Government Regulation No. 121 / 2016 Coll.
Government Regulation on conformity assessment of weighing instruments with non-automatic activities when making them available on the market
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Regulation
Effective from 20.04.2016
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121
GOVERNMENT REGULATION
of 30 March 2016
on the conformity assessment of weighing instruments with non-automatic activities when making them available on the market
The Government mandates, pursuant to Sections 4 and 50 (5) of Act No. 90 / 2016 Coll., on the conformity assessment of specified products when making them available on the market ("the Act '):
Subject matter
(1) This Regulation implements the relevant European Union1 Regulation and regulates the technical requirements for non-automatic weighing instruments which must be met when placed on the market, the conditions and procedures for making them available on the market and the conformity assessment methods.
(2) For the purposes of this Regulation, the following categories of non-automatic weighing instruments shall be distinguished:
(a) determination of weight for trade purposes;
(b) determination of weight for the calculation of fees, charges, taxes, premiums, fines, refunds, compensation or similar types of payment;
(c) determination of weight in the application of legislation or for expert opinions in court proceedings;
(d) mass determination in health care when weighing patients for monitoring, diagnosis and treatment;
(e) determination of weight for the preparation of prescription drugs in pharmacies and determination of weight for analyses carried out in medical and pharmaceutical laboratories;
(f) the determination of the price on the basis of weight for the purposes of direct sales to the public and the preparation of pre-packaged products; and
(g) all uses other than those referred to in (a) to (f).
Definition of terms
This Regulation shall mean:
(a) weighing instruments used to determine the mass of the body by applying gravity to that body; the weights may also be used to determine the additional quantities, quantities, parameters or characteristics related to the mass;
(b) weighing instruments with non-automatic weighing activities requiring intervention by the operator during the weighing process.
Technical requirements for non-automatic weighing instruments
(1) Non-automatic weighing instruments used or intended for the uses referred to in points (a) to (f) of Paragraph 1 (2) (hereinafter referred to as "selected scales") of paragraph 2 shall comply with the essential requirements set out in Annex 1 to this Regulation.
(2) Where non-automatic weighing instruments contain or are linked to devices which are not used or intended for the uses referred to in § 1 (2) (a) to (f), these essential requirements shall not apply to such devices.
Making available on the market and putting into service
(1) Non-automatic weighing instruments may be made available on the market only if the requirements of this Regulation are met.
(2) The instruments selected may be put into service only if the requirements of this Regulation are met. After entry into service, the selected weights shall be maintained in accordance with the requirements of this Regulation.
Manufacturer
(1) When placing the selected scales on the market, the manufacturer shall ensure that those scales are designed and manufactured in accordance with Section 3 (1), draw up the technical documentation set out in Annex 2 to this Regulation and carry out or have carried out one of the conformity assessment procedures provided for in Section 10.
(2) Where the conformity of the selected weights with the relevant requirements has been demonstrated by the relevant conformity assessment procedure referred to in Section 10, the manufacturer shall draw up an EU declaration of conformity and place the CE marking and the supplementary metrological marking on the chosen weight.
(3) The manufacturer shall keep the technical documentation and the EU declaration of conformity for a period of 10 years from the placing on the market of the selected instrument.
(4) The manufacturer shall carry out tests on the samples of the selected scales made available on the market and on the investigation where necessary in view of the risks posed by the selected weights in relation to the manufacturer's intended purpose of use. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the existing risk. The manufacturer shall keep a register of complaints, non-compliant scales and withdrawal of the selected scales and shall keep distributors informed of these activities.
(5) The manufacturer shall ensure that the non-automatic weighing instruments which he has placed on the market bear the type or series number or serial number or other element enabling them to be identified in the manner set out in Annex 3 to this Regulation. In the case of selected scales, the manufacturer shall place the inscriptions referred to in point 1 of Annex 3 to this Regulation; in the case of other non-automatic weighing instruments, place the inscriptions referred to in point 2 of Annex 3 to this Regulation. Where the selected instruments contain devices or are linked to devices which are neither used nor intended for the uses referred to in points (a) to (f) of Paragraph 1 (2), the manufacturer shall place on each such device a symbol of restricted use in accordance with Section 13 (5) and point 3 of Annex 3 to this Regulation.
