Source: https://www.global-regulation.com/translation/poland/2986152/regulation-of-the-minister-of-economy-of-21-december-2005-on-the-essential-requirements-for-personal-protective-equipment.html
Timestamp: 2020-07-10 05:36:39
Document Index: 720580447

Matched Legal Cases: ['§ 1', '§ 2', 'art. 9', '§ 3', '§ 4', '§ 5', '§ 6', '§ 34', '§ 34', '§ 16', '§ 8', '§ 16', '§ 9', '§ 10', '§ 11', '§ 12', '§ 13', '§ 14', '§ 15', '§ 16', '§ 17', '§ 18', '§ 19', '§ 16', '§ 20', '§ 21', '§ 22', '§ 17', '§ 23', '§ 16', '§ 24', '§ 25', '§ 16', '§ 26', '§ 27', '§ 28', '§ 7', '§ 30', '§ 31', '§ 32', '§ 18', '§ 25', '§ 13', '§ 21', '§ 33', '§ 34', '§ 41', '§ 33', '§ 33', '§ 7', '§ 36', '§ 34', '§ 37', '§ 34', '§ 38', '§ 33', '§ 35', '§ 39', '§ 35', '§ 40', '§ 41', '§ 40', '§ 42', '§ 43', '§ 34', '§ 44', '§ 44', '§ 1']

Machine Translation of "Regulation Of The Minister Of Economy Of 21 December 2005 On The Essential Requirements For Personal Protective Equipmen..." (Poland)
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
On the basis of article. 9 of the Act of 30 August 2002 on conformity assessment system (Journal of laws of 2004 No. 204, item 2087 and the 2005 # 64, poz. 565) are managed as follows: Chapter 1 General provisions § 1. [Scope] The regulation defines: 1) essential requirements for personal protective equipment;
2) the conformity assessment procedures;
3) marking of personal protective equipment;
4) CE mark.
§ 2. The provisions of the regulation shall not apply to personal protective equipment: 1) set out in other legislation issued on the basis of art. 9 of the Act of 30 August 2002 on conformity assessment system for placing products on the market and the security of their users;
2) designed and constructed for use by the armed forces or the police and other departments to which tasks should be to ensure compliance with the law and public order;
3) for the purposes of self defense;
4) use by the general public, which protect against adverse weather conditions, moisture, water, or heat;
5) intended for protection and rescue of persons on vessels and aircraft not intended for permanent wear;
6) helmets and visors intended for users of two-or three-wheel motor vehicles.
§ 3. Whenever a regulation is made of individual protection measures, it must be understood of the device or equipment designed to be worn or held by the user in order to protect one or more risks, which might affect its safety or health.
§ 4. 1. Personal protection also include: 1) a team of several devices or several types of protective equipment, which have been assembled by the manufacturer in order to protect against hazards;
2) device or protective equipment connected separately or inseparably with the protective measure of equipment worn or held by the user in order to perform certain actions;
3) spare parts or components of personal protective equipment, essential for their proper functioning and used exclusively for these measures.
2. Each component of personal protective equipment used to connect these measures with other external devices shall be deemed to be an integral part of this measure, even if the component is not intended for wear or hold on a permanent basis by the user for the duration of the emergency.
§ 5. 1. Personal protective equipment may be placed on the market and used only when the protect the health and ensure the safety of users, without risk to the health and safety of other individuals, domestic animals and property, assuming proper handling and use as intended.
2. In order to ensure the protection of users of personal protective equipment can be fixed other than those referred to in regulation requirements for the safety and health protection, provided that they do not result in a modification of individual protection measures in a manner inconsistent with the provisions of the regulation.
3. ability to display at trade fairs and exhibitions of personal protective equipment satisfying the requirements laid down in the regulation, provided that information, highlighting the fact that the prohibition on the acquisition and use of these funds for any purpose, to time to ensure their compliance with the requirements set out in the regulation.
§ 6. 1. In conformity with the essential requirements referred to in the regulation, shall be deemed to be: 1) personal protection included in the measures of simple design, referred to in § 34 paragraph 1. 3, having the CE marking, for which the manufacturer or his authorized representative issued the EC declaration of conformity;
2) personal protective equipment other than that specified in § 34 paragraph 1. 3, having the CE marking, for which the manufacturer or his authorized representative has a certificate proving conformity with the essential requirements laid down in regulation and issued the EC declaration of conformity.
2. If the essential requirements for the protection of the individual determine separate rules, which require placing on it of the CE marking, the manufacturer or his authorized representative acknowledges in the EC declaration of conformity, that the measure is compatible with the provisions of these regulations.
3. If separate provisions allow the manufacturer, or to his authorized representative, during the transitional period referred to in those provisions, to apply only some of their provisions, the CE marking shall indicate conformity of individual protection only with the provisions of these rules, which the manufacturer has applied. In this case, the list of the applied provisions should be placed in the documentation and instructions required for the specified individual protection.
