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Regulation Of The Minister Of Economy Of 21 December 2005 On The Essential Requirements For Personal Protective Equipment

Original Language Title: ROZPORZĄDZENIE MINISTRA GOSPODARKI z dnia 21 grudnia 2005 r. w sprawie zasadniczych wymagań dla środków ochrony indywidualnej

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REGULATION OF THE MINISTER OF ECONOMY 1)

of 21 December 2005

on essential requirements for personal protective equipment 2)

On the basis of art. 9 of the Act of 30 August 2002. a system of conformity assessment (Dz. U. of 2004 Nr 204, pos. 2087 and 2005 No. 64, pos. 565) the following shall be managed:

Chapter 1

General provisions

§ 1. [ Substantive Scope] The Regulation shall specify:

1) essential requirements for personal protective equipment;

2. conformity assessment procedures;

3) how to label personal protective equipment;

4. the model of the CE mark.

§ 2. The provisions of the Regulation shall not apply to personal protective equipment:

1) specified in other provisions issued on the basis of art. 9 of the Act of 30 August 2002. a system of conformity assessment, concerning the placing on the market and safety of the products of their users;

2. designed and constructed for the purposes of military or police forces and other services, the tasks of which shall be to ensure compliance with law and order;

3) for the purpose of self-defence;

4) common use, which protect against adverse weather conditions, moisture, water or heat;

5. for the protection and rescue of persons present on ships and on aircraft not intended for permanent wear;

6) helmets and visionaries intended for users of two-or three-wheel motorcycle vehicles.

§ 3. Whenever a regulation is referred to as an individual protection measure, this must be understood by the equipment or equipment intended to be worn or held by the user in order to protect it from one or more of the risks that may occur. have an impact on its safety or health.

§ 4. 1. Personal protective equipment shall also include:

1) a team of several devices or several types of protective equipment which have been completed by the manufacturer in order to protect against the dangers occurring;

(2) a protective device or equipment combined with a total or inseparable means of individual equipment, worn or kept by the user for the purpose of carrying out certain tasks;

3. interchangeable parts or components of personal protective equipment which are relevant to their proper functioning and used and intended solely for the purpose of these measures.

2. Any sub-assembly of personal protective equipment used to combine these measures with other external devices shall be considered as an integral part of that measure, even if the sub-assembly is not intended to be worn or kept permanently by the user for the entire duration of the hazard.

§ 5. 1. Personal protective equipment may be placed on the market and used only if it protects health and ensures the safety of users, without posing a risk to the health and safety of other persons, domestic animals and property, assume proper operation, as well as use for the intended purpose.

(2) In order to ensure the protection of users, personal protective equipment may be set other than those laid down in the Regulation on safety and health protection, provided that they do not necessitate modification of the measures. individual protection in a way contrary to the provisions of the Regulation.

3. The possibility of displaying on fairs and exhibitions of personal protective equipment which do not meet the requirements laid down in the Regulation shall be allowed, provided that the information which draws attention to the prohibition on the acquisition and use of these products is included in the list of products. any purpose, until such time as they comply with the requirements of the Regulation.

§ 6. 1. In accordance with the essential requirements laid down in the Regulation, it shall be considered to:

1) personal protective equipment included in the means of simple construction referred to in § 34 par. 3, bearing the CE marking, for which the manufacturer or his authorised representative has issued the EC declaration of conformity;

(2) personal protective equipment other than those referred to in paragraph 34 (2). 3, bearing the CE marking, for which the manufacturer or his authorised representative has a certificate confirming compliance with the essential requirements laid down in the Regulation and issued the EC declaration of conformity.

(2) If the essential requirements for an individual protection measure lay down separate provisions which require the CE marking to be affixed to that measure, the manufacturer or his authorised representative shall confirm in the EC declaration of conformity that the measure in point is comply with the provisions of those provisions.

(3) If the separate provisions allow the manufacturer or his authorised representative, during the transitional period referred to in those provisions, to apply only certain of their provisions, the CE marking shall indicate the compatibility of the protection measure. individual only with the provisions of those provisions which the manufacturer has applied. In this case, the list of provisions applied should be included in the documentation and instructions required for a specific individual protection measure.

Chapter 2

Essential requirements for personal protective equipment

§ 7. [ Requirements for personal protective equipment] 1. Personal protective equipment shall:

1. provide sufficient protection against the dangers involved;

2) be designed and constructed in accordance with the requirements of ergonomics in such a way that, under the expected conditions of use, to which they are intended, the user can normally perform all the tasks in case of threat, using simultaneously with adequate protection at the highest possible level.

2. By protection at the highest possible level, which should be taken into account in the design of personal protective equipment, it is necessary to understand the level above which the inconveniences associated with their noses prevent them from being effective use during exposure to hazards or prevent normal operations.

3. The design of personal protective equipment, for anticipated, varied conditions of use, in which several levels of hazard can be separated, the appropriate protection classes shall be taken into account.

4. Personal protective equipment shall be so designed and constructed as to exclude hazards and other inconveniences in the expected conditions of use:

1) the materials from which the parts and materials used in the manufacture of personal protective equipment, including their distribution products, are produced, should not adversely affect the health or the health of the user;

2) the correct state of the surface of the component parts; any component of the personal protective equipment which is in contact or potentially in contact with the user during their use shall be smooth, devoid of sharp edges, performances and edges threatening the user's mutilation;

3) minimizing user obstruction; any obstruction associated with moving, changing the position of the body and perceiving the senses as a result of the use of personal protective equipment should be minimized; at the same time they cannot cause the execution of dangerous movements for the user or other persons.