(6) The manufacturer shall indicate on the non-automatic weighing instruments his name or business name or trade mark, if applicable, and the address for service at which he can be contacted. The address shall indicate the only place at which the manufacturer can be contacted. The contact details shall be given in a language easily understood by end-users and the supervisory authority.
(7) The manufacturer shall ensure that the selected weights which he makes available on the market are accompanied by instructions and information in the Czech language. Such instructions, information and any markings shall be clear, understandable and easily understandable.
Authorised representative
The authorised representative shall keep the EU declaration of conformity and the technical documentation at the disposal of the supervisory authority for a period of 10 years from the placing on the market of the selected instrument.
Importer
(1) Before placing non-automatic weighing instruments on the market, the importer shall ensure that the manufacturer complies with the requirements set out in Article 5 (5) and (6). In the case of selected scales, they shall also ensure that the manufacturer carries out the appropriate conformity assessment procedure referred to in Section 10, that the manufacturer draws up technical documentation, that the selected scales bear the CE marking and the supplementary metrology marking and that the required documents are attached thereto.
(2) The importer shall indicate on the non-automatic weighing instruments his name or business name or trade mark, if any, and the address for service at which he can be contacted. In cases where it would be necessary for the packaging to be opened, the particulars may be given on the packaging and on the document accompanying the weighing instruments with non-automatic activity. The contact details shall be given in a language easily understood by the end-user and the supervisory authority.
(3) The importer shall ensure that the chosen scales are accompanied by instructions and information in the Czech language.
(4) The importer shall carry out tests on samples of selected weighing instruments made available on the market and on investigation, where appropriate in view of the risks posed by the selected weighing instruments. These tests and investigations shall be carried out to the extent necessary to confirm or eliminate the risk. Where necessary, the importer shall keep a register of complaints, non-compliant scales and withdrawal of selected scales and shall keep distributors informed of such activities on an ongoing basis.
(5) The importer shall keep a copy of the EU declaration of conformity for market surveillance purposes for a period of 10 years from the placing on the market of the selected instruments and ensure that technical documentation can be submitted to the supervisory authorities upon request.
Distributor
Before making non-automatic weighing instruments available on the market, the distributor shall verify that:
(a) the manufacturers and importers have complied with the relevant requirements laid down in Articles 5 (5), 5 (6) and 7 (2);
(b) the weights selected shall bear the CE marking and the supplementary metrological marking; and
(c) the selected scales are accompanied by the required documents and instructions and information in the Czech language.
Economic operator identification time
For a period of 10 years from the date of delivery of the selected weight on the market, the operator shall keep the information by which, at the request of the supervisory authority, the economic operator who has supplied the selected weight to him or to whom he has supplied it.
Conformity assessment procedures
(1) For the assessment of the conformity of a selected weight with the essential requirements referred to in Article 3 (1), the following shall apply:
(a) the EU type-examination (Module B) set out in point 1 of Annex 2 to this Regulation and at the same time one of the following procedures:
1. conformity with the type based on the quality assurance of the production process (module D) set out in point 2 of Annex 2 to this Regulation; or
2. conformity with the product verification type (Module F) set out in point 4 of Annex 2 to this Regulation; or
(b) conformity based on the verification of each product (Module G) set out in point 6 of Annex 2 to this Regulation.
(2) The EU type-examination (Module B) is not mandatory for selected scales for which electronic devices are not used and in which a spring is not used to balance the load. For selected weighing instruments not covered by EU type-examination (Module B), the following shall apply:
(a) the quality assurance of the production process (module D1) set out in point 3 of Annex 2 to this Regulation; or
(b) conformity based on product verification (module F1) as set out in point 5 of Annex 2 to this Regulation.
Presumption of conformity
Where the instruments selected are in conformity with harmonised standards to which the references in the Official Journal of the European Union or parts thereof have been published, they shall be deemed to comply with the essential requirements set out in Annex 1 to this Regulation.
EU declaration of conformity
(1) The EU declaration of conformity demonstrates compliance with the essential requirements set out in Annex 1 to this Regulation.
