Government Decree No. 284 / 2000 Coll.
Government Regulation amending Government Regulation No. 172 / 1997 Coll., laying down technical requirements for personal protective equipment
Valid
Regulation
Effective from 02.07.2001
Text versions:
02.07.2001
29.08.2000
284
GOVERNMENT REGULATION
of 3 July 2000
amending Decree No. 172 / 1997 Coll., laying down technical requirements for personal protective equipment
The Government orders pursuant to Section 22 of Act No. 22 / 1997 Coll., on Technical Requirements for Products and on the Amendment and Addition of Certain Acts, as amended by Act No. 71 / 2000 Coll., ("the Act ') to implement Sections 11, 12 and 13 of the Act:
Government Decree No. 172 / 1997 Coll., laying down technical requirements for personal protective equipment, is amended as follows:
1. in Article 1, the following paragraph 1 is inserted:
"(1) This Regulation lays down technical requirements for personal protective equipment, in accordance with the law of the European Communities (1) and the international contract (2).
1) Council Directive 89 / 686 / EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment, as amended by Council Directives 93 / 68 / EEC, 93 / 95 / EEC and 96 / 58 / EC.
2) Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products. '.
Paragraphs 1 and 2 shall become paragraphs 2 and 3.
3.
(1) The products provided for in Article 12 (1) of the Act are personal protective equipment, except:
(a) personal protective equipment which is a specified product under another government regulation which provides for an assessment of compliance with the safety requirements;
(b) personal protective equipment specified in the list of products not covered by the Government Regulation listed in Annex 1 to this Regulation, irrespective of the reason for the removal referred to in (a).
(2) At trade fairs, exhibitions, etc., the demonstration of personal protective equipment which does not comply with the provisions of this Regulation shall not be prevented, provided that this is brought to the attention of a clear indication, including a warning, that sale or use is prohibited for any purpose until the personal protective equipment has been brought into conformity by the manufacturer or importer.
(3) Components of personal protective equipment originating in the Czech Republic or in Member States of the European Community which do not bear the CE marking and which are intended to be incorporated into personal protective equipment may be placed on the market provided that they are not parts essential to the flawless functioning of personal protective equipment. "
4.
(1) Personal protective equipment must comply with the essential health and safety requirements (hereinafter referred to as "essential requirements") set out in Annex 2 to this Regulation.
(2) Where the essential requirements for personal protective equipment are specified by harmonised Czech technical standards (§ 4a (1) of the Act) or by foreign technical standards transposing and complying with the harmonised European standard in the countries of the European Union, the essential requirements shall be deemed to be met. '
5.
Before placing personal protective equipment on the market, the manufacturer or importer shall collect the technical documentation to the extent set out in Annex 3 to this Regulation so that it may, if necessary, be submitted to the competent authorities. In cases resulting from Paragraph 13 (8) of the Act, the importer shall submit to the supervisory authority documentation in the official language of the country in which the product originates or in a language agreed with the supervisory authority. '
6.
(1) In the case of personal protective equipment, except those referred to in paragraph 4, their manufacturer or importer shall ensure, prior to series production, an assessment of the conformity of a sample of the personal protective equipment by an EC type-examination by an authorised person in accordance with Article 6.
(2) The conditions for authorising activities in conformity assessment of personal protective equipment (Section 11 (2) of the Act) are set out in Annex 5 to this Regulation.
(3) In addition, the manufacture of personal protective equipment of complex construction referred to in paragraph 6 shall, at the choice of the manufacturer, be subject either to the verification of the conformity of the product with the certified type pursuant to § 7 or to the assessment of the production quality system pursuant to § 8.
(4) An EC type-examination shall not be carried out for personal protective equipment of a simple design for which the designer, manufacturer or importer may assume that the user is able to evaluate the level of protection against risks which may be recognised by the user in a timely and safe manner.
