Membership of the European Union requires Member States to bring into force the provisions necessary for the implementation of the Community Directives.

on 23 March 1994, the European Parliament and the Council adopted Directive 94 /9/EC on the approximation of the laws of the Member States relating to equipment and protective systems for use in the potentially explosive atmospheres.

Therefore, it is necessary to establish the corresponding internal rules for the adaptation and development of the provisions of that Directive.

On the other hand, Law 21/1992, of 16 July, of Industry, defines the framework in which the Industrial Security has to be developed, establishing the instruments necessary for its implementation, in accordance with the correspond to the different public administrations.

In its virtue, on the proposal of the Minister of Industry and Energy, in agreement with the Council of State and after deliberation of the Council of Ministers, at its meeting of March 1, 1996,

DISPONGO:

Article 1.

1. This Royal Decree applies to protective equipment and systems for use in potentially explosive atmospheres.

2. It also applies to safety, control and setting devices intended to be used outside potentially explosive atmospheres, but which are necessary, or which contribute to the safe operation of protective equipment and systems, in relation to the risks of explosion.

3. For the purposes of this Royal Decree, the following definitions shall apply:

1. Aides and protective systems for use in potentially explosive atmospheres.

(a) Equipment shall mean machines, materials, fixed or mobile devices, control bodies and instrumentation, detection and prevention systems which, alone or in combination, are intended for production, transport, storage, measurement, regulation, energy conversion and material transformation, and which, due to the potential sources of ignition that characterize them, can trigger an explosion.

(b) Protection systems shall mean devices, other than components of the apparatus defined above, the function of which is to immediately stop incipient explosions and/or to limit the affected area. by an explosion, and which are marketed separately as systems with autonomous functions.

(c) "components" means parts which are essential for the safe operation of protective equipment and systems, but which do not have an autonomous function.

2. Explosive Atmosphere.

Mix with air, in atmospheric conditions, of flammable substances in the form of gases, vapours, mists or powders, in which, after an ignition, the combustion is propagated to the totality of the unburned mixture.

3. Potentially Explosive Atmosphere.

Atmosphere that can become explosive due to local and operating circumstances.

4. Group and category of appliances.

(a) Equipment group I is composed of those destined for underground work in the mines and in the parts of their surface facilities, where there may be danger due to the grisu and/or the combustible dust.

(b) The group of apparatus II is composed of those intended for use in other places where there may be danger of the formation of explosive atmospheres.

(c) Annex I describes the categories of equipment that define the required levels of protection.

Protective devices and systems may be designed for particular explosive atmospheres. In this case they should be properly marked.

5. Use according to your target.

Use of apparatus, protection systems and devices referred to in Article 1, in accordance with the groups and categories of apparatus, and with all indications provided by the manufacturer and necessary to ensure the safe operation of the appliances.

4. Excluded from the scope of this Royal Decree:

a) Medical devices for use in a healthcare environment.

(b) Protective equipment and systems where the danger of explosion is due solely to the presence of explosive substances or unstable chemicals.

c) Equipment intended for use in domestic and non-commercial environments, where potentially explosive atmospheres are created very rarely, only as a result of a haphazard gas leak.

(d) Individual protective equipment which is regulated by Royal Decree 1407/1992 of 20 November, as amended by Royal Decree 159/1995 of 3 February 1995 implementing Directive 89 /686/EEC.

e) Marine vessels and "offshore" mobile units, as well as equipment on board such vessels or units.

(f) Means of transport, i.e. vehicles and their trailers intended solely for the transport of persons by air, road network, rail network or water-waterways, and means of transport, where they are designed for Transport of goods by air, public road network, rail network or waterways. Vehicles intended for use in a potentially explosive atmosphere shall not be excluded.

(g) The equipment referred to in Article 223 (1) (b) of the Treaty of Rome.

Article 2.

1. Appliances, protective systems and devices referred to in Article 1 may be placed on the market and put into service only if they do not compromise the safety or health of persons or, where appropriate, domestic animals or animals. property, where such equipment and systems are properly installed and maintained and used in accordance with their destination.

2. However, in cases such as fairs, exhibitions or demonstrations, equipment, protective systems and devices which are not in conformity with the provisions of this Royal Decree shall be permitted, provided that they are indicated. clearly, by means of a visible sign, their non-conformity, as well as the impossibility of acquiring such equipment, protective systems or devices before the manufacturer or his authorised representative established in the Community has made them conformed. Appropriate security measures should be taken at demonstrations to ensure the protection of individuals.

Article 3.

The appliances, protection systems and devices referred to in Article 1, to which this Royal Decree applies, shall comply with the essential health and safety requirements set out in Annex II to them. applicable, taking into account the intended use for the same.

Article 4.

It shall not be prohibited, restricted or impeded for reasons relating to the provisions of this Royal Decree, the placing on the market or the putting into service of:

(a) Appliances, protection systems and devices referred to in Article 1, which comply with the provisions of Article 1.

(b) Components accompanied by a written declaration of conformity, as provided for in Article 8 (3) which are intended for incorporation into an apparatus or system of protection, as defined herein Royal Decree.

Article 5.

1 They shall be deemed to be in accordance with the provisions of this Royal Decree:

(a) The equipment, protective systems and devices referred to in Article 1 which are accompanied by the EC declaration of conformity referred to in Annex X and bearing the CE marking described therein Article 10.

(b) The components referred to in Article 4, accompanied by the written declaration of conformity as provided for in Article 8 (3).

2 Where an UNE or other national standard of a Member State lays down the provisions of a harmonised standard, equipment, protective systems, devices or components which have been manufactured in accordance with that standard, are presumed to be in accordance with the health and safety requirements referred to therein.

