDELINE

“QUALIFICATION OF EQUIPMENT”

QUALIFICATION OF BALANCES

OMCL网络质量管理文件

PA/PH/OMCL (12) 77 7R

仪器确认附件8：天平的确认

1. INTRODUCTION 概述

This document is the 8th Annex to the core document “Qualification of Equipment”, which together should be used when planning, performing and documenting the qualification process of balances.

本文件是“仪器确认”核心文件的第8份附件。在规划、实施和记录天平确认过程中应同时考虑本文件和核心文件。

The core document contains the introduction and general forms for Level I and II of qualification, which are common to all types of instruments.

核心文件中包括了所有类型的仪器通用的第I级和第II级确认所用的概述和通用表格。

Annex 8 contains instrument-related recommendations on parameters to be checked at Level III and IV of qualification and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.

附件9包括与仪器相关第III级和第IV级确认所需检查的参数的建议，以及对应的一般可接受限度，还有可以用来实施这些检查的方法学实际案例。

2. AIM AND SCOPE OF THE GUIDELINE 本指南目标和范围

This guideline describes the requirements for balances (electronic – digital) used in chemical and biological tests in OMCLs.

本指南描述了OMCL在化学和生物检测中所用天平（电子—数字））的要求。

The following types of balances are considered in this guideline (Table 1):

本指南考虑了以下类型的天平（表1）：

Table 1 表1

Type	Ordinary name	Number of digits after decimal position (g)	Accuracy Class
类型	常用名称	小数点后位数	准确度分级
1.	Ultra Micro Balances	7	I
	超微量天平	7	I
2.	Micro Balances	6	I
	微量天平	6	I
3.	Semi-micro Balances	5	I
	半微量天平	5	I
4.	Analytical Balances	4	I
	分析天平	4	I
5.	Precision Balances	1 to 3	II
	精密天平	1至3	II
6.	Technical Balances	0 to 1	III
	技术天平	0-1	III

The classifications are based on the OIML R 76-1 International Recommendation document (see Table 2).

该分类依据为OIML R 76-1国际建议文件（参见表2）。

Accuracy class 准确度分级	Verification scale interval (e) 核查分度值	Number of verification scale intervals 分度值核对值(n=Max/e)		Minimum capacity 最小称量值 (Min) (Lower limit)
		Minimum 最小	Maximum 最大
SpecialⅠ	0.001≤e(*)	50,000(**)	-	100e
High Ⅱ	0.001g≤e≤0.05g 0.1g≤e	100 5,000	100,000 100,000	20e 50e
Medium Ⅲ	0.1g≤e≤2g 5g≤e	100 500	10,000 10,000	20e 20e
OrdinaryⅣ	5g≤e	100	1,000	10e

** For an instrument of class I with d < 0.1 mg, n may be less than 50000. The minimum capacity is reduced to 5 e for grading instruments, i.e. instruments that determine a transport tariff or toll (e.g. postal scales and instruments weighing waste material). On multiple range instruments, the verification scale intervals are e1, e2, …, er with e1 < e2 < … < er. Similar sub-scripts are also used with the terms Min, n and Max.

对于I级天平，如果d< 0.1 mg，n可能会小于50000。最小称量值降低至5e，即用于交通或收费的秤（例如，邮政用秤，和用于称量废物料的秤）。对于多范围天平，核查分度值为e1，e2……er，其中e1 < e2 < … < er。类似脚标也可用于术语Min，n和Max。

On multiple range instruments, each range is treated as if it were an instrument with one range.

对于多范围天平，每个范围都当作是具备一个范围的天平来对待。

For special applications that are clearly marked on the instrument, an instrument may have weighing ranges in classes I and II, or in classes II and III. The instrument as a whole shall then comply with the more severe requirements of 3.9 Variations due to influence quantities and time applicable to either of the two classes (see OIML R76-1 International Recommendation document)

如果仪器上清楚标示的特殊用途，其称量范围可能属于不同级别，如级别I和II或级别II和III。仪器作为一个整体，应符合“3.9由于数量和时间影响引起的波动”中给出的更严格的要求，它适用于2类天平（参见OIMLR76-1国际建议文件）。

Max = Maximum capacity of the balance  天平的最大称量值

e = verification scale interval 核查分度值

e1, ei, er = verification scale interval, rules for indices 核查分度值，指数规则

3. CONSIDERATIONS FOR LEVEL I AND II OF EQUIPMENT QUALIFICATION 仪器第I级和第II级确认考虑

At Level I of the qualification of balances (selection of instruments and suppliers), it is recommended to select a manufacturer of balances that can satisfy the needs of the laboratory and works under ISO 9001 certification.

