DEFINING THE TECHNICAL DESIGN AND MANUFACTURING RULES PROVIDED FOR IN ARTICLE R. 4312-6
1. General rules applicable to all personal protective equipment
1.0. General and scope of application
These general rules apply to all new personal protective equipment mentioned in articles R. 4311-8 to R. 4311-10.
1.0.0. Definition
A user is any person who wears or holds personal protective equipment as defined in articles R. 4311-8 to R. 4311-10, with a view to protecting himself against one or more risks likely to threaten his physical integrity.
1.1. Principles of protection
1.1.1. Ergonomics
Personal protective equipment must be designed and manufactured in such a way that, under the foreseeable conditions of use for which it is intended, the user can carry out his normal activities exposing him to risks, while at the same time having the highest possible level of appropriate protection.
1.1.2. Levels and classes of protection
1.1.2.1. Protection levels as high as possible
The level of protection resulting from the design of the personal protective equipment is that beyond which the constraints resulting from the wearing of the personal protective equipment would prevent its effective use for the duration of exposure to the risk, or the normal performance of the activity.
1.1.2.2. Classes of protection appropriate to different levels of risk
Where various foreseeable conditions of use lead to a distinction being made between several levels of the same risk, personal protective equipment must be designed and manufactured according to the different classes of protection appropriate to each level of risk.
1.2 Safety of personal protective equipment
1.2.1. Absence of risks and other self-generated nuisance factors
Personal protective equipment must be designed and manufactured in such a way as not to give rise to risks and other harmful factors under foreseeable conditions of use.
1.2.1.1. Suitable constituent materials
The constituent materials of personal protective equipment and any degradation products thereof must not be harmful to the hygiene or health of the user.
1.2.1.2. Parts of personal protective equipment in contact with the user
Any part of personal protective equipment which comes into contact or is likely to come into contact with the user while being worn must have an adequate surface finish and in particular be free of asperities, sharp edges or protruding points likely to cause excessive irritation or injury.
1.2.1.3. Maximum permissible impediments for the user
Personal protective equipment must interfere as little as possible with movements, postures and sensory perception. It must not cause actions which endanger the user or other persons.
1.3. Comfort and efficiency factors
1.3.1. Adaptation to the user’s morphology
Personal protective equipment must be designed and manufactured in such a way that it can be placed as easily as possible on the user in the appropriate position and maintained there for the foreseeable duration of wear, taking account of environmental factors, the movements to be performed and the postures to be adopted. To this end, personal protective equipment should be adapted as closely as possible to the wearer’s morphology, by any appropriate means, such as adequate adjustment and fastening systems, or a sufficient variety of sizes.
1.3.2. Lightweight and solid construction
Personal protective equipment shall be as light as possible, without prejudice to its structural strength or effectiveness.
Personal protective equipment must be sufficiently resistant to the effects of environmental factors inherent in foreseeable conditions of use.
1.3.3. Compatibility of personal protective equipment intended to be worn simultaneously by the user
Where, in accordance with the conditions of use defined in the instructions, several models of personal protective equipment of different types are intended to protect adjacent parts of the body simultaneously, they must be compatible with each other.
1.4. Instructions
I.-Each item of personal protective equipment is accompanied by instructions containing, in addition to the name and address of the manufacturer or importer and the name, address and identification number of the body which carried out the EC type-examination, the following information:
a) Instructions for storage, use, cleaning, maintenance, servicing and disinfection. The recommended cleaning, maintenance or disinfecting products must not have any harmful effect on the personal protective equipment or on the user in the context of their instructions for use;
b) The performance obtained during technical examinations designed to ascertain the levels or classes of protection of the personal protective equipment;
c) The accessories that can be used with the personal protective equipment, and the characteristics of the appropriate spare parts;
d) The classes of protection appropriate to different levels of risk and the corresponding limits of use;
e) The date or expiry date of the personal protective equipment or some of its components under the conditions laid down in the rules defined in 2 and 3, in particular paragraph 2.4;
f) The type of packaging suitable for transporting the personal protective equipment;
g) The meaning of the marking, if any.
The instructions must also include any other information required by this Annex.