(2) The EU declaration of conformity shall be drawn up in accordance with the model set out in Annex 4 to this Regulation. The declaration shall contain the information set out in the relevant modules listed in Annex 2 to this Regulation and shall be kept up to date. The EU declaration of conformity shall also be translated into the language (s) required by the Member State of the European Union in which the selected instruments are placed or made available on the market.
(3) Where the selected scales are covered by several European Union harmonisation rules providing for the drawing up of an EU declaration of conformity, a single EU declaration of conformity shall be drawn up with the references to all those rules under which conformity has been assessed, including the references to their publication. This single EU declaration of conformity may take the form of a component consisting of declarations of conformity issued for each Regulation.
CE marking and other markings
(1) The CE marking and the supplementary metrological marking shall be placed on the selected scales or on their production label before they are placed on the market.
(2) The supplementary metrological marking consists of the capital letter "M" and the last two digits of the year in which it was placed, enclosed by a rectangle whose height is equal to the height of the CE marking. The supplementary metrological marking shall be followed immediately by the CE marking. The general principles of the CE marking shall apply mutatis mutandis to the supplementary metrological marking.
(3) The CE marking and the supplementary metrological marking shall be followed by the identification number of the notified body or bodies involved in the control phase of production in accordance with Annex 2 to this Regulation.
(4) The CE marking, the supplementary metrological marking and the identification number of the notified body or bodies may be followed by any other mark indicating a specific risk or use.
(5) The symbol of restricted use referred to in the third sentence of Article 5 (5) and specified in point 3 of Annex 3 to this Regulation, located on the selected weights, must be clearly visible and indelible.
Formal deficiencies
A formal deficiency shall be considered to be:
(a) the CE marking or the supplementary metrological marking has been placed in breach of Article 30 of Regulation (EC) No 765 / 2008 of the European Parliament and of the Council of 9 July 2008 laying down requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339 / 93 or Article 13;
(b) the CE marking or the supplementary metrological marking has not been affixed;
(c) the inscriptions referred to in Article 5 (5) have been placed in contravention of Article 5 (5) or have not been affixed;
(d) the identification number of the notified body involved in the production control phase has been placed in contravention of Article 13 (3) or has not been located;
(e) the EU declaration of conformity has not been drawn up;
(f) the EU declaration of conformity has not been drawn up in accordance with this Regulation;
(g) the technical documentation is missing or incomplete;
(h) the information referred to in § 5 (6) or § 7 (2) is missing or is incorrect or incomplete; or
(i) another administrative requirement referred to in § 5 or § 7 or administrative requirement referred to in § 6 (1), (5) or (6) or § 8 (1), (3), (6) or (7) of the Act has not been complied with.
Transitional provisions
(1) Balances with non-automatic activity meeting the requirements laid down by Government Decree No. 326 / 2002 Coll. may continue to be made available on the market and put into service if they were placed on the market before 20 April 2016.
(2) Valid certificates and other documents certifying the facts established issued by the notified persons under Government Regulation 326 / 2002 Coll. remain valid and shall be considered as certificates and other documents certifying the facts established under this Regulation.
Repeal
Government Decree No. 326 / 2002 Coll., laying down technical requirements for non-automatic weighing instruments, is repealed.
Efficacy
This Regulation shall enter into force on 20 April 2016.
Prime Minister:
Sobotka v. r.
Minister for Industry and Trade:
Ing. Mládek, CSc., v. r.
Příloha č. 1
Annex No 1 to Government Regulation No 121 / 2016 Coll.
ESSENTIAL REQUIREMENTS
The terminology used is the terminology of the International Organisation for Legal Metrology.
Preliminary provisions
If the selected scales are equipped with or attached to more than one indicator or printing device, those devices which repeat the results of the weighing operation and which cannot affect the correct functioning of the scales shall not be subject to the essential requirements if the weighing results are printed or recorded correctly and unremovable by any part of the scales which meets the essential requirements and are accessible to both parties with an interest in the result of the measurement. However, in the case of weighing instruments used for direct sale to the public, the display and printing equipment for the seller and the customer shall comply with the essential requirements.
