Regulation (EU) 2016/425 of the European Parliament and of the CouncilShow full title

ANNEX II U.K. ESSENTIAL HEALTH AND SAFETY REQUIREMENTS

PRELIMINARY REMARKS U.K.

1. The essential health and safety requirements laid down in this Regulation are compulsory. U.K.

2. Obligations related to essential health and safety requirements apply only where the corresponding risk exists for the PPE in question. U.K.

3. The essential health and safety requirements are to be interpreted and applied in such a way as to take into account the state of the art and current practice at the time of design and manufacture, as well as technical and economic considerations which are consistent with a high degree of health and safety protection. U.K.

4. The manufacturer shall carry out a risk assessment in order to identify the risks which apply to his PPE. He shall then design and manufacture it taking into account that assessment. U.K.

5. When designing and manufacturing the PPE, and when drafting the instructions, the manufacturer shall envisage not only the intended use of the PPE, but also the reasonably foreseeable uses. Where applicable, the health and safety of persons other than the user shall be ensured. U.K.

1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE U.K.

PPE must provide adequate protection against the risks against which it is intended to protect.

1.1. Design principles U.K.

1.1.1. Ergonomics U.K.

PPE must be designed and manufactured so that, in the foreseeable conditions of use for which it is intended, the user can perform the risk-related activity normally whilst enjoying appropriate protection of the highest level possible.

1.1.2. Levels and classes of protection U.K.

1.1.2.1. Optimum level of protection U.K.

The optimum level of protection to be taken into account in the design is that beyond which the constraints imposed by the wearing of the PPE would prevent its effective use during the period 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 U.K.

Where differing foreseeable conditions of use are such that several levels of the same risk can be distinguished, appropriate classes of protection must be taken into account in the design of the PPE.

1.2. Innocuousness of PPE U.K.

1.2.1. Absence of inherent risks and other nuisance factors U.K.

PPE must be designed and manufactured so as not to create risks or other nuisance factors under foreseeable conditions of use.

1.2.1.1. Suitable constituent materials U.K.

The materials of which the PPE is made, including any of their possible decomposition products, must not adversely affect the health or safety of users.

1.2.1.2. Satisfactory surface condition of all PPE parts in contact with the user U.K.

Any part of the PPE that is in contact or is liable to come into contact with the user when the PPE is worn must be free of rough surfaces, sharp edges, sharp points and the like which could cause excessive irritation or injuries.

1.2.1.3. Maximum permissible user impediment U.K.

Any impediment caused by PPE to the actions to be carried out, the postures to be adopted and sensory perceptions shall be minimised. Furthermore, use of the PPE must not engender actions which might endanger the user.

1.3. Comfort and effectiveness U.K.

1.3.1. Adaptation of PPE to user morphology U.K.

PPE must be designed and manufactured in such a way as to facilitate its correct positioning on the user and to remain in place for the foreseeable period of use, bearing in mind ambient factors, the actions to be carried out and the postures to be adopted. For this purpose, it must be possible to adapt the PPE to fit the morphology of the user by all appropriate means, such as adequate adjustment and attachment systems or the provision of an adequate range of sizes.

1.3.2. Lightness and strength U.K.

PPE must be as light as possible without prejudicing its strength and effectiveness.

PPE must satisfy the specific additional requirements in order to provide adequate protection against the risks for which it is intended and PPE must be capable of withstanding environmental factors in the foreseeable conditions of use.

1.3.3. Compatibility of different types of PPE intended for simultaneous use U.K.

If the same manufacturer places on the market several PPE models of different types in order to ensure the simultaneous protection of adjacent parts of the body, they must be compatible.

1.3.4. Protective clothing containing removable protectors U.K.

Protective clothing containing removable protectors constitutes PPE and shall be assessed as a combination during conformity assessment procedures.

