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USER’S RESOURCES BOOK

WEIGHING ACADEMY

Weighing Regulations and Standards Measurement

Version 1.01 September 2004

Kadlec, spol. s r.o. Veleslavínova 19 746 01 Opava

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(c) 2004 All rights reserved

Weighing Academy Weight Regulations and Standards

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Table of Contents

Table of Contents ............................................................................................................ 2 2 The Reasons of Weight Accuracy Measurement Nowadays in Relation to Generally

Applicable Regulations and Standards .................................................................. 3 2.1 The International Organization acting in Weighing Field.................................... 3 2.1.1 The Council of the European Union ................................................................. 3 2.1.2 OIML ............................................................................................................. 7 2.1.3 WELMEC.......................................................................................................11 2.1.4 CECIP...........................................................................................................13 2.1.5 EUROMET .....................................................................................................13 2.2 The standards in the weighing field ................................................................13

2.2.1 EN 45501+AC ...................................................................................14 2.2.2 OIML Recommendation R 76..............................................................15 2.2.3 OIML Recommendation R 60..............................................................16 2.2.4 WELMEC Documents .........................................................................16 2.2.5 Standards in the USA.........................................................................17 2.2.6 Standards and next document acquisition ...........................................18

2.3 Metrological Authorities Acting in the Weighing Field .......................................18 2.3.1 National metrological authorities ........................................................18 2.3.2 Notified persons ................................................................................20

2.4 Introduction of the Weighing technique on the Market of the EU......................20 2.4.1 ES Type Testing ............................................................................................22 2.4.2 ES Compliance Declaration with Type .............................................................22 2.4.3 ES Verification...............................................................................................23 2.4.4 ES Verification of any separate product...........................................................23 2.4.5 Modul Approach ............................................................................................23 2.4.6 Illustrations of the market introduction procedure ...........................................24 2.4.7 Practice at market introduction in light of producers ........................................26 2.4.8 Marking of the weighing instruments before market introduction......................26 2.4.9 ES Certificates Database on Type Approval .....................................................27 2.5 Weighing instruments using in business contacts ............................................28 2.5.1 Subsequent Testing.......................................................................................29 2.5.2 Verification Validity........................................................................................29 2.6 Market supervision, Sanctions, Penalties .........................................................30


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2 The Reasons of Weight Accuracy Measurement Nowadays in Relation to Generally Applicable Regulations and Stan-dards Although the weight measurement belongs to the eldest branch of the metrology it is

still one of the most considerably and advanced metrological branches. The weight accuracy measurement is important in the series of the sectors; one can mention for instance, the pharmaceutical industry, medicine or transport.

One can leave out also of course not even using of a weighing technique in series of other applications for instance at the direct sale of goods to the public or at weighing of ready packed goods.

2.1 The International Organization acting in Weighing Field A structure of international organizations in the branch of weighing instruments is

very large. This structure is created by number of international organizations with various range of an incidence, which came into being from the reason of the harmonization of re-quirements on weighing and weighing instruments in separates states. In general light of differences among particular organizations are above all in the rate of binding force of issued documents and required procedures. Next difference can be the territorial separate organi-zations incidence; some of them have the worldwide incidence, the other only within the frame of the certain branch, which can be e.g. the European Union. Within the scope of the European Union, the particular legislative-technical structures of the European Union as e.g. the European Parliament and the Council of the European Union belong to the most important organizations. Next organizations acting within the frame of the European Union are the WELMEC and EUROMET organizations. Evidently, the most significant from the metrology branch and then from the branch of the weighing technique with the worldwide incidence is the OIML organization.

Likewise, the significant CECIP organization associating the weighing technique producers that is the integral part of the international structure cannot be ignored.

2.1.1 The Council of the European Union Basic characteristics: - All countries of the European Union have the representation - Legislative-technical provision of introduction of the weighing instruments on the

market - References www.europarl.org , www.europa.eu.int The Council of the European Union is the principal decision-making authority of the

EU. Formerly it was known under the title „Council of Ministers“ and for short it is called "Council". The countries of the UE take turns for each six months in the Council presidency. One minister from any member state takes part in any session. That, which minister will take part depends on agenda under discussion. The Council can meet as a whole in nine variants, which cover any politics spheres including industry, transport, environment etc. The Council


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in the composition for general matters and external relationships plans and coordinates the work of the Council as a whole.

On 20 June 1990, the Council directive 90/384/EEC on harmonization of the regula-

tions of member states concerning the non automatic weighing instruments has been issued. This directive is divided into two basic parts. The first part is general one and includes legis-lative requirements and procedures. The second part is formed by the annexes I till V, in which the factual metrological requirements on non automatic weighing instruments, con-crete steps at Compliance Assessment, requirements on the weighing instruments marking, liabilities of individual entities participating in Compliance Assessment etc. are defined.

After the temporary ten year’s period, which finished in 2003 it is now possible mar-ket introduction of non automatic weighing instruments only through the procedures accord-ing to this directive respectively also in new EU member states. By the reason that it is the directive of so-called “New Approach”, any weighing instruments complying with its require-ments must be marked with CE symbol and specified metrological M mark. On Figure 1, there is the graphic shape of above mentioned marks illustrated.

Figure 1

At the same time the directive requires that the identification number of the notified

person, which has participated in the Compliance Assessment, and last two ciphers of the year would have been attached at CE marking. The example of resulting marking is illus-trated on Figure 2.

