Republic of Latvia Cabinet Regulation No. 74 Adopted 11 February 2003

Requirements for Personal Protective Equipment, Procedures for Conformity Assessment and Market Supervision Thereof

Issued pursuant to
Section 7 of the Law on Conformity Assessment

1. General Provisions

1. These Regulations prescribe the essential requirements for personal protective equipment and a supervisory mechanism for compliance with the essential requirements when placing personal protective equipment on the internal market for the first time - selling, giving as gifts or handing over for use with or without remuneration, as well as specify the procedures by which market supervision of personal protective equipment shall be performed.

2. Personal protective equipment (hereinafter - protective equipment) are the following devices, articles and systems intended for wearing (holding in the hand) that have been created by a manufacturer for protection of a person against one or several factors dangerous to health or safety:

2.1. devices, articles and systems that consist of several individual mutually connected parts and are intended for protection of the user against dangerous factors caused by one or several hazards;

2.2. protective devices and mechanisms combined (separable or inseparable) with non-protective equipment utilised (worn or held in the hand) by the user for the performance of particular work; and

2.3. interchangeable main components of protective equipment necessary for normal operation of the protective equipment.

3. Any systems placed on the market together with protective equipment for connection thereof to another external additional device shall be regarded as an integral part of protective equipment even if the relevant system is not intended for wearing or holding in the hand for the entire period of hazard.

4. These Regulations shall not apply to:

4.1. protective equipment designed and manufactured especially for the needs of the armed forces or for maintenance of public order (for example, helmets, shields);

4.2. protective equipment intended for self-defence (for example, aerosol canisters);

4.3. protective equipment designed and manufactured for personal use only for protection against:

4.3.1. unfavourable weather conditions (for example, head gear, seasonal clothing, footwear, and umbrellas);

4.3.2. humidity and water (for example, gloves for dishwashing); and

4.3.3. heat (for example, gloves);

4.4. protective equipment intended for the protection or rescue of persons on vessels and aircraft, which protective equipment is not used permanently; and

4.5. helmets and helmets with a face shield intended for protection of persons using motor-powered two or three-wheeled vehicles.

5. The Ministry of Economics in co-operation with the relevant technical committee for standardisation shall recommend to the limited liability company Latvijas standarts [Latvian Standard] a list of adaptable standards.

[20 April 2004]

6. The limited liability company Latvijas standarts shall submit for publication in the newspaper Latvijas Vēstnesis [the official Gazette of the Government of Latvia] a list of those harmonised European standards adapted with the status of Latvian national standards, which are applied for the fulfilment of the requirements prescribed by these Regulations (hereinafter - applicable standards).

[20 April 2004]

7. The conformity assessment of protective equipment shall be assessed by accredited and published in the newspaper Latvijas Vēstnesis conformity assessment institutions (hereinafter - the notified body). Notified bodies shall conform to the following requirements:

7.1. the notified body shall have appropriate personnel and technical facilities at its disposal for the performance of technical and administrative tasks related to examination and supervisory procedures;

7.2. the personnel of the notified body shall perform the assessment and certification professionally, fairly and with technical competence. The personnel shall be responsible that persons who have direct commercial interests related to certification do not affect assessment and certification;

7.3. the personnel of a notified body shall observe confidentiality in regard to information acquired in performing the examination (except for information that upon reasoned request is provided to State supervisory and control institutions); and

7.4. the notified body shall ensure civil liability insurance thereof in relation to activities it is entitled to perform.

[20 April 2004]

8. Protective equipment shall be divided into three categories depending on potential risk. The manufacturer, an authorised representative thereof or importer shall determine the category of the protective equipment.

9. The first category shall include protective equipment of simple construction that protect against the following factors of minimum harm or minimum hazard that may be timely assessed by the user himself or herself:

9.1. against superficial mechanical effect;

9.2. against chemical cleaning materials of weak effect or easily reversible effect;

9.3. against hazardous factors that may occur in handling of hot components and the user is not exposed to the temperature exceeding 50 ºC;

9.4. against atmospheric agents (except for extremes);

9.5. against minor impacts and vibrations that do not affect functions significant for human life and do not cause irreversible bodily damage; and

9.6. against solar radiation.

10. The second category shall include protective equipment that does not conform either to the first or the third category.

11. The third category shall include protective equipment of complicated construction that protects against the dangerous factors which the user himself or herself is not able to evaluate quickly enough and which endanger human life or affect human health negatively and irreversibly:

11.1. filtering respiratory devices for protection against solid and liquid aerosols or irritant, toxic or radioactive gases;

11.2. respiratory devices (including those used for diving) that ensure full insulation from atmosphere;

11.3. protective equipment for body protection that ensures partial protection against hazardous chemical and radioactive substances, hazardous chemical and radioactive products or ionising radiation;

11.4. protective equipment for use at 100 ºC and higher temperature and conditions in which infra-red radiation, flames or a large amount of molten material may be present;

11.5. protective equipment for use at minus 50 ºC and lower temperature;

11.6. protective equipment against falls from height; and

11.7. protective equipment for protection against electric current and dangerous voltage or protective equipment used for isolation when working with high-voltage.

