USER S RESOURCES BOOK WEIGHING ACADEMY. Weighing Regulations and Standards Measurement. Version 1.01 September 2004

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1 USER S RESOURCES BOOK WEIGHING ACADEMY Weighing Regulations and Standards Measurement Version 1.01 September 2004 Kadlec, spol. s r.o. Veleslavínova Opava This project has been funded with the support of the European Community. The content of this project does not necessarily reflect the position of the European Community or the National Agency, nor does it involve any responsibility on their part. (c) 2004 All rights reserved

2 Table of Contents Table of Contents The Reasons of Weight Accuracy Measurement Nowadays in Relation to Generally Applicable Regulations and Standards The International Organization acting in Weighing Field The Council of the European Union OIML WELMEC CECIP EUROMET The standards in the weighing field EN AC OIML Recommendation R OIML Recommendation R WELMEC Documents Standards in the USA Standards and next document acquisition Metrological Authorities Acting in the Weighing Field National metrological authorities Notified persons Introduction of the Weighing technique on the Market of the EU ES Type Testing ES Compliance Declaration with Type ES Verification ES Verification of any separate product Modul Approach Illustrations of the market introduction procedure Practice at market introduction in light of producers Marking of the weighing instruments before market introduction ES Certificates Database on Type Approval Weighing instruments using in business contacts Subsequent Testing Verification Validity Market supervision, Sanctions, Penalties...30 page 2 / 31

3 2 The Reasons of Weight Accuracy Measurement Nowadays in Relation to Generally Applicable Regulations and Standards 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 requirements 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 organizations 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 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 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 page 3 / 31

4 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 regulations 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 legislative 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, concrete 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 market introduction of non automatic weighing instruments only through the procedures according 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 requirements 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 illustrated on Figure 2. Figure 2 Legends: - CE... compliance mark - M... metrological mark notified person number two ciphers of the year of compliance mark attachment The Council Directive 90/384/EEC makes possible for the weighing instruments producers to elect from several various procedures by which the weighing instruments compli- page 4 / 31

5 ance with the directive requirements can be assessed. It is then only on decision of the producer, 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 fulfillment to perform the activity at Compliance Assessment of non automatic weighing instruments. 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 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 particular 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 instruments 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. page 5 / 31

6 Figure 3 page 6 / 31

7 2.1.2 OIML Basic characteristics: - Normalizing activity is the most important - Worldwide incidence - Number of member countries is approximately 60 - Reference 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 organization 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 arrangements 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 assignment to prepare the metrological regulations for various categories of measuring instruments. 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 international standards. They contains namely the basic requirements on measurement instruments, test procedures and also forms of the records of tests using at Compliance Assessment of gauge type with the appropriate OIML Recommendation. The short summary of the documents issued by OIML is illustrated on Figure 4. It includes in the recommendation section only the ones that concern the weighing; overall about 150 OIML Recommendations from the various metrology branch exist. page 7 / 31

8 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 implemented 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 authority for specific type or type series of gauges. Compliance certificate can either be accepted 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 certificate 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 Certification 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 compliance certificates according to 14 OIML Recommendations are registered at 15 th 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 implementation. Therefore at present days the works on agreement of mutual tests results acceptance (the Mutual Acceptance Agreement, shortly MAA treaty) are intensively in progress. 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 certificate existence as an approval protocol, such document can be accepted without any changes. However, if the national legislative modification requires its own type approval certificate issuing, such certificate can be issued pursuant to the tests results acceptance performed for OIML compliance certificate issuing. page 8 / 31

9 Figure 4 page 9 / 31

10 From that reason it concerns the tests results acceptance not compliance certificate acceptance, because the compliance certificate acceptance as such would required in number 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 page 10 / 31

11 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 WELMEC organization was found in The original title was Western European Legal Metrology Co-operation (WELMEC). In 1995, the title was modified to European Cooperation in Legal Metrology, but the original shortcut was preserved. WELMEC is the organization 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 organizations 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 secretariat WG 2 Directive 90/384/EEC NAWI implementation GB WG 4 EN 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 specifying 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. page 11 / 31

12 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 countries 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 Recommendation R 50 R 51 R 61 R 105 R 106 R 107 R 117/ R 118 Title Continuous totalizing automatic weighing instruments (belt weighers) Automatic catchweighing and instruments Automatic gravimetric filling instruments Sets for measurement of liquid mass flow rate Automatic rail-weighbridges Discontinuous totalizing automatic weighing instruments Measuring sets for liquids other than water In the sphere of weighing instruments it concerns some kinds automatic weighing instruments. 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. page 12 / 31