Chapter 2 the essential requirements for personal protective equipment 7. [Requirements concerning personal protective equipment] 1. Personal protective equipment should: 1) provide adequate protection against hazards;
2) be designed and constructed in accordance with the requirements of ergonomics in such a way that in the foreseeable conditions of use, for which they are intended, the user can normally perform all actions in case of an emergency, while adequate protection at the highest possible achievable.
2. By the highest possible protection achievable, that should be taken into account in the design of personal protective equipment, must be understood level, above which the inconvenience associated with the wearing of prevent its effective use during exposure to the risk or prevent the normal activities.
3. In designing the means of an individual defence, to the foreseeable, conditions of use, which can be several levels of risks, allow appropriate protection class.
4. PPE must be so designed and manufactured as to preclude risks and other inconveniences in the foreseeable conditions of use: 1) the materials are manufactured parts and materials used in the manufacturing of personal protective equipment, including products of their decomposition, should not affect the health or hygiene;
2) proper surface condition components; each part of the personal protective equipment that comes in contact with, or that could potentially come into contact with the user during their use, should be smooth, free from sharp edges, projections and the edges of the life-threatening lacerations;
3) minimise the difficulties for the user; any inconvenience associated with moving, changing the position of the body and the perception of the senses as a result of the use of personal protective equipment should be minimized; at the same time, they must not cause the movement dangerous for the user or other persons.
5. Personal protective equipment should be so designed and constructed that can be easy and correct assumption on the user, and leave them in place for the expected useful life, taking into account the prevailing around conditions, gestures and taken body position. Therefore, you should ensure that the optimal adjustment of these measures for the construction of the body using all appropriate means, in particular, appropriate control systems and fittings, or by providing an appropriate size range.
6. Personal protective equipment should be as light as possible, while maintaining the required strength and efficiency.
7. Regardless of the essential requirements referred to in § 16-32, personal protective equipment shall be resistant to environmental factors, under the foreseeable conditions of use.
§ 8. 1. PPE designed to protect the user against several simultaneous risks must be so designed and manufactured as to meet the requirements specific to each of the risks referred to in § 16-32.
2. in the case when the same manufacturer markets several types of personal protective equipment of different classes or different types, designed to ensure the protection of adjacent parts of the body before the combined action of various risks, those measures should be compatible.
§ 9. 1. the manufacturer or his authorized representative, introducing personal protective equipment on the market, you should provide instructions for their use, hereinafter referred to as the "instructions".
2. the statement should contain: 1) the name and address of the manufacturer or his authorized representative;
2) storage, use, cleaning, maintenance, handling and disinfection of personal protective equipment;
3) about: a) recommended by the manufacturer cleaners, preservatives and disinfectants that will not negatively affect the user individual protection measures and on the measures, if applied in accordance with the relevant instructions, (b)) the effectiveness of the protection resulting from the technical tests performed to check the levels or classes of protection, which are characterized by personal protective equipment,
(c)) the appropriate extra equipment personal protective equipment and their spare parts, d) protection class for different levels of risks and related restrictions on use of personal protective equipment, e) kind of packages appropriate to their safe transport;
4) expiry date or shelf-life of personal protective equipment or their specific components;
5) explanation of any determinations;
6) the name, address and identification number of the notified body involved in the conformity assessment process of personal protective equipment.
3. the statement should be prepared accurately and clearly in the Polish language, and in the official languages of the countries of destination of personal protective equipment.
§ 10. 1. If personal protective equipment shall be equipped with a system of regulation, it is necessary to design and perform in a way that prevents setting incorrect parameters adjustment of carrying out without your knowledge under the foreseeable conditions of use.
2. Personal protective equipment covering the parts of the body to be protected should be properly ventilated, so far as is possible, to reduce the secretion of sweat when you use them. If this condition is not possible, these measures should be equipped with systems to absorb sweat.
3. Any restriction of the field of vision caused by personal protective equipment for the face, eyes and respiratory system, should be minimized. The degree of optical neutrality of viewfinders, located in individual protection measures should be adapted to the user performed precision and long-lasting.
4. the measures referred to in paragraph 1. 3, if necessary, should be equipped with a means of anti fog viewfinders.
5. Personal protective equipment designed for users requiring vision correction should be adapted to wearing them with glasses or contact lenses.
§ 11. 1. If the degree of aging of personal protective equipment can have a serious impact on their property, for each copy of the measures placed on the market or convertible components, permanently and legibly, provide the date of production and, if possible, the date of expiry of shelf life. This information should be in a permanent place on the packaging of these measures.
2. If the manufacturer cannot determine the shelf life of personal protective equipment, supplied by the manual should contain the necessary information to enable the purchaser or user of these measures to determine the correct date of expiry of the period of their life, taking into account the quality level of these measures, the conditions for their storage, use, cleaning, and maintenance.
3. If a clear and rapid reduction in the effectiveness of the protection that provide personal protective equipment, can be caused by wear and tear as a result of recommended by the manufacturer for the periodic cleaning or maintenance, the manufacturer shall affix the marketing copy such a measure, if possible, informing you of the permitted number of cleaning or maintenance operations, after which individual protection should be subjected to control the condition or replaced.