5. Personal protective equipment shall be designed and constructed in such a way that it can be easily and correctly assumed by the user and leaving them at the right place for the expected life of the user, taking into account the prevailing conditions of use. conditions, performing movements and receiving body positions. Therefore, it is appropriate to ensure that these measures can be optimally adapted for the construction of the user's body by any appropriate means, in particular the appropriate adjustment and fixing systems, or by ensuring an adequate range of measures. size.

6. Personal protective equipment shall be as lightest as possible, with the required strength and effectiveness of their operation.

7. Irrespective of the essential requirements referred to in § 16-32, the personal protective equipment shall be resistant to the operation of the environmental factors, under the expected conditions of their use.

§ 8. 1. Personal protective equipment designed to protect the user against several simultaneously occurring hazards shall be so designed and made to meet the requirements appropriate to each of the occurring hazards referred to in § 16-32.

2. Where the same manufacturer places several types of personal protective equipment on the market of different classes or types to ensure the protection of adjacent parts of the body before the combined effects of the various hazards, those measures shall be taken into effect. should be compatible.

§ 9. 1. The manufacturer or his authorized representative, by introducing the personal protective equipment, shall provide the instructions for their use, hereinafter referred to as the "instruction".

2. The statement shall include:

1. the name and address of the manufacturer or his authorised representative;

2) how to store, use, clean, maintain, handle and disinfect personal protective equipment;

3. information on:

(a) cleaning, preservative and disinfecting agents recommended by the manufacturer, which will not adversely affect the user's personal protective equipment and those measures if they are used in accordance with the relevant instructions,

(b) the effectiveness of the protection resulting from the technical studies carried out in order to check the levels or classes of protection that are characterised by personal protective equipment,

(c) appropriate additional equipment for personal protective equipment and the characteristics of their spare parts,

(d) a protection class for different levels of risk and the associated restrictions on the use of personal protective equipment,

(e) the type of packaging suitable for their safe transport;

4. the date of validity or the period of durability of the personal protective equipment or of their specific components;

(5) an explanation of any markings;

(6) the name, address and identification number of the notified body participating in the assessment of the conformity of the personal protective equipment.

3. The instruction should be elaborated carefully and comprehensively in Polish and in the official languages of the countries of destination of personal protective equipment.

§ 10. 1. If the personal protective equipment is equipped with a system of adjustment, it shall be designed and carried out in such a way as to prevent the setting of incorrect adjustment parameters made without the user's knowledge in the expected conditions. the use of these resources.

2. Personal protective equipment covering the protected parts of the body should be properly ventilated, as far as it is possible to limit the secretion of the sweat during their use. Where it is not possible to comply with this condition, these measures shall be equipped with arrangements for the absorption of sweat.

3. Any restrictions on the field of vision, caused by personal protective equipment protecting the face, eyes and airways, should be minimized. The degree of optical neutrality of the visionaries, contained in the personal protective equipment, should be adapted to the user's precise and long-lasting tasks.

4. The measures referred to in paragraph 1. 3, if necessary, should be equipped with countermeasures to evaporate the visionaries.

5. Personal protective equipment intended for users requiring vision correction should be adapted to wear them together with their glasses or contact lenses.

§ 11. 1. If the degree of ageing of personal protective equipment can have a serious effect on their properties, on each copy of the measures placed on the market or on their convertible components, it shall be, in a durable and legible manner, indicate the date of their application. the production and, if possible, the date of expiry of the period of durability. This information shall be permanently indicated on the packaging of these measures.

2. If the manufacturer cannot establish the period of durability of the personal protective equipment, the instructions provided by the manufacturer shall contain the necessary information enabling the purchaser or user of those measures to determine the appropriate date of expiry of the period of their individual protection durability, taking into account the quality level of these measures, the conditions for their storage, use, cleaning, operation and maintenance.

3. If a clear and sharp reduction in the effectiveness of the protection provided by personal protective equipment may be caused by consumption as a result of the manufacturer's recommended periodic cleaning or maintenance, the manufacturer should at each the placing on the market of a copy of such a measure shall, if possible, indicate the permissible number of cleaning or maintenance activities carried out, after which the individual protection measure should be subject to control of technical condition or exchange.

4. Where, in the centre of individual protection, the sign referred to in paragraph is not included. 3, information on the permissible number of operations related to their cleaning or maintenance should be given by the manufacturer in the instruction accompanying each copy of the measure.

5. If the anticipated conditions of use of personal protective equipment indicate the risk of their hacking by moving objects, thereby causing danger to their user, these measures should have adequate strength, above which their component parts will be detached, thereby eliminating the risk.

§ 12. Personal protective equipment intended for use:

1. in an explosive atmosphere, shall be so designed and constructed that they cannot be a source of spark or electric arc due to impact or static electricity, respectively, and may not cause the ignition of an explosive mixture;

2) in emergencies or for quick establishment or removal-should be so designed and made that the time needed for their establishment or removal is as short as possible; all elements of personal protective equipment allowing for The correct setting or removal should be such as to enable them to operate quickly and easily.

