Weighing According to Ph. Eur.

White Paper
Ensuring Compliance with Chapter 2.1.7

This white paper describes the weighing requirements according to the European Pharmacopoeia
General Chapter 2.1.7 ‘Balances for analytical purposes’. Compliance with calibration,
performance checks and the life-cycle management defined within this chapter is mandatory
when working according Ph. Eur. monographs.

Table of Contents
1. Introduction 2
2. Role of Pharmacopoeias 2
3. Equipment Performance 3
3.1. Requirements Overview 3
3.2. Calibration 4
3.3. Performance Checks 5
3.3.1. Repeatability Requirement – Minimum Weight 5
3.3.2. Accuracy Requirement 7
3.4. Usage of Built-in Adjustment Weights 9
3.5. Consideration of a Safety Factor 9
4. Summary / Conclusion 10
5. References 11
 1. Introduction
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Weighing is one of the key activities carried out in every quality control (QC) laboratory. It is usually one of
the first steps in an analysis chain, such as the preparation of a sample or a standard for subsequent dilution
and analysis by HPLC or qNMR. For many decades, the United States Pharmacopeia (USP) has set stringent
requirements for balances used for weighing analytes for quantitative measures in its General Chapter 41
“Balances” [1, 2]. These requirements should ensure that weighing errors are small or even negligible within
the analysis. Other Pharmacopoeias have not previously defined similar requirements. This situation changes
from July 2021, when a General Chapter for balances is published in the European Pharmacopoeia (Ph. Eur.) [3].
This General Chapter 2.1.7 “Balances for Analytical Purposes” stipulates requirements that are very closely
aligned with the respective requirements of the USP. The new chapter is mandatory for any weighing procedure
described in a Ph. Eur. monograph from January 1, 2022 and legally enforceable from that date onwards.

This white paper details the weighing requirements of the European Pharmacopoeia, and provides advice
on how to put these requirements into practice to ensure consistently high quality of weighing results. While
the Ph. Eur. General Chapter also discusses the working principle of balances, installation considerations,
environmental influences on weighing and handling of difficult samples, this white paper concentrates on
the “Equipment Performance” section that focuses on the life-cycle management of balances, based on
­periodic calibration, specific performance checks (assessing repeatability and accuracy) and the usage of
built-in weights.

2. Role of Pharmacopoeias

A central document for the pharmaceutical industry is the Pharmacopoeia (or Pharmacopeia), which is a col-
lection of published standards describing requirements for testing of chemical and biological drug substances
and dosage forms, as well as methods of analysis for medicines. These standards are defined to ensure phar-
maceutical products are of the appropriate identity, as well as strength, quality, purity and consistency. While
Pharmacopoeias describe requirements for testing drug substances and dosage forms, they do not apply for
manufacturing of the respective products.

The European Pharmacopoeia is the single reference work for the quality control of medicines in 39 European
countries [4]. It is legally binding for Pharmaceutical companies who intend to place pharmaceutical products in
the market in one of its member states, and is therefore not only relevant for European Pharmaceutical companies
but for Pharmaceutical companies in other regions of the world which intend to export into the European market.
The companies’ procedures need to comply with the applicable chapters and monographs of the compendium
that relate to the quality control of drugs during development, production and marketing processes. As such, it
has a similar legal status as the USP compendium in the United States. It is enforced by regulatory bodies in order
to ensure compliance with applicable requirements of Good Manufacturing Practice that focus on quality control of
pharmaceutical products.

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 3. Equipment Performance
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3.1. Requirements Overview

The European Pharmacopoeia has set stringent requirements for balances in its General Chapter 2.1.7. These
requirements should ensure that weighing errors are small or even negligible within the analysis. Within its
Equipment Performance section, General Chapter 2.1.7 sets three distinct requirements for balances used to
weigh materials according to Ph. Eur. monographs:

• Balances must be periodically calibrated

• Between calibrations, performance checks must be carried out periodically to assess the
- random error (precision) and
- systematic error (accuracy) of the balances

Before we analyze in detail the three requirements on calibration, precision and accuracy, it is important to
understand how accuracy is defined in pharmaceutical regulations. Accuracy is defined in ICH Q2(R1) [5]:

“The accuracy […] expresses the closeness of agreement between the value which is accepted either as a
­conventional true value or an accepted reference value and the value found. This is sometimes termed trueness.”

