ESSENTIAL HEALTH AND SAFETY REQUIREMENTS
I. – General requirements applicable to all PPE-SL
PPE-SL provide adequate protection against the risks involved.
1.1. Design principle
1.1.1. Ergonomics
PSL-PPE must be designed and manufactured in such a way that, under the foreseeable conditions of use for which they are intended, the user can normally carry out the activity exposing him to risks, while having appropriate protection of as high a level as possible.
1.1.2. Levels and classes of protection
1.1.2.1. Levels of protection as high as possible
The optimum level of protection to be taken into account at the design stage is that beyond which the constraints resulting from wearing the PPE-SL would preclude its effective use for the duration of exposure to the risk, or the normal deployment of the activity.
1.1.2.2. Classes of protection appropriate to different levels of a risk
When various foreseeable conditions of use lead to a distinction being made between several levels of the same risk, appropriate classes of protection are taken into account when the PPE-SL is designed.
1.2 Safety of PPE-SL
1.2.1. Absence of “self-generated” risks and other harmful factors
PLS-PPE is 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 PPE-SL and their possible degradation products have no harmful effects on the hygiene or health of the user.
1.2.1.2. Adequate surface condition of any part of a PPE-SL in contact with the user
Any part of a PPE-SL in contact or likely to come into contact with the user during wear is free from asperities, sharp edges, protruding points, etc., likely to cause excessive irritation or injury.
1.2.1.3. Maximum permissible impediments for the user
SL-PPE interferes as little as possible with the gestures to be performed, the postures to be assumed and the perception of the senses. In addition, they do not cause gestures that endanger the user or other people.
1.3. Comfort and efficiency factors
1.3.1. Adaptation of PPE-SL to the user’s morphology
PPE-SL 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 held there for the foreseeable necessary duration of wear, taking account of environmental factors, the gestures to be performed and the postures to be assumed.
To achieve this, PPE-SL must be able to adapt as closely as possible to the user’s morphology, by any appropriate means, such as suitable adjustment and fastening systems, or a sufficient variety of sizes and sizing.
1.3.2. Lightness and structural soundness
SL-PPE shall be as light as possible without prejudice to its structural soundness or effectiveness.
In addition to the specific supplementary requirements, referred to in point 3, which PPE-LS must meet in order to ensure effective protection against the risks to be prevented, they must possess sufficient resistance against the environmental effects inherent in the foreseeable conditions of use.
1.3.3. Necessary compatibility between PPE-SL intended to be worn simultaneously by the user
When several models of PPE-SL of different types or kinds are placed on the market by the same manufacturer with a view to simultaneously ensuring the protection of adjacent parts of the body, they are compatible.
1.4. Manufacturer’s information leaflet
The information leaflet drawn up and compulsorily delivered by the manufacturer with the PPE-SL placed on the market contains, in addition to the name and address of the manufacturer or his authorised representative established in the European Community, any useful data concerning:
a) Instructions for storage, use, cleaning, maintenance, servicing and disinfection. The cleaning, maintenance or disinfecting products recommended by the manufacturer have, in the context of their instructions for use, no harmful effect on the PPE-SL or on the user;
b) The performance achieved during technical examinations designed to verify the levels or classes of protection of PPE-SL ;
c) The accessories that can be used with PPE-SL, together with the characteristics of 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 PPE-SL or of certain of its components;
f) The type of packaging suitable for transporting PPE-SL;
g) The meaning of the marking, where one exists;
h) Where applicable, the references of the European Directives applied providing for the affixing of the CE marking;
i) The name and address and the identification number of the body which issued the EC type-examination certificate.
The information leaflet shall be written in the French language in a precise and comprehensible manner.
II. – Additional requirements common to several types of PPE-SL
2.1. PPE-SL incorporating adjustment systems
Where PPE-SL incorporates adjustment systems, these must be designed and manufactured in such a way that, after adjustment, they cannot become unadjusted independently of the user’s will under the foreseeable conditions of use.