4. where in the middle of the personal protective equipment not marking, referred to in paragraph 1. 3, the maximum permissible number of actions related to their cleaning or maintenance should be stated by the manufacturer in the instructions supplied with each copy of the measure.
5. Where the foreseeable conditions of use of personal protective equipment in particular the risk of their being caught up by moving objects, thereby causing danger to the user, these measures should have adequate strength, above which their constituents will be continued isolation, thereby eliminating this threat.
§ 12. Personal protective equipment intended to be used: 1) in an explosive atmosphere-should be so designed and constructed that they cannot be the source of a spark or arc, caused respectively hit or static electricity, and could not result in the ignition of an explosive mixture;
2) in an emergency or for fast or removal should be so designed and constructed that the time needed for their establishment or taking as short as possible; all items of personal protective equipment, to correct their setting up or removing, should enable quick and easy maintenance.
§ 13. 1. manual supplied by the manufacturer with the PPE of complex design intended to protect against life threatening or threats that can cause severe and irreversible damage to the body or loss of health, including changes to sick leave, which effects according to the manufacturer, the user is not able to conclude at the appropriate time, should include, in particular: 1) the data intended to be used only by competent and trained person that are qualified to their correct interpretation and to ensure the safe use of these measures by the user;
2) description of how to determine whether the personal protective equipment have been properly adjusted and functioning properly during use.
2. If personal protective equipment are equipped with alarm systems run in the absence of a prescribed level of protection, the devices must be designed and arranged in such a way that the user receive the alarm signal of these devices when they are used under conditions for which they are intended.
3. Components of personal protective equipment, that can be adjustable, detachable or replaced by the user, shall be so designed and manufactured that these activities could be made without the use of tools.
4. In the case where personal protective equipment are fitted with a device to connect with other complementary devices, connecting mechanism should be designed and constructed in such a way that the installation only with the relevant complementary devices.
5. If personal protective equipment are fitted with a device for circulating liquids, such equipment should be designed, selected and connected to the proper exchange of liquid near the fully protected part of the user's body measures, irrespective of its position or gestures in the foreseeable conditions of use.
§ 14. 1. The identification marks or reconnaissance, relating directly or indirectly to the safety and health of the user, placed on personal protection measures of a given type or kind, should be made in the form of standard pictograms or ideograms and readable by the estimated period of use.
2. The characters referred to in paragraph 1. 1, should be complete, accurate and understandable enough that it cannot be mistakenly interpreted them. Characters that contain the words or sentences should be worded in Polish and in the official languages of the countries of destination of personal protective equipment.
3. In the case where personal protective equipment or their components are too small, so that you can put on them all or part of the necessary characters, referred to in paragraph 1. 1, information on these characters should be placed on the packaging of these measures and in the instructions provided by the manufacturer.
§ 15. Personal protective equipment made of material intended for use in environments where the presence of each user should be visually indicated, must be equipped with one or more appropriately disposed items or devices emitting or reflecting visible radiation of appropriate luminous intensity and photometric properties and colorimetric properties.
§ 16. 1. Personal protective equipment to prevent: 1) of injuries caused by falling or projecting objects or collisions of body parts with other obstacles to prevent injuries caused in particular by crushing or puncturing part protected by these measures should provide shock absorption beats to at least this level of impact energy above which dimensions or mass center of the protective cushioning impact would prevent efficient use in the expected period;
2) falls from a height or their effects-should contain the harness and subsystem of bonding-shock connected to the point; These measures should be so designed and constructed that under the foreseeable conditions of use the vertical drop of the user was minimized in order to avoid collisions with obstacles, and the braking force does not exceed the threshold value above which a user could suffer injury or the result would break or crack any of the elements, causing the fall of the user;
3) falls due to slipping – should be designed, constructed and equipped with additional elements to provide sufficient grip by grip and friction taking into account the type, as well as the condition of the surface.
2. Personal protective equipment referred to in paragraph 1. 1, paragraph 2, should also ensure the maintenance of the user after braking the fall in the correct position, to wait for help.
3. manual supplied together with the PPE to protect against falls from a height should also include information about: 1) the requirements for the anchor point and the minimum free space below the user;
2) how to set up and join a subsystem of bonding-cushioning to the anchor point.
§ 17. 1. Personal protective equipment to prevent the effects of the mechanical vibrations should ensure the correct vibration harmful to vulnerable parts of the body.
2. The value of acceleration vibrations transmitted to the user should not exceed the maximum intensities referred to in the provisions on maximum concentrations and intensities of factors harmful to health in the working environment.
§ 18. Personal protective body parts before the static compression should be sufficiently capable of attenuating its effects of oppression, in order to prevent serious injury or chronic complaints.
§ 19. The materials used for the production of personal protective equipment and components provided for to protect all or part of the body against the surface injuries, in particular, abrasions, przekłuciami, cuts and zgnieceniami and injuries referred to in § 16 and 17, should be chosen, designed and constructed to ensure sufficient protection against these threats, under the foreseeable conditions of use.