12. The manufacturer or an authorised representative thereof shall prepare technical documents. Upon request the technical documents shall be presented to market supervision institutions.

13. The technical documents shall include the following information:

13.1. technical file of the protective equipment:

13.1.1. complete and detailed plans (schemes) of protective equipment, as well as calculations and prototype test results that approve conformity of the protective equipment to requirements specified in Chapter 4 of these Regulations; and

13.1.2. a list of essential requirements and standards applied, but if there are none such, technical specifications determined during design;

13.2. description of examination method and control parameters utilised in an undertaking to control the conformity of protective equipment manufactured to the applicable standards and to maintain the quality level; and

13.3. information referred to in Paragraph 57 of these Regulations;

14. If the manufacturer of imported protective equipment does not have a registered authorised representative in Latvia, the importer of the protective equipment shall be responsible for compliance with these Regulations and conformity to essential requirements.

2. Conformity Assessment Procedures

15. The manufacturer or an authorised representative thereof shall ensure conformity assessment procedures appropriate to the category of protective equipment:

15.1. protective equipment of the first category - module A;

15.2. protective equipment of the second category - modules B + C; and

15.3. protective equipment of the third category - modules B + C2 or module B + D (at the manufacturer's choice).

2.1. Internal Control by Manufacturer (Module A)

16. Internal control by the manufacturer (module A) shall be procedures in which the manufacturer or an authorised representative thereof ensures conformity of protective equipment to the requirements of these Regulations and:

16.1. draw up a declaration of conformity (Annex 1) certifying that protective equipment placed on market conforms to the requirements of these Regulations; and

16.2. marks the protective equipment with a CE mark in conformity with the requirements specified in Chapter 3 of these Regulations.

17. The manufacturer or an authorised representative thereof shall provide the market supervision institutions specified in Paragraph 89 of these Regulations with access to the documentation referred to in Paragraphs 13 and 57 of these Regulations.

2.2. Type-examination of Protective Equipment (Module B)

18. Type-examination of protective equipment (module B) is a procedure in which an notified body on the basis of application provided by the manufacturer or an authorised representative thereof, shall establish and approve (certify) conformity of a sample of the protective equipment to the requirements of these Regulations.

[20 April 2004]

19. The manufacturer or an authorised representative thereof shall submit an application for a type-examination of particular protective equipment only to one notified body.

[20 April 2004]

20. In an application the manufacturer or an authorised representative thereof shall specify the name (for natural persons - name, surname), address of the manufacturer and an authorised representative thereof and the registration number of an undertaking (for natural persons - personal identity number). The documents referred to in Paragraphs 13 and 57 of these Regulations and samples of protective equipment shall be attached to the application.

21. After receipt of an application from the manufacturer or an authorised representative thereof, an notified body shall:

21.1. examine the technical documents of the manufacturer to determine conformity thereof to the applicable standards. If the manufacturer has not used or has partly used the applicable standards or the relevant applicable standards are not developed, prior to the verification of documentation referred to in Sub-paragraph 13.1 of these Regulations, the notified body shall examine the conformity of technical specifications utilised by the manufacturer to the essential requirements specified in these Regulations; and

21.2. verify the sample of protective equipment:

21.2.1. ascertain whether the sample has been manufactured in accordance with the technical documents of the manufacturer and the protective equipment may be completely safely used for the intended purposes; and

21.2.2. perform necessary examinations and tests to ascertain the conformity of the sample to the applicable standards. If the manufacturer has not used or has partly used the applicable standards or the relevant applicable standards are not developed an notified body shall perform the examinations and tests necessary to ascertain whether the sample conforms to the technical specifications utilised by the manufacturer and essential requirements specified in these Regulations.

[20 April 2004]

22. If the sample conforms to the requirements specified in these Regulations, an notified body shall issue to the manufacturer a type-examination certificate of protective equipment, which certifies conformity of the protective equipment to the type. The certificate shall specify examination results and conditions for the issuance of the certificate. If necessary, the certificate shall be accompanied by descriptions and drawings that allow the certified sample to be identified.

[20 April 2004]

23. A notified body shall keep a type-examination certificate of protective equipment and descriptions and drawings attached thereto for 10 years after the placing on the internal market of the last protective equipment and upon reasoned request issue copies of the certificate to market supervision institutions, other notified bodies, as well as the Ministry of Welfare and the Ministry of Economics.

[20 April 2004]

24. If a notified body has taken a decision not to issue a type-examination certificate of protective equipment, it shall notify the manufacturer or authorised representative of the manufacturer and other notified bodies thereof, as well as specify the reason for refusal and the procedures for appealing the decision.