在天平第I级确认（选择仪器和供应商）中，建议选择可以满足化验室需求，并且在ISO9001认证体系下运行的天平生产商。

At Level II of the qualification of balances (installation and release for use), it is recommended to check all the requirements set during the selection of the instrument and calibration should be performed before putting into service by an accredited external service supplier, or internally by appropriately qualified personnel, using certified reference weights according to an approved procedure.

在天平第II级确认（安装和放行使用）中，建议检查所有仪器选择中设定的要求，在由经过认证的外部服务商提供服务，或者由内部具备适当资质的人员接手管理之前要进行校正。校正要使用经过认证的标准砝码根据批准的程序进行。

4. REQUIREMENTS FOR BALANCE USE 天平使用要求

Location of the Balance 天平定位

The accuracy and precision of weighing results are closely associated with the location of the balance. OMCLs should ensure that the balance can work under optimal conditions (weighing room/laboratory, weighing bench, temperature, light, air, etc.).

称量结果的准确度和精密度与天平的位置紧密相关。OMCL应保证天平在最优条件下工作（称重室/化验室、称重台、温度计、照明、空气等）。

It is recommended that balances of types 1 to 6 (see Table 1 above) are located in a specially designed weighing room that is vibration-proof, dust-free and has an anti-static floor. For substances that are sensible to static electricity it is also possible to use an ionising unit.

建议1-6类天平（参见表1）放置在经过特殊设计的称量室，防震、无尘，地板抗静电。如果称量对静电敏感的物质，也可以使用离子化单元。

If a balance of type 1 to 6 is located in a laboratory outside of the weighing room, then the weighing bench on which it is placed should be in a separate part of the laboratory that is vibration-proof and dust-free. For balances of types 1 to 4, a stable bench should be used.

如果1-6类天平放置在称重室外的化验室里，则摆放天平的称重台应与化验室分开，要防震和无尘。对于1-4类天平，要使用稳定的称重台。

It should be ensured that the weighing bench is stable, no matter from what material it is made. The weighing bench should not deform when work is carried out on it and it must be vibration-proof or the transfer of vibrations must not influence the weighing process. If there is a risk of instability, the balance should be equipped with a stability indicator so that the weight is only registered or printed after stabilisation of the balance.

不管称重台材质是什么，要保证称重台是稳定的。称重时称重台不应变形，称重台必须防震或震动转移必须不得影响称重过程。如果有可能不稳定，则天平应该装配稳定指示器，这样只有在天平稳定后才会登记或打印。

The weighing bench should be non-magnetic (i.e. no steel plates) and protected against electrostatic charges (no plastic or glass).

称重台应该无磁性（即没有铁盘），防止静电产生（没有塑料或玻璃）。

Temperature 温度

As weighing results are influenced by temperature, OMCLs should ensure a constant temperature is maintained in weighing rooms/laboratories. The typical drift of balances of types 1 and 2 is 1-2 ppm/°C. The deviation should not exceed more than 5 °C per hour.

由于称重值受到温度的影响，OMCL应保证在称重间/化验室维持恒定的温度。1类和2类天平的一般飘移量为1-2 ppm/°C。偏差不应超过5 °C/小时。

Atmospheric humidity空气湿度

The optimum relative humidity (% RH) during a weighing process is between 40 % to 60 % for balances of class I and II (see Table 1). The relative humidity may be expanded to 20 % to 80 % in cases where the accuracy and linearity of measurements are not affected.

I级和II级天平在称量时最佳的相对湿度（%RH）为40-60%。如果测量准确度和线性不受影响的话，相对湿度可以放宽到20-80%。

Light 照明

Balances should be protected from direct sunlight (heat).

