Government Decree No. 21 / 2003 Coll.
Government Regulation laying down technical requirements for personal protective equipment
Valid
Effective from 01.05.2004
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21
GOVERNMENT REGULATION
of 9 December 2002
laying down technical requirements for personal protective equipment
The Government orders pursuant to Article 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. and Act No. 205 / 2002 Coll., (hereinafter referred to as "the Act") to implement Sections 11a (2) (c), 11 (2), 12 (1) and (3) and 13 (2) of the Act:
Basic provisions
(1) This Regulation lays down technical requirements for personal protective equipment in accordance with European Community law (1).
(2) For the purposes of this Regulation, any device or device intended to be worn or held by an individual for protection against one or more health and safety risks shall be considered a personal protective device. A personal protective equipment shall also be considered as:
(a) a technical assembly consisting of several manufacturers of non-parts-linked devices or devices, for the protection of an individual against one or more potentially simultaneously acting risks;
(b) a protective device or device connected separately or inseparably with personal fittings without protective effect, worn or held by an individual in the course of a particular activity;
(c) an replaceable component of a personal protective device which is necessary for its flawless functioning and is used exclusively for that device.
(3) Any system placed on the market together with a personal protective device intended to be connected to another external supplementary device shall be considered as an integral part of that device, even if it is not intended for permanent wearing or holding by the user as long as it is exposed to risk.
(4) For the purposes of this Regulation, personal protective equipment shall not be considered as:
(a) personal protective equipment which is a specified product pursuant to another government regulation issued in implementation of a law laying down the conditions for their placing on the market and the safety requirements;
(b) personal protective equipment as defined by the list of products in Annex 1 to this Regulation, irrespective of whether they are exempted under (a).
(5) The products provided for in this Regulation are personal protective equipment within the meaning of Article 12 (1) (a) of the Act.
Conditions for placing on the market and putting into service of personal protective equipment
(1) Personal protective equipment must comply with the essential safety and health requirements set out in Annex 2 to this Regulation (hereinafter referred to as "essential requirements") and may be placed on the market and put into service only if, when properly maintained and used for the intended purpose, it protects health and guarantees the safety of users without endangering the health, safety of other persons, domestic and livestock or property.
(2) The essential requirements shall be deemed to be met if the personal protective equipment conforms to a harmonised Czech technical standard or, where appropriate, to a foreign technical standard transposing a harmonised European standard in the Member States of the European Union (§ 4a of the Act).
(3) A personal protective device which does not comply with the requirements of this Regulation may be displayed or displayed at fairs, exhibitions and the like only if the visible sign draws attention to this fact and to the prohibition of its provision or use for any purpose until the personal protective equipment has been brought into conformity by the manufacturer or his authorised representative.
Conformity assessment procedures
(1) Before placing a personal protective equipment on the market, the manufacturer or his authorised representative shall collect the technical documentation to the extent set out in Annex 3 to this Regulation so that it can be submitted to the supervisory authorities, if necessary, shall provide the EC type-examination referred to in Section 4, with the exception of the personal protective equipment referred to in paragraph 2, and shall proceed in accordance with Section 7.
(2) In the case of personal protective equipment of a simple design, the design of which is based on the fact that the user can evaluate the level of protection provided against the individual successively effective minimum risks which can be recognised in a timely and safe manner by the user, EC type-examination is not required. This category covers only personal protective equipment intended to protect the user against:
(a) mechanical action having surface effects (for example, gardening gloves, thimbles);
(b) slightly aggressive detergents, the effect of which can be easily excluded (e.g. protective gloves against dilute solutions of cleaning products),
(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 exceptional or extreme (for example, headgear, seasonal clothing, footwear),
(e) weak impacts and vibrations which do not affect vital parts of the body and whose effects cannot cause irreversible damage (e.g. light protective helmets against scalping of hair, gloves, light footwear),
(f) sunlight (sunglasses).
(3) In the case of personal protective equipment of complex construction intended to protect against fatal hazards or risks which may seriously and irreversibly harm health and where the design is based on the fact that their immediate effects cannot be recognised by the user in a timely manner, the manufacturer shall, in addition to the procedure referred to in paragraph 1, provide, at his choice, for the control of manufactured personal protective equipment either in accordance with the procedure laid down in § 5 or § 6. This category covers exclusively:
(a) filter products for the protection of respiratory organs against fixed and liquid aerosols or against irritant, dangerous, toxic or radioactive gases;
(b) breathing protection devices ensuring full insulation to the surrounding atmosphere, including diving devices;
(c) personal protective equipment providing only time-limited protection against chemical activity or ionising radiation;
(d) intervention devices for use in hot environments, with effects comparable to air at a temperature of 100 ° C or more, where infrared radiation, flame or spray may or may not be 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 protecting against fall from a height;
(g) personal protective equipment against the risks caused by electricity and dangerous voltage or those used as high voltage insulation.