§ 13. 1. Instructions supplied by the manufacturer together with personal protective equipment of a complex structure designed to protect against life threatening or hazards that can cause severe and irreversible damage to the body or loss of health, including lesion, the effects of which, according to the manufacturer, are not in a position to state at the appropriate time, should include in particular:

1) data intended for use only by competent and trained persons who are qualified for their proper interpretation and ensure the safe use of these resources by the user;

2) a description of how to check that the personal protective equipment has been properly adjusted and whether it is properly functioning during use.

2. If the personal protective equipment is equipped with alarm devices to be activated in the absence of a prescribed level of protection, these devices shall be designed and placed in such a way that the user receives an alarm signal from those devices. devices when they are used in the conditions to which they are intended.

3. Components of personal protective equipment, which may be regulated, disconnected or exchanged by the user, shall be so designed and manufactured so that these operations can be performed without the use of tools.

4. In the case where the personal protective equipment is equipped with a device enabling the connection to other complementary devices, the connecting mechanism should be designed and made in such a way that it can be installed only with the appropriate complementary devices.

5. If the personal protective equipment is equipped with a liquid circulation device, such a device shall be so designed, selected and connected so that it is possible to properly replace the liquid in the vicinity of the fully protected part of the user's body measures, regardless of its position or the movements performed under the expected conditions of use.

§ 14. 1. Identification and/or recognisable signs, relating directly or indirectly to the safety and health of the user, placed on the personal protective equipment of a given type or type, should be made in the form of standardised pictograms or ideograms and legibly for the foreseeable period of use of these measures.

2. The characters referred to in paragraph. 1, should be complete, accurate and comprehensible enough so that they cannot be misinterpreted. The characters containing the words or sentences should be formulated in the Polish language and in the official languages of the countries of destination of personal protective equipment.

3. Where the personal protective equipment or the components thereof are too small to be placed on them all or part of the necessary characters referred to in paragraph 1. 1, the information concerning these marks shall be indicated on the packaging of these measures and in the instructions provided by the manufacturer.

§ 15. Personal protective equipment made of material intended for use under conditions in which the presence of any user should be visually signalled, must be fitted with one or more properly arranged components or devices. emitting or reflecting visible radiations of an appropriate light intensity and photometric and colorimetric properties.

§ 16. 1. Personal protective equipment to prevent:

1) injuries caused by falling or projecting objects or collisions of parts of the body with other obstacles, in order to prevent injuries caused in particular by crushing or curbing a part protected by such measures-should provide a shock absorbing at least to such an impact energy level, above which the dimensions or mass of the impacted impact protection measure would make it impossible to use effectively over the expected period;

2) the falls from the height or their effects-should include a harness and a co-amortising subsystem combined with a anchorage point; these measures should be so designed and constructed that, under the expected conditions of their use, the road of falling user was minimized in order to avoid collision with obstacles, and the braking force did not exceed the threshold above which the user would have suffered the injuries of the body or there would be a break or rupture of any of the elements, causing a fall User

3. falls due to slipping-shall be designed, constructed and equipped with additional components, to ensure sufficient adhesion by faulting and friction taking into account the type and condition of the surface.

2. The personal protective equipment referred to in paragraph. In accordance with Article 1 (2), they should also ensure that the user is maintained after a fall in the right position, so that the user can wait for the assistance.

3. The instruction provided with the individual protection measures protecting against falls from the height should also contain information about:

1) the requirements for the anchorage point and the minimum free space available below the user;

2) the proper way of setting up the harness and attaching of the co-amortising subsystem to the anchorage point.

§ 17. 1. Personal protective equipment to prevent the effects of mechanical vibration shall ensure adequate attenuation of vibrations detrimental to the endangered parts of the user's body.

2. The value of vibration accelerations transmitted to the user should not exceed the maximum permissible rates specified in the provisions on the maximum permissible concentrations and intensities of factors harmful to health in the environment work.

§ 18. Personal protective equipment protecting parts of the body against static pressure should cushion the effects of the oppression in sufficient detail to prevent serious injury to the body and to the chronic ailments.

§ 19. Materials used in the manufacture of personal protective equipment and their constituents intended for the protection of the whole body or parts thereof from surface injuries, in particular abrasions, clutches, cuts and crushes, and injuries, which are referred to in paragraphs 16 and 17, should be such that they are designed and constructed so as to ensure sufficient protection against those risks, under the expected conditions of use of those risks.

§ 20. 1. Personal protective equipment to prevent drowning, in particular narcotics, waistcoats and lifejackets, should flow to the surface as soon as possible without endangering the health of the user, and to maintain the user of these measures on the surface, even in the case of loss of consciousness, in a position allowing breathing, waiting for assistance.

2. The measures referred to in paragraph 1. 1, can be completely or partially made of materials maintained on the surface of the liquid or can also be filled with gas released manually or automatically, as well as inflatable lips.

3. The personal protective equipment referred to in paragraph. 1, under the expected conditions of use, shall be:

1) resistant to impacts on the surface of liquids and on environmental factors associated with the liquid, without harm to their proper functioning;

2) quickly and completely filled with gas or air.