II – The instructions must be written in French in a precise and comprehensible manner.
2. Additional rules common to several types of personal protective equipment
2.0. Application
In addition to the other technical rules defined in this annex, personal protective equipment having the common characteristics respectively provided for in the following paragraphs must comply with the technical rules defined therein.
2.1. Personal protective equipment incorporating adjustment systems
Where personal protective equipment incorporates adjusting systems, these must be designed and manufactured in such a way that, once adjusted, they cannot be adjusted independently of the user’s will under the foreseeable conditions of use.
2.2. Personal protective equipment covering the parts of the body to be protected
Personal protective equipment enclosing the parts of the body to be protected must be sufficiently ventilated to limit perspiration resulting from wearing. Where this is not possible, it should be fitted with sweat-absorbing devices where technically possible.
2.3 Personal protective equipment for the face, eyes or respiratory tract
Personal protective equipment for the face, eyes or respiratory tract should restrict the user’s field of vision and eyesight as little as possible.
The ocular systems of this personal protective equipment have a degree of optical neutrality compatible with the more or less meticulous or prolonged nature of the user’s foreseeable activities.
If necessary, they should be treated to prevent fogging or fitted with devices to prevent fogging.
The models of personal protective equipment intended for users with corrective eyewear must be compatible with the wearing of corrective glasses or contact lenses.
2.4. Personal protective equipment subject to ageing
Where the performance of personal protective equipment is likely to be significantly affected by ageing, the date of manufacture or the expiry date must be indelibly marked, without any risk of misinterpretation, on the packaging and, if possible, on each item or interchangeable component of personal protective equipment.
If it is not possible to give a commitment as to the lifespan of personal protective equipment, the instructions referred to in paragraph 1.4 shall include information enabling a reasonably practicable expiry date to be determined, taking into account the quality level of the model and the actual conditions of storage, use, cleaning, inspection and maintenance.
Where there is likely to be a rapid and significant deterioration in the performance of personal protective equipment as a result of ageing attributable to the periodic use of the recommended cleaning procedure, a mark indicating the maximum number of cleanings beyond which the equipment should be overhauled or reformed must be affixed to each item or, failing this, mentioned in the instructions.
2.5. Personal protective equipment likely to be caught during use
Where the foreseeable conditions of use include, in particular, a risk of the personal protective equipment being caught by a moving object likely to cause a hazard to the user, the personal protective equipment must have an appropriate resistance threshold beyond which the breaking of one of its component parts will eliminate the hazard.
2.6. Personal protective equipment intended for use in potentially explosive atmospheres
Personal protective equipment intended for use in potentially explosive atmospheres must be designed and manufactured in such a way that it cannot be the source of an electric or electrostatic arc or spark, or spark resulting from an impact, which could ignite an explosive mixture.
2.7. Personal protective equipment which must be put on or taken off quickly
Personal protective equipment intended for rapid intervention or which has to be put on quickly must be designed and manufactured in such a way that it can be put on in as short a time as possible. Personal protective equipment which has to be removed quickly shall be designed and manufactured for this purpose.
Where personal protective equipment includes devices enabling it to be held in the appropriate position on the user or to be removed, it must be designed and manufactured in such a way that it can be operated easily and quickly.
2.8. Personal protective equipment for use in very dangerous situations
The instructions supplied with personal protective equipment for use in very dangerous situations contain information intended for competent, trained and qualified persons who are able to interpret them and have them applied by the user.
It also describes the procedure to be used to check that the personal protective equipment fitted to the user is correctly adjusted and fit for use.
Where personal protective equipment has an alarm device which operates when there is a failure in the level of protection normally provided, it must be designed and arranged in such a way that the alarm can be perceived by the user under the foreseeable conditions of use of the personal protective equipment.
2.9. Personal protective equipment with user-adjustable or removable components
Where personal protective equipment has user-adjustable or removable components for replacement purposes, these must be designed and manufactured in such a way that they can be easily adjusted, fitted and removed without the use of tools.
2.10. Personal protective equipment which can be connected to another external supplementary device
Where personal protective equipment is fitted with a connecting system which can be connected to another additional device, the connecting device must be designed and manufactured in such a way that it can only be fitted to a device of the appropriate type.