(4) The conformity assessment documents (Section 13 (7) of the Act) kept by the manufacturer or his authorised representative include a technical file, an EC declaration of conformity and an EC type-examination certificate.
EC type-examination
(1) EC type-examination is a procedure whereby a notified person2) ascertains and certifies conformity of a personal protective device with the requirements of this Regulation.
(2) An application for an EC type-examination shall be submitted by the manufacturer or his authorised representative of one of the notified persons selected for the type of personal protective equipment to be assessed. The application shall be accompanied by an adequate number of samples of the product. The application shall contain:
(a) identification details of the manufacturer or his authorised representative and of the establishment which produces the personal protective equipment (for a natural person, the name and surname and permanent residence or place of business, the name or business name and registered office of the legal person);
(b) the technical file referred to in Annex 3 to this Regulation supplied by the manufacturer.
(3) Noticed person at EC type-examination
(a) examine the technical file supplied by the manufacturer to establish its suitability with regard to the technical standards referred to in Article 2 (2). If the manufacturer has not applied the technical standards referred to in Article 2 (2), or has applied them only partially, or in the absence of such standards, the notified person shall review the suitability of the technical specifications used by the manufacturer to establish their conformity with the essential requirements before reviewing the technical file supplied by the manufacturer,
(b) test the sample of the product by:
1. verify that the personal protective equipment has been manufactured in accordance with the technical file supplied by the manufacturer and can be used completely safely for its intended purpose,
2. carry out the necessary assessments and tests to establish compliance of the product sample with the technical standards referred to in Article 2 (2); and
3. where the manufacturer has not applied or only partially applied the technical standards referred to in Article 2 (2), or where such standards do not exist, the notified person shall carry out the necessary assessments and tests to establish the conformity of the product with the technical specifications used by the manufacturer and the conformity of the product with the essential requirements.
(4) If the sample of the product complies with the essential requirements, the notified person shall issue the applicant with an EC type-examination certificate (hereinafter referred to as the certificate). The certificate shall contain the conclusions of the examination, the conditions associated with its issue, the descriptions and the display of the certified personal protective equipment necessary for its identification.
(5) The Office for Technical Standardisation, Metrology and State Testing (hereinafter "the Office"), the Commission of the European Communities (hereinafter "the Commission"), the other persons notified and the competent authorities of the Member States of the European Union may, on request, obtain a copy of the certificate and, on reasoned request, a copy of the technical file supplied by the manufacturer and a copy of the report of the assessments and tests carried out.
(6) A person who refuses to issue a certificate shall inform the Office and the relevant notified persons accordingly. The notified person shall inform the Office and the competent authorities of the Member State of the European Union in which the certificate was issued.
EC product quality management system
(1) The EC quality management system of the product is a procedure whereby:
(a) the manufacturer shall take all measures to ensure that the manufacturing process, including the exit check and the testing of personal protective equipment, ensures the homogeneity of the production, conformity of the personal protective equipment with the type described in the certificate and compliance with the relevant essential requirements;
(b) the notified person chosen by the manufacturer shall carry out the necessary checks on personal protective equipment carried out at random at intervals of less than one year.
(2) A sample of a personal protective equipment taken by a notified person shall be subjected, for the purpose of demonstrating compliance, to the findings and tests referred to in the technical standards referred to in Article 2 (2) or necessary to demonstrate the conformity of the product with the essential requirements.
(3) Where the manufacturer has chosen to check in accordance with paragraph 1, points (a) and (b) shall apply. (b) the notified person, other than that which has issued the relevant certificate, shall cooperate with the notified person who has issued the certificate in the event of difficulties in assessing the conformity of the sample.
(4) The notified person shall provide the manufacturer with a test report. Where it is stated in the conclusion of the Protocol that production is not homogeneous, that the personal protective equipment checked does not conform to the type described in the certificate or that it does not meet the essential requirements, the notified person shall take measures appropriate to the seriousness of the errors identified and inform the Authority.
(5) The manufacturer shall submit the report of the notified person to the supervisory authorities upon request.