§ 20. 1. Personal protective equipment to prevent drowning, in particular shoulder pads, vest and suits, should emerge to the surface as soon as possible, without risk to the health of the user, and keep the user of these measures on the surface, even in the case of loss of consciousness, in a position which permits breathing while waiting for help.
2. the measures referred to in paragraph 1. 1, can be completely or partially made of materials remaining on the surface of the liquid or gas may be released manually or automatically, as well as inflatable lips.
3. Personal protective equipment referred to in paragraph 1. 1, under the foreseeable conditions of use should be: 1) impact-resistant of the liquid surface and environmental factors associated with the liquid, without harming their proper functioning;
2) rapidly and completely filled with gas or air.
4. If the predicted specific conditions for the use of personal protective equipment that require certain types of measures to prevent drowning must be: 1) with inflation devices and light or sound signalling devices;
2) equipped for hooking and fixing the body, allowing the user to draw from the liquid;
3) suitable for prolonged use under permanent threat, if he liquid or in situations that require immersion in it.
§ 21. Personal protective equipment in the form of clothing for effective duration on the surface of the water should ensure user safety during their use and enable it, in particular, swimming, escape from danger or rescue other at risk of drowning people, not limited freedom of movement.
§ 22. 1. PPE designed to prevent harmful effects of noise should reduce the noise to the extent that the maximum sound level and received by the user, does not exceed the limit values laid down in the provisions referred to in § 17 paragraph 2. 2.2. The measures referred to in paragraph 1. 1, should have a label indicating the value of noise suppression and the pointer value of comfort provided by the measure, and if this is not possible, the label should be placed on the packaging.
§ 23. 1. Thermal insulation and mechanical strength of personal protective equipment intended to protect all user's body or a part of the body against the effects of high temperature or fire should be adapted to the foreseeable conditions of use.
2. the materials from which they are made personal protective equipment and components of these measures designed to protect against heat radiation or convection heat, should have the appropriate coefficient of heat flux and exclude inflammation of these measures.
3. where the outer surface of the materials from which they are made personal protective equipment or components of these individual protection measures, should reflect thermal radiation, its reflective power must be adjusted to the heat flux in the range of infrared radiation.
4. the materials from which they are made personal protective equipment and components of these measures intended for brief use in high-temperature environment, as well as personal protective equipment, which may be exposed to hot spatter large amounts of melted materials should have a thermal insulation that prevents the penetration of the majority of the accumulated heat until the user leaves the dangerous area and pictures of personal protective equipment.
5. the materials from which they are made personal protective equipment and components of these measures: 1) exposed to splashes of large amounts of hot materials, should provide sufficient mechanical shock and prevent injuries referred to in § 16 and 17;
2) that can accidentally come into contact with flames and those that are used for the production of fire equipment, should be resistant to inflammation, corresponding to the hazard class under the foreseeable conditions of use. They may not melt in contact with flame or spread the flames.
§ 24. 1. Complete and ready-to-use PPE intended for the protection against the effects of high temperature or fire should meet the following requirements: 1) the quantity of heat transmitted by these means to the user's body should be small enough so that when their use is not followed by the accumulation of heat in the affected parts of the body, resulting in a feeling of pain or damage to health;
2) should prevent the penetration of liquid or vapour and does not cause burns resulting from contact between its protective coating and the user;
3) if they are equipped with: a) cooling, designed to absorb heat by means of liquid evaporation or solid sublimation, should be so designed and constructed so that the volatile substances were discharged out of the coating, and not towards you (b)) to breathe – should be designed and constructed in such a way as to meet their protective function in the foreseeable conditions of use.
2. In the instructions supplied with each copy of the personal protection intended for brief use in high-temperature environment, the manufacturer shall include the information necessary to determine the maximum permissible user exposure to the heat penetrating through these measures during their use in accordance with their intended purpose.
§ 25. 1. PPE designed to protect all or part of the user's body from the cold should have a thermal and mechanical resistance, right under the foreseeable conditions of use.
2. the materials constituting the measures referred to in paragraph 1. 1, and these measures should have interference indicator heat flux as small as is required by the foreseeable conditions of use.
3. flexible Materials and other components of intended for use in an environment with low temperatures should be the level of flexibility required to perform the necessary movements and postures.
4. the materials from which they are made personal protective equipment and components of these measures, which may be splashed by large amounts of cold substances, should provide enough cushioning and to prevent mechanical injuries referred to in § 16 and 17.
5. Complete and ready-to-use personal protective equipment designed to protect against heat loss should meet the following requirements: 1) the quantity of cold transmitted by PPE to the user must be small enough to wear these measures prevent the accumulation of cold in any point of the protected parts of the body, including the ends of the fingers and toes – to a level that could cause a feeling of pain or health hazards;
2) prevent the penetration of such liquids as rain water and do not cause injuries resulting from contact between its protective coating.
6. If personal protective equipment are equipped with a breathing device, the device should retain their protective properties under the foreseeable conditions of use.
7. In the instructions supplied with each copy of personal protective equipment intended for short-term use in low-temperature environments, the manufacturer shall include information concerning the maximum permissible user exposure to the cold penetrating through the means of personal protection.
