121/2016 Sb.
GOVERNMENT REGULATION
of 30 March 2004. March 2016
on conformity assessment scales means their activities, making available on the
market
The Government directs pursuant to § 4 and § 50 para. 5 of law No. 90/2016 Coll.
conformity assessment of specified products when they are making available on the market (hereinafter
"the Act"):
§ 1
The subject of the edit
(1) this regulation incorporates the relevant provision of the European Union ^ 1) and
regulates the technical requirements for the balance with a package of activities that
must comply when placing on the market, the conditions and procedures for their
making available on the market and the conformity assessment methods.
(2) for the purposes of this regulation, the distinction between these categories of instrument use
package:
and for the purposes of determining weight) of trade,
b) determination of mass to calculate fees, tariffs, taxes, premiums,
fines, compensation, indemnity or similar type payments,
(c)) determination of mass in the application of laws or the
expert opinions in judicial proceedings,
d) determination of mass in medicine for weighing patients for the purposes of
monitoring, diagnosis and medical treatment,
e) determination of mass for making up medicines on prescription in a pharmacy
and determination of mass in analyses carried out in medical and
pharmaceutical laboratories,
f) pricing based on the weight, for the purposes of direct sales
the public and the preparation of prepackaged and
g) all other uses than those listed in points (a)) to
(f)).
§ 2
Definition of terms
In this regulation means
and measuring apparatus, weights) that is used to determine the mass of a body
by using the action of gravity on that body; weights can also be used to
specify additional quantities, quantities, parameters or characteristics
properties related to mass,
(b)) means activities weights weights that require operator intervention
during the weighing process.
§ 3
Technical requirements for balance with a package of activities
(1) balance with a package of activities used or intended for use
referred to in § 1 (1). 2 (a). a) to (f)) (hereinafter referred to as "selected scales") must
meet the essential requirements laid down in annex 1 to this regulation.
(2) if the means of activities include weight equipment or are
associated with devices that are not being used or intended for use
referred to in § 1 (1). 2 (a). a) to (f)), these essential requirements are to
such devices do not apply.
§ 4
Making available on the market and putting into service
(1) balance with a package of activities can be supplied on the market only if
the requirements of this regulation are met.
(2) the selected weights can be placed in service only if they are satisfied
the requirements of this regulation. After putting into operation must be selected scales
maintained in accordance with the requirements of this regulation.
§ 5
The manufacturer of the
(1) when placing on the market of weights selected manufacturer shall ensure that these weights
have been designed and manufactured in accordance with § 3 (1). 1, shall establish the technical
documentation set out in annex 2 to this regulation and shall
have carried out one of the conformity assessment procedures provided for in paragraph 10.
(2) if the compliance of the instruments with the appropriate requirements of selected competent
the conformity assessment procedure referred to in article 10 shown, the manufacturer shall draw up a
EU Declaration of conformity and affix the CE marking to the selected scale and complementary
Metrology marking.
(3) the manufacturer shall keep the technical documentation and the EU Declaration of conformity
a period of 10 years after the selected weight on the market.
(4) the manufacturer shall carry out tests on samples selected weights that came on the market and
the investigation, if it is necessary due to the risks they present
the selected weight relative to the intended use by the manufacturer. These
tests and investigations are carried out to the extent necessary to confirm or
refutation of the risks involved. The producer keeps records of complaints,
non-conforming selected scales and download selected instruments from the circulation and continuously
These activities inform distributors.
(5) the manufacturer shall ensure that the scales with a package of activities
that said, on the market bear a type, batch or serial number or or
other element allowing their identification, as laid down in
Annex 3 to this regulation. In the case of selected balance manufacturer places
the inscriptions referred to in point 1 of annex 3 to this regulation; in the case of
other scales means activities places the inscriptions referred to in point 2
Annex 3 to this regulation. If the selected device balances
or are associated with devices that are not being used or intended for
use referred to in section 1 (1). 2 (a). a) to (f)), places the manufacturer on each
such a device, the symbol of limited use in accordance with § 13 para. 5 and with
point 3 of annex 3 to this regulation.
(6) the manufacturer shall indicate the scales means the activities of your name or
business name or trade mark and the address for service, at
which he can be contacted. The address must indicate a single point at which you can
contact the manufacturer. Contact details are given in a language easily
understood by end-users and the supervisory authority.
(7) the manufacturer shall ensure that the selected instrument, which comes on the market,
accompanied by instructions and information in Czech language. These tutorials, information and
any labelling must be clear, comprehensible and easy to understand.
§ 6
Authorized representative
Authorized representative shall keep the EU Declaration of conformity and the technical
documentation for the requirements of a supervisory authority for a period of 10 years after the selected
weighing on the market.
§ 7
The importer
(1) before putting weights on the market activity means the importer shall ensure that the
that a manufacturer has complied with the requirements set out in § 5 para. 5 and 6. On selected
the weights shall also ensure that the manufacturer has made the assessment procedure
compliance referred to in paragraph 10, that the manufacturer has drawn up the technical documentation,
to the selected weight bearing the CE marking and the supplementary metrology marking and,
they were accompanied by the required documents.
