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

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

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.

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.

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.

1. GENERAL REQUIREMENTS APPLICABLE TO ALL PPE

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

1.1. Design principles 1.1.1. Ergonomics 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 1.1.2.1. Optimum level of protection 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 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 1.2.1. Absence of inherent risks and other nuisance factors 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 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 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 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 1.3.1. Adaptation of PPE to user morphology

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 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 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

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 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 Union harmonisation legislation;

(j) the name, address and identification number of the notified body or bodies involved in the conformity assessment of the PPE;

(k) references to the relevant harmonised standard(s) used, including the date of the standard(s), or references to the other technical specifications used;

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

2. ADDITIONAL REQUIREMENTS COMMON TO SEVERAL TYPES OF PPE 2.1. PPE incorporating adjustment systems 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

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 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 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

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 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 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

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 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