(5) Personal protective equipment of a simple construction include exclusively personal protective equipment intended to protect their user against:
(a) surface mechanical action (e.g. gardening gloves, thimbles),
(b) weakly aggressive detergents easily excluded (e.g. protective gloves against dilute cleaners),
(c) risks in the handling of hot articles which do not expose users to temperatures above 50 ° C or to dangerous impacts (e.g. gloves, aprons for professional use);
(d) climatic effects which are not extreme (e.g. headgear, seasonal clothing, footwear),
(e) minor impacts and vibrations which cannot cause injury to vital parts of the body and whose effect cannot cause permanent damage (e.g. light head protection against scalping of hair, gloves, light footwear); or
(f) sunlight (sunglasses).
(6) Verification of the conformity of a product with a certified type or assessment of a production quality system shall be carried out for complex construction personal protective equipment intended to protect life and to protect against risks which may seriously and permanently harm health and for which the designer may assume that the user is unable to identify these hazards in a timely manner. This category covers exclusively:
(a) personal respiratory protective equipment with filters against irritant, dangerous, toxic or radioactive aerosols containing solid or liquid particles or against gases;
(b) personal protective equipment for protecting the respiratory organs, ensuring full insulation to the surrounding atmosphere, including breathing appliances for diving;
(c) personal protective equipment providing only time-limited protection against chemical pollutants or ionising radiation;
(d) intervention devices for use in hot environments, with effects comparable to air at a temperature of 100 ° C or more in which risks may arise from infrared radiation, flames or the spray of large quantities of molten material;
(e) intervention devices for use in cold environments, with effects comparable to or below the air temperature of -50 ° C;
(f) personal protective equipment to protect against fall from height or depth;
(g) personal protective equipment against risks caused by electrical current and dangerous voltage or insulating personal protective equipment used in high voltage work.
(7) If other government regulations apply to personal protective equipment, then
(a) in the case of other government regulations which include other aspects and also provide for the location of the CE marking for products originating in the Czech Republic or in the Member States of the European Community or the drawing up of declarations of conformity for other products, the CE marking or the declaration of conformity shall also indicate compliance with the provisions of these other regulations of the Government;
(b) if, however, one or more of these regulations of the Government for a transitional period allow the manufacturer or importer to choose which provisions it will apply, the CE marking of products originating in the Czech Republic or in the European Community shall only indicate compliance with those Regulations applied by the manufacturer. In such a case, the list of regulations used in the prescribed accompanying documentation, warnings or instructions required by the relevant Regulations shall be annexed to the relevant personal protective equipment. ';
7.
(1) EC type-examination [Paragraph 12 (4) (b) of the Act] is a procedure whereby an authorised person assesses the conformity of a sample (prototype) of a personal protective device with the requirements of this Regulation and confirms that the sample of a personal protective device complies with those requirements.
(2) An application for an EC type-examination shall be submitted by the manufacturer or importer to one authorised person selected for the type of personal protective equipment to be assessed. The application shall contain:
(a) the name and address of the manufacturer and of the production unit producing the personal protective equipment, and, in the case of imported products, the information on the manufacturer and the manufacturing site;
(b) the technical file referred to in point 1 of Annex 3 to this Regulation;
(c) the sample (prototype) in the quantity necessary for the assessment of conformity.
(3) The authorised person shall proceed with the EC type-examination by reviewing the technical file supplied by the manufacturer or importer before carrying out the sample tests and assessing its accuracy and completeness with regard to the technical standards referred to in Article 3 (2). Where the manufacturer has not applied or only partially applied the technical standards referred to in Article 3 (2), or where such standards do not exist, the authorised person shall examine the suitability of the technical specifications used by the manufacturer to establish their conformity with the essential requirements before checking the technical file supplied.