1.4. Manufacturer's instructions and information U.K.

In addition to the name and address of the manufacturer, the instructions that must be supplied with the PPE must contain all relevant information on:

(a)

instructions for storage, use, cleaning, maintenance, servicing and disinfection. Cleaning, maintenance or disinfectant products recommended by manufacturers must have no adverse effect on the PPE or the user when applied in accordance with the relevant instructions;

(b)

performance as recorded during relevant technical tests to check the levels or classes of protection provided by the PPE;

(c)

where applicable, accessories that may be used with the PPE and the characteristics of appropriate spare parts;

(d)

where applicable, the classes of protection appropriate to different levels of risk and the corresponding limits of use;

(e)

where applicable, the month and year or period of obsolescence of the PPE or of certain of its components;

(f)

where applicable, the type of packaging suitable for transport;

(g)

the significance of any markings (see point 2.12);

(h)

the risk against which the PPE is designed to protect;

(i)

the reference to this Regulation and, where applicable, the references to other [F1 relevant United Kingdom] legislation;

(j)

the name, address and identification number of the [F2 approved] body or bodies involved in the conformity assessment of the PPE;

(k)

references to the relevant [F3 designated] standard(s) used, including the date of the standard(s), or references to the other technical specifications used;

(l)

the internet address where the F4 ... declaration of conformity can be accessed.

Textual Amendments

F1 Words in Annex 2 para. 1.4(i) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F2 Word in Annex 2 para. 1.4(j) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F3 Word in Annex 2 para. 1.4(k) substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F4 Word in Annex 2 para. 1.4(l) omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

The information referred to in points (i), (j), (k) and (l) need not be contained in the instructions supplied by the manufacturer if the F5 ... declaration of conformity accompanies the PPE.

Textual Amendments

F5 Word in Annex 2 para. 1.4 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(a)(v); 2020 c. 1, Sch. 5 para. 1(1)

2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL TYPES OF PPE U.K.

2.1. PPE incorporating adjustment systems U.K.

If PPE incorporates adjustment systems, the latter must be designed and manufactured so that, after adjustment, they do not become undone unintentionally in the foreseeable conditions of use.

2.2. PPE enclosing the parts of the body to be protected U.K.

PPE must be designed and manufactured in a way that perspiration resulting from use is minimised. Otherwise it must be equipped with means of absorbing perspiration.

2.3. PPE for the face, eyes and respiratory system U.K.

Any restriction of the user's face, eyes, field of vision or respiratory system by the PPE shall be minimised.

The screens for those types of PPE must have a degree of optical neutrality that is compatible with the degree of precision and the duration of the activities of the user.

If necessary, such PPE must be treated or provided with means to prevent misting-up.

Models of PPE intended for users requiring sight correction must be compatible with the wearing of spectacles or contact lenses.

2.4. PPE subject to ageing U.K.

If it is known that the design performance of new PPE may be significantly affected by ageing, the month and year of manufacture and/or, if possible, the month and year of obsolescence must be indelibly and unambiguously marked on each item of PPE placed on the market and on its packaging.

If the manufacturer is unable to give an undertaking with regard to the useful life of the PPE, his instructions must provide all the information necessary to enable the purchaser or user to establish a reasonable obsolescence month and year, taking into account the quality level of the model and the effective conditions of storage, use, cleaning, servicing and maintenance.

Where appreciable and rapid deterioration in PPE performance is likely to be caused by ageing resulting from the periodic use of a cleaning process recommended by the manufacturer, the latter must, if possible, affix a marking to each item of PPE placed on the market indicating the maximum number of cleaning operations that may be carried out before the equipment needs to be inspected or discarded. Where such a marking is not affixed, the manufacturer must give that information in his instructions.

2.5. PPE which may be caught up during use U.K.

Where the foreseeable conditions of use include, in particular, the risk of the PPE being caught up by a moving object thereby creating a danger for the user, the PPE must be designed and manufactured in such a way that a constituent part will break or tear, thereby eliminating the danger.

2.6. PPE for use in potentially explosive atmospheres U.K.

PPE 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, electrostatic or impact-induced arc or spark likely to cause an explosive mixture to ignite.

2.7. PPE intended for rapid intervention or to be put on or removed rapidly U.K.

Those types of PPE must be designed and manufactured in such a way as to minimise the time required for putting on and removing the equipment.

Where PPE comprises fixing systems enabling the PPE to be maintained in the correct position on the user or removed, it must be possible to operate such systems quickly and easily.

2.8. PPE for intervention in very dangerous situations U.K.

The instructions supplied by the manufacturer with PPE for intervention in very dangerous situations must include, in particular, data intended for competent, trained persons who are qualified to interpret them and ensure their application by the user.

The instructions must also describe the procedure to be adopted in order to verify that PPE is correctly adjusted and functional when worn by the user.