[20 April 2004]

2.3. Declaration of Type Conformity (Module C)

25. Declaration of type conformity of protective equipment (module C) is a part of the conformity assessment procedures in which the manufacturer or an authorised representative thereof shall ensure and certify conformity of protective equipment to the type described in a type-examination certificate and requirements specified in these Regulations.

26. The manufacturer or an authorised representative thereof shall draw up a declaration of conformity (Annex 1).

27. The manufacturer or an authorised representative thereof shall mark each protective equipment, which conforms to the requirements of these Regulations with a CE marking in conformity with the requirements specified in Chapter 3 of these Regulations.

2.4. Monitoring of Final Assessment of Protective Equipment (Module C2)

28. The manufacturer or an authorised representative thereof shall submit to a notified body an application for monitoring of final assessment (module C2).

[20 April 2004]

29. Final assessment of protective equipment shall include the following measures:

29.1. during the manufacturing process and examination and tests of a final product of protective equipment, the manufacturer shall ensure the homogeneity of the protective equipment and conformity to the sample described in the type-examination certificate of the protective equipment and essential requirements of these Regulations;

29.2. a notified body shall perform the necessary random examinations not less frequently than once a year and issue the reports of final assessment of protective equipment to the manufacturer; and

29.3. a notified body shall select samples of protective equipment and examine them by performing the tests specified in the applicable standards, as well as the tests necessary to determine conformity of the protective equipment to the essential requirements specified in these Regulations.

[20 April 2004]

30. If a notified body, which assesses conformity of samples, has determined that additional information is necessary for conformity assessment, but a type-examination certificate of protective equipment has been issued by another notified body, then the institution which assesses conformity of samples shall notify thereof the notified body which has issued the type-examination certificate of protective equipment.

[20 April 2004]

31. If a notified body determines that the protective equipment are not homogenous or they do not conform to a type-examination certificate or requirements specified in these Regulations, it shall notify the market supervision authorities accordingly.

[20 April 2004]

32. Upon request of market supervision institutions the manufacturer shall present a report of final assessment of protective equipment issued by a notified body.

[20 April 2004]

2.5. Quality Assurance System of Protective Equipment (Module D)

33. The manufacturer or an authorised representative thereof shall submit to a notified body an application for approval of quality assurance system (module D). The application shall include:

33.1. information regarding the category of protective equipment and documentation of the sample approved;

33.2. documentation of the quality assurance system; and

33.3. a written undertaking to fulfil all the requirements determined by the quality assurance system, as well as to ensure the conformity and efficiency thereof.

[20 April 2004]

34. The documentation of quality assurance system shall include:

34.1. quality assurance objectives, organisational scheme, liability and powers of officials in relation to the quality of products;

34.2. description of examinations and tests performed after the manufacturing of protective equipment; and

34.3. information regarding means for the evaluation of the efficiency of the quality assurance system.

35. A notified body shall assess whether the quality assurance system conforms to the system described in the relevant documentation, assess elements of the quality assurance system, examining in particular whether the quality assurance system ensures conformity of protective equipment manufactured to the approved sample. A conclusion regarding the examination and the decision taken shall be sent to the manufacturer.

[20 April 2004]

36. The manufacturer or an authorised representative thereof shall notify a notified body, which has certified the relevant protective equipment quality assurance system regarding planned changes in the quality assurance system. The notified body shall evaluate whether the planned changes will affect conformity of the protective equipment to the approved (certified) type of protective equipment and notify the manufacturer regarding the decision taken.

[20 April 2004]

37. The manufacturer or an authorised representative thereof shall provide a notified body with possibilities to inspect, test and control storage of the protective equipment, as well as access to the following information:

37.1. documentation of quality assurance system;

37.2. technical documentation; and

37.3. quality assurance manual.

[20 April 2004]

38. A notified body shall regularly, but not less than once every three years, perform supervision of the protective equipment quality assurance system during which it shall ascertain whether the manufacturer complies with the certified quality assurance system, and issue an examination (audit) report to the manufacturer.

[20 April 2004]

39. The notified body is entitled to perform not previously notified examinations (audits) of the quality assurance system. The necessity and frequency of such examinations shall be determined depending on the supervision system utilised. After the examination (audit) the notified body shall issue an examination (audit) report to the manufacturer.

[20 April 2004]

40. The manufacturer or an authorised representative thereof upon request of the market supervision institutions shall present the report issued by the notified body.

[20 April 2004]

3. CE Marking

41. If a notified body has assessed the conformity of the protective equipment and recognised that it conforms to the requirements specified in these Regulations, the manufacturer has ensured conformity of the protective equipment to essential requirements. The manufacturer shall mark each item of protective equipment and packaging thereof with the CE marking (Annex 2) so that the marking is clearly visible and legible, as well as indelible during the whole period of use of the protective equipment.