§ 26. 1. PPE designed to protect all or part of the body against the effects of electric current must properly isolate you from the voltage to which it may be exposed in the most unfavourable foreseeable conditions of use.
2. the materials from which they are made personal protective equipment and components of these measures should be designed, selected and combined to provide the smallest possible passage of electric current through the protective coating of these measures, measured during the tests performed at voltages corresponding to the tensions which may occur in real life conditions. In any case, the passage of electric current through the protective shell of personal protective equipment should be less than the maximum permissible values generally accepted, corresponding to the threshold of tolerance of the human body.
3. Personal protective equipment intended only for use when you work with electrical installations which are or may be energized, should have a mark placed on the packaging as well, specifying in particular: 1) class of individual protection, or if the corresponding operating voltage;
2) serial number, and date of manufacture.
4. The protective shell of the measures referred to in paragraph 1. 3, leave free space for you to type the dates of transfer of funds to use and perform periodic tests or checks.
5. the manufacturer of the measures referred to in paragraph 1. 1, should the instructions include information about the specific purpose of such measures and the scope and frequency of testing insulation properties, which should be carried out in the period of use of personal protective equipment.
§ 27. 1. Personal protective equipment to prevent acute or chronic eye diseases caused by non-ionizing radiation should absorb or reflect radiation harmful band spectrum, at a level corresponding to the specified degree of protection. At the same time, there must be a perception of contrasts and the ability to recognize colors and passing visible light, which is also specified for the various degrees of protection.
2. the measures applied to eye protection should be so designed and constructed that for each harmful wave, spectral transmission factor was such that the energy flux density harmful radiation that can reach the user's eye through the filter of, was minimal and does not exceed the permissible values of this radiation.
3. The quality of the personal protective equipment used for eye protection do not deteriorate and they may not lose their property in connection with the operation of the radiation.
4. Personal protective equipment used for eye protection should be tagged. The designation must specify the appropriate degree of protection for the data.
5. Filters designed to protect eyes from radiation sources one type should be classified in ascending order of their degree of protection.
6. the manufacturer shall affix to each individual filter protective marking identifying the degree of protection appropriate for the threat.
7. manual supplied together with the measures referred to in paragraph 1. 1, should also contain information on the curve the transmission values of radiation, intended to enable select the most appropriate personal protective equipment, taking account of factors specific to the actual conditions of their use, in particular, the distance from the source and the spectral energy of the radiation at that distance.
§ 28. 1. the materials from which they are made personal protective equipment and components of these measures, designed to protect all or part of the body against radioactive contamination, including radioactive dust, gases, liquids or mixtures thereof, shall be so designed, constructed, selected and combined to effectively prevent the penetration of these substances under the foreseeable conditions of use.
2. Depending on the type and status of the substances referred to in paragraph 1. 1, the tightness of the personal protective equipment and components of these measures can be obtained by the use of impervious coating or by appropriate means, in particular, ventilation systems and pressure, designed to prevent the loss of these substances.
3. disinfection Substances used in the process of disinfecting contaminated protective substances referred to in paragraph 1. 1, may not restrict the possibility of using these measures, the expected shelf life.
section 29. 1. Ppe intended to provide complete user protection against external irradiation or, if this is not possible, to ensure the Suppression of the irradiation should be so designed and constructed that counter only weak electron radiation, in particular beta or weak Photon, in particular X, gamma.
2. the materials constituting the measures referred to in paragraph 1. 1, and those measures should be designed, connected and selected in a manner which ensures that the necessary level of protection required under the foreseeable conditions of use, without at the same time, extend the period of user exposure to the radiation, resulting from difficulties in carrying out the movements, the adoption of appropriate body position and movement, and comply with the requirements referred to in § 7 para. 6.3. The measures referred to in paragraph 1. 1, should have a designation containing information about the type and thickness of the materials from which they are made.
§ 30. 1. PPE designed to protect the respiratory system should enable to provide you with these measures suitable for air breathing, when it is located in the polluted atmosphere or in an atmosphere with insufficient oxygen.
2. Air, referred to in paragraph 1. 1, must be obtained by using the appropriate method, in particular by filtering polluted air by means of an individual defence or supply wires with unpolluted source.
3. the materials constituting the personal protective equipment referred to in paragraph 1. 1, and those measures should be designed, selected and combined to provide you proper breathing and respiratory hygiene throughout the period of use under the foreseeable conditions of use.
4. The tightness of the craniofacial, pressure drop during the inhalation of air, as well as in the case of equipment cleansing effectiveness of air purification, should sufficiently protect against ingress from the atmosphere pollutants harmful to health and hygiene.
5. Personal protective equipment referred to in paragraph 1. 1, should be marked with an identification mark of the manufacturer and the information about the specific characteristics of the equipment. Information along with instructions should enable the trained and qualified user to these measures correct.
6. In the instructions supplied with the cleansing equipment manufacturer shall include information on the maximum period of storage hardware new and stored in original packaging.