Where PPE incorporates an alarm which is activated in the absence of the level of protection normally provided, the alarm must be designed and placed so that it can be perceived by the user in the foreseeable conditions of use.

2.9. PPE incorporating components which can be adjusted or removed by the user U.K.

Where PPE incorporates components which can be attached, adjusted or removed by the user for replacement purposes, such components must be designed and manufactured so that they can be easily attached, adjusted and removed without tools.

2.10. PPE for connection to complementary equipment external to the PPE U.K.

Where PPE incorporates a connexion system permitting its connection to other complementary equipment, the means of attachment must be designed and manufactured in such a way as to enable it to be mounted only on appropriate equipment.

2.11. PPE incorporating a fluid circulation system U.K.

Where PPE incorporates a fluid circulation system, the latter must be chosen or designed and placed in such a way as to permit adequate fluid renewal in the vicinity of the entire part of the body to be protected, irrespective of the actions, postures or movements of the user under the foreseeable conditions of use.

2.12. PPE bearing one or more identification markings or indicators directly or indirectly relating to health and safety U.K.

Where PPE bears one or more identification markings or indicators directly or indirectly relating to health and safety, those identification markings or indicators must, if possible, take the form of F6 ... pictograms or ideograms. They must be perfectly visible and legible and remain so throughout the foreseeable useful life of the PPE. In addition, those markings must be complete, precise and comprehensible so as to prevent any misinterpretation. In particular, where such markings include words or sentences, the latter must be written in [F7 English].

Textual Amendments

F6 Word in Annex 2 para. 2.12 omitted (31.12.2020) by virtue of The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(b)(i)(aa); 2020 c. 1, Sch. 5 para. 1(1)

F7 Word in Annex 2 para. 2.12 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(b)(i)(bb); 2020 c. 1, Sch. 5 para. 1(1)

Where PPE is too small to allow all or part of the necessary marking to be affixed, the relevant information must be mentioned on the packaging and in the manufacturer's instructions.

2.13. PPE capable of signalling the user's presence visually U.K.

PPE intended for foreseeable conditions of use in which the user's presence must be visibly and individually signalled must have one (or more) judiciously positioned means or devices for emitting direct or reflected visible radiation of appropriate luminous intensity and photometric and colorimetric properties.

2.14. Multi-risk PPE U.K.

PPE intended to protect the user against several potentially simultaneous risks must be designed and manufactured in such a way as to satisfy, in particular, the essential health and safety requirements specific to each of those risks.

3. ADDITIONAL REQUIREMENTS SPECIFIC TO PARTICULAR RISKS U.K.

3.1. Protection against mechanical impact U.K.

3.1.1. Impact caused by falling or ejected objects and collisions of parts of the body with an obstacle U.K.

PPE intended to protect against this type of risk must be sufficiently shock-absorbent to prevent injury resulting, in particular, from the crushing or penetration of the protected part, at least up to an impact-energy level above which the excessive dimensions or mass of the means of shock-absorption would preclude effective use of the PPE for the foreseeable period of wear.

3.1.2. Falls U.K.

3.1.2.1. Prevention of falls due to slipping U.K.

The outsoles of protective footwear intended to prevent slipping must be designed and manufactured or equipped with additional means so as to ensure adequate grip, having regard to the nature or state of the surface.

3.1.2.2. Prevention of falls from a height U.K.

PPE intended to prevent falls from a height or their effects must incorporate a body harness and a connexion system which can be connected to a reliable external anchorage point. It must be designed and manufactured so that, under the foreseeable conditions of use, the vertical drop of the user is minimised to prevent collision with obstacles while the braking force does not attain the threshold value at which physical injury or the opening or breakage of any PPE component which might cause the user to fall can be expected to occur.

Such PPE must also ensure that, after braking, the user is maintained in a correct position in which he may await help if necessary.

The manufacturer's instructions must specify, in particular, all relevant information relating to:

(a)

the characteristics required for the reliable external anchorage point and the necessary minimum clearance below the user;

(b)

the proper way of putting on the body harness and of attaching the connexion system to the reliable external anchorage point.

3.1.3. Mechanical vibration U.K.

PPE designed to prevent the effects of mechanical vibrations must be capable of ensuring adequate attenuation of harmful vibration components for the part of the body at risk.