[20 April 2004]

42. The CE marking of the third category protective equipment shall be accompanied by an identification number of such notified body, which has performed examination of the module C2 or D.

[20 April 2004]

43. Marks or inscriptions, which can be confused with the CE marking must not be placed on the protective equipment and the packaging thereof.

44. The manufacturer may enlarge or reduce the size of the CE marking, taking into account the proportions provided in the sample.

45. Both components of the CE marking are of the same vertical size, and this size may not be less than five millimetres.

4. Essential Requirements for Health and Safety Protection of Users of Protective Equipment

46. The protective equipment shall ensure adequate protection against the relevant expected dangerous factor.

47. The protective equipment shall be ergonomically designed and manufactured so that in conditions of application the user performing activities related to the risk has maximum protection.

48. The highest possible level of protection is an optimum protection level, which ensures effective use of the protective equipment.

49. The protection class shall conform to the relevant level of hazard specified in applicable standards. If conditions of application change and various levels of the same risk are possible, the highest level of potential risk shall be taken into account in developing the protective equipment.

50. The protective equipment shall be designed and manufactured so as to reduce the effects of hazardous factors to the permissible level in application conditions.

51. Materials and parts of the protective equipment (including decomposition products thereof) may not affect health and hygiene of the user.

52. Parts of the protective equipment that come or may come into contact with the user may not have surface roughness, sharp corners, projections and other formations that might cause irritation or injury.

53. In designing the protective equipment limitations caused by the protective equipment to user perception, movement and postures to be adopted shall be reduced as much as possible. The protective equipment may not cause such movements of the user, which cause a threat to him or her or another person.

54. The use of protective equipment shall be easy and appropriate to circumstances, movements and postures of the user. The protective equipment shall be adjusted to the construction of a human body utilising adjustment and attachment systems, as well as the user shall be provided with protective equipment of adequate size.

55. The protective equipment shall be designed to be as light as possible without reducing design strength and efficiency, which ensures adequate protection against a particular harmful or dangerous factor.

56. If the manufacturer has provided the use of several different protective equipment concurrently for the protection against several dangerous factors, the protective equipment must be mutually compatible.

57. In placing protective equipment on the market, it shall be accompanied by information regarding the manufacturer and an authorised representative thereof (name and address) and the following information prepared by the manufacturer or an authorised representative thereof in the official language:

57.1. use of the protective equipment (storage, utilisation, cleaning, maintenance, servicing and disinfection). Cleaning, maintenance and disinfection products recommended by the manufacturer may not have harmful effects on the protective equipment or user, when correctly used;

57.2. technical capacities of the protective equipment that have been determined in examinations specifying the level and class of protection of the protective equipment;

57.3. appropriate accessories of the protective equipment and characteristics of spare parts;

57.4. risk levels and restrictions of use appropriate to the protection class of the protective equipment;

57.5. obsolescence deadline or period of the protective equipment;

57.6. type of packaging for transportation of the protective equipment;

57.7. significance of indications and markings used;

57.8. regulatory enactments the requirements of which have been complied with in designing and manufacturing the protective equipment; and

57.9. name, address and identification number of such notified body, which has approved the type of the protective equipment.

[20 April 2004]

58. Adjustment systems of the protective system shall be designed so as under conditions of use the state of their adjustments may not change without the knowledge of the user.

59. Protective equipment enclosing parts of the body to be protected shall ensure adequate ventilation thereof to reduce perspiration during the use of the protective equipment. If it is not possible, the protective equipment shall be equipped with devices, which absorb perspiration.

60. Protective equipment provided for protection of face, eyes and respiratory tract shall limit visibility as little as possible.

61. The degree of optical neutrality of the protective equipment shall conform to the type of activity of the user. If necessary, protective equipment shall be treated or provided with facilities to prevent moisture formation.

62. Models of protective equipment provided for users requiring sight correction shall be used with spectacles or contact lenses.

63. If utilisation of protective equipment for intended purposes may be affected significantly by the obsolescence thereof, the manufacturer shall indicate a clearly legible date of manufacture and, if possible, the obsolescence period and a term of validity on each unit of the protective equipment to be placed on the market or the packaging thereof, or on replaceable components.

64. If the manufacturer does not specify the ageing period or a term of validity of the protective equipment, it shall provide information that would enable the user to determine the period of use himself or herself taking into account the quality, storage and use, as well as the cleaning, maintenance and servicing conditions of the relevant protective equipment.

65. If the periodic cleaning recommended by the manufacturer facilitates rapid deterioration of the protective equipment, information regarding the maximum number of cleaning operations prior to the repeat examination or the suspension of use of the protective equipment shall be attached to each item of the protective equipment placed on the market or provided in the instructions for use.