§ 31. 1. PPE designed to prevent contact between the surface around the user's body or parts of the body, including the skin and eyes, with hazardous substances or infectious agents, should protect against intrusion or penetration of these substances by a protective coating in the foreseeable conditions of use.
2. the materials constituting the personal protective equipment referred to in paragraph 1. 1, and those measures should be designed, selected and combined to ensure, as far as possible, the total air tightness, which will allow for long-term daily use of personal protective equipment, and if this is not possible, should ensure the tightness of the limited short period of use.
3. where hazardous substances or infectious agents have a high degree of infiltration capacity due to its characteristics or the foreseeable conditions of use, personal protective equipment should be tested to their classification depending on the effectiveness of their actions.
4. Personal protective equipment, that are considered compliant with the studies, referred to in paragraph 1. 3, should be provided with the information containing in particular names, and if this is not possible – marking substances used during the tests and the period where it will be protected.
5. in the instructions supplied with the measures referred to in paragraph 1. 1, the manufacturer shall include explanation of markings used substances referred to in paragraph 1. 4, a detailed description of the tests and all the information necessary to determine the maximum permissible period of use of such measures in the different foreseeable conditions.
§ 32. 1. Devices for breathing in scuba diving equipment should ensure provision of user gaseous mixture intended for breathing, with particular reference to the maximum depth of immersion.
2. where required by the foreseeable conditions of use, equipment, diving equipment should consist of: 1) clothes protecting against pressure resulting from the depth of immersion, which satisfies the requirements referred to in § 18, or from the cold, which satisfies the requirements referred to in § 25;
2) the alarm device for early warning of an impending lack of supply of breathing gas mixtures, which satisfies the requirements referred to in § 13 para. 2;
3) life-saving suit enabling the return to the surface of the water, which satisfies the requirements referred to in § 21.
Chapter 3 the conformity assessment procedures and marking protective § 33. [Documentation on the specific measure personal protection] The manufacturer or his authorized representative prior to launch the specified individual protection completes the documentation required for this measure, in order to present it at the request of the competent authority.
§ 34. 1. the manufacturer or his authorized representative before the start of serial production of PPE other than those mentioned in paragraph 1. 3 should provide a copy of the pattern of individual protection to EC type-examination referred to in section 38.
2. Ec type-examination shall not be required in the case of personal protective equipment belonging to the measures of simple design, if the designer decided that the user can himself assess the level of effectiveness of their action against minimal risks, the effects of which, when they are gradual, can be easily identified in good time.
3. Personal protective equipment included in the measures of simple design includes only measures designed to protect against: 1) mechanical action whose effects are superficial.
2) cleaning materials with poor operation and easily reversible effects;
3) risks related to manipulation of hot components which does not expose you to the temperature higher than 50 ° c (323 K), or the dangerous impact;
4) weather, without taking into account the factors of exceptional and extreme;
5) minor impacts and vibrations which do not affect the essential for the life of the areas of the body and whose effects cannot cause irreversible damage to the body;
6) sunlight.
4. Personal protective equipment included in the measures of complex design intended to protect against the risk to life or against threats that can cause serious and irreversible damage to the body or lesions, and whose immediate effects, according to the designer, the user is not able to identify in a timely manner, subject to, depending on the manufacturer's choice, the procedure referred to in section 40, or procedure, referred to in § 41.
5. personal protective equipment with complex design include: 1) respiratory protection against solid or liquid aerosols or irritant, dangerous, toxic or radiotoksycznymi gases;
2) respiratory, providing full insulation from the atmosphere, including equipment used to diving;
3) measures to ensure limited at the time of protection against chemical risks or ionizing radiation;
4) emergency equipment for use in high-temperature environments the effects of which are comparable to those of an air temperature of 100 ° c (373 K) or higher and which can be infrared radiation, flames or a big splatter of molten material;
5) emergency equipment for use in low-temperature environments the effects of which are comparable to those of an air temperature of-50 ° c (223 K) or less;
6) means to protect against falls from a height;
7) means to protect against electrical risks, hazardous voltage electric current or which are used as insulation during the execution of the work under high voltages.
section 35. 1. the manufacturer or his authorized representative shall submit to the competent authorities the documentation referred to in § 33. Documentation should include information about measures taken by the manufacturer in order to ensure compliance of the individual protection with the essential requirements laid down in regulation.
2. in the case of individual protection measures other than those of simple design documentation referred to in § 33, should also contain: 1) the technical documentation of personal protective equipment consisting of: a) summary and detailed drawings along with the necessary calculation notes and the results of prototype tests in so far as this is necessary to determine their compliance with the essential requirements, b) a list of the essential requirements and harmonised standards or other requirements referred to in § 7-32, applied in the design of the model of individual protection;
2) description used by the manufacturer of the control and test facilities measurement, intended to check compliance of production PPE with the harmonized standards or other technical specifications and to maintain quality level of production of those measures;
3) a copy of the instruction for the user.
§ 36. 1. The manufacturer or his authorised representative shall issue for individual protection measures the EC declaration of conformity.