In other words, the accuracy requirement described in General Chapter 2.1.7 stipulates a test that assesses
­systematic deviations, the bias, of the balance. This concept is called “trueness” in all other fields of metrology,
and defined as such in the International Vocabulary of Metrology (VIM) [6].

The precision of the balance, on the other hand, is assessed with a repeatability test. Precision is defined in
a similar way in the Pharmaceutical Industry and in the VIM. ICH Q2(R1) provides the following definition:

“The precision […] expresses the closeness of agreement (degree of scatter) between a series of measurements
obtained from multiple sampling of the same homogeneous sample under the prescribed conditions […]”.

a) Accurate, but not precise b) Precise, but not accurate

Figure 1: a) Results which are accurate (true) but not precise (repeatable) show a wide spread around the central point; b) Results which
are precise but not accurate are tightly clustered but not around the central point.

In simple terms, the two tests stipulated by Ph. Eur. General Chapter 2.1.7 are intended to assess the random
and systematic errors of the balance. By defining specific acceptance criteria for both tests, it ensures that both
random and systematic errors of the instrument are minimized. As will be elaborated upon later more in detail,
both acceptance criteria are expressed as relative limit values, 0.10%:

“Performance checks are carried out to evaluate the random and systematic error of a balance; they consist of
measuring precision and accuracy respectively and comparing the results obtained to pre-defined acceptance
criteria. Balances are considered suitable if none of these errors exceed 0.10 per cent.”

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From a practical perspective, this requirement is quite stringent and ensures that the weighing error is usually
small, if not negligible, compared to errors in the subsequent process steps described in the individual mono-
graphs when drug substances are tested (e.g. dilution, HPLC analysis, etc.).

It is worthwhile noting that the performance requirements defined as per Ph. Eur. General Chapter 2.1.7 are
­commensurate with the requirements set in USP General Chapter 41.

3.2. Calibration

Let us analyze the first of the three requirements of Ph. Eur. General Chapter 2.1.7 that stipulates periodic calibration
of the balances used to work according monographs of the compendium.

Calibration is a set of activities carried out on a measuring instrument to understand its behavior. This is done by
establishing a relationship between known values (measurement standards) and the associated measured val-
ues (indications) of the instrument being calibrated. This relationship consists of deviations and their associated
uncertainties. The International Vocabulary of Metrology (VIM) provides this definition of calibration:

“Operation that, under specified conditions, in a first step, establishes a relation between the quantity values with
measurement uncertainties provided by measurement standards and corresponding indications with associated
measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a
measurement result from an indication.”

It is evident that the relationship between the known and the measured values can only be established if the asso-
ciated measurement uncertainties are derived. Unfortunately, in practice there is a widespread misconception about
calibration, as many users outside of the calibration laboratory do not consider measurement uncertainty when
“calibrating” an instrument. Measurement uncertainty quantifies how far away from the true value a measurement
result might reasonably be with a certain likelihood.

The calibration requirement stipulated in General Chapter 2.1.7 builds on this concept by stating:

“Calibration is part of balance qualification and is performed by the user or by a suitable competent body. Its aim
is to establish traceability of measurement results to the SI units (metrological traceability). The calibration results
include measurement uncertainty and are documented in a calibration certificate.”

It is worthwhile noting that the competence of a calibration laboratory can be assessed according to the
ISO / IEC 17025 standard [7]. Accreditation by an accreditation body is the formal process that confirms that
a laboratory is competent and fulfils the requirements stipulated by ISO / IEC 17025. The calibration guideline
EURAMET cg-18 “Calibration of non-automatic weighing instruments” has developed to the global de-facto
standard and is the most widespread guideline to calibrate balances, and commonly used as basis for
­accreditation [8, 9, 10].

At this point it is relevant to introduce another misconception about calibration – that is, besides being calibrated,
an instrument can also be adjusted. Adjustment is defined in the VIM as:

“Set of operations carried out on a measuring system so that it provides prescribed indications corresponding
to given values of a quantity to be measured.”

In other words, when adjusting an instrument, its indications are modified in a way so that they correspond – as
far as possible – to the quantity values of the measurement standards applied. Unfortunately, many users apply
the words calibration and adjustment interchangeably, incorrectly, or even randomly. Quite often, they talk about
calibrating a weighing instrument when they mean adjusting it. The VIM also emphasizes this by stating:

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“Adjustment of a measuring system should not be confused with calibration, which is a prerequisite for adjustment.
After an adjustment of a measuring system, the measuring system must usually be recalibrated.”