66. If protective equipment may be caught up by moving objects during use and endangers the user, the protective equipment shall have a specific resistance threshold above which the constituent parts thereof break and prevent the danger.

67. Items of protective equipment, which have been intended for use in explosive atmospheres, shall be designed and manufactured so as they cannot become the source of an electric current, electrostatic charge or impact-induced arc and ignite an explosive mixture.

68. Protective equipment intended for use in emergency situations or rapid installation and/or removal shall be designed and manufactured so that the time period of installation and/or removal is as short as possible. Any integral systems requiring correct positioning or removal shall be rapid and easy to use.

69. If the protective equipment is intended for use in conditions of increased danger (protective equipment of the third category), together with the protective equipment the manufacturer shall provide information - description of procedures for adjustment and determination of readiness of use - which has been provided only for specially trained persons whose qualification allows the explanation and appropriate utilisation thereof.

70. If the protective equipment has an alarm device, which starts operating when a normal level of protection is not ensured, the device shall be placed so that the user can perceive the alarm signal under conditions of use.

71. Components of the protective equipment which the user can adjust, attach or remove for replacement shall be such that the referred to activities may be performed without instruments.

72. If the protective equipment is intended for connection to another device, the connection mechanism shall be such that it can be connected only to the intended device.

73. If the protective equipment has a fluid circulation system, it shall ensure the fluid circulation in the immediate vicinity of the body to be protected irrespective of user gestures, position or movement under conditions of use.

74. Identification marks directly or indirectly relating to the health and safety of a user shall be placed on the protective equipment. The referred to signs shall be clear and unambiguous throughout the whole time period of use of the protective equipment. Use of pictograms and ideograms utilised in the European Union states is recommended. If the relevant signs contain words or sentences, the text must be in the official language.

75. If protective equipment or components thereof are too small to affix pictograms and ideograms thereon, they shall be indicated on the packaging or in the instructions for use together with the relevant explanations.

76. If protective equipment (for example, clothing, footwear) is intended to determine visually and individually the location of the user, the protective equipment shall have one or several alarm devices or devices for the emission of direct or reflected visible light of the relevant intensity with appropriate photometric and colorimetric characteristics.

77. If protective equipment is intended for the protection of the user against several risk factors simultaneously, it shall comply with the requirements providing protection against each of these factors.

78. Protection equipment for the protection of the user against mechanical impacts (shocks) shall comply with the following requirements:

78.1. the protective equipment shall be shock-absorbent in order to prevent injuries, which may result from the impact of falling, flying or thrown objects or collisions of parts of the user's body with an obstacle. The protective equipment shall protect the parts of the body against crushing or penetration by any object in the protected part of the body at least up to such impact-energy level, which the size and weight of the shock-absorbing part ensure under conditions of use;

78.2. protection of the user of protective equipment against falls:

78.2.1. in order to protect against slipping, the outsoles for footwear shall be designed or supplemented with additional elements to ensure adequate adhesion with surface by grip and friction (depending on the characteristics and state of the surface);

78.2.2. in order to prevent falls from a height, protective equipment shall be equipped with body harness and attachment systems, which shall be connected to a reliable anchorage point. Protective equipment shall reduce to a minimum the possibility of the user falling, prevent collisions and falls or injuries in rapid braking (the braking force may not exceed the threshold value at which any component of the protective equipment is damaged), as well as ensure that after braking the body of the user remains in such state as the user may await the necessary help; and

78.2.3. in the instructions for use the manufacturer shall particularly characterise an anchorage point, provide information regarding the height at which the user may be present, as well as indicate how to put on (wear) body harnesses correctly and how to attach attachment systems to a reliable anchorage point; and

78.3. the protective equipment for the protection of a user against mechanical vibrations shall ensure the reduction of impact of hazardous vibrations to the exposed parts of the body or whole body of the user. When transmitted vibration affect the user, the acceleration values may not exceed the maximum permissible daily vibration values.

79. Protective equipment for protection of parts of the user's body against compression or crush shall attenuate the referred to effect to prevent injuries or chronic complaints.

80. Protective equipment for protection of parts of the user's body against superficial injuries (for example, abrasion, perforation, cuts, bites) shall ensure adequate resistance to rubbing, perforation, cuts and other foreseeable risks under normal conditions of use.