Figure 2

Legends: - CE ... compliance mark - M .... metrological mark - 0104 ... notified person number - 99 ... two ciphers of the year of compliance mark attachment The Council Directive 90/384/EEC makes possible for the weighing instruments pro-

ducers to elect from several various procedures by which the weighing instruments compli-


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ance with the directive requirements can be assessed. It is then only on decision of the pro-ducer, which procedure he will elect as optimal, however in any case the participation of the notified person is necessary in the certain moment. The notified person is the metrological authority that is able pursuant to verified capability and under the legislative conditions ful-fillment to perform the activity at Compliance Assessment of non automatic weighing instru-ments. On Figure 3 there is a schematic representation of the possible procedures of the Compliance Assessment for non automatic weighing instruments illustrated.

So called harmonized standards exist for any directive of New Approach and thus for

the Council directive 90/384/EEC. The explanation of the term „harmonized“ standard for the directive is following: requirements in harmonized standard are in compliance with the requirements existing in the directive thus if the weighing instruments are constructed to comply with requirements of harmonized standard, it is guaranteed that they will comply with directive technical requirements too. Actually it is some „cook book“ for the producers. In addition, the standard usually includes the series of other requirements upon the frame of directive requirements.

For the Council directive 90/384/EEC one harmonized standard namely EN 45501 +

AC standard exists. This standard contains besides metrological and technical requirements also procedures of non automatic weighing instruments testing at type verification and type Compliance Assessment.

At that moment, it is convenient to mention another clearly metrological Directive of

New Approach, which is presently in phase of the implementation into legislative of the par-ticular member states. It is the Council Directive 2004/22/EC of measuring instruments from the 31 of March 2004 for short called MID. This directive concerns among others also the weighing instruments namely several kinds of the non automatic weighing instruments. After temporary period, it will be possible market introduction of non automatic weighing instru-ments by the procedures according to this directive.

It is conceived likewise as the Council Directive 90/384/EEC so that in the preamble

there are general requirements and procedures and factual metrological requirements are stated in the annexes for the separate kinds of gauges. One of these annexes concerns the non automatic weighing instruments requirements.


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Figure 3


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2.1.2 OIML

Basic characteristics: - Normalizing activity is the most important - Worldwide incidence - Number of member countries is approximately 60 - Reference www.oiml.org

The International Organization of Legal Metrology shortly OIML, was found in Paris

on 12 of October 1955 as intergovernmental contractual organization with the aim of the help to harmonize national metrological regulations of its members, to fulfill the role of an information centre and help to hold the topicality of the legislative in the metrology sphere with respect to the dynamic development of measurement technologies. The OIML organiza-tion extended step by step for another countries till contemporary 60 permanent members. 49 another countries has an observer status.

The OIML structure was conceived with emphasis on utmost flexibility and variability at actions of great number of concerned subjects.

Every four years the international conference (The International Conference on Legal

Metrology) is convened, which determines the basic politics, budget rules and possibilities of OIML metrological regulations implementation support.

The OIML administration centre is The International Bureau of Legal Metrology (shortly BIML), the residence of which is in Paris. BIML ensures the conference arrange-ments and provides the information flow in the frame of OIML structures and at the same time towards professional public. It issues also any official OIML documents.

The International Committee of Legal Metrology (shortly CIML) governs the technical activities of the OIML and supervises them. Any member country has one representative in CIML.

The Technical Committees and Subcommittees composed from representatives of the member countries are accredited by own technical activities of OIML. The ones have an as-signment to prepare the metrological regulations for various categories of measuring instru-ments. At such activity, the OIML cooperates with other organizations such as ISO or IEC not to occur duplicate works at standard creation.

The preparation of metrological regulations of various alignment and purpous belong

to the basic activities of OIML. For instance, documents of a general character, publications, technical wordbooks and above all OIML Recommendations belong here.

Perhaps the most important documents are OIML Recommendations. These are the documents, which are prepared by the technical committees and have the character of in-ternational standards. They contains namely the basic requirements on measurement in-struments, test procedures and also forms of the records of tests using at Compliance As-sessment of gauge type with the appropriate OIML Recommendation.

The short summary of the documents issued by OIML is illustrated on Figure 4. It in-

cludes in the recommendation section only the ones that concern the weighing; overall about 150 OIML Recommendations from the various metrology branch exist.


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The OIML certification system is based on the Compliance Assessment of gauge type with the appropriate OIML Recommendation.

The OIML certification system for measuring instruments has been consequently im-plemented system for issuing, registering and using certificates of gauge type compliance since 1991 with the requirements of the appropriate OIML Recommendations. This system works on principle of voluntary accepting of compliance certificate issued by an issuing au-thority for specific type or type series of gauges. Compliance certificate can either be ac-cepted in the complete wording already without the technical tests of the gauge or can be used at implementation of the technical test of the appropriate gauge. This system generally simplifies and speeds the activities of particular subjects that are concerned with the gauge type approval, above all in substantial way reduces costs connected with the type approval and substantially speeds the whole approval process.

The condition of the possible using of the OIML Recommendation for compliance cer-

tificate issuing is that the Recommendation includes namely: a) Metrological requirements on gauge, b) Testing procedures, c) Test reports.

General procedures and principles of the certification system are included in OIML Certificate System for Measuring Instruments document, that was in 2003 revised, and the mark of which is P1.

Issuing authorities are registered to separate OIML Recommendations and can issue the compliance certificate according to appropriate OIML Recommendation. OIML Certifica-tion system is continuously extended with next OIML Recommendations pursuant to of which the gauge type compliance certificates can be issued. Presently it is possible to issue the compliance certificate according to 40 OIML Recommendations for 39 gauge kinds. 1181 compliance certificates according to 14 OIML Recommendations are registered at 15th of January. The statistics OIML certification system is illustrated on Figure 5.

As started to show, the absolute voluntariness in compliance certificate acceptance is

not ideal and in the interests of producers as well as OIML is a certain degree obligation im-plementation. Therefore at present days the works on agreement of mutual tests results acceptance (the Mutual Acceptance Agreement, shortly MAA treaty) are intensively in pro-gress.