天平应防止太阳光（热）直射。

Air 空气

OMCLs should not place balances in the airflow of air conditioners or devices with ventilators (such as computers or large laboratory equipment), next to doorways or in areas of high traffic. This is because in addition to the potential temperature drift, strong air currents can interfere with the functioning of balances. If a balance is placed in a laminar flow workstation, e. g. for weighing of toxic material, the cabinet should be suitable for the intended use.

OMCL不应将天平放置在空调或有通风的设备（例如计算机或大型化验室设备）气流下，在门廊或往来人多的地方。这是因为除了潜在的温度飘移外，强气流也会干扰天平的运行。如果天平放置在层流工作站里，例如，为了称量有毒物料，则柜体应适合既定用途。

Weighing vessel 称重用容器

OMCLs must ensure that:

OMCL必须保证

-          the smallest possible weighing vessels are used.

-          使用尽可能最小的称重容器。

-          if the materials that the weighing vessel is made of have a high degree of electrical insulation (such as glass and plastic), they are not electrostatically charged.

-          如果称重容器的材质是高度绝缘材料（例如玻璃和塑料），保证它们不会产生静电。

-          the weighing vessel and the sample it contains should have the same temperature as their surroundings.

-          称重用容器和其所称量的样品应该与其环境具有相同的温度。

-          if the weighing vessel has been removed from a drying oven or dishwasher, it should be cooled to room temperature prior to being placed on the balance.

-          如果称重用容器是从干燥箱或洗涤机中拿出来的，则在放置到天平上之前要冷却到室温。

-          depending on the type of balance, it is recommended to use cotton gloves.

-          根据天平的类型，建议使用棉手套。

-          no magnets should be placed on the balance or into the weighing vessel.

-          磁体不得放置在天平上或称重用容器里。

5. REQUIREMENTS FOR WEIGHTS USED IN THE QUALIFICATION 用于确认的砝码要求

Weights used for qualification should:

确认用砝码应：

-          be clean and, if necessary, wiped with ethanol. In the latter case a waiting time must be taken into account before the weight is used

-          清洁，必要时，使用乙醇擦拭。如果使用乙醇擦拭，在砝码使用之前必须考虑擦拭后等待一定时间。

-          be stored in a dust-free environment.

-          存贮在无尘环境中。

-          be handled with care; the use of cotton gloves or forceps/tweezers is especially recommended.

-          小心取放，特别建议使用棉手套或镊子/钳子。

-          have a suitable accuracy, depending on the type of balance.

-          根据天平的类型具有适当的准确度。

-          be calibrated by an accredited external service provider.

-          由有资质的外部服务商进行校正。

-          be re-calibrated periodically.

-          定期再校正。

-          be clearly marked after each calibration.

-          每次校正之后清楚标示。

-          not be made of magnetisable material.

-          不要用易磁化的材料制作。

-          the verification (in use control, see Table 3) may be done with non-calibrated weights.

-          核查（在用控制，参见表3）时可以使用没有校正过的砝码。

6. FREQUENCY OF QUALIFICATION 确认频次

OMCLs must ensure that qualification/calibration of balances is done on receipt (i.e. immediately after delivery) or prior to their first use and after any repair or move.

OMCL必须保证在接收时（即，收货后立即）或初次使用前，或在修理或移动之后进行天平的确认/校正。

The frequency of qualification/calibration depends on the extent of use of the balances and is at the discretion of individual OMCLs.

确认/校正的频次取决于天平使用程度，由各OMCL自由裁度。

Qualification/calibration must be performed in accordance with a pre-determined protocol in which acceptance criteria are defined. An external calibration should be performed by organisations accredited as calibrating laboratories according to ISO/IEC 17025 or, if performed internally, the laboratory should satisfy the same requirements in terms of measurement standards, calibration procedure, use of certified weights and qualification of personnel.