EC quality assurance system through supervision
(1) The EC quality assurance system is a procedure whereby the notified person approves the quality management and supervision system referred to in paragraph 6 with the manufacturer to determine whether the manufacturer complies with the obligations arising from the approved quality management system.
(2) The manufacturer shall submit an application for approval of the quality management system to the notified person chosen by him. The application shall contain:
(a) any information relating to the relevant category of personal protective equipment, including, where appropriate, documentation relating to a certified sample;
(b) documentation on the quality management system; and
(c) the manufacturer's undertaking to fulfil and maintain the obligations arising from the quality management system in order to remain proportionate and effective.
(3) The manufacturer shall, within the framework of the quality management system, submit each personal protective equipment to the extent specified in Section 5 (2) for assessment of its conformity with the relevant essential requirements. The documentation of the quality management system shall contain in particular a description of:
(a) the quality objectives, the organisational structure, the scope of management responsibility and their competences and responsibilities as regards product quality;
(b) the checks and tests to be carried out after manufacture; and
(c) means enabling the quality management system to function effectively.
(4) Notified person
(a) assess the quality management system in order to determine whether it complies with the provisions of paragraph 3; in the case of quality systems which apply the relevant standard, compliance with those provisions shall be presumed;
(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 type described in the certificate; and
(c) notify the manufacturer of the decision containing the results of the check, stating the reasons.
(5) The manufacturer shall inform the notified person who approved the quality management system of any planned changes to that system. The amended person shall review the proposed changes and decide whether the changed quality management system complies with the relevant provisions. They shall notify the manufacturer of their decision. The notification shall contain the conclusions of the review and the reasoned assessment decision.
(6) Supervision of the manufacturer operated by the quality management system is a procedure designed to ensure that the manufacturer complies properly with the obligations arising from the approved quality management system. Under this procedure,
(a) the manufacturer shall allow the notified person for supervision purposes to enter the premises intended for the control, testing and storage of personal protective equipment and shall provide him with all the information required, in particular:
1. documentation on the quality management system,
2. technical documentation; and
3. quality management manuals,
(b) the notified person shall carry out a regular audit to ensure that the manufacturer maintains and uses an approved quality management system; a copy of the audit report shall be transmitted to the manufacturer,
(c) the notified person may also make unannounced visits to the manufacturer; for such visits, the notified person shall provide the manufacturer with a visit report and, where appropriate, an audit report;
(d) the manufacturer shall submit, on request to the supervisory authorities, a report of the notified person.
EC declaration of conformity
EC declaration of conformity is part of a conformity assessment procedure whereby the manufacturer or his authorised representative:
(a) draw up declarations for submission to the competent authorities using the forms set out in Annex 4 to this Regulation certifying that the personal protective equipment placed on the market complies with the requirements of this Regulation;
(b) each personal protective equipment bears the CE marking referred to in Article 8.
CE marking and other marking
(1) The CE marking, the graphic form of which is provided for by a special legislation, (3) shall be placed on each piece of personal protective equipment in such a way that it is visible, legible and indelible throughout the intended life of the personal protective equipment. However, where this is not possible in view of the characteristics of the product, the CE marking may be affixed to the packaging. The different parts of the CE marking shall be substantially the same height, which shall not be less than 5 mm; for small-size personal protective equipment, these minimum dimensions need not be complied with. The personal protective equipment shall not bear a mark which could mislead anyone with regard to the CE marking.
(2) In the case of participation of a notified person in the production control phase as referred to in Sections 5 and 6, its identification number shall be added.
(3) The personal protective equipment or its packaging may bear any additional marking provided that the visibility and legibility of the CE marking are not thereby reduced.
(4) The CE marking on a personal protective device shall indicate that the product complies with the technical requirements laid down in all the legislation applicable to it and which provides for or allows such marking and that the procedure laid down in the conformity assessment procedure has been followed. However, if one or more laws allow the manufacturer, for a transitional period, to choose which provisions he will follow, the CE marking shall indicate compliance only with those laws or their provisions used by the manufacturer. In this case, the documentation, warnings or instructions required by the legislation concerned and annexed to the products concerned shall indicate the relevant legislation of the European Communities or their provisions applied by the manufacturer.