The aim of the OIML top-priority project is the creation of the legal metrology system in the sphere of compliance assessment of gauge type in the OIML certification system with a certain degree of the obligation for such countries that will become the members of this system.

The structure MAA treaty will be two-leveled so a document of a common character will exist and to particular gauge types so called DoMC (Declaration of Mutual Confidence) will exist, which will be signed by individual members. By its signature, the member obliges to accept the test results performed according to the appropriate OIML Recommendation. The advantage of such system is a great variability and flexibility with respect to national legislative requirements. If e.g. the national legislative makes possible OIML compliance cer-tificate existence as an approval protocol, such document can be accepted without any changes. However, if the national legislative modification requires its own type approval cer-tificate issuing, such certificate can be issued pursuant to the tests results acceptance per-formed for OIML compliance certificate issuing.


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Figure 4


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From that reason it concerns the tests results acceptance not compliance certificate acceptance, because the compliance certificate acceptance as such would required in num-ber of member countries time-consuming challenging legislative change and it is probable that the appropriate legislative change would not be approved in some countries.

Figure 5


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2.1.3 WELMEC

Basic characteristic:

- The members are the countries of the EU and European Economic Area - Legislative-technical and information activity - Close relation to OIML and European legislative-technical structure - Reference www.welmec.org

WELMEC organization was found in 1990. The original title was Western European Legal Metrology Co-operation (WELMEC). In 1995, the title was modified to European Co-operation in Legal Metrology, but the original shortcut was preserved. WELMEC is the or-ganization for European cooperation in the branch of legal metrology the members of which are national metrological authorities acting in the sphere of legal metrology. The primary aim of the WELMEC is creating of mutual confidence among the authorities of legal metrology, actions harmonization and information exchange.

The Comitee and work groups create the inner structure of the WELMEC. The

comitee consists of WELMEC members’ representatives and observers from other organiza-tions as EUROMET, OIML etc.

In the frame of the WELMEC organization 7 work groups are established, any of

which has a secretariat in other member country.

Group Work groups activities secretariatWG 2 Directive 90/384/EEC NAWI implementation GB WG 4 EN 45000 application on notified authorities NO WG 5 Metrological supervision GB WG 6 Ready packed goods NL WG 7 Software for measuring instruments DE WG 8 Directive MID FR WG 10 Gauges for liquids other than water NL

For the sphere of non automatic weighing instruments, the activity of the work group

WG 2 is principle. This work group issued the series of documents specifying and explaining the requirements of the Council Directive 90/384/EEC, and documents more precisely speci-fying the procedures of the separate parts of non automatic weighing instruments, technical requirements for the non automatic weighing instruments and its components. On Figure 6 there is the summary of above mentioned documents.


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Figure 6

In the frame of the WELMEC organization, the significant activity in the sphere of the

type approval and testing at the type approval so called Type Approval Agreement (TAA) exists.

WELMEC Type Approval Agreement is the international agreement among EU coun-tries on acknowledgments of the results assessment performed according to the chosen OIML Recommendations. It is the similar activity as MAA agreement under OIML but with such difference that it is only the activity in the frame of EU.

At present days, it is possible upon this agreement to concede the approval results

according to OIML Recommendation of number 8. These are Recommendations as follows:

OIML Recommenda-tion

Title

R 50 Continuous totalizing automatic weighing instruments (belt weighers)

R 51 Automatic catchweighing and instruments R 61 Automatic gravimetric filling instruments R 105 Sets for measurement of liquid mass flow rate R 106 Automatic rail-weighbridges R 107 Discontinuous totalizing automatic weighing instruments R 117/ R 118 Measuring sets for liquids other than water

In the sphere of weighing instruments it concerns some kinds automatic weighing in-

struments. The fundamental condition is, that in certificate of the type approval or in the single compliance declaration there had to be unambiguously stated there, that the gauge meets any requirements of the relevant OIML Recommendation.


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The next significant contribution of the WELMEC organization is the acquisition of processing and publication of important information of legal metrological system in separate member states of the EU. On WELMEC organization web site, the information site is about any member country, which contains information on the country (area, population, capital city etc.), information on organizational structure and principles of the metrological system, listing of gauges subjecting to the regulation, information on type approval and verification and information on implementation of the Council Directive 90/384/EEC.

2.1.4 CECIP Basic characteristics: - Members are the European producers of the weighing technique - Producers representation in international organizations CECIP (Comité Européen des Constructeurs d‘Instruments de Pesage) organization

consists of representatives of the European producers of the weighing technique and has the permanent seat in Paris. Today it has 13 members and its principal mission is the represen-tation of interests of producers of the weighing technique on the international level among others in organizations as e.g. WELMEC.

2.1.5 EUROMET Basic characteristics: - Members are the representatives of European national metrological authorities - Corporate project coordination EUROMET (European Collaboration in Measurement Standards) is the organization for

the cooperation of European national metrological authorities at common projects in the sphere of the research, interlaboratory comparisons, mutual consultations and agreements on sequence. It was found in 1938 and today it has 25 members, the summary of which is stated on Figure 7.

2.2 The standards in the weighing field In the weighing sphere, the series of documents of normative character exists. First it

is necessary to mention the harmonized standard EN 45501+AC. Next documents with the standards character are the appropriate OIML Recommendations. Next documents closely associated with above stated standards as well as with Council Directives are so called Guidy WELMEC.

As well as the harmonized standard EN exists in the EU simultaneously with OIML Recommendation, the similar standards exist often in the countries outside EU. We can men-tion for comparison e.g. NIST Handbooks using in the USA.