4. If the envisaged specific conditions for the use of personal protective equipment require, certain types of anti-drowning measures should be:

1. equipped with an inflatable device and in light or audible signaling devices;

2) equipped with a device for attaching and attaching the body, enabling the user to be drawn from the liquid;

3) adapted for long term use under conditions of constant risk of the user, in case it falls into a liquid or in situations requiring immersion in it.

§ 21. Personal protective equipment in the form of clothing for effective maintenance on the surface of the water should provide the user with safety during their use and enable him, in particular, to swim, escape from danger or saving others at risk of drowning, without limiting the freedom of movement.

§ 22. 1. Personal protective equipment intended to prevent harmful effects of noise should reduce the noise to such an extent that the maximum level of sound A is perceived by the user, does not exceed the limit values specified in the provisions referred to in § 17 (1). 2.

2. The measures referred to in paragraph 1. 1, should have labels indicating the value of noise attenuation and the value of the comfort indicator provided by the given measure, and if that is not possible, the label shall be placed on the packaging of that measure.

§ 23. 1. Thermal insulation and mechanical resistance of personal protective equipment intended to protect the whole body of a user or part of its body before the effects of a high temperature or fire should be adapted to the predicted the conditions of use of those measures

2. The materials from which the personal protective equipment and the components of these products are made for protection against heat radiation or convection heat should have a suitable thermal flow penetration rate and exclude the use of these measures.

3. Where the external surface of the materials from which the personal protective equipment or components of these personal protective equipment are carried out should reflect the heat radiation, its bounding ability should be adjusted to heat flux in the area of infrared radiation.

4. The materials from which the personal protective equipment is made and the components of those measures intended for short-term use in a high-temperature operation, as well as personal protective equipment which may be exposed to the operation hot splashes of large quantities of melted materials, should have thermal insulation, preventing the penetration of most accumulated heat until the user leaves the danger area and pictures of conservation measures individual.

5. The materials from which the personal protective equipment and components of these measures are carried out:

1) exposed to the splashes of large quantities of hot materials-should provide sufficient amortisation of mechanical impacts and prevent injuries referred to in § 16 and 17;

2) which may inadvertently have contact with flames and those that are used for the production of fire equipment-should be characterized by resistance to inflammation, corresponding to the hazard class under the expected conditions of use. They must not melt in contact with the flame or spread the flames.

§ 24. 1. Complete and ready-to-use personal protective equipment designed to protect against the effects of high temperature or fire should meet the following requirements:

1. the amount of heat that passes through these means to the user's body shall be sufficiently small to ensure that, during their use, the accumulation of heat in the endangered part of the body causing the pain or health of the body to be affected is not present;

2) they should prevent the penetration of liquids or vapour and not cause burns resulting from contact between their protective coating and the user;

(3) if they are equipped with:

(a) refrigerants for heat absorption, acting on a vapour evaporation basis or solidification of solids, shall be so designed and constructed that release of the volatile substances is discharged outside the protective coating and not in the User direction

(b) to breathe-shall be designed and constructed in such a way as to comply with its protective function in the expected conditions of use.

2. In the instruction accompanying each individual copy of the individual protection product intended for short term use in a high-temperature operation, the manufacturer shall include the information necessary for the determination of the maximum permissible the user's exposure to the heat penetrating through these agents when used in accordance with their intended use.

§ 25. 1. Personal protective equipment designed to protect whole or part of the user's body before the cold should be characterized by thermal insulation and mechanical resistance, suitable under the expected conditions of use.

2. The materials from which the measures referred to in the paragraph are taken. 1, and the components of these measures shall have a heat flux penetration rate as small as is required under the expected conditions of use.

3. Flexible materials and other components of the means intended for use in a low-temperature environment should maintain the level of flexibility required to perform the necessary movements and to take appropriate positions.

4. The materials of which the personal protective equipment are made and the components of those measures which can be sprayed by large quantities of cold substances, should provide sufficient amortisation of mechanical impact and prevent injuries, o which are referred to in paragraphs 16 and 17.

5. Complete and ready-to-use personal protective equipment designed to protect against heat loss shall meet the following requirements:

1) the amount of cold penetrating by personal protective equipment to the user should be small enough to prevent the accumulation of cold at any point of the protected part of the body, including the ends of the fingers at the hands of the user, during the wearing of these measures; legs-to a level that could cause a feeling of pain or a health risk;

2) prevent the penetration of such liquids as the rainwater and do not cause injuries resulting from contact between their protective coating and the user.

6. If the personal protective equipment is equipped with a breathing device, this device shall retain its protective properties under the expected conditions of use.

7. In the instruction accompanying each individual copy of the personal protective equipment intended for short term use in low temperature environments, the manufacturer shall include information on the user's maximum permissible exposure to the cold penetrating through the individual protection measure.

§ 26. 1. Personal protective equipment designed to protect the whole body or parts thereof from the effects of an electrical current should properly isolate the user from the voltage to which it may be exposed in the most unfavourable the expected conditions of use of the measures.

2. The materials of which the personal protective equipment and the components of these measures are made shall be so designed, selected and combined to ensure that the electrical current flow through the protective coating of these measures is as low as possible, measured during the tests carried out at tensions corresponding to the tensions that may occur under real conditions. In any case, the electrical current flow through the protective coating of the personal protective equipment shall be lower than the maximum generally accepted limit value, corresponding to the human body's tolerance threshold.