(2) the importer shall indicate the scales means the activities of your name or
business name or trade mark and the address for service, at
which he can be contacted. In cases where, to this end it was necessary to
Open the cover, the data may be indicated on the packaging and in the document accompanying the
those with the means of activities. Contact details are given in the language
that is easy to understand for the final user and the supervisory authority.
(3) the importer shall ensure that the selected instrument is accompanied by instructions and
the information in the Czech language.
(4) the importer carries out tests on samples selected weights that came on the market and
the investigation, if that is appropriate to the risks they present selected
the scales. These tests and the investigation is carried out to the extent necessary for the
the confirmation or refutation of the risk. If necessary, leads importer
a register of complaints, non-conforming selected weights and download selected
the weights of the circulation and shall inform the activities of these distributors.
(5) the importer for a period of 10 years following the placing on the market of weights selected stores
a copy of the EU Declaration of conformity for the purposes of monitoring the market and ensures
that the supervisory authorities can be presented upon request technical
documentation.
§ 8
Distributor
The Distributor before delivery of the means of activities on the scales with the market checks
whether
and manufacturers and importers meet) the requirements set out in § 5 para.
5 and 6 and § 7 (2). 2,
(b)) of the selected weight bearing the CE marking and the supplementary metrology marking and,
(c)) are the selected instruments accompanied by the required documents and tutorials and
the information in the Czech language.
§ 9
Time for the identification of the operator
Economic operator for a period of 10 years from the delivery of the selected weight on the market
stores the data that can be used at the request of the supervisory authority to determine
the operator, who had selected the weight added or which it
He added.
§ 10
The conformity assessment procedures
(1) to assess the conformity with the essential requirements of the selected weight according to § 3
paragraph. 1 shall apply
and) the EU type-examination (module B) referred to in point 1 of annex 2 to the
This regulation and at the same time one of the following procedures:
1. conformity to type based on quality assurance of the production process
(module D) set out in point 2 of annex 2 to this regulation, or
2. conformity to type based on product verification (module F) as provided for in
point 4 of annex 2 to this regulation, or
b) conformity based on unit verification (module G)
laid down in point 6 of annex 2 to this regulation.
(2) the EU type-examination (module B) is not required for selected instruments
which are not applied to electronic devices and in which the measuring unit
the spring is used to balance the load. For selected instruments that are
does not apply the EU type-examination (module B), it shall be
and quality assurance) (module D1) provided for in point
3 of annex 2 to this regulation, or
b) conformity based on product verification (module F1) set out in point 5 of
Annex 2 to this regulation.
§ 11
Presumption of conformity
If you are selected in conformity with the harmonised standards which have been
published references in the official journal of the European Union, or parts thereof,
It is thought that they are in compliance with the essential requirements laid down in
Annex 1 to this regulation.
§ 12
EU Declaration of conformity
(1) the EU Declaration of conformity to meet 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 statement contains the information set out in
relevant modules set out in annex 2 to this regulation and shall
still be updated. EU Declaration of conformity shall be translated also into the language
or languages required by the Member State of the European Union, in which the
the selected weight shall place or make available on the market.
(3) If the selected weight is subject to more rules for harmonisation
The European Union providing for the elaboration of EU Declaration of conformity,
draw up a single EU Declaration of conformity with links to all of these
legislation under which it was considered a match, including links to their
publication. This single EU Declaration of conformity may take the form of a folder
consisting of declarations of conformity issued to individual regulations.
section 13 of the
The CE marking and other markings
(1) the CE marking and supplementary metrology marking shall be placed on the selected
weights or on their plate before placing them on the market.
(2) the supplementary metrology marking consists of the capital letter "M" and the last
two digits of the year in which it was located, bounded by the rectangle whose
height is equal to the height of the CE marking. The supplementary metrology marking
immediately follows the "CE" marking. The General principles of the CE marking apply to
the supplementary metrology marking accordingly.
(3) the CE marking and supplementary metrology marking followed by a
the identification number of the notified body or bodies that are
involved in the production control phase in accordance with Annex 2 to this
of the regulation.
(4) the CE marking, the supplementary metrology marking and,
the identification number of the notified body or bodies may be followed by
any other mark indicating a special risk or use.
(5) the Symbol of limited use, as referred to in § 5 para. 5 the third sentence and
closer specified in point 3 of annex 3 to this regulation, located on the
selected scales must be clearly visible and indelible.