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Figure 7

2.2.1 EN 45501+AC

Standard EN 45501 on metrological aspects of non automatic weighing instruments

has been issued in 1992 and in 1993 was issued the change AC: 1993. As amended the standard EN 45501 + AC contains namely important parts as follows:

- General definitions - Metrological requirements - Technical requirements on automatic or non automatic weighing instruments - Requirements on electronic weighing instruments - Technical requirements on non automatic weighing instruments - Weighing instruments marking - Verification procedures, so the tests at the type approval and tests at verification

of compliance with the type - Testing procedures for non automatic weighing instruments - Supplemental tests for electronical weighing instruments


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- Testing procedure for the resistance against emission by highfrequency electro-magnetic field

According to this standard the weighing instruments are divided to these accuracy

categories, categories , , and . Any weighing instruments of the particular accuracy categories are the fundamental metrological values of weighing instrumentsy. The most important are the upper weightness limit (Max), lower weightness limit (Min), testing segment (e), actual segment value (d) and the number of test segments (n). The relation among those values and weighing instrument accuracy category is given in the table as fol-lows:

Table 1

n = Maxle min max

min

Special 0,001 g ≤ e 3) 50 000 4) 100e

High 0,001 g ≤ e ≤ 0,05 g 0,1 g ≤ e

100 5 000

100 000 100 000

20e 50e

Middle 0,1 g ≤ e ≤ 2 g

5 g ≤ e 100 500

10 000 10 000

20e 20e

Common 5 g ≤ e 100 1 000 10e

The standard at the same time defines values of the greatest allowed mistakes at primary verification in the following table.

Table 2

Category Category Category Category

± 0,5 e ± 1 e ± 1,5 e

0 ≤ m ≤ 50 000 50 000 ≤ m ≤ 200 000 200 000 ≤ m

0 ≤ m ≤ 5 000

5 000 ≤ m ≤ 20 000

20 000 ≤ m ≤ 100 000

0 ≤ m ≤ 500

500 ≤ m ≤ 2 000

2 000 ≤ m ≤ 10 000

0 ≤ m ≤ 50

50 ≤ m ≤ 200

200 ≤ m ≤ 1 000

So, if we have e.g. weighing machines of accuracy category with testing segment

e = 1 kg, then according to column 4 in Table 2 is the maximum allowed mistake till 500 kg ± 0,5 kg, over 500 kg till 2000 kg ± 1 kg and over 2000 till 10 000 kg ± 1,5 kg.

2.2.2 OIML Recommendation R 76 Standard EN 45501 preparations came from the OIML Recommendation R 76: 1988.

Today are valid the OIML Recommendation R 76-1: 1992 and OIML R76-2: 1993. OIML Recommendation R 76-1 has the title „Non automatic weighing instruments,

part 1: metrological and technical requirements - tests“. It is conceived very similarly as the standard EN 45501 and if it is different so only in details.

OIML Recommendation R 76-2 has the title „ Non automatic weighing instruments, part 2: type approval potocols“. This second part contains any digestedly elaborated testing protocols for tests performed at the type approval of non automatic weighing instruments. These protocols are used by metrological authorities at types testing of non automatic


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weighing instruments according to the Council Directive 90/384/EEC, in which is today the principal importance of this document.

2.2.3 OIML Recommendation R 60

OIML R 60 Recommendation with the title „Metrological regulation for load cells“ is

today valid in version from 2000. It is the regulation that makes possible the single load cells testing. The regulation has following parts:

- Terminology - Units - Metrological requirements - Maximum allowed mistakes - Requirements on the load cells equipped by electronics - Metrological inspection This recommendation is one of the fundamental pillars of so called „Modul Approach“

at compliance assessment of non automatic weighing instruments. This approach makes possible on certain conditions the separate testing of the weighing instruments moduls. On stated condititions, the tested moduls can be then combined without next tests.

2.2.4 WELMEC Documents The summary of documents issued by WELMEC for the sphere of non automatic

weighing instruments is evident from Figure 6. Now we mention their content. Guide 2: Directive 90/384/EEC: Common application serves both weighing instru-

ments producers and metrological authorities responsible for Compliance Assessment of weighing instruments. It includes the series of practical information in relation to the Council Directive 90/384/EEC and EN 45501+AC standard. Here e.g. the proposals of the documents issuing at compliance assessment, numbers formats summary of ES certificates of the type approval using by metrological authorities, information on currencies using in the separate member states of EU, information on gravity zones in the scope of EU etc. are mentioned.

Guide 2.1: Guide for Testing Indicators contains the requirements and procedures at testing of scoring and indicator instruments using for non automatic weighing instruments. For matter of interest, here tests performed for PC using as scoring and indicator unit are mentioned.

Guide 2.2: Guide for Testing Point of Sale Devices: it contains the specification of the requirements and procedures for testing of peripheral additional instruments such as points of sale, bar-code readers, additional printers and displays using at direct sale to the public.

Guide 2.3: Guide for Examining Software provides information on the test procedures of the software using at non automatic weighing instruments.

Guide 2.4: Guide for Load Cell describes procedures at testing of load cells using namely in non automatic weighing instruments. Next it contains among others common con-structional salvations of common types of load cells introduction with respect to the load carrier construction.

Guide 2.5: Guide for Modular Approach and Testing of PCs and other Digital Periph-eral Devices contains the description of general procedures at the approval of the weighing instruments by the modul approach, so by the approval of the separate parts of non auto-matic weighing instruments. It contains also the examples of weighing systems diagrams with respect to the approval and marking.


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Guide 2.6: Guide for the testing of automatic catchweighing instruments contains test procedures of automatic catchweighing instruments.