2. The EC declaration of conformity should contain: 1) the name and address of the manufacturer and its authorized representative, if it is established in the European Union;
2) full description of individual protection, in particular with the name, type, serial number;
3) a statement that the new means of personal protection is compatible with the provisions of this regulation and with the harmonized standards have been applied; number of standards for personal protective equipment referred to in § 34 paragraph 1. 2 and 3;
4) a statement that the new means of personal protection is identical with the Centre of the personal protection of EC type-examination certificate mentioning the certificate number issued by the notified body with the name, address and phone number of the notified body;
5) a statement that the new means of personal protection is subject to the procedure referred to in section 40 or 41 § under the supervision of the notified body giving the name, address and phone number of the notified body;
6) place and date of its drawing up;
7) name and surname of the person authorized to sign on behalf of the manufacturer or his authorized representative.
§ 37. Conformity assessment procedures at the stage of design and production of PPE other than those referred to in § 34 paragraph 1. 3 participate notified bodies, which should satisfy the criteria set out in article. 19 paragraph. 2 of the Act of 30 August 2002 on the conformity assessment system and the following additional criteria: 1) have the necessary means and equipment;
2) staff should have adequate technical competence and professional integrity;
3) when carrying out research, preparing the reports, issuing the certificates and performing the surveillance provided for in regulation employees should be independent of all circles, groups or persons directly or indirectly concerned means of personal protection.
§ 38. 1. Ec type-examination is the procedure by which a notified body finds that a specific pattern of individual protection meets the requirements set out in the regulation.
2. the manufacturer or his authorized representative shall submit an application for review in one notified, as the Committee responsible for the means of personal protection.
3. the application referred to in paragraph 1. 2, should include: 1) the name and address of the manufacturer or his authorized representative and the name and address of the establishment, the specified individual protection;
2) the documentation referred to in § 33.
4. the application referred to in paragraph 1. 2, should be included with the corresponding number of copies of the design of individual protection, necessary to carry out the assessment of conformity.
5. The notified body carries out the EC type assessment on the basis of: 1) the evaluation of the technical documentation referred to in § 35, in order to check whether they have been taken into account the requirements of the harmonized standards;
2) the pattern of individual protection by: a) check whether the measure has been manufactured in conformity with the technical documentation.
(b)) to check whether this measure can be used safely for its intended purpose, (c)) to carry out necessary research and verification of the conformity of the model of individual protection with the harmonized standards.
6. If during the conduct of the EC type-examination, the notified body finds that a manufacturer has not applied, or partly applied the harmonized standards or where there are no such standards, the notified body shall: 1) before carrying out the assessment of technical documentation checks to see if the manufacturer has applied the correct specifications with respect to the essential requirements;
2) shall carry out the necessary evaluations and studies in order to determine the conformity of the model with the specifications applied by the manufacturer, provided that these specifications are appropriate for the essential requirements.
§ 39. 1. Where the design of individual protection assessed type EC meets the requirements in the relevant legislation, the notified body shall issue the applicant a certificate of EC type-examination and shall forthwith inform the applicant.
2. The certificate shall contain the results of the evaluation and information about the conditions of his release, the descriptions and drawings necessary for identification of the evaluated individual protection.
3. The notified body shall, at the request of the European Commission, the other notified bodies and the competent authorities of the other Member States of the European Union, can pass the a copy of the EC type-examination certificate issued, and in justified cases-also a copy of the technical documentation and reports from studies and reviews.
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 the placing on the market of individual protection.
5. the notified body, that refused to issue EC type-examination certificate shall inform the other notified bodies.
6. If the notified body shall withdraw certificate of EC type-examination, it shall inform the authority that the unit has notified.
§ 40. 1. Quality control of manufactured PPE is the procedure, according to which: 1) the manufacturer shall take all measures necessary to ensure that the manufacturing process, including final control and testing manufactured personal protective equipment, assured the homogeneity of production and the conformity with the type as described in the EC type-examination certificate and with the relevant essential health and safety requirements set out in the regulation;
2) a notified body chosen by the manufacturer shall carry out the necessary checks on the manufacturing process of personal protective equipment, at least once a year;
3) within the framework of the controls referred to in paragraph 2, the notified retrieves the appropriate sample design of personal protective equipment and shall evaluate them on the basis of the tests laid down in harmonised standards or tests necessary to check the conformity of the model of these measures with the essential requirements.
2. In the case of difficulties relating to the conformity assessment of samples – if the notified body referred to in paragraph 1. 1 point 2, is a different entity than the one that issued the EC type-examination certificate-this unit should contact the entity that has issued the EC type-examination certificate.
3. the notified body shall transmit the report to the manufacturer of the studies referred to in paragraph 1. 1 paragraph 3. If the report concludes that production is not homogeneous or that the tested individual protection do not conform to the type described in the EC type-examination certificate, or does not correspond to the essential requirements, the notified body shall take appropriate action in relation to the identified deficiencies and shall inform the Minister responsible for the economy.
4. The manufacturer shall make available the report referred to in paragraph 1. 3, at the reasoned request of stakeholders.