(4) The person authorised to test the sample shall:
(a) verify that the sample (prototype) has been manufactured in accordance with the technical file and can be used for the intended purpose;
(b) carry out the findings and tests necessary to assess the conformity of the sample with the technical standards referred to in Article 3 (2);
(c) unless the manufacturer has applied or only partially applied the technical standards referred to in Article 3 (2) or, in the absence of such standards, the authorised person shall carry out the necessary tests and tests to confirm the conformity of the sample with the technical specifications used by the manufacturer and the compliance of the sample with the essential requirements.
(5) If the sample (prototype) complies with the essential requirements, the authorised person shall issue an EC type-examination certificate for products originating in the Member States of the European Community or in the Czech Republic, and a type-certificate for other products. The authorised person shall transmit the certificate to the manufacturer or importer. The certificate shall contain the conclusions of the detection, verification and test results, the conditions associated with its release, the description and display of the certified personal protective equipment necessary for its identification.
(6) The evidence of the conformity assessment method used (Section 13 (8) of the Act) includes the technical documentation, the results of the tests carried out and the certificate referred to in Section 6 (5).
(8) The Office and other authorised persons may obtain a copy of the certificate issued in accordance with Article 6 (5) and, on reasoned request, a copy of the technical file supplied by the manufacturer and a copy of the report on the checks and tests carried out.
(10) An authorised person who refuses to issue a certificate pursuant to Article 6 (5) shall inform the Office and other authorised persons thereof. Where an authorised person withdraws a certificate issued pursuant to Article 6 (5) on grounds of non-compliance with the essential requirements, he shall inform the Office thereof, stating the reasons for the decision. ';
8. in Article 7 (1) (a), the words "and conformity with the relevant essential requirements of this Regulation" shall be inserted after the words "the manufacturer" and the words "or the importer" shall be inserted after the words "the manufacturer."
9. Paragraph 7 (2) reads as follows:
"(2) A sample of a personal protective device taken by an authorised person shall be subjected to the findings and tests referred to in the technical standards referred to in Article 3 (2) or necessary to demonstrate the conformity of the product with the essential requirements. ';
10. in Article 7 (3), the words "Article 6 (5)" and the words "type" shall be deleted and the words "which certificate" shall be inserted after the words "Article 6 (5)" and the words "type" shall be deleted;
11. in Article 7 (4), the following sentence shall be added at the end: "In such a case, the authorised person shall take appropriate measures appropriate to the seriousness of the errors found and inform the Office."
12. In Article 7, the following paragraph 5 is added:
"(5) The manufacturer or importer shall submit the report of the authorised person to the supervisory authorities on request. ';
13.
(1) The assessment of the quality system of production (Section 12 (4) (d) of the Act) is a procedure whereby the authorised person approves the quality management and supervision system provided for in Section 9 to determine whether the manufacturer complies with the obligations under the approved quality management system.
(2) Within this procedure, the manufacturer shall submit an application for approval of the quality management system to an authorised person of his choice. The application shall contain:
(a) all data relating to the relevant category of personal protective equipment, including, where applicable, documentation relating to the certified type;
(b) documentation on the quality management system, which includes, in particular, a description of the purpose of the quality system, the organisational schemes, the extent of the responsibilities of the managers and their competence in ensuring quality, a description of the tests and checks to be carried out after production and a description of the means used to check the effective functioning of the quality management system;
(c) a guarantee of compliance with the obligations arising from the quality management system and of maintaining its applicability and effectiveness.
(3) The manufacturer shall, within the framework of the quality management system, submit each personal protective equipment to the examination referred to in Article 7 (2) for the assessment of the conformity of the product with the relevant essential requirements.
(4) Authorised person
(a) assess the quality management system and decide whether it fulfils the conditions referred to in paragraph 3. For quality management systems complying with the relevant technical standards referred to in Article 3 (2), the authorised person shall assume that the system complies with these provisions,
(b) carry out all necessary objective evaluations of the components of the quality management system as part of the audit and in particular check that the system ensures compliance of the manufactured personal protective equipment with the certified type;
(c) they shall notify the manufacturer of the decision containing the results of the check and of the reasons in substance.