Guide 3.1 Explanations and interpretations explains and specifies some terms of the Council Directive 90/384/EEC and EN 45501+AC standard, the interpretation of which need not be quite unified. It states also practical examples helping to understand exactly these terms. 2.2.5 Standards in the USA

For comparison with the states of the EU we mention e.g. standards in the USA. In the USA so called Handbook 44 is used, which contains the metrological requirements on any gauges liable the regulation in the USA. At presents Handbook 44 edition 2003 is applicable. To such gauges of course non automatic weighing instruments belong to which are defined require-ments by the similar way as in the EU however they are different in some points. For illustra-tion the table similar to Table 1 from the EN 45501 standard defining the weighing instru-ment categories is shown here.

Table 3


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2.2.6 Standards and next document acquisition Harmonized standards as well as the other ones can be better obtained at national

normalizing institutions. Standards are usually for disposition for payment. The summary of harmonized standards to directives of new approach can be found on the web sites of the European Union e.g. on www.newapproach.org address.

Most of OIML documents, namely recommendations can be ordered on web sites of the OIML organization. Documents are for disposition for payment respectively mostly in English or French.

WELMEC Documents are freely available for download from web site of the WELMEC organization.

Handbook 44 standard is freely available for download from web site of national met-rological authority of the USA, National Institute of Standards and Technology (NIST) on www.nist.gov.

2.3 Metrological Authorities Acting in the Weighing Field

Integral parts of the metrological system of the EU in the weighing sphere are metro-logical authorities among them above all national metrological authorities and notified per-sons belong. The national metrological authority can be at the same time a notified person and it is often so, however it is not a condition. Notified person can be also other subject if it meets required conditions. At the same time, it is not a condition for any member state of the EU to have a notified person, although it can have several ones respectively for the same directive and procedure of compliance assessment. 2.3.1 National metrological authorities

National metrological authorities of the member states of the EU are associated in EUROMET organization (see the article 1.5). The assignment of the national metrological authority is always the realization of etalons of fundamental measuring units, transmission of such units according to the diagram of sequence, a participation in international comparisons etc.

Next activities of national metrological authorities depends on the metrological system in respective state, it can be a safeguarding of the metrological inspection of gauges (type ap-proval, verification), capability assessment of other subjects acting in the field of the metrol-ogy etc. The metrological system in Czech Republic where the national metrological authority is Český metrologický institut (ČMI) looks like as follows:

ČMI as national metrological authority:

- Implements an operation of state authority in the sphere of metrology com-mended to ČMI by the act 505/1990 of Code on metrology as amended;

- Safeguards standardisation of units and scales of physical and technical values on top level

- Preserves, improves and internationally compares government etalons of the Czech Republic, including transfer of values of weighing units to secondary etalons

- Performs a research and development in the sphere of metrology;


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- Controlls the creation of reference materials and its certification - Safeguards participation in interenational cooperation in the fields of fundamental

and legal metrology and reference materials and participates in representation of Czech metrology in international organizations (Metric Convention, OIML, WEL-MEC, EUROMET, NCSLI)

- Processes and issues metrological regulations for transfer procedures of unit quan-tities of values from government etalons onto etalons of lower ranks, for verfica-tion of specified gauges, resp. calibration methodologies for operating gauges

- Participates in processing of concepts of regulations for specified gauges

Any information about ČMI can be found on web site www.cmi.cz.

Figure 8


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2.3.2 Notified persons

Notified persons enter to procedures of the compliance assessment according to the directives of new approach and then the Council Directive 90/384/EEC. Any directive defines exactly the steps that can be performed only by a notified person.

Notification system is similar in separate member states. In any state one notified person is, which verificate or let verificate (e.g. by acreditation) applicant competence of notification. If the applicant is competent, he is authorized in the scope of the state and noti-fied in the scope of the EU (or reported) for required procedures of compliance assessment and notified person allots the subject the identification number.

Notified person according to Council Directive 90/384/EEC is obliged to record the ac-tual list of obtained applications, issued certificates, thrown applications, additions and changes of already issued certificates. Notified person reports this information to all member states and fortwith informs them about cancellation of ES certificates of type approval.

According to the Directive 90/384/EEC notified person performs or participates in ac-tivities as follows:

- ES type testing - ES supervision at ES compliance assessment with the type - ES verification - ES verification of any separate product It is also important to realize, that every notified person may work to the extent of

approved procedures in the area of the whole EU and the producer may address any notified person according to its own deliberation.

- It is Important to make inquiries, whether the notified person may perform re-spective procedure, because not every notified person covers the whole range of the Council Directive 90/384/EEC. For example in Germany, there is number of notified persons there, but only one from them is notified to ES type testing. Other notified persons are notified to ES testing, ES testing of any separate prod-uct or ES compliance assessment with the type.

2.4 Introduction of the Weighing technique on the Market of the EU Introduction of the non automatic weighing instruments on the market of the EU is

possible since 2003 and for new member states since 1 May 2004 only by the procedures Compliance Assessment according to the Council Directive 90/384/EEC. Accordingly, before long it will be necessary to act at market introduction of some kinds of automatic weighing instruments according to the Council Directive 2004/22/EC on measuring instruments.

Market introduction is defined as a moment when the weighing instrument is for the first time against payment or free of charge offered for handover for the purpose of distribu-tion or using or when the property rights are for the first time ceded to them.

Weighing instruments used only as follows, are subject to the procedures of Compli-ance Assessment according to Council Directive 90/384/EEC:

- Weight determination in business contact - Weight determination for the purpose of assertion of acts and regulations - Weight determination in health service at weighing of patients for the purpose of

monitoring, diagnostics and treatment


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- Weight determination at preparation of medicaments on prescriptions in drug stores

- Weight determination at analysis performed in medical and pharmaceutical labo-ratories

- Price determination pursuant to the weight for the purposes of direct sale to the public and preparation ready packed goods

At other weighing instruments, the compliance is not assessed; however the weighing

instruments must be marked according to article 2 of the annex IV of the Council Directive 90/384/EEC.