3. Personal protective equipment intended solely for use during work performed with electrical installations which are or may be energised shall bear an indication also affixed to the packaging, specifying in particular:

1) the class of the individual protection product or the corresponding working voltage;

(2) the serial number and the date of manufacture of the measure.

4. On the protective coating of the measures referred to in paragraph. 3, leave room for the date of transmission of the funds to be used for the use and carrying out of periodic examinations or checks.

5. The producer of the measures referred to in paragraph 5. 1, the instructions shall include information on the specific purpose of such measures and the scope and frequency of studies of insulating properties which should be carried out during the period of use of the personal protective equipment.

§ 27. 1. Personal protective equipment to prevent acute or chronic eye diseases caused by non-ionising optical radiation should absorb or deflect radiation in the harmful spectrum band at the level corresponding to the specified the degree of protection. At the same time, the perception of contrasts and the possibility of colour recognition and permeation of visible radiation must be ensured, the level of which is also determined for individual degrees of protection.

2. The means used for the protection of the eyes shall be so designed and constructed that, for every harmful wavelength of the spectral wavelength, the permeation factor shall be such that the density of the energy stream of the harmful radiation that can reach the eyes the user through the filter of the means used, was as small as possible and did not exceed the permissible value of this radiation.

3. The quality of personal protective equipment used for the protection of the eyes shall not deteriorate and they shall not lose their properties in connection with the effects of radiation.

4. Personal protective equipment used for the protection of the eyes should be marked. The indication shall specify the degree of protection appropriate to the risks concerned.

5. Filters designed to protect the eyes from the radiation of sources of one type should be classified in the ascending order of their degrees of protection.

6. The manufacturer shall place on each copy of the protective filter a mark indicating the degree of protection appropriate to the hazard.

7. The instruction provided along with the measures referred to in paragraph. 1, it shall also contain information on the radiation permeation curve, designed to allow the selection of the most appropriate personal protective equipment, taking into account the factors relevant to their actual conditions the use, in particular the distance from the source and the distribution of the spectral energy of radiation at that distance.

§ 28. 1. The materials from which the personal protective equipment and components are made, intended to protect the whole body or parts of the body against radioactive contamination, including radioactive dust, gases, liquids or their mixtures, should be so designed, constructed, chosen and combined to effectively prevent the penetration of those substances in the expected conditions of use.

2. Depending on the type and condition of the substances referred to in paragraph. 1, the necessary tightness of the personal protective equipment and components of these measures may be obtained by the use of an impermeable protective coating or by appropriate means, in particular ventilation and pressure systems, designed to prevent re-dispersion of these substances.

3. Decontamination substances used in the process of decontamination of the personal protective equipment of contaminated substances referred to in paragraph 1, they shall not limit the possibility of the reuse of such measures, within the expected period of durability.

§ 29. 1. Personal protective equipment intended to provide full protection of the user against external irradiation or, if this is not possible, to ensure the suppression of this irradiation should be so designed and made They only counteracted to weak electron radiation, in particular beta or photon, in particular X, gamma.

2. The materials from which the measures referred to in the paragraph are taken. 1, and the components of these measures should be designed, combined and selected in such a way as to ensure the necessary level of protection required under the expected conditions of use, without at the same time extending the user exposure period to radiation, resulting from obstruction of movement, acceptance of appropriate body positions and movement, and meet the requirements referred to in § 7 paragraph. 6.

3. The measures referred to in paragraph 1. 1, they shall bear an indication containing information of the type and thickness of the materials from which they are made.

§ 30. 1. Personal protective equipment intended for the protection of the respiratory system shall be such as to enable the user to provide the means of breathing air when it is in a polluted atmosphere or in an atmosphere of insufficient oxygen content.

2. The air referred to in paragraph 1, must be obtained by appropriate methods, in particular by filtering contaminated air through individual protection measures or by providing the wires from an unpolluted source.

3. The materials from which the personal protective equipment referred to in the paragraph is carried out. 1, and the components of those measures shall be so designed, selected and combined to ensure that the user is able to breathe and breathe in the right of breathing during the entire period of application under the expected conditions of use.

4. The tightness of the facial part, the pressure drop during the inhalation of the air, and when the cleaning equipment is used, the air purification efficiency should be sufficiently protected against penetration from the atmosphere of the pollutants harmful to the health and hygiene of the user.

5. The personal protective equipment referred to in paragraph. 1, should be marked with the manufacturer's identification mark and information on the detailed characteristics of the equipment. The information, together with the instructions, should enable the trained and qualified user of these measures to properly apply them.

6. In the instructions accompanying the purification equipment, the manufacturer shall include information on the maximum period of storage of the new equipment and storage in original packages.

§ 31. 1. Personal protective equipment intended to prevent the surface contact of the whole body of the user or part of the body, including the skin and eyes, with dangerous substances or infectious agents, should protect against the passage of or the penetration of these substances through the protective coating under the expected conditions of use.

2. The materials from which the personal protective equipment referred to in the paragraph is carried out. 1, and the components of such measures shall be so designed, selected and combined to ensure, as far as possible, a complete tightness which will allow for long-term daily use of personal protective equipment, and if this is not possible, should ensure tightness limited in the shortened use period.