确认/校正必须根据预定的方案实施。方案中要定义可接受标准。外部校正应由经根据ISO/ICE17025认证为校正实验室的机构实施。如果内部做校正，则实验室应满足相同要求，即相同测量标准、校正程序、使用经过认证的砝码和有资质的人员。

Table 3 prescribes the parameters, typical frequencies and tolerance limits for the qualification of balances for periodic and motivated instrument checks (Level III) and in-use instrument checks (Level IV)

表3描述了定期和主动仪器检查（第III级）和在用仪器检查（第IV级）中天平确认的参数、一般频次和允许限度。

Table 3 表3

Parameter to be checked	Frequency	Typical tolerance limit
要检查的参数	频次	一般允许限度
Levelling	every day before weighing begins	Acceptance limits of the balance
调正	每天使用前	天平的可接受限度
Internal calibration (adjustment) (automatic or manual)	every day before weighing begins	Automatic acceptance limits of the balance
内部校正（调整）（自动或手动）	每天使用前	天平的自动可接受限度
Verification (in use control)	At least once a week	OMCLs shall define their own acceptance criteria
核查（在用控制）	至少每周一次	OMCL应定义其自己的可接受标准
Accuracy	Frequency to be defined by OMCL, typically once a year	OMCLs shall define their own acceptance criteria
准确度	由OMCL定义，一般一年一次	OMCL应定义其自己的可接受标准
Linearity	Frequency to be defined by OMCL, typically once a year	OMCLs shall define their own acceptance criteria (k = 1±0.0001)
线性	由OMCL定义，一般一年一次	OMCL应定义其自己的可接受标准(k = 1±0.0001)
Precision	Frequency to be defined by OMCL, typically once a year	OMCLs shall define their own acceptance criteria (SD = maximum 5*d)
精密度	由OMCL定义，一般一年一次	OMCL应定义其自己的可接受标准(SD = maximum 5*d)
Eccentricity	Frequency to be defined by OMCL, typically once a year	OMCLs shall define their own acceptance criteria (RSD = 0.05%)
四角误差	由OMCL定义，一般一年一次	OMCL应定义其自己的可接受标准(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 in Table 3 (recommended, not obligatory):

除了表3中所述的项目外，还可以进行确认测试项目（建议，并非强制）：

Parameter to be checked	Frequency (recommended)	Typical tolerance limit
要检查的参数	频次（建议）	一般允许限度
Linearity error	once every six months	OMCLs shall define their own acceptance criteria (≤ accuracy of the balances)
线性误差	第6个月一次	OMCL应定义其自己的可接受标准（≤天平准确度）
Drift test	once every six months	OMCLs shall define their own acceptance criteria (RSD = 0.05%)
飘移测试	每6个月一次	OMCL应定义其自己的可接受标准（RSD = 0.05%）
Minimum weight	once a year	OMCLs shall define their own acceptance criteria depending on the type of the balance
最小称量	每年一次	OMCL应根据天平类型定义其自己的可接受标准
Measurement uncertainty	once a year	OMCLs shall define their own acceptance criteria depending on the type of the balance
测量不确定度	每年一次	OMCL应根据天平类型定义其自己的可接受标准

7. QUALIFICATION PROCEDURE 确认程序

Verification 核查

Verification of the balance is performed by placing a suitable weight (depending on the type of balance) in the centre of the weighing pan once and comparing the result with pre-defined acceptance criteria. The same weight should always be used in these verifications.

天平核查时，在称重盘中心放置适当重量的砝码（根据天平类型不同而不同），将实测结果与预定的可接受标准进行比较。在此核查中应一直使用同一只砝码。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL自行确定。

Accuracy 准确度

The accuracy of the balance is checked by weighing at least three different certified weights that cover the usual weighing range of the balance. It is recommended that the weights have approximately 5%, 50% and 100% of the maximum capacity of the balance (or of the maximum weight used on the balance), depending on the type of balance. It is recommended that the weighing is repeated at least 5 times for every weight, particularly, when the results shall also be used in the test for precision.