Simplified diagram of possible procedures of Compliance Assessment for non auto-matic weighing instruments is here as follows. Their choice is absolutely on decision of a producer eventually empowered representative.

At such procedures the documents are issued by various subjects participated in pro-

cedures of the compliance assessment. The documents have exactly defined the purpose and these are as follows:

- ES Type Approval Certificate - Compliance Declaration - Compliance Certificate Notified person as the output from ES type testing issues ES Type Approval Certifi-

cate and its purpose is documenting that the type (ev. type series) of the weighing instru-ments meets the requirements of the Council Directive 90/384/EEC.

The producer or empowered representative issues the Compliance Declaration before presentation of the weighing instruments for ES testing or ES testing of any separate prod-


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uct. The producer or empowered representative issues ES declaration of the compliance with the type before its market introduction.

Notified Person issues the Compliance Certificate as the output from ES testing or ES testing of any separate product and documents by it that specific weighing instrument (identified by production numbers) are in compliance with requirements of the Council Direc-tive 90/384/EEC.

2.4.1 ES Type Testing ES Type testing is the procedure at which the Notified Person assesses, whether the

appropriate type of the weighing instruments meets the requirements of the Council Direc-tive 90/384/EEC.

ES Type testing is not obligatory for the weighing instruments at which the elctronical equipments are not used and in the measuring unit of which is not used a spring for balanc-ing a loading and for the weighing instruments constructed for a specified usage.

The separate partial steps at ES Type testing are as follows: - The application of the producer or empowered representative - Supply of samples of weighing instruments to Notified Person - Revisions and tests performed by Notified Person - Issuing of ES certificate of type approval by Notified Person in the positive case The application for ES type testing must contain the identification data on producer

ev. empowered representative, appropriate documentation and declaration in written that the application was not handed to other Notified Person.

The applicant provides to the Notified Person samples of the weighing instruments representing the intended production on which the Notified Person will perform the revision and tests to check up whether the weighing instruments meets the requirements of the Council Directive 90/384/EEC.

If the type of the weighing instruments meets the requirements of the Council Direc-tive 390/384/EEC the Notified Person will issue the ES Type Approval Certificate of the gauge containing tests conclusions, conditions of validity, data necessary for the identification of approved weighing instruments and description of their function and securing with marks. The certificate validity is usually 10 years from its issuing and can be prolonged for next 10 years. The applicant is obliged to notify the appropriate Notified person any change of the approved type.

2.4.2 ES Compliance Declaration with Type ES Compliance Declaration with type (production quality guarantee) is the procedure,

at which the producer, having adequately established the quality system subjected to the ES supervision, declares, that the appropriate weighing instruments are in compliance with the type described in the ES Certificate of the Type Approval and meets the requirements of the Council Directive 90/384/EEC.

The Notified Person must approve the quality system of the producer and in addition performs the ES supervision upon approved quality system in such way. The purpose of the ES supervision is to ensure the producer woul carry out the obligations resulting from the approved quality system.


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2.4.3 ES Verification ES Verification is the procedure when the producer or empowered representative en-

sures and declares the compliance of the weighing instruments with the requirements of the Council Directive 90/384/EEC and the type described in the ES Certificate of the Type Ap-proval.

The Notified Person will perform the appropriate inspections and tests of any sepa-rate weighing instrument to verify the compliance of the product with the type described in the ES Certificate of the Type Approval and so with the requirements of the Council Directive 90/384/EEC. The Notified Person adds or lets add its identification number and issues the Compliance Certificate on any weighing instruments at which the compliance with the requirements was proved.

2.4.4 ES Verification of any separate product ES Verification of any separate product is the procedure when the producer or em-

powered representative ensures and declares the compliance of the weighing instruments universally constructed for specified using with the requirements of the Council Directive 90/384/EEC. Pursuant to the international agreements and practice, the compliance can be assessed by such procedure practically at any non automatic weighing instruments. How-ever, the procedure is not use for the serial producted weighing instruments because any piece would have had to go through complete tests as at ES Type Testing (e.g. EMC tests, thermal tests etc.). So, it can be used in the case when the separate components of the weighing instruments are separately tested.

Notified person will perform the appropriate inspections and tests of any separate weighing instrument to verify the compliance of the product with the requirements of the Council Directive 90/384/EEC. The Notified Person adds or lets add its identification number and issues the Compliance Certificate on any weighing instruments at which the compliance with the requirements was proved.

2.4.5 Modul Approach The so called „Modul Approach“ is used in practice at the procedures of the Compli-

ance Assessment namely for the weighing instruments of higher weightness ( e.g. the weighing instruments of road vehicles weighing). This procedure is based on the testing and certification of separate components of the weighing instruments from which the resulting weighing instrument is put together.

Load cells (according to OIML Recommendation R 60) and scoring units (according to EN 45501+AC standard) are currently tested separately. The result of such tests is the Test Certificate.

Also in the case of the Modul Approach it is necessary to meet the requirements and procedures of the Compliance Assessment according to the Council Directive 90/384/EEC. So, ES Certificate of the Type Approval must exist or each separate product must be verifi-cated (ES verification).

Modul ES Certificate of the Type Approval contains most often the table of the scoring units with references to appropriate test certificates and general condition for using of all suitable load cells having the test certificate. Then ES Verification can be required of such completed weighing instrument to which it is necessary to propose in addition the calculation of moduls compatibility, by which the producer declare the pertinence of used combination of single components.


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At the procedure of the ES Verification of any separate product, it is necessary i.a. to present to the Notified Person the calculation of the compatibility of moduls and the appro-priate test certificates for used scoring unit and used load cells.