3. In the case where dangerous substances or infectious agents have a high degree of penetration capacity due to their properties or anticipated conditions of use, the personal protective equipment should be subjected to tests for the purpose of their classification according to the effectiveness of their performance.

4. Personal protective equipment, which shall be considered to comply with the test specifications referred to in paragraph 1. 3, should be accompanied by information containing, in particular, the names and, where this is not possible, the determination of the substances used during the tests and the period during which protection will be provided.

5. In the statement accompanying the measures referred to in paragraph 1. 1, the manufacturer shall include an explanation of the determinations used for the substances referred to in paragraph 1. 4, a detailed description of the tests and any information necessary to determine the maximum permissible period of use of such measures in the various envisaged conditions.

§ 32. 1. breathing equipment in diving equipment shall ensure the supply of a gas mixture to the user, with particular reference to the maximum depth of immersion.

2. In cases where the envisaged conditions of use so require, the equipment of the diving equipment shall consist of:

1. pressurised clothing resulting from the depth of immersion, meeting the requirements referred to in § 18, or before the cold, meeting the requirements referred to in § 25;

2. an alarm device intended for rapid alert on the impending absence of a gas mixture to be breathable, which satisfies the requirements referred to in § 13 (1) (b). 2;

3) a rescue suit to return to the surface of the water, meeting the requirements referred to in § 21.

Chapter 3

Conformity assessment procedures and the manner of marking of personal protective equipment

§ 33. [ Documentation for the specified individual protection measure] The manufacturer or his authorised representative shall, prior to the placing on the market of a particular individual protection measure, complete the documentation required for the measure in order to present it at the request of the competent authorities.

§ 34. 1. The manufacturer or his authorized representative prior to the start of the serial production of personal protective equipment other than those mentioned in the paragraph. It shall provide a copy of the model of the individual protection measure to the EC type-assessment referred to in paragraph 38.

2. EC type assessment is not required for personal protective equipment included in simple construction measures if the designer considered that the user can assess the level of performance of their performance against the minimum risks, the effects, if they are progressively increasing, can be easily and at the right time identified.

3. Personal protective equipment included in simple construction measures shall include only measures designed to protect against:

1) the actions of mechanical factors, the effects of which are surface-related;

2) cleaners with weak action and easily reversible effects;

3) threats related to the manipulation of hot objects, which does not expose the user to a temperature higher than 50 ° C (323 K) or to dangerous impacts;

4) atmospheric factors, without taking into account exceptional and extreme factors;

5) weak strokes and vibrations that have no effect on vital areas of the body and whose effects cannot cause irreversible damage to the body;

6) sunlight.

4. Personal protective equipment included in a means of a complex structure designed to protect against life threatening or against threats that may cause serious and irreversible damage to the body or lesions, and which direct effects of the action, according to the designer, the user is not able to identify at the appropriate time, they are subject, depending on the choice of the manufacturer, the procedure referred to in § 40, or the procedure referred to in § 41.

5. Personal protective equipment with a complex structure includes:

1. respiratory protective equipment to protect against solid or liquid aerosols or to irritating, dangerous, toxic or radiotoxic gases;

2) respiratory protective equipment, providing full insulation from the atmosphere, including the equipment used for diving;

3) measures providing limited time protection against chemical hazards or ionizing radiation;

4. rescue equipment for use in high temperature environments with effects comparable to that of air at 100 ° C (373 K) or above and where infrared, flames or large splashes may occur. melted material;

5. rescue equipment for use in low-temperature environments with effects comparable to that of air at -50 ° C (223 K) or lower;

6) means to protect against falls from a height;

7) means to protect against electrical hazards, hazardous voltage electrical current or such, which are used as insulators when performing work under high voltage.

§ 35. 1. The manufacturer or his authorised representative shall provide the competent authorities with the documentation referred to in § 33. The documentation shall include information on the action taken by the manufacturer to ensure that the individual protection measure complies with the essential requirements laid down in the Regulation.

2. In the case of personal protective equipment other than means of simple design, the documentation referred to in § 33 shall also include:

1. technical documentation of the personal protective equipment covering:

(a) pooled and detailed drawings, together with the necessary calculations and the results of the prototype tests, in so far as this is necessary to determine their conformity with the essential requirements,

(b) a list of the essential requirements and harmonized standards or other requirements referred to in paragraphs 7 to 32 used for the design of the model of the individual protection measure;

2) a description of the control-measuring equipment used by the manufacturer to check the conformity of the production of personal protective equipment with harmonised standards or other technical requirements and to maintain an appropriate level the quality of their production;

3) a copy of the instructions intended for the user.

§ 36. 1. The manufacturer or his authorised representative shall issue an EC declaration of conformity for the protection measures.

2. The EC declaration of conformity shall include:

1. the name and address of the manufacturer and his authorised representative, if it is established within the territory of the European Union;

2. a complete description of the individual protection measure, in particular with the name, type, serial number;

(3) a statement that the new individual protection measure complies with the provisions of this Regulation and with harmonised standards, where applicable; the number of the standards should be provided-for the personal protective equipment referred to in § 34 paragraph 2 and 3;

(4) a statement that the new individual protection measure is identical to that of an individual protection product subject to an EC type-examination certificate stating the number of the certificate issued by the notified body, giving its name, address and number a notified body;

5) a statement that the new personal protective measure is subject to the procedure laid down in § 40 or § 41 under the supervision of a notified body with the name, address and number of the notified body;

6) the place and date of its preparation;

7. the name of the person empowered to sign the signature on behalf of the manufacturer or his authorised representative.