天平准确度应采用至少3个不同重量的经过认证的标准砝码来检查。3个砝码重量应覆盖天平日常使用范围。根据天平的类型，建议砝码重量为天平最大称量值的5%、50%和100%（或者是天平所用最大砝码）。建议每个砝码至少称量5次，尤其是当结果也用于精密度测试时。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL确定。

Linearity 线性

The results obtained from a series of accuracy checks can be used to calculate the correlation coefficient and to check for linearity. The correlation coefficient is calculated by comparing the nominal and measured masses of the weights.

从准确度检查中所获得的结果可以用来计算相关系数，检查线性。相关系统是从名义值和实测值计算所得。

The acceptance criteria for the correlation coefficient shall be defined by each individual OMCL.

相关系统的可接受标准应由各OMCL自行确定。

(Proposed criterion: k = 1±0.0001).

（建议标准：k = 1±0.0001）

Precision 精密度

The precision of the balance should be verified by weighing at least 5 times a weight that is equivalent to approximately 50% of the maximum capacity of the balance. It is recommended to repeat the test with a weight that is equivalent to approximately 5% of the maximum capacity of the balance, if the balance is used at the lower range.

天平的精密度应采用天平最大称量值约50%重量的砝码称量至少5次来确定。如果天平实际所用称重量处于范围内较低处，建议采用天平最大称量值约5%重量的砝码重复此测试。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL自行确定。

(Proposed criterion: SD = max 5*d, where d = (actual) scale interval (e.g. d=0.1 mg)).

（建议标准：SD = 最大5d，此外d值=（实际）分度值（例如，d=0.1mg））。

Eccentricity四角误差

The eccentricity test should be carried out using a weight equivalent to at least 30% of the maximum capacity of the balance (or of the maximum weight used on the balance). The weight should be placed between halfway to ? of the distance from the centre of the pan to its edge and be measured at each location in the following sequence: centre, front left, back left, back right, front right, and (optional) again centre.

四角误差采用约为天平最大称量值30%左右（或者是天平所用的最大砝码）的砝码测试。砝码应当放置在称量盘中心至其边缘3/4距离的中间，在每边放置次序如下：中央、左前、左后、右前、右后、（最好）再次中央。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL自行确定

(Proposed criterion: RSD not more than 0.05%, calculated from all weighings at different locations on the pan).

（建议标准：RSD不得过0.5%，由放置在称量盘不同位置的所有称量结果计算）

201312 PA/PH/OMCL (12) 77 7R 欧盟OMCL仪器确认附件8：天平的确认 2/2  

Linearity error 线性误差

Linearity error is tested at least 3 times using four weights of defined masses whose aggregate total mass is approximately equal to half of the maximum capacity, depending on the type of balance.

线性误差采用指定质量的4个砝码分别测量至少3次。根据天平类型的不同，4只砝码总质量应约为最大称量值的一半。

First, the combined mass of all four weights is weighed and recorded. Then, two sub-sets of weights are made and their masses are recorded.

首先，称量所有4只砝码的总重量并记录读数。然后，将砝码两两组合称量并记录读数。

The linearity error of the balance is an absolute value calculated by the difference between the combined mass of all four weights and the sum of the masses from the two sub-sets of weights, divided by 2.

计算所有4只砝码的总重量和两两组合时砝码的总重量之间的差异绝对值，除以2即为天平的线性误差。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL自行定义。

(Proposed criterion: linearity error ≤ accuracy of the balances).

（建议标准：线性误差≤天平的准确度）

Drift test 飘移测试

A drift test is only performed on 5, 6 or 7 decimal scale balances. It is carried out by repeated measurements (every 5 minutes for 30 minutes) of a control weight (depending on the type of balance) in the morning and afternoon.

飘移测试只是针对天平的小数点后第5、6、7位。在上午和下午采用受控砝码（根据天平类型不同而不同）重复测量（每5分钟一次，持续30分钟）。

The mean measurement, standard deviation and relative standard deviation can be calculated from the resulting data. The drift can also be extracted from the trend analysis of the verification test (Table 3).

对测量结果计算平均值、标准偏差和相对标准偏差。飘移值也可以从核查测试数据的趋势分析中提取出来。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL自行定义。

(Proposed criterion: RSD = 0.05%).

（建议标准：RSD = 0.05%）

Minimum weight 最小称量值

The minimum weight value depends on the type of balance. It is determined from technical data and the external calibration certificate.