The construction of load carrier and placing of load cells is absolutely the responsibil-ity of the weighing instrument producer; it is possible to use here the WELMEC 2.4 Docu-ment, that contains so called non conflicting constructions, and declare the compliance with such document. The specifications of the cell producer must be kept of course at placing of the load cell. The construction of the load carrier can be other than according to WELMEC 2.4. document e.g. for the technological reasons. In such case, it is suitable to present the statistical calculation of the construction.

2.4.6 Illustrations of the market introduction procedure The difference between the Modul Approach and classical one can be represented on

two following examples of the procedure of the Compliance Assessment of the non auto-matic weighing instruments.

The most common procedure of the market introduction for common business weigh-

ing instruments, which are not conceived modularly, looks like as follows:

Non automatic weighing instruments

Accuracy category Max = 6 kg, e = 2 g

Application for ES Type Testing to Notified Person

Tests and the assessment of the weighing instruments as a whole According to the article 8.1 of the EN 45501+AC standard

ES Certificate of Type Approval

Application for ES Verification including Compliance Declaration

ES Type Approval Certificate copy

Tests according to the article 8.2 of EN 45501+AC standard

Compliance certificate + weighinginstruments marking with the identification number of the


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Notified Person eventually with compliance marks if the weighing instrument has not already been marked

bythe producer

Market introduction

For the weighing instruments conceived by Modul Approach two procedures of the

Compliance Assessment, which are equivalent, can be used with an advantage:


Accuracy category Max = 60 000 kg, e = 20 kg

Load cells of type xyz, scoring a indicator unit of type abcd

Application for ES Type Verification to Noti-

fied person

Tests and weighing instruments assess-ment as a whole and load cells of type xyz

separately and scoring unit of type abcd

according to the article 8.1 of the EN 45501+AC standard

Modul ES Type Approval certificate and Test Certificates for load cells

and scoring unit

Application for Test certificate to Notified

Person For load cells of type xyz scoring unit of type abcd

Cells tests according to OIML R 60 Scoring unit tests according to EN

45501+AC

Test Certificate for load cells and scoring unit

Application for ES Verification including

Compliance Declaration ES Type Approval Certificate copy

ev. appropriate Test certificate copy Moduls compatibility calculation

Tests according to the article 8.2 of the EN

Application for ES Verification of any sepa-

rate product Compliance Declaration

Appropriate Test Certificate copy Moduls compatibility calculation

Tests according to the article 8.2 of the EN


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45501+AC standard

Compliance Certificate + weighing instru-ments marking with the number of Notified

Persons ev. with marks of the compliance if the

weighing instrument has not already been marked by the producer like this

45501+AC standard

Certifikát compliance + označení vah číslem notifikované persons

a případně značkami compliance pokud není váha již takto označena výrobcem

Market introduction

2.4.7 Practice at market introduction in light of producers

The number of possible procedures for market introduction is always for disposition

at market introduction according to the directives of new approach, but on the other side the responsibility for the product lies on the producer´s shoulders. The producer declares the compliance of its product with the requirements of the directive and if it would find out that the product through that declaration is not in compliance with the requirements of the direc-tive, the strict sanctions would follow to the producer.

At option of suitable procedure it is shown, that for great producers that produce the weighing instruments in large series the procedure of ES compliance authentication with type is advantageous. However, this procedure is quite elaborately applied on the weighing in-struments sensible on the change of acceleration of gravity and big weighing instruments completed up on place of usage. Great producers as well as uses for them the services of notified persons at ES Verification.

For middle and smaller producers it is preferable to use the notified persons at ES Verification and ES Verification of any separate product.

2.4.8 Marking of the weighing instruments before market introduction

The Council Directive 90/384/EEC in annex IV exactly determines how the weighing

instruments subjected to the procedure of Compliance Assessment must be marked at mar-ket introduction. The weighing instruments must be marked with marks of compliance e.g. according to Figure 2 or e.g. as follows:

Other notices required by the Council Directive 90/384/EEC are as follows:

• ES Type Approval certificate number

• Mark or name of the producer


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• Accuracy category

• Upper limit of weightness Max

• Lower limit of weightness Min

• Testing segment e and e.g. as follows:

• Production number

• Identification mark on any unit, if the weighing instruments consists of separate but interconnected units

• Scale segment if it is different from e, in the form d = .......

• Upper limit of adding taring equipment in the form T = +.......

• Lower limit of substracting taring equipment in the form T = -........

• Load capacity, if it is different from Max, in the form Lim.....

• Segment of taring equipment, if it is different from d in the form dT = .......

• Special temperature limit in the form ...°C/...°C

• Ratio between loading carrier and loading

If the weighing instruments contains or are interconnected on instrument that is not the sub-ject of the compliance assessment, any of such instruments must be marked by the mark of limited usage. This mark looks as follows:

It is necessary further to safeguard most of the non automatic weighing instruments against incompetent access to metrologically substantial data. In any ES compliance certifi-cate and eventually in test certificate on scoring and indicator unit the places are stated that must be safeguarded and the way of such safeguarding.

For safeguarding of such places so called official marks are used which are given by national metrological legislative, and any metrological authority has different mark. Most often they are in the form of self-adhesive labels that are depreciated at the attempt of the unstuck or in the form of suspension seals.

Most often various calibration switches, connecting cabinets of load cells, screws pro-hitibive the input to the gauge etc. are safeguarded.

2.4.9 ES Certificates Database on Type Approval


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With respect to the colossal assortment of the weighing instruments offered by vari-ous producers on the EU market, exist also considerable quantity of ES certificates of type approval of the non automatic weighing instruments. Then it was necessary to implement the unified database determined both for producers or empowered representatives and notified persons. On the basis of such requirement the EMeTAS database came into being

This database contains documents as follows: - ES certificates of the type approval - Test certificates on weighing instruments components - WELMEC Documents - Notified persons list - Council Directive 90/384/EEC Text in English, German and French - The summary of safety marks using by metrological authorities We prepare also the annection of the list of producers that has assessed the produc-

tion quality system, they can then use the procedure of ES compliance assessment with type.