Metrological requirements
1. Weight units
The mass units used are measuring units established by other legislation (m2) governing the metrology area.
The following units are permitted to be used for weighing instruments:
(a) SI units: kilogram, microgram, milligram, gram, tonne,
(b) other unit outside SI: metric carat in the case of weighing precious stones.
For weighing instruments intended for making available on the market of a Member State in which the use of a trojan ounce in the case of precious metal weighing is permitted, the relevant essential requirements set out below shall be converted into that unit by simple conversion.
2. Precision classes
2.1 The following classes of accuracy are defined:
(a) I special,
(b) II high,
(c) III medium;
(d) IIII common.
The specification of these classes is given in Table 1.
Table 1
| Třídy přesnosti | ||||
|---|---|---|---|---|
| Třída | Ověřovací dílek (e) | Dolní mez váživosti (Min) | Počet ověřovacích dílků n = ((Max) / (e)) | |
| Minimální hodnota | Minimální hodnota | Maximální hodnota | ||
| I | 0,001 g ≤ e | 100 e | 50 000 | — |
| II | 0,001 g ≤ e ≤ 0,05 g | 20 e | 100 | 100 000 |
| 0,1 g ≤ e | 50 e | 5 000 | 100 000 | |
| III | 0,1 g ≤ e ≤ 2 g | 20 e | 100 | 10 000 |
| 5 g ≤ e | 20 e | 500 | 10 000 | |
| IIII | 5 g ≤ e | 10 e | 100 | 1 000 |
The lower limit of gravity is reduced to 5 e for weights in Classes II and III determining the transport tariff.
2.2. Scale sections
2.2.1 The actual scale part (d) and the verification part (e) are in the form of:
1 × 10k, 2 × 10k, or 5 × 10k units,
k is an integer or zero.
2.2.2. For all weighing instruments except weighing instruments with auxiliary indicating equipment:
d = e.
2.2.3. The following conditions shall apply to instruments with auxiliary indicators:
e = 1 × 10k g,
d < e ≤ 10 d.
These conditions do not apply to tier I weights with d < 10-4 g for which e = 10-3 g.
3. Classification
3.1. Weights with one weighing range
Balances fitted with auxiliary indicators belong to the class I or Class II. For these weights, for these two precision classes, the lower limit of gravity shall be determined from the third column of Table 1 by replacing the verification panel (e) with the actual section of the scale (d).
If d < 10-4 g, the upper limit of gravity may be in the class I lower than 50,000 e.
3.2. Weights with multiple ranges
Multiple weighing ranges are permitted provided they are clearly marked on the scales. Each individual weighing range shall be classified according to point 3.1. If the weighing ranges belong to different accuracy classes, the weights shall meet the strictest of the requirements applicable to the accuracy classes to which the weighing ranges fall.
3.3. Weights with multiple ranges
3.3.1 One-scale scales may have several partial weighing ranges (multiple-scale weights).
Weights with multiple ranges shall not be equipped with an auxiliary indicator device.
3.3.2. Each partial weighing range, even for multi-scale weighing instruments, is defined as follows:
(a) with its verification part ei, e (i + 1) > ei,
(b) its upper limit of gravity, Max, with Maxr = Max and
c) its lower limit of gravity Mini, with Mini = Max (i - 1) and Min1 = Min
where:
i = 1, 2,... r,
i = number of partial weighing range,
r = total number of partial weighing ranges.
All weightings refer to the net load, regardless of the value of the used tar.
3.3.3. The sub-weighting ranges are classified according to Table 2. All partial weighing ranges fall within the same class of accuracy, which is the class of balance accuracy.