2.11. Personal protective equipment incorporating a fluid circulation system
Where personal protective equipment incorporates a fluid circulation system, the latter must be such as to ensure an appropriate renewal of the fluid in the vicinity of the entire part of the body to be protected, whatever the gestures, postures or movements of the user under the foreseeable conditions of use.
2.12. Personal protective equipment bearing one or more health and safety markings or signs
Markings or signs relating directly or indirectly to health and safety on personal protective equipment must be perfectly legible and remain so for the foreseeable life of the equipment. These marks shall be complete, precise and comprehensible, so as to avoid any misinterpretation. In particular, where such marks include words or phrases, these shall be written in French.
Where the limited dimensions of a piece of personal protective equipment or component of personal protective equipment do not allow all or part of the necessary marking to be affixed, this shall be mentioned on the packaging and in the instruction leaflet provided for in paragraph 1.4.
2.13. Personal protective clothing suitable for visual identification of the user
Personal protective clothing intended for foreseeable conditions of use in which it is necessary to signal the user’s presence individually and visually must comprise one or more devices or means, judiciously placed, emitting direct or reflected visible radiation of appropriate luminous intensity and photometric and colorimetric properties.
2.14. Personal protective equipment designed to protect against several risks incurred simultaneously
Any personal protective equipment intended to protect the user against several risks likely to be encountered simultaneously must be designed and manufactured in such a way as to comply with all the rules specific to each of these risks as laid down in this Annex.
3. Additional rules specific to the risks to be prevented
3.0. Application
In addition to the other technical rules set out in this annex, personal protective equipment must comply with the technical rules set out in the following paragraphs, which are applicable to it according to the risks it is intended to prevent.
3.1. Protection against mechanical impact
3.1.1. Shocks resulting from falling or thrown objects and impacts of part of the body against an obstacle
Personal protective equipment appropriate to the risk of impact resulting from falling or thrown objects or from a part of the body striking an obstacle must be designed and manufactured in such a way as to be capable of absorbing the effects of such impact while preventing any injury, in particular through crushing or penetration of the protected part, up to a level of impact energy beyond which the excessive dimensions or mass of the absorbing device would prevent the effective use of the personal protective equipment for the foreseeable duration of its use.
3.1.2. Falling persons
3.1.2.1. Prevention of slips and falls
The soles of footwear intended to prevent slipping are designed, manufactured or fitted with appropriate attachments, so as to ensure good grip, by engagement or friction, depending on the nature or condition of the ground.
3.1.2.2. Preventing falls from height
Personal protective equipment intended to prevent falls from a height or their effects must include a device for gripping the body and a connecting system that can be connected to a safe anchorage point. It must be designed and manufactured in such a way that, when it is used under foreseeable conditions of use, the difference in height of the body is as small as possible in order to avoid any impact with an obstacle, without the braking force reaching the threshold for the occurrence of bodily injury, or the threshold for the opening or breaking of a component of this personal protective equipment, which could result in the user falling.
After braking, they also ensure that the user is in the correct position to wait for help if necessary.
The instruction manual provided for in paragraph 1.4 specifies:
-the characteristics required for the safe anchorage point, as well as the minimum air draught required below the user ;
the correct way of donning the body-gripping device and connecting its attachment system to the safe anchorage point.
3.1.3. Mechanical vibration
Personal protective equipment intended to prevent the effects of mechanical vibration must be designed and manufactured in such a way as to be able to attenuate appropriately the vibration components which are harmful to the part of the body to be protected.
3.2. Protection against static compression of a part of the body
Personal protective equipment intended to protect a part of the body against static compressive stress must be designed and manufactured in such a way as to be able to attenuate its effects in such a way as to avoid acute injury or chronic illness.
3.3. Protection against physical aggression such as rubbing, punctures, cuts and bites
The constituent materials and other components of personal protective equipment intended to protect all or part of the body against superficial mechanical aggression such as rubbing, pricking, cutting or biting must be such that this personal protective equipment has a resistance to abrasion, perforation and cutting appropriate to the foreseeable conditions of use.