3.2. Protection against static compression of a part of the body U.K.

PPE designed to protect a part of the body against static compressive stress must be sufficiently capable of attenuating its effects so as to prevent serious injury or chronic complaints.

3.3. Protection against mechanical injuries U.K.

PPE constituent materials and other components designed to protect all or a part of the body against superficial injuries, such as abrasion, perforation, cuts or bites, must be chosen or designed and incorporated so as to ensure that those types of PPE provide sufficient resistance to abrasion, perforation and gashing (see also point 3.1) under the foreseeable conditions of use.

3.4. Protection in liquids U.K.

3.4.1. Prevention of drowning U.K.

PPE designed to prevent drowning must be capable of returning to the surface as quickly as possible, without danger to health, a user who may be exhausted or unconscious after falling into a liquid medium, and of keeping the user afloat in a position which permits breathing while awaiting help.

PPE may be wholly or partially inherently buoyant or may be inflated by gas which can be manually or automatically released, or inflated orally.

Under the foreseeable conditions of use:

(a)

PPE must, without prejudice to its satisfactory operation, be capable of withstanding the effects of impact with the liquid medium and the environmental factors inherent in that medium;

(b)

inflatable PPE must be capable of inflating rapidly and fully.

Where particular foreseeable conditions of use so require, certain types of PPE must also satisfy one or more of the following additional requirements:

(a)

they must have all the inflation devices referred to in the second subparagraph, and/or a light or sound-signalling device;

(b)

they must have a device for hitching and attaching the body so that the user may be lifted out of the liquid medium;

(c)

they must be suitable for prolonged use throughout the period of activity exposing the user, possibly dressed, to the risk of falling into the liquid medium or requiring the user's immersion in it.

3.4.2. Buoyancy aids U.K.

Clothing intended to ensure an effective degree of buoyancy, depending on its foreseeable use, shall be safe when worn and afford positive support in the liquid medium. In foreseeable conditions of use, this PPE must not restrict the user's freedom of movement but must enable the user, in particular, to swim or take action to escape from danger or to rescue other persons.

3.5. Protection against the harmful effects of noise U.K.

PPE intended to prevent the harmful effects of noise must be capable of attenuating the latter so that the exposure of the user does not exceed the limit values laid down [F8 in the Control of Noise at Work Regulations 2005 (S.I. 2005/1643) and the Control of Noise at Work Regulations (Northern Ireland) 2006 (S.R. 2006 No.1)].

Textual Amendments

F8 Words in Annex 2 para. 3.5 substituted (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 35 para. 3(45)(c); 2020 c. 1, Sch. 5 para. 1(1)

Each item of PPE must bear labelling indicating the noise attenuation level provided by the PPE. Should that not be possible, the labelling must be fixed to the packaging.

3.6. Protection against heat and/or fire U.K.

PPE designed to protect all or a part of the body against the effects of heat and/or fire must possess thermal insulation capacity and mechanical strength appropriate to the foreseeable conditions of use.

3.6.1. PPE constituent materials and other components U.K.

Constituent materials and other components intended for protection against radiant and convective heat must possess an appropriate coefficient of transmission of incident heat flux and be sufficiently incombustible to preclude any risk of spontaneous ignition under the foreseeable conditions of use.

Where the external surface of those materials and components must be reflective, the reflective power must be appropriate to the intensity of the heat flux due to radiation in the infrared range.

Materials and other components of equipment intended for brief use in high-temperature environments and of PPE which may be splashed by hot products such as molten material must also possess sufficient thermal capacity to retain most of the stored heat until after the user has left the danger area and removed the PPE.

PPE materials and other components which may be splashed by hot products must also possess sufficient mechanical-impact absorbency (see point 3.1).

PPE materials and other components which may accidentally come into contact with flame and those used in the manufacture of industrial or fire-fighting equipment must also possess a degree of non-flammability and thermal or arc heat protection corresponding to the risk class associated with the foreseeable conditions of use. They must not melt when exposed to flames nor contribute to flame propagation.

3.6.2. Complete PPE ready for use U.K.

Under the foreseeable conditions of use:

(a)

the quantity of heat transmitted by PPE to the user must be sufficiently low to prevent the heat accumulated during wear in the part of the body at risk from attaining, under any circumstances, the pain or health impairment threshold;

(b)

PPE must, if necessary, prevent liquid or steam penetration and must not cause burns resulting from contact between its protective integument and the user.