2.2 PPE-SL “enveloping” the parts of the body to be protected
PPE-SL “enveloping” the parts of the body to be protected are sufficiently ventilated, as far as possible, to limit perspiration resulting from wearing; failing this, they are fitted, if possible, with devices to absorb sweat.
2.3 Face or eye PPE-SL
Face or eye PPE-SL restrict the user’s field of vision and eyesight as little as possible.
The ocular systems of these types of PPE-SL possess a degree of optical neutrality compatible with the nature of the user’s more or less meticulous or prolonged activities.
If necessary, they are treated or fitted with devices to prevent fogging.
The PPE-SL models intended for users with corrective eyewear are compatible with the wearing of corrective glasses or contact lenses.
2.4. PPE-SL subject to ageing
Where the performance targeted by the designer for PPE-SL when new is recognised as likely to be significantly affected by an ageing phenomenon, the date of manufacture or, if possible, the expiry date are marked, indelibly and without risk of misinterpretation, on each specimen or interchangeable component of PPE-SL placed on the market, as well as on the packaging.
While it is not possible to make a commitment as to the lifespan of a PPE-SL, the manufacturer must mention in its information leaflet any useful data enabling the purchaser or user to determine a reasonably practicable expiry date, taking into account the quality level of the model and the actual conditions of storage, use, cleaning, servicing and maintenance.
In cases where a rapid and significant deterioration in the performance of PPE-SL is expected to result from ageing attributable to the periodic implementation of a cleaning process recommended by the manufacturer, the latter shall, if possible, affix to each specimen of PPE-SL placed on the market a marking indicating the maximum number of cleanings beyond which the equipment should be overhauled or reformed; failing this, the manufacturer shall mention this data in its information leaflet.
2.5. PPE-SL likely to be caught during use
Where the foreseeable conditions of use include in particular a risk of the PPE-SL being caught by a moving object likely thereby to create a hazard for the user, the PPE-SL has an appropriate resistance threshold beyond which the rupture of one of its constituent parts eliminates the hazard.
2.6. PPE-SL intended for rapid intervention or requiring rapid donning and/or removal
These types of PPE-SL are designed and manufactured so that they can be donned or removed in as short a time as possible.
When they incorporate fastening and extraction systems enabling them to be held in the appropriate position on the user or to be removed, these must be able to be manoeuvred easily and quickly.
2.7. PPE-SL with user-adjustable or user-removable components
Where PPE-SL have user-adjustable or user-removable components for replacement purposes, these are designed and manufactured so that they can be easily adjusted, assembled and disassembled without tools.
2.8. PPE-SL connectable to another supplementary device, external to the PPE-SL
Where PPE-SL are fitted with a connecting system connectable to another supplementary device, their connecting member is designed and manufactured in such a way that it can only be fitted to a device of the appropriate type.
2.9. PPE-SL comprising a fluid circulation system
When PPE-SL comprise a fluid circulation system, the latter is chosen, or designed, and arranged in such a way 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.
2.10. PPE-SL bearing one or more identification or signalling marks relating directly or indirectly to health and safety
The identification or signalling marks relating directly or indirectly to health and safety, borne by these types of PPE-SL, are preferably perfectly legible harmonised pictograms or ideograms and remain so for the foreseeable life of such PPE-SL.
These marks shall also be complete, precise and comprehensible, so as to avoid any misinterpretation. In particular, where such marks include words or phrases, these shall be in the official language or languages of the Member State of use.
When the restricted dimensions of a PPE-SL (or PPE-SL component) do not allow all or part of the necessary marking to be affixed, this shall be mentioned on the packaging and in the manufacturer’s information leaflet.
2.11. PPE-SL clothing and accessories suitable for visual signalling
PPE-SL clothing and accessories intended, under foreseeable conditions of use, to signal individually and visually the presence of the user comprise one or more devices or means judiciously placed, emitting direct or reflected visible radiation, with appropriate luminous intensity and photometric and colorimetric properties.