3.4. Prevention of drowning
3.4.0. Safety waistcoats, armbands and life-saving suits
Personal protective equipment intended for the prevention of drowning is designed and manufactured in such a way as to be able to bring any exhausted or unconscious user immersed in a liquid medium to the surface as quickly as possible, without endangering his health, and to float him in a position enabling him to breathe while awaiting rescue. To this end, they have sufficient intrinsic total or partial buoyancy or, failing this, are inflated either by means of a gas released automatically or manually, or by mouth.
Under foreseeable conditions of use:
-the personal protective equipment referred to in the first paragraph is such that it can withstand, without prejudice to its proper functioning, the effects of impact with the liquid medium and the environmental factors inherent in that medium;
-inflatable personal protective equipment is such that it can inflate quickly and completely.
Where this is required by particular foreseeable conditions of use, the personal protective equipment referred to in the first paragraph also includes:
-if inflatable, all the inflation devices mentioned in the first paragraph ;
-a light or sound signalling device;
-a body attachment and gripping device enabling the user to be removed from the liquid environment.
The personal protective equipment referred to in the first paragraph is suitable for prolonged use throughout the activity exposing the user, who may be wearing it, to the risk of falling or requiring the user to be immersed in the liquid medium.
3.4.1. Buoyancy aids
Buoyancy aids provide an effective degree of buoyancy according to their foreseeable use, are safe to wear and provide positive support in the water. Under the foreseeable conditions of use, it does not impede the user’s freedom of movement and enables him in particular to swim or to act to escape danger or to rescue other persons.
3.5. Protection against the harmful effects of noise
Personal protective equipment intended to prevent the harmful effects of noise must be designed and manufactured in such a way as to be able to attenuate it adequately.
Each item of personal protective equipment intended to prevent the harmful effects of noise shall bear a marking indicating the level of sound attenuation and the level of comfort it provides. Where this is not possible, the marking is affixed to the packaging.
3.6. Protection against heat or fire
Personal protective equipment designed to protect all or part of the body against the effects of heat or fire must have a thermal insulation capacity and mechanical resistance appropriate to the foreseeable conditions of use.
3.6.1. Materials and other components of personal protective equipment against heat or fire
The constituent materials and other components intended to protect against radiant and convective heat are characterised by an appropriate coefficient of transmission of the incident heat flux and by a degree of incombustibility sufficiently high to prevent any risk of self-ignition under the foreseeable conditions of use.
Where the external part of these materials and components must have reflective properties, these must be appropriate to the heat flux emitted by radiation in the infrared range.
The materials and other components of personal protective equipment intended for use for short periods in hot environments and of personal protective equipment likely to be subjected to hot splashes, such as large splashes of molten material, shall have sufficient heat capacity to release most of the stored heat only after the user has removed himself from the place of exposure to the risks and discarded his personal protective equipment.
Materials and other components of personal protective equipment liable to receive large splashes of hot products must be designed and manufactured in such a way as to absorb mechanical shocks sufficiently, under the conditions specified in paragraph 3.1.1.
The materials and other components of personal protective equipment liable to come into accidental contact with a flame and those used in the manufacture of fire-fighting equipment are characterised by a degree of non-flammability corresponding to the level of risk incurred under the foreseeable conditions of use. They do not melt under the action of flame or contribute to its propagation.
3.6.2. Complete ready-to-use personal protective equipment
Under foreseeable conditions of use of complete, ready-to-use personal protective equipment against heat or fire :
1° The quantity of heat transmitted to the user through his personal protective equipment is sufficiently low to ensure that the heat accumulated during wear in the part of the body to be protected does not in any case reach the pain threshold or a level such that it is likely to cause any harm to health.
2° Personal protective equipment must, if necessary, prevent the penetration of liquids or vapours and must not cause burns resulting from contact between its protective envelope and the user.
Where personal protective equipment incorporates refrigeration devices enabling incidental heat to be absorbed by evaporation of a liquid or by sublimation of a solid, it must be designed in such a way that the volatile substances thus released are evacuated outside the protective enclosure and not towards the user.