最小称量值取决于天平的类型。这是从技术数据和外部校正证书来确定的。

The acceptance criteria shall be defined by each individual OMCL.

可接受标准应由各OMCL自行确定。

(Proposed criterion: tolerance 0.5%, k=3 for class I balances and 1%, k=3 for class II and III balances).

（建议标准：I级天平允差0.5%，k=3，II级和III级天平1%，k=3）。

Measurement uncertainty 测量不确定度

The measurement uncertainty can be calculated according to GUM or other relevant documents or can be determined from the external calibration certificate.

测量不确定度可以根据GUM或其它相关文件来计算，也可以根据外部计算证书的结果来确定。

A simplified procedure is proposed as follows:

简化程序建议如下：

A weight of approximately 50% of the maximum capacity of the balance (depending on the type of balance) is weighed at least 10 times and the mean measurement, standard deviation and relative standard deviation are calculated.

取约为天平最大称量值（根据天平类型不同而不同）50%的砝码，称重至少10次，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.

可接受标准应由各OMCL自行定义。

Proposed criterion: measurement uncertainty is satisfactory if three times the standard deviation 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.

建议标准：如果10次重复测量值的标准偏差乘以3，除以所称的重量（约为天平最大称量值的50%）不超过0.001，则认为测量不确定度令人满意。

Alternatively to the above described qualification procedures the OMCL may use the guide OIML R76-1 from the International Organisation of Legal Metrology (current edition, see point 10. References).

如果不采用上述确认程序，OMCL也可以使用国际法定计量组织指南OIML R76-1（现行版本，参见参考文献第10点）。

8. QUALIFICATION REPORT 确认报告

After the qualification procedure, OMCLs should appropriately record the results.

在确认完成后，OMCL应恰当记录结果。

The following minimum information should be included:

应最少包括以下信息：

-          Title of the report

-          报告标题

-          Identification of the report

-          报告编号

-          Version number of the master copy.

-          主文件的版本号

-          Entity that performed the qualification.

-          实施确认的主体

-          Page numbering.

-          页码

-          Date.

-          日期

-          Unique identification of the weights used and their qualifications (unless specified in another quality document). Traceability to certificates must be provided.

-          所用砝码唯一识别号及其证书（除非在另一质量文件里说明）。必须写明证书的可追溯性。

-          Unique identification of the balances.

-          天平的唯一识别号

-          Qualification results and acceptance criteria.

-          确认结果和可接受标准

-          Conclusion (e.g. PASS/FAIL).

-          结论（例如，合格/不合格）

-          Name and signature of the operator who performed the qualification.

-          实施确认的人员姓名和签名

-          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).

-          放行天平使用的负责人姓名和签名（最好是与实施确认的人员不同的人员）

Note: 注

If an OMCL requests qualification/calibration from an external company, it must be ensured that this minimal information is contained in the external calibration report/certificate. The responsible person in the OMCL should evaluate and approve this report/certificate as a release for use of the balances.

如果一个OMCL要求一个外部公司进行确认/校正，则必须保证最少有这些信息包括在外部校正报告/证书里。OMCL负责人应评估和批准此报告/证书来放行天平的使用。

9. GLOSSARY 术语

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 being measured.

准确度是测量值与被测质量的真值接近的程度。

Calibration 校正

Calibration is a demonstration that an instrument or a device produces results within specified limits when compared to those produced by a standard (or a reference standard that is traceable to a national or international standard) over an appropriate range of measurements.

校正是证明一台仪器或装置在一个适当的测量范围内，所产生的结果相比于由标准（或者是可以追踪至国家或国际标准的对照标准物）产生的结果，其误差在指定限度内。

Calibration is a determination of the deviation between measurements and the true value under specified measuring conditions.

校正是在指定的测量条件下，确定测量值与真实值之间的误差。

Drift (Sensitivity Drift ) 飘移

Drift is a progressive (continuously upward or continuously downward) change in the display of the digital readouts of balances, which means that weight readings are not stable.