The concept presented in this VIM statement is also highlighted in General Chapter 2.1.7 of Ph. Eur.:

“To ensure traceability, it is recommended to perform calibration before any maintenance operation is carried
out that significantly alters its measurement performance. ‘Significant’ operations include repairs, transfer of the
balance to another location or mechanical adjustment of one or more weighing parameters. The balance must
be re-calibrated after significant operations. Re-calibration is not necessary after less significant operations,
which include levelling the balance or adjustment using built-in weights.”

With this statement, the European Pharmacopoeia builds a solid foundation to promote the concept of “as found”
and “as left” calibration as an important component to ensuring traceability and validity of measurement results
performed on the balance during routine use.

3.3. Performance Checks

After discussing the requirement of calibration, let us now focus on the requirements of the two performance
checks that shall be carried out periodically between calibrations.

3.3.1. Repeatability Requirement – Minimum Weight

Ph. Eur. General Chapter 2.1.7 states:

“Use a single weight denomination preferably in the lower end of the measurement range, for example not more
than 5 per cent of the maximum capacity of the balance […]. Zero the instrument, place the chosen test load on
the weighing pan and record the indication. Repeat the whole procedure, including zeroing, at least 10 times.
The repeatability is satisfactory if

2 × s
× 100 ≤ 0.10 […].
msnw

NOTE: if s < 0.41 × d, where d is the readability (scale interval) of the balance, replace s by 0.41 × d

s = standard deviation of the indicated values […]

msnw = s mallest net weight […]. This value is defined by the user as the smallest net amount of substance that
will be weighed on the balance.”

This requirement defines a specific test with an acceptance criterion that the balance shall meet. At this point,
it is important to understand the rounding rules that are applied throughout all Ph. Eur. chapters. The General
Notices state in the section “Limits”:

“In determining compliance with a numerical limit, the calculated result of a test or assay is first rounded to the
number of significant figures stated […]. The limits, regardless of whether the values are expressed as percent-
ages or absolute values, are considered significant to the last digit shown (for example 140 indicates 3 signifi-
cant figures). The last figure of the result is increased by one when the part rejected is equal to or exceeds one
half-unit, whereas it is not modified when the part rejected is less than a half-unit.”

In other words, the mathematical rounding rules are applied when the observed or calculated values are rounded
to the number of decimal places of the limit expression. As an example, a relative standard deviation of 0.1049%
would be rounded to 0.10% (which corresponds to the number of decimal places of the 0.10% acceptance

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criterion). With this value, the balance would pass the repeatability test. A relative standard deviation of 0.1050%
would be rounded to 0.11%, and the balance would fail the repeatability test. Note that this rounding procedure is
significantly different from rounding rules in all other fields of applied and legal metrology where the formatting of
any given limit value has no effect at all on the rounding of a measurement result.

Independent from any test results, a lower limit of the repeatability of 0.41 × d is prescribed, where d is the scale
interval of the balance, also called readability. This limitation accounts for the rounding error of a digital indication.
General Chapter 2.1.7 provides the explanation for the lower limit of the standard deviation:

“The lower limit of 0.41 × d for the standard deviation originates from the rounding error of the balance. Given that
weighing operations comprise two readings (tare and net sample weight), and as the rounding error allocated to a
single reading is calculated as 0.29 × d, in this case the propagation of errors by a quadratic sum gives 0.41 × d.”

A very important consequence of the repeatability requirement is the concept of minimum weight (which should not
be confused with the smallest net weight the user wants to weigh on the balance). General Chapter 2.1.7 states:

“Based on the result of the repeatability test, the minimum weight (mmin ) of the balance can be determined.
The “minimum weight” is the smallest net sample mass that can be weighed on the balance, whilst continuing
to comply with the repeatability test criterion.”

2 × s 2 × s × 100
Based on the repeatability test criterion, × 100 ≤ 0.10, all masses equal or larger than conform
msnw 0.10
with this requirement. The smallest mass that satisfies this criterion is called minimum weight:
2 × s × 100
mmin = = 2,000 × s
0.10
It is expressed in General Chapter 2.1.7 that the smallest acceptable standard deviation is 0.41 × d, based on the
rounding of a digital indication as described above. Therefore, the smallest possible minimum weight on a balance
with a readability d is 2,000 × 0.41 × d = 820 × d, e.g., on a semi micro balance with a readability of 0.01 mg the
smallest possible minimum weight is 8.2 mg. Usually, minimum weight is higher than this threshold.

mmin >> 820 × d

For example, when the standard deviation of ten repeated measurements on a semi micro balance is 0.007 mg,
then the minimum weight would be calculated as 2,000 × 0.007 mg = 14 mg. This example underlines that in
all cases the minimum weight needs to be determined experimentally. The standard deviation varies depending
on the installation location and on the instrument itself. Therefore, it cannot be derived from specifications that
are published in data sheets, and the assumption of applying the smallest possible minimum weight of 820 × d
is not valid.