Table 2
| Váhy s vícenásobným rozsahem | ||||
|---|---|---|---|---|
| i = 1, 2, ... r i = číslo dílčího vážicího rozsahu r = celkový počet dílčích vážicích rozsahů | ||||
| Třída | Ověřovací dílek (e) | Dolní mez váživosti (Min) | Počet ověřovacích dílků | |
| Minimální hodnota | Minimální hodnota(1) | Maximální hodnota | ||
| n = ((Maxi) / (e(i+1))) | n = ((Maxi) / ei)) | |||
| I | 0,001 g ≤ ei | 100 e1 | 50 000 | — |
| II | 0,001 g ≤ ei ≤ 0,05 g | 20 e1 | 5 000 | 100 000 |
| 0,1 g ≤ ei | 50 e1 | 5 000 | 100 000 | |
| III | 0,1 g ≤ ei | 20 e1 | 500 | 10 000 |
| IIII | 5 g ≤ ei | 10 e1 | 50 | 1 000 |
(1) For i = r, the corresponding column of Table 1, where e is replaced by er.
4. Accuracy
4.1 When applying the procedures set out in Section 10, the indication error shall not exceed the largest permissible indication error in Table 3. In the case of a digital indication, the error shall be corrected to a rounding error.
The largest permissible errors apply to net values and values of the treads for all possible loads except the pre-selected treads.
Table 3
| Největší dovolené chyby | ||||
|---|---|---|---|---|
| Zatížení | Největší dovolená chyba | |||
| Třída I | Třída II | Třída III | Třída IIII | |
| 0 ≤ m ≤ 50 000 e | 0 ≤ m ≤ 5 000 e | 0 ≤ m ≤ 500 e | 0 ≤ m ≤ 50 e | ± 0,5 e |
| 50 000 e < m ≤ 200 000 e | 5 000 e < m ≤ 20 000 e | 500 e < m ≤ 2 000e | 50 e < m ≤ 200 e | ± 1,0 e |
| 200 000 e < m | 20 000 e < m ≤ 10 0000 e | 2 000 e < m ≤ 10 000 e | 200 e < m ≤ 1 000 e | ± 1,5 e |
4.2 The greatest permissible errors in use are twice the greatest permissible errors referred to in point 4.1.
5. The weighing results shall be reproducible and shall be reproducible by other indicating devices used and other balancing methods used.
The weighing results shall be sufficiently resistant to changes in the load position on the load carrier.
6. The scales shall respond to minor load changes.
7. Influencing variables and time
7.1 The weights of the classes of accuracy II, III and IIII, which could be used in the inclined position, shall be sufficiently resistant to tilting, which may occur in normal use.
7.2 The scales shall meet the metrological requirements in the temperature range specified by the manufacturer. The value of this range is at least equal to
(a) 5 ° C for Class I weights;
(b) 15 ° C for class II weights;
(c) 30 ° C for weights of Class III or IIII.
If the manufacturer does not determine the temperature range, the range from - 10 ° C to + 40 ° C shall apply.
7.3 The weights supplied from the power grid shall meet the metrological requirements under normal voltage fluctuations.
The battery-operated weights shall indicate a voltage reduction below the required minimum value and shall either continue to function correctly under these circumstances or shall be automatically disabled.
7.4 Electronic weighing instruments, with the exception of class I and II weights, for which e is less than 1 g, shall meet the metrological requirements under high relative humidity conditions at the top between its temperature range.
7.5 The loading of Class II, III or IIII weights over a longer period shall have a negligible effect on the load indication or zero indication immediately after removal of the load.
7.6 Under other conditions, the scales must either continue to function correctly or be automatically disabled.
Design and construction
8. General requirements
8.1 The scales shall be so designed and constructed that they retain their metrological parameters when properly installed and used in the environment for which they are intended. The mass value must be displayed.
8.2 Where electronic weighing instruments are subject to interference, they shall not exhibit serious errors, or such serious errors shall be automatically detected and indicated.
The electronic balance shall automatically detect a serious error by means of visual or audible signals, as long as the user removes the failure or the failure disappears.
8.3 The requirements of paragraphs 8.1 and 8.2 shall be fulfilled for a period considered to be normal from the point of view of the intended use of the scales.
Digital electronic devices shall always ensure adequate control of the correct operation of the measurement process, indication equipment and all storage and transmission of data.
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Regulation Information
| Citation | Government Regulation No. 121 / 2016 Coll., on the conformity assessment of weighing instruments with non-automatic action in making them available on the market |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.04.2016 |
|---|---|
| Effective from | 20.04.2016 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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