(5) The manufacturer shall inform the authorised person who approved the quality management system of any planned changes to that system. The authorised person shall examine the proposed changes and decide whether the changed quality management system complies with the relevant provisions. They shall communicate their decision to the manufacturer. The communication shall contain the results of the inspection and a reasoned decision. ';
14.
(1) The purpose of the supervision of the manufacturer operated by the quality management system is to ensure that the manufacturer complies accurately with the obligations arising from the approved quality management system.
(2) The manufacturer shall allow the authorised person for supervision purposes to enter the premises for the purpose of carrying out checks and tests and checks on the storage of personal protective equipment and shall provide him with all the necessary supporting documents, in particular:
(a) documentation of the quality management system;
(b) technical documentation;
(c) quality management manuals.
(3) The person authorised shall carry out a regular audit to ensure that the manufacturer complies with and uses the approved quality management system. A copy of the audit report shall be provided by the manufacturer. The authorised person may also make unannounced visits to the manufacturer. In the case of such visits, the manufacturer shall provide a visit report and, where appropriate, an audit report. The manufacturer shall, upon request, submit to the supervisory authorities a report of the authorised person. ';
15. in Article 10 (1) (e), the words "harmonised Czech technical standards" are replaced by the words "technical standards referred to in Article 3 (2)."
16. The following Section 10a is inserted after Section 10:
(1) For personal protective equipment originating in the Czech Republic or in the Member States of the European Community which comply with the requirements of this Regulation, the CE marking provided for in Annex 4 to this Regulation shall be affixed to each product instead of issuing a declaration of conformity and an EC declaration of conformity certifying that the personal protective equipment placed on the market complies with the provisions of this Regulation. The particulars of the EC declaration of conformity are set out in Annex 6 to this Regulation. The EC declaration of conformity shall be processed only for the needs of the supervisory authorities.
(2) The CE marking shall be affixed to each piece of the personal protective equipment manufactured in such a way that it is visible, legible and indelible throughout its intended life; However, if this is not possible in view of the characteristics of the product, the CE marking may be affixed to the packaging. In the case of the participation of an authorised person at the production control stage, as provided for in Sections 7, 8 and 9, its identification number shall be attached.
(3) Other permissible markings may be affixed to the personal protective equipment or its packaging, provided that the visibility and legibility of the CE marking are not thereby reduced. ';
17. In Annex 2, the title reads:
"ESSENTIAL HYGIENIC AND SECURITY REQUIREMENTS '.
18. In Annex 2, the title of point 1.1.2.1 reads: "Highest possible level of protection '.
19. in Annex 2, point 1.4, the following points (h) and (i) are added:
"(h) where applicable, references to the legislation used in accordance with Article 5 (7) (b);
(i) the name, address and identification number of the authorised person involved at the design stage of the personal protective equipment. ';
20. In Annex No 2, point 2.8, "paragraph 4 'is replaced by" paragraph 5'.
21. In Annex 2, point 2.14, the words "(see point 3) 'shall be added at the end of the sentence.
22. in Annex 2, point 3.5, including footnote 3, shall read:
"3.5 Protection against harmful effects of noise
A personal protective device intended to prevent the harmful effects of noise shall be able to dampen the noise to such an extent that the equivalent levels of sound perceived by the user do not exceed, under any circumstances, the maximum permissible values laid down by the specific legislation. If no specific legislation is issued, the daily limit limits laid down in the Council Directive shall apply. 3)
Each personal protective equipment shall bear the indication of the degree of noise attenuation and the value of the personal protective equipment comfort index; where this is not possible, the label shall be placed on the packaging.
3) Council Directive 86 / 188 / EEC of 12 May 1986 on the protection of workers from the risks caused by exposure to noise at work. '
23. In the first sentence of point 3.6.1 of Annex 2, the word "ignition 'is replaced by" spontaneous ignition'.
24. In Annex 2, paragraph 3.9.1, the heading "Optical radiation 'is replaced by" Non-ionising radiation' and in the first sentence the word "Optical 'is replaced by" Non-ionising'.