As stated in the repeatability requirement, the smallest net weight is defined as the smallest quantity that the user
wants to weigh on the device on a day-to-day basis. The smallest net weight is a user requirement and should
not be confused with the minimum weight, which is a property of the instrument and is calculated as described
above. With these two definitions, the following statement applies: When the smallest net weight (the user wants
to weigh) is equal to or larger than the minimum weight (as calculated from the repeatability of the balance), then
the repeatability criterion of General Chapter 2.1.7 is satisfied.

Let us now come back to the first sentence of the section of General Chapter 2.1.7, describing the repeatability test:

“Use a single weight denomination preferably in the lower end of the measurement range, for example not more
than 5 per cent of the maximum capacity of the balance […].

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 Indication
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Test weight Standard deviation ≈ constant
easy to handle

Test weight
­difficult to handle

Load
≤ 5% capacity
Figure 2: Test weight selection for repeatability testing. The test weight does not need to be at the working point of the balance. Ph. Eur.
Chapter 2.1.7 recommends choosing a test weight that is 5% of the balance capacity or just below. This is consistent with recommendations
of USP General Chapter 1251.

An important implication of the statement above is the fact that it is not appropriate to select a test load at, or
close to, the working point of the balance when determining the minimum weight from a measured repeatability.
For example, on a semi-microbalance with an expected minimum weight of around 20 mg, it is not required
to use a test weight of 20 mg for the repeatability test. General Chapter 2.1.7 suggests selecting a test load of
not more than 5 percent of the nominal capacity of the balance, e.g. a 10 g load for a balance with a nominal
capacity of 200 g. A test load that is sufficiently larger than the expected minimum weight is easier to handle and
avoids introducing handling errors during the repeatability test that could negatively influence the assessment of
the instrument’s performance.

3.3.2. Accuracy Requirement

In addition to repeatability, Ph. Eur. General Chapter 2.1.7 stipulates assessing the accuracy of the balance. Three
important weighing parameters can affect the accuracy of the balance: sensitivity, linearity and eccentricity. The
weighing parameter that most significantly affects accuracy is the sensitivity. In simple terms, the sensitivity char-
acterizes the change of indication of the balance divided by the change in load, e.g. a balance without sensitivity
deviation would indicate exactly the weighing value that corresponds to an applied test load at nominal capacity.
A balance with a sensitivity deviation would therefore indicate either a larger or a smaller weighing value as com-
pared to the applied test load [11]. As sensitivity is the weighing parameter that most significantly affects the accu-
racy of the balance, it is considered sufficient to only assess sensitivity when carrying out performance checks.
However, the acceptance criterion for sensitivity is set to half of the overall accuracy acceptance criterion of 0.10%
as explained in the General Chapter:

“In practice, performance checks focus on the two weighing parameters that most significantly affect the perfor-
mance of the instrument, i.e. repeatability, for precision, and sensitivity as the main component of the accuracy
of the balance.

Accuracy is also impacted by two other parameters: eccentricity and linearity. […] Therefore, the acceptance cri-
terion for each individual parameter can be set at 0.05 per cent. While accuracy is impacted by all three param-
eters, the impact of eccentricity and linearity is typically less than that of sensitivity. Hence, during a perfor-
mance check on accuracy, it can be considered sufficient to investigate sensitivity only (at 0.05 per cent) […].”

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Indication
Repeatability error

Accuracy error

Accuracy
testing
not reliable

Load
5% capacity 100% capacity
Figure 3: Test weight selection for accuracy testing. The test weight shall be between 5% and 100% of the balance capacity.

The accuracy test describes an assessment of the systematic error of the instrument. It should be noted that at
the lower end of an analytical balance’s measurement range, repeatability is the most dominant contribution
factor to balance errors. Therefore, it is not meaningful to assess accuracy with small test weights, as a potential
systematic error would be masked entirely by the limited precision of the instrument, expressed by its repeatability.
To avoid using small loads for testing systematic deviations, Ph. Eur. General Chapter 2.1.7 stipulates that the
mass of the test load shall be at least 5% of the balance’s capacity.