Where personal protective equipment includes breathing apparatus, the latter must, under the foreseeable conditions of use, perform the protective function assigned to it.
The instructions for each item of personal protective equipment intended for use for short periods of time in hot environments must include information enabling the maximum permissible duration of exposure of the user to the heat transmitted by the equipment to be determined.
3.7. Protection against the cold
Personal protective equipment designed to protect all or part of the body against the effects of cold must have a thermal insulation capacity and mechanical strength appropriate to its foreseeable conditions of use.
3.7.1. Materials and other components of personal protective equipment against the cold
The constituent materials and other components of personal protective equipment intended for protection against the cold must have a coefficient of transmission of the incident heat flux which is as low as required by the foreseeable conditions of use. The materials and other flexible components of personal protective equipment intended for use in cold environments must retain a degree of flexibility appropriate to the actions to be performed and the postures to be assumed.
The materials and other components of personal protective equipment likely to be subjected to large splashes of cold products must absorb mechanical shocks sufficiently under the conditions specified in paragraph 3.1.1.
3.7.2. Complete personal protective equipment, ready for use
Under foreseeable conditions of use of complete, ready-to-use personal protective equipment against the cold :
1° The flow transmitted to the user through his personal protective equipment is such that the cold accumulated during wear at any point on the part of the body to be protected, including the ends of the fingers or toes in the case of the hand or foot, does not in any case reach the pain threshold or a level such that it is likely to cause any harm to health.
2° Personal protective equipment must, as far as possible, prevent the penetration of liquids such as rainwater and must not cause injuries resulting from contact between its protective envelope and the user.
Where personal protective equipment includes breathing apparatus, the latter must, under the foreseeable conditions of use, perform the protective function assigned to it.
The instructions for each item of personal protective equipment intended for use for short periods of time in cold environments must include information enabling the maximum permissible duration of exposure of the user to the cold transmitted by the equipment to be determined.
3.8. Protection against electric shock
Personal protective equipment designed to protect all or part of the body against the effects of electric current must have a degree of insulation appropriate to the voltage values to which the user is likely to be exposed under the most unfavourable foreseeable conditions.
To this end, the constituent materials and other components of such personal protective equipment are such that the leakage current, measured through the protective enclosure under test conditions involving voltages corresponding to those likely to be encountered in situ, is as low as possible and in any case lower than the conventional maximum permissible value corresponding to the tolerance threshold.
Personal protective equipment intended exclusively for work or operations on live electrical installations or installations likely to be live must bear, as well as its packaging, a marking indicating in particular the class of protection or the relevant operating voltage, the serial number and the date of manufacture. This personal protective equipment also has a space on the outside of the protective cover for subsequent marking of the date of putting into service and the tests or examinations to be carried out periodically.
The instructions provided for in paragraph 1.4 specify the exclusive use of this personal protective equipment and the nature and frequency of the dielectric tests to which it is subject.
3.9. Protection against radiation
3.9.1. Non-ionising radiation
Personal protective equipment intended to prevent the acute or chronic effects of sources of non-ionising radiation on the eye must be designed and manufactured in such a way as to be able to absorb or reflect the major part of the energy radiated in harmful wavelengths without excessively impairing the transmission of the non-harmful part of the visible spectrum, the perception of contrasts and the distinction of colours, when the foreseeable conditions of use so require.
To this end, the protective lenses are designed and manufactured in such a way as to have, in particular, for each harmful wave, a spectral transmission factor such that the irradiance density of the radiation likely to reach the user’s eye through the filter is as low as possible.
In addition, the lenses are such that they do not deteriorate or lose their properties under the effect of the radiation emitted under the foreseeable conditions of use and each specimen is characterised by the protection step number to which the curve of the spectral distribution of its transmission factor corresponds.
The eyepieces intended for radiation sources of the same type are classified in ascending order of their protection step numbers. The instructions provided for in paragraph 1.4 include transmission curves enabling the most appropriate personal protective equipment to be selected, taking into account factors inherent in the actual conditions of use, such as the distance from the source and the spectral distribution of the energy radiated at that distance.
Each filtering lens is marked with the number of the level of protection it provides.