81. Protective equipment for protection of the user against drowning shall conform to the following requirements:

81.1. the protective equipment shall also return the user to the surface of the liquid medium as quickly as possible without danger to health of the user when the user is helpless or unconscious after a fall, and keep the user on the surface of the liquid medium so as he or she may breathe until the arrival of help;

81.2. in conformity with the foreseeable environment of use, the protective equipment may be completely or partially floating, inflated by air or gas which can inflate in the protective equipment automatically, the filling device may be operated manually or the protective equipment may be inflated orally. Inflatable protective equipment shall inflate easily and fully;

81.3. normal operation of the protective equipment shall not be affected by impacts with the surface of the liquid and by environmental effects;

81.4. if required by conditions of use, the protective equipment shall be equipped with inflation devices, as well as with light and sound signalling devices;

81.5. if required by conditions of use, the protective equipment shall have a device for hitching and attaching the body so that the user may be lifted out of the liquid medium;

81.6. if a user who wears protective equipment (clothing) is subject to the risk of falling into a liquid medium or he or she has to immerse therein, the relevant protective equipment (clothing) shall be designed and manufactured for prolonged use; and

81.7. the protective equipment (clothing) shall provide adequate protection of the user against drowning, without restriction of movements of the user and help him or her to swim or perform relevant actions to avoid drowning or to rescue other persons.

82. Protective equipment for prevention of harmful effects of noise shall ensure that noises perceived by the user do not exceed the permissible norms specified in regulatory enactments. The marking on protective equipment, but if it is not possible, - on the packaging of the protective equipment, shall indicate the noise attenuation level and comfort indexes provided by the relevant protective equipment.

83. Protective equipment for protection against heat and/or flame shall conform to the following requirements:

83.1. protective equipment shall ensure thermal insulation and mechanical strength appropriate to the conditions of use;

83.2. components and materials utilised in protective equipment shall be appropriate for the protection of the user against radiant and convective (natural air circulation) heat, they shall have appropriate heat transmission coefficient to prevent ignition of the protective equipment under conditions of use;

83.3. the reflective power of a protective equipment with reflective outer surface shall conform to the intensity of heat flow in the infrared range of the relevant radiation;

83.4. protective equipment intended for short-term use in a high temperature and protective equipment which may be splashed by hot liquid or upon which large quantity of hot molten material may fall shall have such thermal capacity as to retain most of the heat until a user has left the endangered place and removes or takes off the protective equipment;

83.5. materials and components of the protective equipment, which may be splashed by a large quantity of hot liquid, shall have properties of impact absorption conforming to the requirements referred to in Sub-paragraph 78.1 of these Regulations;

83.6. materials and components of protective equipment utilised in fire-fighting equipment and which may come into contact with flames shall have a degree of non-flammability appropriate to the conditions of use. The referred to materials and components shall not melt when exposed to flames, as well as not facilitate flame propagation;

83.7. the heat transmitted from the protective equipment to the user shall be sufficiently low and in wearing of the protective equipment shall not cause heat accumulation on any part of the body up to such a risk level exceeding the pain threshold and causing respiration impairments;

83.8. if necessary, the protective surface of the protective equipment shall prevent liquid or steam penetration not causing burns to the user;

83.9. if the protective equipment has refrigeration devices for the absorption of heat by a method of liquid evaporation or sublimation (evaporation of solid substance), they shall discharge the vapour outside and not towards the user;

83.10. if the protective equipment has a breathing device, the device shall ensure protection appropriate to conditions of use; and

83.11. if the protective equipment is intended for short-term use in high temperature, the manufacturer shall specify in the instructions for use the maximum permissible time the user may be present in a high temperature.

84. Protective equipment for protection against cold shall conform to the following requirements:

84.1. protective equipment shall ensure thermal insulation and mechanical strength appropriate to the conditions of use;

84.2. a coefficient of thermal transmission of materials and components utilised in protective equipment shall be low, which ensures appropriate thermal insulation of the user under conditions of use. Flexible materials and components of protective equipment intended for utilisation at low temperatures shall retain adequate flexibility for the user to adopt necessary postures and to move appropriately;

84.3. materials and components of the protective equipment, which may be splashed by a large quantity of cold liquid, shall have properties of impact absorption conforming to the requirements referred to in Sub-paragraph 78.1 of these Regulations;

84.4. the cold transmitted from protective equipment to the user shall be sufficiently low and during wearing of the protective equipment the cold shall not accumulate under any circumstances in any part of the body (including tips of fingers and toes) to be protected up to such risk level which exceeds the pain threshold or causes health impairment;

84.5. prevents the penetration of liquid (for example, rainwater), as well as injuries resulting from contact between cold integument and the user;

84.6. if the protective equipment has a breathing device, the device shall ensure protection appropriate to conditions of use; and

84.7. if the protective equipment is intended for short-term use in low temperature, the manufacturer shall specify in the instructions for use the maximum permissible time the user may be present in low temperature.

85. Protective equipment for protection against electric current shall conform to the following requirements:

85.1. the protective equipment shall sufficiently insulate the user against voltage to which he or she may be exposed under conditions of use;

85.2. materials and construction of the protective equipment shall ensure that the leakage current is as little as possible and in any case less than the maximum permissible limit level;

85.3. if the protective equipment is intended for use during activities with electrical equipment, which has or may have voltage, the protection class, operating voltage, serial number and the date of manufacture thereof shall be indicated on the protective equipment;

85.4. an adequate space for the date of entry into service and the dates of periodic examinations conducted or to be conducted shall be provided on the protective equipment; and

85.5. the manufacturer shall indicate in the instructions for use the scope of utilisation of the protective equipment and the method and frequency of dielectric examinations to be conducted during use.