§ 14
Formal defects
A formal deficiency is considered when
and) the CE marking or the supplementary metrology marking is placed in the
contrary to the article. 30 European Parliament and Council Regulation (EC) no 765/2008
of 9 June. July 2008 setting out the requirements for accreditation and
market surveillance relating to the marketing of products and repealing
Regulation (EEC) No 339/93, or section 13,
(b)) the CE marking or the supplementary metrology marking has not been affixed,
c) inscriptions specified in § 5 para. 5 have been placed in violation of § 5 para. 5
or have not been located,
d) identification number of the notified body involved in the control phase
production was located in violation of § 13 para. 3 or not,
e) EU Declaration of conformity has not been drawn up,
f) EU Declaration of conformity has not been drawn up in accordance with this
by regulation,
g) technical documentation is missing or incomplete,
(h)), the information specified in § 5 para. 6 or § 7 para. 2 are missing, or are
incorrect or incomplete, or
I) was not fulfilled other administrative requirement referred to in section 5, or section 7 of the
or administrative requirement referred to in section 6 (1). 1, 5, or 6, or section 8
paragraph. 1, 3, 6, or 7 of the Act.
§ 15
Transitional provisions
(1) balance with a package of activities meeting the requirements laid down
Government Ordinance No. 326/2002 Coll. may continue to be placed on the market and
put into service if they have been placed on the market before the date of 20. April
2016.
(2) valid certificates and other documents certifying the detected
fact released persons notified pursuant to Decree-Law No.
326/2002 Coll., shall remain in force and shall be deemed the certificates and other
the documents certifying the facts established under this regulation.
section 16 of the
Regulation (EEC)
Government Regulation No. 326/2002 Coll. laying down technical requirements
on the scale means the activities, is hereby repealed.
§ 17
The effectiveness of the
This Regulation shall enter into force on 20 March 2004. April 2016.
Prime Minister:
Mgr. Sobotka in r.
Minister of industry and trade:
Ing. Mládek, CSc., r.
Č. 1
THE BASIC REQUIREMENTS
The terminology used is the international organization of legal terminology
Metrology.
Introductory provisions
If the scales are equipped with more than one indicating or
a printing device or connected to it, do not apply to this
the device, which repeated the results of weighing operations and that cannot
affect the proper function of the instrument, the essential requirements if the results are
Dear printed or recorded correctly and indelibly either
parts of the instrument, which meets the basic requirements, and these results are
accessible to both parties interested in the measurement result. In the case of the scales
used for direct sales to the public, however, the demonstrative and printing
the seller and the customer's equipment must satisfy the essential
requirements.
Metrological requirements
1. Units of weight
Used units of weight are measuring units provided for other
Law ^ 2) governing the area of metrology.
For the scales is the use of the following units:
and SI units): kilogram, microgram, milligram, gram, tonne,
(b)) other unit outside SI: metric carat, if weighing precious
stones.
For instruments that are intended for supply to the market of the Member State in which the
It is allowed to use in the case of dear Troy ounce of precious metals,
the relevant essential requirements as laid down below, converted to this drive
using a simple conversion.
2. accuracy classes
2.1. The following accuracy classes:
and special,)
(b)), (II) high,
(c)) III medium,
(d)) normal IIII.
Specification of these classes is given in table 1.
Table 1
I---------------------------------------------------------------------------------------------------I
I class of accuracy I
I-------I---------------------I---------------------I-----------------------------------------------I
(I) class I, verification scale interval and the lower bound of capacity and the number of verification intervals and
And (e) and (Min) and n = ((Max)/(e))
I-------I---------------------I---------------------I--------------------------I--------------------I
I I I the minimum value, the minimum value and the maximum value of I
I-------I---------------------I---------------------I--------------------------I--------------------I
I I I = 0.001 g e and 100 < e I I-50 000 and
I-------I---------------------I---------------------I--------------------------I--------------------I
I II I = 0.001 g e and 20 < e and 100 and 100 000 and
I I ei,
(b)) its capacity Maxi with Maxr = Max, and
(c)) its minimum capacity Mini with Mini = Max (i-1) Min1 =
Min
where:
I = 1, 2, ... r,
I = partial weighing range number,
r = total number of partial weighing ranges.
All of the maximum capacity applies to the NET load, regardless of the value
the used tare.
3.3.3 partial weighing ranges are classified according to the table 2. All
partial weighing ranges fall into the same class of accuracy, which is a class
the accuracy of the instrument.
Table 2
I---------------------------------------------------------------------------------------------------I
Even multi-interval instruments I
I---------------------------------------------------------------------------------------------------I
I, i = 1, 2, ... r I
I i = partial weighing range number and
R = total number of partial weighing ranges and
I-------I---------------------I---------------------I-----------------------------------------------I
(I) class I of the verification scale interval (e) and the lower bound of capacity and the number of verification intervals and
I I I (Min) I I
I I I---------------------I--------------------------I--------------------I
I I I the minimum value, the minimum value (1) and the maximum value of I
I-------I---------------------I---------------------I--------------------------I--------------------I
I I I I n = ((Max)/(e (i + 1)) and n = ((Max)/ei))
I-------I---------------------I---------------------I--------------------------I--------------------I
I I I 0.001 g = ei 100 < and e1 and I-50 000 and
I-------I---------------------I---------------------I--------------------------I--------------------I
I II I 0.001 g = ei 20 < e1 and 5 000 and 100 000 and
I I