2.12. “Multi-risk” PPE-SL
Any PPE-SL intended to protect the user against several risks likely to be incurred simultaneously is designed and manufactured in such a way as to meet in particular the essential requirements specific to each of these risks (see point III).
III. – Additional requirements specific to the risks to be prevented
3.1. Protection against mechanical shocks
3.1.1. Shocks resulting from falling or thrown objects and impacts of a part of the body against an obstacle
PPE-SL suitable for this type of risk must be able to absorb the effects of a shock avoiding any injury, in particular through crushing or penetration of the protected part, at least up to a shock energy level beyond which the excessive dimensions or mass of the damping device would prevent the effective use of PPE-SL for the foreseeable necessary duration of wear.
3.1.2. Falls by persons
3.1.2.1. Prevention of falls by slipping
The outsoles of footwear suitable for the prevention of 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.
3.1.3. Mechanical vibration
SL-PPE intended to prevent the effects of mechanical vibration must be able to attenuate appropriately the vibration components harmful to the part of the body to be protected.
The effective value of the accelerations transmitted by these vibrations to the user must in no case exceed the limit values recommended as a function of the maximum foreseeable daily exposure time of the part of the body to be protected.
3.2. Protection against compression (static) of a part of the body
SL-PPE intended to protect a part of the body against compressive (static) stress must be able to attenuate the effects so as to prevent acute injuries or chronic ailments.
3.3. Protection against physical aggression (rubbing, pricking, cutting, biting)
The constituent materials and other components of PPE-SL intended for the protection of all or part of the body against superficial mechanical aggression such as rubbing, pricking, cutting or biting must be chosen or designed and arranged in such a way that these types of PPE-SL possess a resistance to abrasion, perforation and slashing (see also point 3.1) appropriate to the foreseeable conditions of use.
3.4. Prevention of drowning and buoyancy aids
3.4.1. Prevention of drowning
PPE-SL intended for the prevention of drowning must be able to bring a possibly exhausted or unconscious user immersed in a liquid medium to the surface as quickly as possible, without endangering his health, and float him in a position allowing him to breathe while awaiting rescue. PPE-SL must be able to have full or partial intrinsic buoyancy or obtained by inflation either by means of a gas released automatically or manually, or by mouth.
In foreseeable conditions of use:
– PPE-SL must be able to withstand, without prejudice to their proper operation, the effects of impact with the liquid medium as well as the ambient factors inherent in that medium;
– inflatable PPE-SL must be able to inflate rapidly and completely.
Where particular foreseeable conditions of use so require, certain types of PPE-SL also meet one or more of the following additional requirements:
– include all the inflation devices referred to in the second paragraph or a light or sound signalling device;
– include a device for attaching and gripping the body enabling the user to be extracted from the liquid medium;
– be suitable for prolonged use throughout an activity exposing the user, who may be dressed, to a risk of falling or requiring him to be immersed in the liquid medium.
3.4.2. Buoyancy aids
This is a garment providing an effective degree of buoyancy according to its foreseeable use, safe to wear and providing positive support in the water. Under the foreseeable conditions of use, this PPE-SL does not hinder the wearer’s freedom of movement, in particular by enabling him or her to swim or act to escape danger or rescue other people.
3.5. Protection against solar radiation
SL-PPE intended to prevent the acute or chronic effects of non-ionising radiation sources on the eye must be able to absorb or reflect most of the energy radiated in harmful wavelengths, without however 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, 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 and in no case exceeds the maximum permissible exposure limit value.
In addition, the lenses do not deteriorate or lose their properties under the effect of solar radiation under the foreseeable conditions of use, and each specimen placed on the market is characterised by the protection step number to which the curve of the spectral distribution of its transmission factor corresponds.
Eyepieces suitable for radiation sources of the same kind are classified in ascending order of their protection step numbers, and the manufacturer presents, in particular in his information leaflet, the transmission curves enabling the most appropriate PPE-SL to be chosen, 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.
The protection step number of each filtering eyepiece specimen is marked by the manufacturer.