标称是天平读数时显示值的持续变化（持续增加或持续减少），它表示重量读数不稳定。

Environmental factors affect instrument stability (drift): e. g. temperature, static electricity, air flow and vibrations.

环境因素影响仪器稳定性（飘移）：例如，温度、静电、气流和震动。

Eccentricity 四角误差

Eccentricity is an error relating to variations in the positioning of weights on the weighing pan.

四角误差是与砝码在称重盘上摆放位置差异有关的误差。

Levelling 水平测试

Levelling is a procedure to ensure the balance is in the horizontal position.

水平测试是保证天平处于水平位置的程序。

Linearity 线性

Linearity refers to the ability to deliver identical sensitivity throughout the weighing capacity of a balance.

线性指一台天平在整个称重范围内传递相同感应的能力。

Linearity error 线性误差

Linearity error is the difference between the digital display for a weight that weighs 50% of the full weighing capacity of the instrument and its true mass.

线性误差是指50%的最大称量值处天平显示值与所用砝码真实质量之间的差异。

Measurement uncertainty 测量不确定度

Measurement uncertainty is a parameter, associated with the result of a measurement,  that characterises the dispersion of the values that could reasonably be attributed to the measurement variable (VIM 3.9).

测量不确定度是一个参数，与测量结果一起，表示可以合理归因于测量变量的值的分散特性。

Measurement uncertainty is generally expressed by the standard uncertainty u or the expanded measurement uncertainty U(confidence interval). There are several ways of calculating the measurement uncertainty, one of them is given in the GUM.

测量不确定度通常采用标准不确定度u或者扩展测量不确定度U（置信区间）来表述。计算测量不确定度有几种方法，在GUM里给出了其中一个。

Precision 精密度

Precision is a measure of the reproducibility of results from independent measurements.

精密度是单个测量结果可重现性的衡量。

Qualification 确认

See OMCL Guideline “Qualification of equipment – Core document”, PA/PH/OMCL (08) 73 2R.

参见OMCL指南“仪器确认—核心文件”，PA/PH/OMCL (08) 73 2R。

Weights 砝码

Weights are objects, regulated in regard to their physical and metrological characteristics such as shape, dimensions, material, surface quality, nominal value, density, magnetic properties and maximum permissible error.

砝码是物体，受到其物理和计量学特性的约束，如形状、尺寸、材质、表面质量、名义值、比重、磁性特性和最大允许误差。

10. REFERENCES 参考文献

?  OIML R 111-1(E), current edition (E), (OIML = International Organisation of Legal Metrology).

?  OIML R 76-1(E), current edition.

?  METTLER TOLEDO guidelines 梅特勒托利多指南

· Proper Weighing with Laboratory Balances 正确使用实验室天平称量

· Good Weighing Practice? 优良称重规范

?  ILAC G24 2007 (OIML D10 2007) GUIDELINES FOR THE DETERMINATION OF CALIBRATION INTERVALS OF MEASURING INSTRUMENTS

?  ILAC G24 2007 (OIML D10 2007)测量仪器校正周期确定指南

?  INTERNATIONAL VOCABULARY OF METROLOGY – BASIC AND GENERAL CONCEPTS AND ASSOCIATES TERMS (VIM), JCGM 100: 2008

?  国际计量词汇—基本和通用概念和相关术语（VIM），JCGM 100: 2008

?  EVALUATION OF MEASUREMENT DATA – GUIDE TO THE EXPRESSION OF UNCERTAINTY IN MEASUREMENT (GUM), JCGM 200: 2008

?  测量数据的评估—测量中不确定度（GUM）的表述指南，JCGM 200: 2008

?  ILAC P10: 2013, ILAC POLICY ON THE TRACEABILITY OF MEASUREMENT RESULTS

?  ILAC P10: 2013,测量结果可追溯性ILAC原则

?  ISO 9001

?  EURAMET cg-18, Version 3.0, 2011

?  US Pharmacopoeia <41 >美国药典<41>

?  Internet pages: 网页

http://www.msl.irl.cri.nz/sites/all/files/training-manuals/tg25-december2-2010.pdf

http://gmponblog.vinvarun.biz/2008/08/sop-calibration-of-balances.html

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