§ 37. In conformity assessment procedures at the design and production stage of personal protective equipment other than those referred to in Paragraph 34 (1) of the 3. The notified bodies shall participate, which shall comply with the criteria set out in the Article. 19 (1) 2 of the Act of 30 August 2002. the conformity assessment system and the following additional criteria:

1) dispose of the necessary means and equipment;

2. employees should have the appropriate technical competence and conduct themselves with professional ethics;

3. when carrying out the tests, preparing the reports, issuing the certificates and performing the supervision set out in the Regulation, the employees should be independent of all wheels, groups and persons, directly or indirectly interested in the measures individual protection.

§ 38. (1) The EC type assessment shall be the procedure by which the notified body finds that a specific model of an individual protection measure fulfils the requirements set out in the Regulation.

2. The manufacturer or his authorised representative shall submit an application for an EC type-assessment in one notified body, appropriate for the individual protection measure concerned.

3. The application referred to in paragraph 1. 2, it shall contain:

1. the name and address of the manufacturer or his authorised representative, and the name and address of the establishment producing the specific measure of individual protection;

2) the documentation referred to in § 33.

4. The application referred to in paragraph 1. 2, the appropriate number of copies of the model of the personal protective equipment necessary to carry out the conformity assessment should be attached.

5. The notified body shall carry out an EC type assessment on the basis of:

1) the assessment of the technical documentation referred to in § 35, in order to verify whether the requirements of the harmonised standards have been taken into account;

(2) assessment of the design of the individual protection measure by:

(a) to verify that the measure has been produced in accordance with the technical documentation.

(b) verifying that the measure can be used safely in accordance with its intended purpose,

(c) carry out the necessary tests and verify the conformity of the design of the individual protection product with harmonised standards.

(6) If, in carrying out an EC type-examination, a notified body finds that the manufacturer has not applied or partially applied the harmonised standards, or where such standards do not exist, the notified body shall:

1. prior to carrying out the assessment of the technical documentation, it shall verify that the manufacturer has applied the appropriate specifications in relation to the essential requirements;

2. shall carry out the necessary assessments and tests to determine the conformity of the design with the specifications applied by the manufacturer, provided that these specifications are appropriate for the essential requirements concerned.

§ 39. (1) If the model of an individual protection product subject to EC type assessment meets the requirements laid down in the relevant provisions, the notified body shall issue an EC type-assessment certificate to the applicant and shall inform the applicant without delay.

2. The certificate should contain the results of the EC type assessment and the information about the conditions of its issuance, the descriptions and drawings necessary for the identification of the assessed personal protection product.

3. The notified body, at the request of the European Commission, of other notified bodies and competent authorities of the other Member States of the European Union, may forward a copy of the issued EC type assessment certificate and, where appropriate, a copy of the technical documentation and the reports on the examinations and evaluations carried out.

4. The manufacturer or his authorized representative shall keep the technical documentation referred to in § 35, for a period of 10 years from the date of placing on the market of the personal protective equipment.

5. A notified body which has refused to issue an EC type-assessment certificate shall inform the other notified bodies thereof.

6. If the notified body withdraws an EC type-assessment certificate, it shall inform the body which notified the notified body.

§ 40. 1. Quality control of the produced personal protective equipment shall be the procedure whereby:

1. the manufacturer shall take all necessary steps to ensure that the production process, including the final control and testing of the individual protective equipment produced, ensures the homogeneity of their production and conformity with the type described in the EC type-approval certificate and with the relevant essential safety and health requirements laid down in the Regulation;

2. the notified body chosen by the manufacturer shall carry out the necessary checks on the production process of the personal protective equipment, at least once a year;

3. within the framework of the checks referred to in point 2, the notified body shall take appropriate samples of the design of the personal protective equipment and evaluate them on the basis of the tests carried out, as specified in the harmonised standards or tests necessary for the verification of the conformity of the design of these measures with the essential requirements.

2. In the event of difficulties in the assessment of the conformity of the samples taken, where the notified body referred to in paragraph 2 is concerned. Article 1 (2) is a different entity than the one which issued the EC type-assessment certificate-the entity should contact the entity which issued the EC type-assessment certificate.

3. The notified body shall provide the manufacturer with a report of the tests carried out referred to in paragraph 1. 1 point 3. If it is found in the report that the production is not homogeneous or that the test subject to the individual protection measure does not correspond to the type described in the EC type-assessment certificate or does not conform to the essential requirements, the notified body it shall take appropriate action in relation to the deficiencies identified and inform the Minister responsible for the economic affairs of the matter.

4. The manufacturer shall make available the report referred to in paragraph. 3, on a reasoned request from the entities concerned.