25.
"Annex 3 to Government Decree No. 172 / 1997 Coll.
TECHNICAL DOCUMENTATION BY PRODUCER OR IMPORTER
The documentation referred to in Article 4 shall contain all relevant information on the devices used by the manufacturer to ensure that the personal protective equipment complies with the relevant essential requirements.
In the case of personal protective equipment referred to in Article 5 (1), the dossier shall include in particular:
1. a technical file consisting of:
(a) general and detailed drawings of the personal protective equipment supplemented, where necessary, by calculations and results of sample tests to the extent necessary to verify compliance with the essential requirements;
(b) the full list of essential requirements and standards referred to in Article 3 (2) or other technical specifications taken into account when designing the product;
2. a description of the means of control and testing used by the manufacturer or importer to verify compliance of the manufacture of the personal protective equipment with the technical standards referred to in Article 3 (2) or other technical specifications and to maintain the quality level;
3. copies of the information instructions set out in Annex 2, point 1.4. ';
26. the following Annexes 4, 5 and 6 are added:
"Annex No. 4 to Decree No. 172 / 1997 Coll.
CE MARKING
1. The graphical form of the CE marking is laid down in a separate legislation.4)
2. For small-size personal protective equipment, the minimum size requirement of at least 5 mm may not be complied with.
3. In the case of the participation of an authorised person at the production control stage as referred to in Sections 7, 8 and 9, the CE marking of conformity shall be accompanied by its identification number.
Příloha č. 5
Annex No 5 to Decree No. 172 / 1997 Coll.
AUTORISATION CONDITIONS
The conditions of authorisation under Section 11 (2) of the Act are:
(a) the necessary personnel equipment and the necessary means, equipment or equipment;
(b) professional competence and professional integrity of workers;
(c) the independence of staff and technical staff carrying out tests, preparing reports, issuing certificates and carrying out verifications under this Regulation, directly or indirectly involved in personal protective equipment,
(d) the confidentiality of the staff of the authorised person as to the facts which they are aware of in the activities of the authorised person under this Regulation;
(e) liability insurance (§ 11 (3) of the Act).
The fulfilment of the conditions referred to in points (a) and (b) shall be regularly checked by the Technical Standardisation, Metrology and State Testing Office (Section 11 (4) of the Act).
Příloha č. 6
Annex 6 to Decree No. 172 / 1997 Coll.
MODEL EC DECLARATION OF CONFORMITY
Explanatory notes:
(1) Trade name and full address; the authorised representatives shall also indicate the trade name and address of the manufacturer.
2) Description of personal protective equipment - make, type, serial number, etc.
3) Name and address of the authorised person.
4) Delete as appropriate.
5) The name and function of the person authorised to sign on behalf of the manufacturer or his authorised representative.
4) Decree No. 291 / 2000 Coll., laying down the graphic form of the CE marking. '
For a period of one year from the date of entry into force of this Regulation, the provisions of Article 10 may apply to products not intended for placing on the market of the European Community.
This Regulation shall enter into force on the day of the publication of the Protocol to the Europe Agreement on Conformity Assessment and Acceptance of Industrial Products in the Collection of International Contracts, with the exception of Sections 1a (1), 6 (7) and 6 (9), which shall take effect on the date on which the Treaty of Accession of the Czech Republic to the European Union enters into force. This date shall cease to apply to Articles 6 (8) and 6 (10).
Prime Minister:
v. JUDr. Rychetský v. r.
Minister for Industry and Trade:
Doc.
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Regulation Information
| Citation | Decree No. 284 / 2000 Coll., amending Decree No. 172 / 1997 Coll., laying down technical requirements for personal protective equipment |
|---|---|
| Regulation Type | Regulation |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 29.08.2000 |
|---|---|
| Effective from | 02.07.2001 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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