If PPE incorporates refrigeration devices for the absorption of incident heat by means of liquid evaporation or solid sublimation, the design of such devices must be such that any volatile substances released are discharged beyond the outer protective integument and not towards the user.

If PPE incorporates a breathing device, that device must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.

The manufacturer's instructions accompanying PPE intended for brief use in high-temperature environments must, in particular, provide all relevant data for the determination of the maximum permissible user exposure to the heat transmitted by the equipment when used in accordance with its intended purpose.

3.7. Protection against cold U.K.

PPE designed to protect all or a part of the body against the effects of cold must possess thermal insulating capacity and mechanical strength appropriate to the foreseeable conditions of use for which it is intended.

3.7.1. PPE constituent materials and other components U.K.

Constituent materials and other components suitable for protection against cold must possess a coefficient of transmission of incident thermal flux as low as required under the foreseeable conditions of use. Flexible materials and other components of PPE intended for use in a low-temperature environment must retain the degree of flexibility required for the necessary gestures and postures.

PPE materials and other components which may be splashed by cold products must also possess sufficient mechanical-impact absorbency (see point 3.1).

3.7.2. Complete PPE ready for use U.K.

Under the foreseeable conditions of use, the following requirements apply:

(a)

the flux transmitted by PPE to the user must be sufficiently low to prevent the cold accumulated during wear at any point on the part of the body being protected, including the tips of fingers and toes in the case of hands or feet, from attaining, under any circumstances, the pain or health impairment threshold;

(b)

PPE must as far as possible prevent the penetration of such liquids as rain water and must not cause injuries resulting from contact between its cold protective integument and the user.

If PPE incorporates a breathing device, that device must adequately fulfil the protective function assigned to it under the foreseeable conditions of use.

The manufacturer's instructions accompanying PPE intended for brief use in low-temperature environments must provide all relevant data concerning the maximum permissible user exposure to the cold transmitted by the equipment.

3.8. Protection against electric shock U.K.

3.8.1. Insulating equipment U.K.

PPE designed to protect all or part of the body against the effects of electric current must be sufficiently insulated against the voltages 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 those types of PPE must be chosen or designed and incorporated so as to ensure that the leakage current measured through the protective integument under test conditions at voltages correlated with those likely to be encountered in situ is minimised and, in any event, below a maximum conventional permissible value which correlates with the tolerance threshold.

Together with their packaging, PPE types intended exclusively for use during work or activities in electrical installations which are or may be under tension must bear markings indicating, in particular, their protection class or corresponding operating voltage, their serial number and their date of manufacture. A space must also be provided outside the protective integument of such PPE for the subsequent inscription of the date of entry into service and those of the periodic tests or inspections to be conducted.

The manufacturer's instructions must indicate, in particular, the exclusive use for which those PPE types are intended and the nature and frequency of the dielectric tests to which they are to be subjected during their useful life.

3.8.2. Conductive equipment U.K.

Conductive PPE intended for live working at high voltages shall be designed and manufactured in such a way as to ensure that there is no difference of potential between the user and the installations on which he is intervening.

3.9. Radiation protection U.K.

3.9.1. Non-ionising radiation U.K.

PPE designed to prevent acute or chronic eye damage from sources of non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths without unduly affecting the transmission of the innocuous part of the visible spectrum, the perception of contrasts and the ability to distinguish colours where required by the foreseeable conditions of use.

To that end, eye protective equipment must be designed and manufactured so as to possess, for each harmful wavelength, a spectral transmission factor such that the radiant-energy illumination density capable of reaching the user's eye through the filter is minimised and under no circumstances exceeds the maximum permissible exposure value. PPE designed to protect the skin against non-ionising radiation must be capable of absorbing or reflecting the majority of the energy radiated in the harmful wavelengths.

Furthermore, the glasses must not deteriorate or lose their properties as a result of the effects of radiation emitted under the foreseeable conditions of use and all marketed specimens must bear the protection-factor number corresponding to the spectral distribution curve of their transmission factor.

Glasses suitable for radiation sources of the same type must be classified in the ascending order of their protection factors and the manufacturer's instructions must indicate, in particular, how to select the appropriate PPE taking into account the relevant conditions of use such as the distance from the source and the spectral distribution of the energy radiated at that distance.