Notification of the imposition of a safeguard measure
In the event that a protective measure has been imposed on a personal protective device under a specific legislation, 4) the notification of the decision to impose a protective measure under Article 7 (8) of the Act shall state whether the non-conformity was caused by:
(a) failure to comply with the essential requirements referred to in Article 2 (1);
(b) incorrect application of the technical standards referred to in Article 2 (2); or
(c) shortcomings in the technical standards referred to in Article 2 (2).
Authorisation conditions
(1) The conditions laid down in Annex 5 to this Regulation shall apply to the authorisation of legal persons under Article 11 (2) of the Act. Legal persons meeting the criteria laid down in the relevant harmonised technical standards shall be deemed to comply with the relevant conditions.
(2) The authorised person becomes a notified person in accordance with the procedure laid down in Article 11 (7) of the Act.
Transitional and final provisions
(1) Valid certificates or other documents issued on the basis of Government Decree No. 172 / 1997 Coll., as amended by Government Decree No. 284 / 2000 Coll., may be used for conformity assessment purposes under this Regulation unless they are repealed under the conditions laid down by law.
(2) Persons in charge of conformity assessment activities under Government Regulation No. 172 / 1997 Coll., as amended by Government Regulation No. 284 / 2000 Coll., shall be deemed to be persons in charge of activities under this Regulation.
The following shall be deleted:
1. Decree No. 172 / 1997 Coll., laying down technical requirements for personal protective equipment.
2. Government Regulation No 284 / 2000 Coll., amending the Government Regulation laying down technical requirements for personal protective equipment.
Efficacy
This Regulation shall enter into force on the date of the entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Prime Minister:
PhDr. Špidla v. r.
Minister for Industry and Trade:
Ing. Rusnok v. r.
Příloha č. 1
Annex No. 1 to Government Decree No. 21 / 2003 Coll.
COMPLETE LIST OF PERSONAL PROTECTION INSTRUMENTS TO WHICH THIS REGULATION IS NOT INCLUDED
This Regulation shall not apply to the following types of protective equipment:
1. Personal protective equipment specially designed and manufactured for the armed forces or for the purpose of ensuring public order (helmets, shields and so on).
2. Personal protective equipment for self-defence (aerosol dispensers, personal deterrent devices and so on).
3. Personal protective equipment designed and manufactured for private use against:
(a) unfavourable climatic conditions (headgear, seasonal clothing, footwear, umbrellas and so on);
(b) moisture and water (gloves for washing dishes and so on),
(c) heat (gloves and so on).
4. Personal protective equipment which is not permanently worn, intended to protect or rescue persons on board vessels or aircraft.
5. Helmets and pupils designed for users of single or two-track motor vehicles.
Příloha č. 2
Annex No 2 to Government Decree No. 21 / 2003 Coll.
ESSENTIAL SAFETY AND HEALTH REQUIREMENTS
1. GENERAL REQUIREMENTS FOR ALL PERSONAL PROTECTION EQUIPMENT
Personal protective equipment shall provide adequate protection against any risks involved.
1.1 Principles of design
1.1.1 Ergonomics
The personal protective equipment shall be designed and constructed in such a way that the user can normally carry out a risk-bearing activity under the intended conditions of use, using appropriate protection at the highest possible level.
1.1.2. Levels and classes of protection
1.1.2.1. Maximum level of possible protection
The optimum level of protection shall be considered to be the level of protection beyond which the restrictions imposed by the use of a personal protective device would prevent its effective use during the period of exposure to the user's risk or during the normal execution of the activity.
1.1.2.2. Protection classes corresponding to different risk levels
Where the intended conditions of use differ in such a way as to distinguish between several levels of the same risk, the relevant protection classes shall also be taken into account in the design of the personal protective equipment.
1.2 Disability of personal protective equipment
1.2.1. Dangerous and other restrictive properties
The personal protective equipment shall be designed and constructed in such a way that dangerous and disruptive properties are excluded under the intended conditions of use.
1.2.1.1. Conformity of materials used
Personal protective equipment materials, including degradation products, shall not adversely affect the user's hygiene or health.
1.2.1.2. Fitness of the surface of all personal protective equipment in direct contact with the user
Any part of a personal protective device which is in contact with or in possible contact with the user shall be free from inequalities, sharp edges, projections and so on, which could cause excessive irritation or injury.
1.2.1.3. Maximum permissible limits for users
The movements carried out, the positions taken and sensory perception may be limited to the minimum possible by personal protective equipment. The use of a personal protective device shall not lead to movements which would endanger users or other persons.