“Sensitivity is assessed using a single test load with a mass between 5 per cent and 100 per cent of the capacity
of the balance. Zero the instrument, place the selected test load on the weighing pan and record the indication.
The sensitivity is satisfactory, if

| m − I |
× 100 ≤ 0.05
m

m = nominal weight of the test load, or its conventional mass […], e.g. in grams;
I = indication, e.g. in grams.”

Ph. Eur. General Chapter 2.1.7 also stipulates a requirement for the accuracy of the test loads used for the test.

“It is generally sufficient to use the nominal weight as the test load value for the assessment, as long as the rela-
tive maximum permissible error of the test load (i.e. the maximum permissible error of the test load divided by the
nominal weight) is not more than one third of the sensitivity test specification (0.05 per cent). If this ratio cannot
be achieved, the conventional mass value of the test load (stated on the calibration certificate of the weight) must
be used for the assessment. In this case, the user must ensure that the weight uncertainty divided by the nominal
weight is not greater than one third of 0.05 per cent.”

The weight requirement is not very stringent, and in many cases, weights of an OIML accuracy class of F1 or F2
(or alternatively of an ASTM accuracy class 3 or 4) are sufficient. For example, a microbalance with a capacity
of 20 g is tested with a 20 g test weight, thereby using its nominal mass value. The maximum permissible error
(mpe) of this 20 g test weight shall not exceed 0.016% of 20 g, i.e. 3.33 mg. A 20 g test weight of an OIML
accuracy class F2 has an mpe of ± 0.8 mg (see OIML R111-1, Table 1 [12]), so it is more than sufficient to satisfy
the weight accuracy requirement of General Chapter 2.1.7.

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3.4. Usage of Built-in Adjustment Weights

In addition to testing weighing instruments with external weights, it is accepted practice to adjust the instruments
by means of built-in reference weights. Such practice allows a reduced frequency of sensitivity tests with external
reference weights [13, 14, 15, 16].

“In addition to testing weighing instruments with external weights, it is accepted practice to adjust the instruments
by means of built-in weights. This makes it possible to reduce the frequency of sensitivity tests with external ref-
erence weights. For electronic balances with a built-in weight, daily sensitivity testing with an external reference
weight is not considered necessary […].”

At this point, it is appropriate to comment on a very frequent misconception that has been prevalent in the industry
for decades. Almost everybody in the pharmaceutical industry who works in quality control, talks about a “daily
balance test” which usually assesses the accuracy of the balance (not the repeatability). It is anchored in the
mindset of generations of people working with balances, who believe that it is mandatory test the balance on a
daily basis. This dates back to the age of mechanical balances where – due to wear, tear and abrasion of criti-
cal mechanical components – a daily check was advisable. This is no longer the case with electronic balances,
and specifically for electronic balances with a built-in weight, a daily test of sensitivity with an external reference
weight is outdated practice. Ph. Eur. General Chapter 2.1.7, and also other references [13, 14, 15, 16] focus on a
testing approach where the quality management system of the user defines the frequencies of calibration and the
individual performance checks.

“The frequency of the qualification and performance checks is defined in each user’s quality management system.”

It is state-of-the-art to apply a risk-based approach for qualification activities within quality management systems,
which is also an expectation of pharmaceutical regulations. For weighing, it is usually the impact of an inaccurate
weighing and the required weighing process tolerance which are taken into consideration when assessing the risk
of the application.

3.5. Consideration of a Safety Factor

The performance of a balance is influenced by a variety of factors (environmental changes, different operators,
different tare vessels, etc.) and will therefore change over time. Periodic performance checks are stipulated by
Ph. Eur. General Chapter 2.1.7 to ensure that the balance is continuously fulfilling the repeatability and accuracy
requirements, i.e. that it is “fit for its intended purpose”. One parameter that is specifically sensitive to changes
of the environment and user handling is repeatability, especially when weighing small amounts of substances
on analytical or microbalances. Minimum weight will therefore also fluctuate over time as it is calculated from
repeatability. By setting the smallest net weight to a value which is sufficiently higher than the minimum weight,
determined at one specific time under the prevalent environmental conditions, the user ensures that the instru-
ment is “fit for purpose” irrespective of variations of the instrument performance. In other words, the smallest net
weight that the user would like to weigh during typical balance use should be sufficiently higher than the mini-
mum weight that was determined at a specific time.