§ 41. 1. The quality assurance System production in by monitoring is the procedure, according to which: 1) the manufacturer maintains an appropriate system of quality assurance in production, including the production process of personal protective equipment;
2) manufacturer makes a request to the notified body for assessment and approval of its quality assurance system production in;
3) within the framework of the quality assurance system production in each copy of personal protective equipment should be assessed, and the study referred to in § 40 paragraph 1. 1 paragraph 3, in order to verify the compatibility of these measures with the relevant essential requirements.
2. the application referred to in paragraph 1. 1, paragraph 2, should include: 1) information about the kind of manufactured PPE, and where appropriate, also the documentation on the approved model of these measures;
2) the obligation to fulfil the obligations arising from the quality assurance system production in and to maintain its adequacy and effectiveness;
3) documentation on the quality assurance system production in, containing the description of a) quality assurance purposes an organization chart, the responsibilities of management and of its powers to maintain the quality of manufactured PPE, b) methods carried out inspection and testing of personal protective equipment and storage conditions after these measures, c) of the measures to be applied in order to verify the effective functioning of the quality assurance system production.
3. the notified body, the assessment of the quality assurance system production in, should determine whether it satisfies the requirements referred to in paragraph 1. 1 paragraph 3. It is understood that these requirements are met in the case of the use of quality assurance systems of production in accordance with the relevant harmonised standards.
4. the notified body carrying out the audit of the quality assurance system production in assessing individual components of the system, in particular, checks whether the system shall ensure compliance of the manufactured personal protective equipment to the approved pattern.
5. the notified body shall communicate to the producer of the assessment report referred to in paragraph 1. 4, along with the findings resulting from the audit.
6. the manufacturer shall immediately inform the notified body which has made assessing the production quality assurance system of planned changes to the system. A notified body verifies the proposed changes and evaluate whether the modified quality assurance system production will meet the requirements. Of the decision in this case, the notified body shall inform the manufacturer. The notification should include the results of the review and the rationale for the decision on the assessment.
§ 42. 1. the notified body supervises an approved quality assurance system production in, in order to confirm that a manufacturer correctly fulfils the obligations arising out of the approved system.
2. the notified body shall exercise the supervision referred to in paragraph 1. 1, in accordance with the following procedure: 1) the manufacturer shall authorize the notified body to carry out an inspection of the testbed, storage and control of personal protective equipment, and provides access to the necessary documentation, in particular: (a) the quality assurance system documentation) in production, (b)) the technical documentation, (c)) the book of quality;
2) the notified body carries out periodic audits manufacturer in order to determine whether the manufacturer is maintaining and applying the approved quality system, and provides copies of the reports of these audits;
3) the notified body may make unannounced visits to the manufacturer, which draws up a report and delivers it to the manufacturer.
3. the manufacturer provides a report of the audit and the visits referred to in paragraph 1. 2 paragraph 2 and 3, at the reasoned request of stakeholders.
§ 43. 1. the manufacturer shall affix the CE marking to individual protection measures, which meet the essential requirements referred to in regulation and have been subjected to conformity assessment procedures. In the case of the personal protective equipment referred to in § 34 paragraph 1. 4 and 5 next to the CE marking shall be the identification number of the notified body, which evaluates the control system manufactured personal protective equipment.
2. the CE marking shall be affixed to each copy of the individual protection in a visible, easily legible and resistant to blurring for the lifetime of this measure. If this is necessary due to the properties of the protection of the individual, it is permissible to place the CE marking on the package.
3. the CE marking shall be affixed to the means of personal protection in a way that is misleading. Other marking may be affixed to the means of personal protection or on their packaging, if not reduce the visibility and legibility of the CE marking.
4. a model for the CE mark set out in the annex to the regulation.
Chapter 4 final provision § 44. [Entry into force] The regulation shall enter into force on 1 January 2006.3) Chapter 4 final provision § 44.
Minister of economy: p. g. Woźniak 1) economy Minister directs Government Department – the economy, based on § 1 paragraph 1. 2 paragraph 1 of the regulation of the Prime Minister from 31 October 2005 on the detailed scope of the Minister of economy (OJ No 220, poz. 1888).
2) the provisions of this Regulation implement Council directive of the European Communities No. 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment (OJ. EC-L 399 of 30.12.1989, as amended. d.; Oj. EU Polish Special Edition, chapter. 13, t 10, p. 98).
3), this regulation was preceded by a regulation of the Minister of economy, labour and social policy of 31 March 2003 on the essential requirements for personal protective equipment (OJ No 80, item. 725).
Annex 1. [A MODEL OF THE MARK CE]
The annex to the regulation of the Minister of economy of 21 December 2005 (2173) CE MARK
The CE mark shall consist of the initials "CE" the following shapes: in the case of reduction or enlargement of the CE mark, you must keep the proportions shown in the above figure.
The individual elements of the CE marking should be the same height, which may not be less than 5 mm.
Requirements for the minimum dimension may not be retained in the case of personal protective equipment with small dimensions.
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