3.9.2 Ionising radiation
3.9.2.1. Protection against external radioactive contamination
The constituent materials and other components of personal protective equipment designed to protect all or part of the body against radioactive dusts, gases, liquids or mixtures thereof are such that the equipment effectively prevents the penetration of contaminants under the foreseeable conditions of use.
Depending on the nature or state of the contaminants, the required impermeability is achieved by the impermeability of the protective enclosure or by any other appropriate means such as ventilation systems and pressurisation to prevent back diffusion of these contaminants.
Where decontamination measures are applicable to personal protective equipment, such equipment may be decontaminated in such a way as not to prejudice its re-use under the conditions defined in the instructions.
3.9.2.2. Limited protection against external irradiation
The personal protective equipment designed to protect the user against external exposure to radiation such as beta electron radiation, X-rays or gamma rays is such that it can sufficiently attenuate the effects of such exposure.
The constituent materials and other components of this personal protective equipment are such that the level of protection afforded to the user is as high as required by the foreseeable conditions of use, without any impediment to the user’s movements, postures or movements resulting in an increase in the duration of exposure.
Personal protective equipment must bear markings indicating the nature and thickness of the constituent material(s) corresponding to the foreseeable conditions of use.
3.10. Protection against dangerous substances or preparations and infectious agents
3.10.1. Respiratory protection
Personal protective equipment intended to protect the respiratory tract against dangerous substances or preparations or infectious agents must be such that it can supply the user with breathable air when the latter is exposed to a polluted atmosphere or one with an insufficient oxygen concentration.
Breathable air supplied to the user by his personal protective equipment is obtained by appropriate means, in particular by a supply from an unpolluted source or after filtration of polluted air through the protective device or means.
The materials and other components of this personal protective equipment are such that the user’s respiratory function and hygiene are adequately ensured for the duration of wear, under the foreseeable conditions of use.
The degree of tightness of the facepiece, the pressure drop on inhalation and, in the case of filtering devices, the purification capacity are such that, in the case of a polluted atmosphere, the penetration of contaminants is sufficiently low not to harm the health or hygiene of the user.
Personal protective equipment is marked to identify the manufacturer. It also includes an indication of the characteristics specific to each type of equipment, so that, together with the instructions, any trained and qualified user can make appropriate use of this equipment.
In addition, in the case of filtering equipment, the instructions indicate the expiry date for storage of the filter in its original packaging.
3.10.2. Protection against skin or eye contact
Personal protective equipment designed to prevent superficial contact of all or part of the body with dangerous substances or preparations or with infectious agents must be such that it can prevent the penetration or diffusion of such substances, preparations or agents through the protective enclosure, under the foreseeable conditions of use.
To this end, the constituent materials and other components of this personal protective equipment must be such as to ensure total impermeability, allowing, if necessary, prolonged daily use or, failing this, limited impermeability necessitating a restriction on the duration of wear.
When, due to their nature and the foreseeable conditions of their use, certain dangerous substances or preparations or certain infectious agents have a high penetration power resulting in a limited period of protection for the corresponding personal protective equipment, the latter is tested in order to classify it according to its effectiveness. Personal protective equipment is marked with the names or, where there are no such names, the codes of the substances, preparations or agents used in the tests and the corresponding protection time. In addition, the instructions provided for in paragraph 1.4 shall indicate the meaning of the codes, a detailed description of the tests and the data enabling the maximum permissible duration of wear of the equipment under the various foreseeable conditions of use to be determined.
3.11. Safety features of diving equipment
1. The breathing apparatus of diving equipment is capable of supplying the user with a breathable gas mixture under foreseeable conditions of use, taking into account in particular the maximum depth of immersion.
2. Where the foreseeable conditions of use so require, diving equipment includes :
(a) A suit to protect the wearer against the pressure resulting from the depth of immersion or against the cold, in accordance with paragraphs 3.2 and 3.7 to 3.7.2;
(b) An alarm device to warn the wearer in good time of a subsequent lack of supply of breathable gaseous mixture, in accordance with paragraph 2.8;
(c) A rescue suit enabling the wearer to return to the surface, in accordance with paragraph 3.4.1.