1.3 Comfort and effectiveness
1.3.1 Adaptation of personal protective equipment to the user's character
The personal protective equipment shall be so designed and manufactured as to facilitate the user's deployment in the correct position, and to remain in that position for the intended period of use, taking into account the surrounding effects, the movements carried out, and positions taken. For this purpose, it shall be possible to adapt the personal protective equipment to the user's character by any appropriate means such as suitable adjustment and attachment systems or ensuring sufficient size selection.
1.3.2. Mass and structure strength
The personal protective equipment shall have the lowest possible mass while maintaining its structural strength and efficiency.
In addition to the specific additional requirements which the personal protective equipment must satisfy in accordance with point 3 in order to provide adequate protection against the risk involved, it shall also be able to withstand the effects of the surrounding area under the intended conditions of use.
1.3.3 Compatibility of various personal protective equipment intended for simultaneous use
Where the same manufacturer places on the market several models of personal protective equipment of different types or types to ensure the simultaneous protection of adjacent parts of the body against the combined risks, these models shall be compatible.
1.4. Information provided by the manufacturer
When placing the personal protective equipment on the market, instructions shall be issued and provided by the manufacturer containing, in addition to the identification details of the manufacturer or his authorised representative, all relevant information on:
(a) storage, use, cleaning, maintenance, adjustment and disinfection. The cleaning, maintenance and disinfection devices recommended by the manufacturer shall have no adverse effect on the personal protective equipment or users when used in accordance with the relevant instructions;
(b) the achieved effectiveness of the personal protective equipment as determined during the technical tests to check the levels or classes of protection;
(c) appropriate accessories to the personal protective equipment and the characteristics of the spare parts concerned;
(d) classes of protection corresponding to different levels of risk and resulting limits of use;
(e) the period of expiry of the service life or of the service life of the personal protective equipment or its specific components;
(f) the type of packaging suitable for transport;
(g) the importance of all indications (see paragraph 2.12);
(h) legislation if it has been applied in accordance with Article 8 (4);
(i) identification details of the notified person (name or business name and registered office) who participated in the design of the personal protective equipment and its identification number.
These instructions shall be accurate and comprehensible and shall be drawn up at least in the language of the Member State of the European Union to which the personal protective equipment is intended.
2. ADDITIONAL REQUIREMENTS COMMON TO MORE SPECIES OR TYPE OF PERSONAL PROTECTION
2.1 Personal protective equipment with adaptation systems
If the personal protective equipment is fitted with adaptation systems, such systems shall be designed and manufactured in such a way that the intended conditions of use do not result in incorrect settings without the user's knowledge.
2.2 Personal protective equipment "surrounding" body parts
Where possible, the personal protective equipment surrounding the protected parts of the body shall be ventilated sufficiently to reduce sweating arising from use; if this is not the case, they shall be equipped with sweat absorbers.
2.3 Personal protective equipment for face, eyes and respiratory organs
Any restriction of the user's visual field or vision due to personal protective equipment for the face, eyes or respiratory system shall be minimised.
The degree of optical neutrality of devices for these types of personal protective equipment shall be compatible with the corresponding type of more or less precise or long-lasting activity of the user.
If necessary, personal protective equipment shall be modified or equipped with moisture-producing accessories.
Personal protective equipment intended for users with vision correction shall allow the wearing of glasses or contact lenses.
2.4. Personal protective equipment subject to ageing
Where it is known that the proposed parameters of the new personal protective equipment may be significantly affected by ageing, any piece of personal protective equipment or an interchangeable component placed on the market shall bear an unremovable indication of the date of manufacture or, if possible, the date of application in such a way as to exclude any misinterpretation; the information must also be unremovable on the packaging.
If the manufacturer is unable to provide a guarantee regarding the life of the personal protective equipment, his instructions shall provide all necessary information enabling the customer or user to clearly identify the date of application, taking into account the product quality level and the actual storage, use, cleaning, adjustment and maintenance conditions.
If there is a likelihood of appreciable and rapid deterioration of the efficacy of the personal protective equipment caused by ageing resulting from the regular repetitive cleaning procedure recommended by the manufacturer, the manufacturer shall, as far as possible, place on each personal protective equipment placed on the market a label indicating the maximum number of cleaning operations which require the control or disposal of the personal protective equipment after which it is necessary; The manufacturer shall provide this information in the instructions if no labelling is possible.
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Regulation Information
| Citation | Government Regulation No. 21 / 2003 Coll., laying down technical requirements for personal protective equipment |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.02.2003 |
|---|---|
| Effective from | 01.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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