13 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 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 representation of interests of producers of the weighing technique on the international level among others in organizations as e.g. WELMEC 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 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 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 mention for comparison e.g. NIST Handbooks using in the USA. page 13 / 31

14 Figure EN AC Standard EN on metrological aspects of non automatic weighing instruments has been issued in 1992 and in 1993 was issued the change AC: As amended the standard EN 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 page 14 / 31

15 - Testing procedure for the resistance against emission by highfrequency electromagnetic 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 follows: Table 1 n = Maxle min min max Special 0,001 g e 3) ) 100e High 0,001 g e 0,05 g e 0,1 g e e Middle 0,1 g e 2 g e 5 g e e Common 5 g e e 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 0 m m m m 50 ± 1 e m m m m 200 ± 1,5 e m m m m 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 kg ± 1,5 kg OIML Recommendation R 76 Standard EN preparations came from the OIML Recommendation R 76: Today are valid the OIML Recommendation R 76-1: 1992 and OIML R76-2: 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 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 page 15 / 31

16 weighing instruments according to the Council Directive 90/384/EEC, in which is today the principal importance of this document OIML Recommendation R 60 OIML R 60 Recommendation with the title Metrological regulation for load cells is today valid in version from 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 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 instruments 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 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 constructional 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 Peripheral 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 automatic weighing instruments. It contains also the examples of weighing systems diagrams with respect to the approval and marking. page 16 / 31

17 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 AC standard, the interpretation of which need not be quite unified. It states also practical examples helping to understand exactly these terms 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 requirements by the similar way as in the EU however they are different in some points. For illustration the table similar to Table 1 from the EN standard defining the weighing instrument categories is shown here. Table 3 page 17 / 31

18 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 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 metrological authority of the USA, National Institute of Standards and Technology (NIST) on Metrological Authorities Acting in the Weighing Field Integral parts of the metrological system of the EU in the weighing sphere are metrological authorities among them above all national metrological authorities and notified persons 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 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 approval, verification), capability assessment of other subjects acting in the field of the metrology 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 commended 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; page 18 / 31

19 - 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 quantities of values from government etalons onto etalons of lower ranks, for verfication 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 Figure 8 page 19 / 31

20 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 notified 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 actual 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 activities 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 respective 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 product 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 distribution 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 Compliance 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 page 20 / 31

21 - Weight determination at preparation of medicaments on prescriptions in drug stores - Weight determination at analysis performed in medical and pharmaceutical laboratories - 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 automatic 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 procedures 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 Certificate and its purpose is documenting that the type (ev. type series) of the weighing instruments 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- page 21 / 31

22 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 Directive 90/384/EEC 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 Directive 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 balancing 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 Directive 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 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. page 22 / 31

23 2.4.3 ES Verification ES Verification is the procedure when the producer or empowered representative ensures 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 Approval. The Notified Person will perform the appropriate inspections and tests of any separate 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 ES Verification of any separate product ES Verification of any separate product is the procedure when the producer or empowered 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. However, 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 Modul Approach The so called Modul Approach is used in practice at the procedures of the Compliance 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 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 verificated (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. page 23 / 31

24 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 appropriate test certificates for used scoring unit and used load cells. The construction of load carrier and placing of load cells is absolutely the responsibility of the weighing instrument producer; it is possible to use here the WELMEC 2.4 Document, 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 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 automatic weighing instruments. The most common procedure of the market introduction for common business weighing 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 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 AC standard Compliance certificate + weighinginstruments marking with the identification number of the page 24 / 31

25 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: Non automatic weighing instruments Accuracy category Max = kg, e = 20 kg Load cells of type xyz, scoring a indicator unit of type abcd Application for ES Type Verification to Notified person Tests and weighing instruments assessment 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 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 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 Application for ES Verification of any separate product Compliance Declaration Appropriate Test Certificate copy Moduls compatibility calculation Tests according to the article 8.2 of the EN Tests according to the article 8.2 of the EN page 25 / 31

26 45501+AC standard AC standard Compliance Certificate + weighing instruments 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 Certifikát compliance + označení vah číslem notifikované persons a případně značkami compliance pokud není váha již takto označena výrobcem Market introduction 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 directive, 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 instruments 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 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 market 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 page 26 / 31

27 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 d T =... 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 subject 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 certificate 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 prohitibive the input to the gauge etc. are safeguarded ES Certificates Database on Type Approval page 27 / 31