§ 41. 1. The system of ensuring the quality of EC production by monitoring shall be the procedure whereby:

1. the manufacturer shall maintain an adequate system of quality assurance for EC production, including the production process of personal protective equipment;

2. the manufacturer shall request the selected notified body to assess and approve its system of quality assurance of EC production;

(3) within the framework of the EC production quality assurance system, each copy of the personal protective equipment should be assessed and examined as referred to in Paragraph 40 (1) of the Treaty. 1 point 3, to verify the compliance of these measures with the relevant essential requirements.

2. The application referred to in paragraph 2. 1 point 2, shall include:

1. information on the type of personal protective equipment produced and, where appropriate, the documentation of the approved design of the said measures;

2) a commitment to fulfil the obligations arising from the system of ensuring the quality of EC production and to maintain its adequacy and effectiveness;

3. documentation on the EC production quality assurance system, including a description of:

(a) the objectives of quality assurance, the organisation chart, the responsibilities of the management and its competence to maintain the quality of the personal protective equipment produced,

(b) methods of checks and tests carried out on individual protection measures and storage conditions after those measures have been produced,

(c) the measures to be applied in order to verify the effectiveness of the system of quality assurance of EC production.

(3) The notified body shall, when assessing the quality assurance system for EC production, determine whether it complies with the requirements referred to in paragraph 3. 1 point 3. It is understood that these requirements are met in the case of the use of EC production quality assurance systems in conformity with the relevant harmonised standards.

(4) The notified body carrying out an audit of the EC production quality assurance system shall evaluate the individual components of that system and, in particular, verify that the system ensures the conformity of the personal protective equipment produced. the approved pattern of those measures.

(5) The notified body shall provide the manufacturer with a report of the assessment referred to in paragraph 1. 4, together with the positions and conclusions resulting from the audit.

6. The manufacturer shall immediately notify the notified body which has assessed the quality assurance system of EC production, of the planned changes to that system. The notified body shall verify the proposed changes and assess whether the revised system of quality assurance for EC production will meet the requirements. The notified body shall inform the manufacturer of the decision taken in that case. The notification shall include the results of the examination and the reasons for the assessment decision.

§ 42. 1. The notified body shall supervising the approved system of quality assurance of EC production, in order to confirm that the manufacturer correctly fulfils the obligations arising from the approved system.

2. The notified body shall exercise the supervision referred to in paragraph 2. 1, in accordance with the following procedure:

1. the manufacturer shall entitle the notified body to inspect the research posts, places of storage and control of the personal protective equipment and make the necessary documentation available for inspection, and in particular:

(a) documentation of the EC production quality assurance system,

(b) technical documentation,

(c) quality books;

2. the notified body shall carry out the periodic audits of the manufacturer with a view to determining whether the manufacturer maintains and applies the approved quality system and provides copies of the reports from those audits;

3. the notified body may make unannounced visits to the manufacturer from which it draws up a report and supplies it to the manufacturer.

3. The manufacturer shall make available a report of the audits and visits referred to in the paragraph. 2 points 2 and 3, on a reasoned request from the entities concerned.

§ 43. 1. The manufacturer shall affix the CE marking to the personal protective equipment which complies with the essential requirements laid down in the Regulation and has been subject to conformity assessment procedures. In the case of personal protective measures referred to in Paragraph 34 (1), 4 and 5, next to the CE marking, the identification number of the notified body shall be affixed, which shall assess the control system of the personal protective equipment produced.

2. The CE marking shall be affixed to each copy of the individual protection product in a visible, legible and harshly resistant manner throughout the period of use of the said product. If this is necessary in view of the characteristics of the individual protection product, the affixing of the CE marking on the packaging of these measures may be allowed.

(3) The CE marking should be affixed to the personal protective equipment in a manner which does not mislead. Other markings may be placed on personal protective equipment or on their packaging, unless the visibility and legibility of the CE marking is reduced.

4. The model of the CE mark shall be defined in the Annex to

Chapter 4

Final provision

§ 44. [ Entry into force] This Regulation shall enter into force on 1 January 2006. 3)

Chapter 4

Final provision

§ 44.

Minister of Economy: P. G. Woźniak

1) Minister of Economy heads the government administration department-economy, pursuant to § 1 paragraph. 2 point 1 of the Regulation of the Prime Minister of 31 October 2005. on the detailed scope of the action of the Minister of Economy (Dz. U. Nr 220, pos. 1888).

2) The provisions of this Regulation shall implement the provisions of the Council of the Council of the European Communities No 89 /686/EEC of 21 December 1989. on the harmonisation of the laws of the Member States relating to personal protective equipment (Dz. Urz. EC L 399 of 30.12.1989, as late. zm.; Dz. Urz. EU Polish Special Edition, rozdz. 13, t. 10, str. 98).

3) This Regulation was preceded by the Regulation of the Minister of Economy, Labour and Social Policy of 31 March 2003. on the essential requirements for personal protective equipment (Dz. U. Nr 80, poz. 725).

Annex 1. [ PATTERN OF THE CE MARK]

Annex to the Regulation of the Minister of Economy
of 21 December 2005 (pos. 2173)

FORMULA OF CE MARK

The CE mark shall consist of the letters 'CE' of the following shapes:

infoRgrafika

In the case of reduction or expansion of the CE mark, the proportions shown in the above figure shall be preserved.

The individual components of the CE mark shall be of the same height, which shall not be less than 5 mm.

Requirements for minimum dimensions may not be retained in the case of personal protective equipment with small dimensions.