EMeTAS database makes possible the searching according to various filters; unques-tionable advantage is that it can search any text chain stated directly in the certificate text.

All notified persons conduce to database and some of them have already used it for securing of information flow exclusively of that database.

You can obtain the database at The EMeTAS Consortuim, the contacts are given on web sites www.emetas.org.

Some of notified persons have in addition their own databases, though they all have the same disadvantage because they contain only documents issued just by this notified per-son.

The database of the weighing instruments producers have the similar lack, they also contain only information on the appropriate producer. 2.5 Weighing instruments using in business contacts

The Council Directive 90/384/EEC concerns only the procedures for market introduc-

tion of the non automatic weighing instruments. After market introduction, the non auto-matic weighing instruments similarly as the other gauges will get under the force of the na-tional legislative modification defining the system of the inspection and supervision.

The system of the inspection and supervision can be different in the separate mem-ber states of EU, in some countries only supervision activity upon gauges in operation is made after the market introduction in different intervals. In many countries, however the consequent verification in exatly given terms is required otherwise the weighing instruments could not be used in business contact.

As example we can give the legal metrological system implemented in the Czech Re-public by the act number 505/1990 of Code as amended and executive regulations of Minis-try of Trade and Industry to this act.

Validity term of the verification for non automatic weighing instruments in Czech Re-public is two years. The first two years term starts to be counted after market introduction. This term is counted since the year when the compliance mark was attached. This data is marked on the weighing instrument as two ciphers of the year of the compliance mark at-tachment (see Figure 2). Before expiring of this term, the user is obliged to require the sub-ject authorized to perform the verification and consenquential verification.

Here you can see the schematic illustration of the whole system of the legal inspec-tion of the non automatic weighing instruments.


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Compliance Assessment with requirements of the Council Directive 90/384/EEC

Market introduction

Application for the subsequent verification before term expiring

Tests according to the national metrological requirements harmonized with requirements of the Council Directive 90/384/EEC

Weighing instruments marking with official marks eventually issuing of the written document

2.5.1 Subsequent Testing

The subsequent verification is carried out according to the national regulations that

are harmonized with the requirements of the EN 45501+AC standard. It cannot happen that the weighing instruments placed on the market in compliance with the Council Directive 90/384/EEC do not meet the requirements of appropriate national regulations.

At subsequent verification, it is inspected whether the gauge embodies required met-rological characteristics. If it is so, the gauge is on the appropriated places secured with the official marks and eventually the document is issued confirming that the gauge is verified. The number of cycles of subsequent verification is not limited namely not even by the valid-ity of ES certificate of the type approval, subsequent verification can be carried out through-out service life of the weighing instruments.

2.5.2 Verification Validity


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By national legislative regulation the situations are described when the gauge verifi-cation validity expires. Verification validity expires, if:

- The validity term of its verification has expired,

- The changes or modifications of specified gauge were performed that can affect its metrological characteristics,

- Specified gauge was damaged in such way that it could loose some of its charac-teristic decisive for its verification,

- The official mark was depreciated eventually removed, or

- It is apparent that also at intact verifying of the specified gauge the specified gauge looses the required metrological characteristics,

- The place of using of the specified gauge in the case where stated by the gauge type certificate, was changed.

2.6 Market supervision, Sanctions, Penalties

Supervision authority, e.g. in Czech Republic it is the Czech Trade Inspection (Česká

obchodní inspekce) performs the supervision of that, whether the compliance declaration was issued for non automatic weighing instruments placing on the market or whether the product was marked in specified way ev. The specified document was issued or inclosed to it and whether the characteristics of specified products introducted on the market meets the specified technical requirements.

Supervision authority can impose a fine up to 20 millions CZK (c. 630.000 €) on anyone who:

- Without authorization or faulsly used the Czech mark of the compliance, certifi-cate or other document issued by the authorized person in accordance to the compliance assessment, or who has falsified them

- Placed on the market or distributed the specified products without the compli-

ance declaration or with faulsy or without authorization compliance declaration or without specified marking or faulsy or without authorization CE marking or other marking specified by government regulation

- Do not fullfil the decision of the protective provision.

Supervision authority can impose a fine up to 1 million CZK (c. 31.000 €) to producers, import-ers, distributors or other persons specified in the government regulations, who will not provide to supervision authority in specified term required grounds or true information or will not make possible their revision or do not fullfil the liabilities or otherwise impede the proceedings proce-dure. Questions:


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1. What Directive of new approach concerns the non automatic weighing instruments and their market introduction? Council Directive 90/384/EEC

2. Is international recommendation having the character of standards issued by OIML, WELMEC or CECIP? OIML

3. What accuracy categories are the weighing instruments divided to according to EN 45501+ AC standard? Do tříd , , a

4. Who makes decisision of the option of the appropriate procedure of Compliance As-sessment: notified person, Euromet or the producer? Gauge producer

5. What OIML recommendation contains requirements for load cells? OIML R 60

6. What work group of WELMEC is engaged in the sphere of non automatic weighing in-struments? WG 2

7. What organization associates the representatives of the non automatic weighin in-struments producers? CECIP

8. Fill in the name of the database of ES certificates of the type approval for non auto-matic weighing instruments. EMeTAS

9. Does the validity of gauge testing lapse in the case that the gauge was damaged but no characteristic decisive for its testing was changed? No

10. Is it possible to carry out the subsequent verification nevertheless the validity of ES certificate of the type approval has expired? Yes, the validity of ES certificate limits only the possibility of market introduction of the non automatic weighing instruments.

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