The relevant protection factor number must be marked on all specimens of filtering eye protective equipment by the manufacturer.

3.9.2. Ionising radiation U.K.

3.9.2.1. Protection against external radioactive contamination U.K.

PPE constituent materials and other components designed to protect all or a part of the body against radioactive dust, gases, liquids or mixtures thereof must be chosen or designed and incorporated so as to ensure that this equipment effectively prevents the penetration of the contaminants under the foreseeable conditions of use.

Depending on the nature or condition of these contaminants, the necessary leak-tightness can be provided by the impermeability of the protective integument and/or by any other appropriate means, such as ventilation and pressurisation systems designed to prevent the back-scattering of these contaminants.

Any decontamination measures to which PPE is subject must not prejudice its possible reuse during the foreseeable useful life of those types of equipment.

3.9.2.2. Protection against external irradiation U.K.

PPE intended to provide complete user protection against external irradiation or, failing this, adequate attenuation thereof, must be designed to counter only weak electron (e.g. beta) or weak photon (e.g. X, gamma) radiation.

The constituent materials and other components of these types of PPE must be chosen or designed and incorporated so as to provide the degree of user protection required by the foreseeable conditions of use without leading to an increase in exposure time as a result of the impedance of user gestures, posture or movement (see point 1.3.2).

PPE must bear a mark indicating the type and equivalent thickness of the constituent material(s) suitable for the foreseeable conditions of use.

3.10. Protection against substances and mixtures which are hazardous to health and against harmful biological agents U.K.

3.10.1. Respiratory protection U.K.

PPE intended for the protection of the respiratory system must make it possible to supply the user with breathable air when exposed to a polluted atmosphere and/or an atmosphere having an inadequate oxygen concentration.

The breathable air supplied to the user by PPE must be obtained by appropriate means, for example after filtration of the polluted air through PPE or by supply from an external unpolluted source.

The constituent materials and other components of those types of PPE must be chosen or designed and incorporated so as to ensure appropriate user respiration and respiratory hygiene for the period of wear concerned under the foreseeable conditions of use.

The leak-tightness of the facepiece and the pressure drop on inspiration and, in the case of the filtering devices, purification capacity must keep contaminant penetration from a polluted atmosphere low enough not to be prejudicial to the health or hygiene of the user.

The PPE must bear details of the specific characteristics of the equipment which, in conjunction with the instructions, enable a trained and qualified user to employ the PPE correctly.

In the case of filtering equipment, the manufacturer's instructions must also indicate the time limit for the storage of new filters kept in their original packaging.

3.10.2. Protection against cutaneous and ocular contact U.K.

PPE intended to prevent the surface contact of all or part of the body with substances and mixtures which are hazardous to health or with harmful biological agents must be capable of preventing the penetration or permeation of such substances and mixtures and agents through the protective integument under the foreseeable conditions of use for which the PPE is intended.

To this end, the constituent materials and other components of those types of PPE must be chosen or designed and incorporated so as to ensure, as far as possible, complete leak-tightness, which will allow where necessary prolonged daily use or, failing this, limited leak-tightness necessitating a restriction of the period of wear.

Where, by virtue of their nature and the foreseeable conditions of their use, certain substances and mixtures which are hazardous to health or harmful biological agents possess high penetrative power which limits the duration of the protection provided by the PPE in question, the latter must be subjected to standard tests with a view to their classification on the basis of their performance. PPE which is considered to be in conformity with the test specifications must bear a marking indicating, in particular, the names or, in the absence of the names, the codes of the substances used in the tests and the corresponding standard period of protection. The manufacturer's instructions must also contain, in particular, an explanation of the codes (if necessary), a detailed description of the standard tests and all appropriate information for the determination of the maximum permissible period of wear under the different foreseeable conditions of use.

3.11. Diving equipment U.K.

The breathing equipment must make it possible to supply the user with a breathable gaseous mixture, under foreseeable conditions of use and taking account in particular of the maximum depth of immersion.

Where the foreseeable conditions of use so require, the diving equipment must comprise the following:

(a)

a suit which protects the user against cold (see point 3.7) and/or pressure resulting from the depth of immersion (see point 3.2);

(b)

an alarm designed to give the user prompt warning of an approaching failure in the supply of breathable gaseous mixture (see point 2.8);

(c)

a lifesaving device enabling the user to return to the surface (see point 3.4.1).