86. Protective equipment for protection against radiation shall conform to the following requirements:

86.1. for protection of the user of protective equipment against non-ionising radiation:

86.1.1. the protective equipment under conditions of use shall prevent acute or chronic eye injury, absorb or reflect the majority of energy radiated in the harmful wave spectrum without disturbing the perception of harmless visible wave spectrum, contrasts and colours;

86.1.2. protective glasses of the protective equipment shall ensure such coefficients of spectral transmission (translucency) in each range of harmful wave spectrum so that the radiant energy illumination density, which may reach eyes of the user through the filter, is minimum and does not exceed the maximum permissible level;

86.1.3. protective glasses of the protective equipment shall not deteriorate and lose their properties due to the effect of radiation;

86.1.4. a protection coefficient corresponding to the spectral distribution curve shall be indicated on each protective equipment placed on market; and

86.1.5. protective glasses provided for radiation sources of the same type shall be classified in ascending order in conformity with the protection coefficient thereof. The manufacturer shall specify such radiation characteristic curves according to which the most appropriate protective equipment shall be selected taking into account the distance to the radiation source and spectral distribution of the energy radiated at the relevant distance. The manufacturer shall indicate the relevant number of protection factor on each protective glass;

86.2. protective equipment for protection of the user against ionising radiation:

86.2.1. materials and components of protective equipment intended for protection against radioactive dust, gases, liquids or mixtures thereof shall ensure that the referred to contamination does not reach the user under conditions of use;

86.2.2. necessary isolation (depending on the type of contamination) shall be ensured by an impermeable protective integument of the protective equipment, ventilation or pressurisation systems;

86.2.3. the process of decontamination of the protective equipment from contamination may not damage the protective equipment or affect further use thereof in foreseen period of use; and

86.2.4. protective equipment for full or partial protection against external irradiation shall ensure protection against weak electron source beta radiation or weak photon source gamma radiation. Materials and components of protective equipment shall ensure such degree of user protection, which prevents the increase of radiation exposure time to the user if he or she moves or changes the state of the body. The material of which the protective equipment has been manufactured and the thickness of such material appropriate to the conditions of use shall be indicated on the protective equipment.

87. Protective equipment for protection against dangerous chemical substances, dangerous chemical products, as well as infectious particles shall conform to the following requirements:

87.1. protective equipment for protection of respiratory tract:

87.1.1. the protective equipment shall supply the user with adequate amount of breathable air if the surrounding atmosphere is polluted or it does not have sufficient amount of oxygen;

87.1.2. air received by the user through the protective equipment shall be filtrated through the protective device or supplied through pipes from an unpolluted air storage facility;

87.1.3. materials and components of the protective equipment shall ensure under conditions of use normal respiration and hygiene to a user during the whole period of use;

87.1.4. the isolation of a user's face, inspiration pressure (for filtering devices) and degree of purification of breathable air shall be such as the polluted atmosphere does not endanger the health or hygiene of the user;

87.1.5. the protective equipment shall bear the manufacturer's identification mark and the characteristics of the protective equipment of the relevant category, in order that a user would be able to use the protective equipment correctly after becoming acquainted with the instructions for use; and

87.1.6. if the protective equipment has filtering devices, the manufacturer shall specify in the instructions for use the period of validity of filters;

87.2. protective equipment for protection of user's skin and eyes:

87.2.1. protective equipment for the protection of user's skin or eyes against dangerous substances and infectious particles under conditions of use shall prevent direct contact thereof with the user's body or diffusion through the protective integument of the protective equipment;

87.2.2. construction, materials and elements of protective equipment shall ensure leak-tightness thereof, if it is not possible, - partial leak-tightness (in the referred to case the period of use of the protective equipment shall be limited);

87.2.3. if the relevant dangerous chemical or infectious particles possess high penetrative or diffusion powers, and the period of use of the protective equipment is limited, the examinations (tests) of the applicable standard shall be performed to the protective equipment in conformity with the classification of the protection level and the efficiency level;

87.2.4. if due to properties or conditions of use of the protective equipment individual substances or a very strong infectious reagent limits the period of protection of the protective equipment, examinations shall be performed to the protective equipment to determine limitations for use; and

87.2.5. explanations of the codes, detailed description of examinations (tests) of the applicable standard and the information that is necessary for the determination of the maximum period of use of the protective equipment in various intended conditions of use shall be included in the instructions for use.