This concept is quantified with a safety factor. For applications within the scope of Ph. Eur. General Chapter 2.1.7,
where minimum weight is calculated based on the standard deviation of repeatability, a safety factor may be
defined as the quotient between smallest net weight and minimum weight. As an example, if the user wants to
weigh 30 mg on a semi micro balance (i.e. when the smallest net weight is 30 mg), and the minimum weight
was determined to be 15 mg, the safety factor is 2.

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Smallest net weight, e.g. 30 mg

24 mg
Safety Adjustment 21 mg
factor (by service)
16 mg

Determined
14 mg minimum
Calibration interval Calibration interval weight

Time
At installation As-found As-left

Figure 4: The minimum weight varies over time due to changing environmental conditions. The orange dots represent the minimum weights
as derived from repeatability determination during as-found and as-left calibrations. In order to ensure that the smallest net weight of the
weighing application is always larger than the minimum weight at the time of weighing, a safety factor should be applied. To ensure
traceability of the weighing results, an as-found calibration is carried out before servicing / adjusting the instrument.

4. Summary / Conclusion

Accurate weighing is of utmost importance for any quality related weighing application. The European
Pharmacopoeia General Chapter 2.1.7 has defined clear requirements to ensure that any weighing application
within a Ph. Eur. monograph does not significantly contribute to the overall error of the analysis. In addition to
using a calibrated balance, requirements for repeatability and accuracy are established, and characterized by
an assessment against a specified tolerance (0.10%). An important consequence of the repeatability test is
that the minimum weight can be calculated, which establishes the smallest amount of net substance that should
be weighed in order to comply with the tolerance requirement. The weighing requirements of Ph. Eur. General
Chapter 2.1.7 are commensurate with the requirements set in USP General Chapter 41. Therefore, the European
Pharmacopoeia has made an important step towards an international harmonization of weighing requirements
within different pharmaceutical compendia.

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 5. References

[1] USP General Chapter 41 “Balances”, United States Pharmacopeial Convention, Rockville, USA.
[2] “Weighing According to US Pharmacopeia”, White Paper, METTLER TOLEDO, 30540114A, 2019.
[3] Ph. Eur. General Chapter 2.1.7 “Balances for Analytical Purposes”, European Pharmacopoeia, EDQM Council
of Europe, Strasbourg, France.
[4] European Pharmacopoeia, EDQM, https://www.edqm.eu/.
[5] ICH Q2 (R1), “Validation of Analytical Procedures: Text and Methodology”, International Conference on
Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2005.
[6] JCGM 200 (VIM), “International Vocabulary of Metrology – Basic and General Concepts and Associated
Terms”, 3rd ed., JCGM, 2010.
[7] ISO / IEC 17025, “General Requirements for the Competence of Calibration and Testing Laboratories”,
International Organization for Standardization, Geneva, 2017.
[8] EURAMET cg-18, “Guidelines on the Calibration of Non-automatic Weighing Instruments”, 4th ed.,
EURAMET, 2015.
[9] K. Fritsch, “EURAMET cg-18 – state-of-the-art calibration guideline for non-automatic weighing instruments”,
ACTA IMEKO 8(3), pp. 10–18, 2019.
[10] “Calibration of Weighing Instruments – Weighing in the Safe Weighing Range”, White Paper, METTLER TOLEDO,
30260956, 2015.
[11] R. Nater, A. Reichmuth, R. Schwartz, M. Borys, P. Zervos, “Dictionary of Weighing Terms – A Guide to the
Terminology of Weighing”, Springer Berlin Heidelberg, 2009, ISBN 978-3-64202013-1.
[12] OIML R111-1, “Weights of Classes E1, E2, F1, F2, M1, M1–2, M2, M2–3 and M3, Part 1: Metrological and Technical
Requirements”, OIML, 2004.
[13] USP General Chapter 1251 “Weighing on an Analytical Balance”, United States Pharmacopeial Convention,
Rockville, USA.
[14] Questions and Answers to Current Good Manufacturing Practices, Good Guidance Practices,
Level 2 Guidance – Equipment, U.S. Food and Drug Administration, Rockville, USA, retrieved from
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm124777.htm
[15] LAB 14, “Guidance on the calibration of weighing machines used in testing and calibration laboratories”,
6th ed., United Kingdom Accreditation Service UKAS, Feltham, UK, 2019.
[16] ASTM E898 – 20, “Standard Practice for Calibration of Non-automatic Weighing Instruments”, ASTM,
Conshohoken, USA, 2020.

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