88. Protective equipment provided for diving shall conform to the following requirements:

88.1. protective equipment shall supply a user with a gaseous mixture suitable for respiration taking into account the maximum depth of immersion; and

88.2. if necessary in relevant conditions of use, the protective equipment shall:

88.2.1. protect a user against the pressure resulting from the depth and, if necessary, against cold;

88.2.2. be equipped with a life-saving kit which provides a user with a possibility to return on the surface of liquid medium; and

88.2.3. be equipped with a signalling device, which warns the user regarding potential distortions in supply with the gaseous mixture suitable for respiration.

5. Market Supervision

89. The Consumer Rights Protection Centre in the field of trade and provision of services and the State Labour Inspection at workplaces shall carry out the supervision of protective equipment market, ensuring placing on the market of only such items of protective equipment which conform to the requirements specified in these Regulations and which are appropriately installed, maintained and used without danger to human health and life.

90. If a market supervision institution determines that the protective equipment does not conform to the requirements specified in these Regulations, it shall take measures specified in regulatory enactments to prevent the placing on the market and use of the relevant protective equipment.

91. If a market supervision institution determines that items of protective equipment with CE marking correctly used for intended purposes still create a hazard to human health and life or cause a loss to the environment, it shall suspend the placing on the market of the relevant protective equipment and prohibit use thereof. The market supervision institution shall send the relevant information specifying a reason to the importer and manufacturer of the protective equipment or an authorised representative thereof.

91.¹ The market supervision institution shall perform the following measures:

91.¹ 1. if there is cause to have doubts regarding the conformity of protective equipment to essential requirements or applicable standard requirements, in respect of the correctness of the use of standards or the sufficiency of the standard, it shall organise a sample assessment of the protective equipment and shall provide an opinion regarding the conformity of the protective equipment to essential requirements attaching thereto the results of the assessment; and

91.¹ 2. it shall notify the Ministry of Economics regarding the determination of non-conformity of the protective equipment and the administrative measures performed if there are determined cases, which may be considered to be systematically observed errors in the protective equipment design, construction or manufacture. The notification shall have attached the documents referred to in Sub-paragraph 91.¹.1 and the evaluation of the consequences caused by the non-conformity.

[20 April 2004]

91.² The Ministry of Economics shall notify the European Commission regarding the determination of non-conforming cases and the measures performed.

[20 April 2004]

91.³ Protective equipment, which in accordance with entered into international agreements and the procedures specified therein, which are recognised in the states of the European Union and the European Economic Area, shall be recognised in Latvia.

[20 April 2004]

92. The presentation (advertising) of protective equipment that do not conform to the requirements of these Regulations in trade fairs, exhibitions and other places shall be allowed if a clearly visible indication has been affixed thereto that the referred to protective equipment may not be purchased or utilised until the manufacturer or its authorised representative has ensured the conformity thereof with requirements of these Regulations.

6. Closing Provisions

93. Cabinet Regulation No. 248 of 25 July 2000, Regulations regarding Personal Protective Equipment (Latvijas Vēstnesis, 2000, No. 272/274), is repealed.

94. These Regulations shall come into force on 1 April 2003.

Informative Reference to European Union Directives

Legal provisions arising from directives 89/686/EEC, 93/68/EEC, 93/95/EEC and 96/58/EC have been included in these Regulations.

Prime Minister E. Repše

Minister for Welfare D. Staķe

 

Annex 1
Cabinet Regulation No. 74
11 February 2003

Declaration of Conformity

(Name, registration No., address of the manufacturer or his or her authorised representative)

declares that the new personal protective equipment

(description, manufacturer, type, serial No)

1) conforms to the requirements set out by Cabinet Regulations regarding personal protective equipment, procedures for conformity assessment and market supervision thereof (in which the legal norms arising from directives 89/686/EEC, 93/68/EEC, 93/95/EEC and 96/58/EC have been included) and by the applicable standards No. _________, is identical to the personal protective equipment, which has the type-certificate (for second and third category personal protective equipment) No. _________ issued by

(certification institution (name and address))

certificate type (second or third category for personal protective equipment) No._________;

2) it has been assessed in compliance with		procedures in accordance with
	(module C2 or D)

Cabinet Regulations regarding requirements regarding personal protective equipment, procedures for conformity assessment and market supervision thereof. The referred to procedures have been performed under the supervision of the notified body (for second and third category personal protective equipment

	.
(name, registration number, address)

	(date)

(person (position and surname) entitled to sign on behalf of the manufacturer or the authorised representative)		(signature)

[20 April 2004]

Minister for Welfare D. Staķe

 

Annex 2
Cabinet Regulation No. 74
11 February 2003

CE Marking

The CE conformity marking which certifies conformity of protective equipment to essential requirements is made up of capital letters CE. The sample of the marking is as follows:

Minister for Welfare D. Staķe

 

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Translation © 2006 Tulkošanas un terminoloģijas centrs (Translation and Terminology Centre)