3 The Ministry of Industry and Energy shall publish, by means of a resolution of the competent industrial safety management centre, for information purposes, the references of the UNE standards referred to in the previous paragraph, updating them in the same way.

Article 6.

When it is considered that the harmonised standards referred to in the previous Article do not fully conform to the relevant essential requirements, the General Administration of the State shall submit the matter to the Standing Committee. set up by Council Directive 83 /189/EEC, setting out the relevant reasons for the purposes of Article 6.1 of Directive 94 /9/EC.

Article 7.

1 Where it is established that certain devices, protective systems or devices bearing the CE marking and are used in accordance with their destination may endanger the safety of persons and, where appropriate, of persons domestic animals or property, the competent authority shall take all necessary measures to remove such equipment, protective systems or devices from the market or to prohibit its placing on the market, putting into service, or limit their free movement.

For the purposes referred to in Article 7 (2) of Directive 94 /9/EC, the General Administration of the State shall immediately inform the European Commission of those measures, indicating the reasons for the decision taken and, If the non-compliance is due to:

(a) That the essential requirements referred to in Article 3 are not met.

(b) incorrect application of the rules referred to in Article 5 (2).

(c) A loophole in the own rules referred to in Article 5 (2).

2 Where an apparatus, protection system or device does not conform to the CE conformity marking, the competent authority shall take the appropriate measures against the person who has affixed the marking and the General Administration the State shall inform the European Commission and the other Member States thereof.

Article 8.

1. The procedures for assessing the conformity of apparatus, including, if necessary, the devices referred to in Article 1 (2) are as follows:

(a) Equipment group I and II; category of apparatus M1 and 1.

For the affixing of the CE marking, the manufacturer or his authorised representative established within the Community shall follow the EC type-examination procedure (set out in Annex III) in combination, according to his choice, with the procedure concerning the quality assurance of production (set out in Annex IV), or the procedure concerning the verification of the products (set out in Annex V).

(b) Group I and II; category of apparatus M2 and 2.

1. For internal combustion engines and for electrical appliances in those groups and categories, the manufacturer or his authorised representative established within the Community for the purposes of affixing the CE marking shall continue to the EC type-examination procedure (set out in Annex III) in combination with the procedure for conformity with the type (set out in Annex VI), or the procedure relating to the quality assurance of the product (collected in the Annex VII).

2. For the other apparatus of those groups and categories, the manufacturer or his authorised representative established within the Community for the purposes of affixing the CE marking shall follow the procedure relating to internal control of the manufacture (as listed in Annex VIII), and communicate the dossier provided for in paragraph 3 of Annex VIII to a notified body, which shall acknowledge receipt of the dossier as soon as possible and keep it.

(c) Group II; category of apparatus 3.

For the affixing of the CE marking, the manufacturer or his legally established representative in the Community shall follow the procedure relating to the internal control of manufacture (set out in Annex VIII).

d) Equipment group I and II.

In addition to the procedures referred to in paragraphs (a), (b) and (c) above, for the purposes of affixing the CE marking, the manufacturer or his authorised representative established within the Community may also choose to follow the procedure. EC verification per unit (set out in Annex IX).

2. For protection systems with an autonomous function, the conformity shall be established in accordance with paragraph 1 (b) or (d).

3. The procedures referred to in paragraph 1 shall apply to the components referred to in Article 4 (2) except as regards the affixing of the CE marking. The manufacturer or his authorised representative established within the Community shall issue a certificate stating the conformity of those components with the provisions of the Directive which apply to it and indicating the characteristics of those components. components and the conditions for incorporation into an appliance or protective system which contribute to the compliance with the essential requirements applicable to the finished protective equipment or systems.

4. In addition, for the affixing of the CE marking, the manufacturer or his authorised representative established within the European Community may follow the procedure relating to internal control of manufacture (as set out in Annex VIII) with regard to the security referred to in paragraph I. 3.7. of Annex II.

5. By way of derogation from paragraphs 1 to 4, the competent bodies of the Autonomous Communities may, on duly justified request, authorise the placing on the market and the putting into service of protective equipment and systems, and individual devices referred to in Article 1 (2) for which the procedures referred to in paragraphs 1 to 4 have not been applied and the use of which is in the interest of protection.

6. Documents and correspondence relating to the procedures referred to in the aforementioned paragraphs shall be drawn up in Spanish or in a language accepted by the notified body.

7. Where the apparatus, protective systems and devices referred to in Article 1 (2) are the subject of other Community directives relating to other aspects and provide for the affixing of the CE marking referred to in Article 10, the indicate that the devices, protection systems and devices referred to in Article 1 (2) are also considered to be in conformity with the provisions of those Directives.

However, should one or more of those Directives allow the manufacturer to choose, during a transitional period, the system to be applied, the CE marking shall only indicate conformity with the provisions of the Directives. applied by the manufacturer. In such a case, the references of those Directives, as published in the Official Journal of the European Communities, must be included in the documents, brochures or instructions required by those Directives accompanying the appliances, protection systems and devices referred to in Article 1.

Article 9.

1. The Spanish authorities responsible for carrying out the certification procedures referred to in the previous Article (which the Directive refers to as "notified bodies" for all EC Member States) must be the bodies of control referred to in Chapter I of Title III of Law 21/1992 of 16 July 1992, of Industry, which shall be authorized by the competent authority of the Autonomous Community where the Organisms commence their activity or radiate their facilities; applying the procedures laid down in that Law, and must meet the requirements minima set out in Annex XI to this Royal Decree, as well as the other requirements laid down in that Law and implementing rules applicable to them.

The control bodies which satisfy the assessment criteria laid down in the relevant harmonised standards of the EN 45000 series shall be presumed to comply with the requirements of that Annex XI.

2. The Autonomous Communities which grant the authorizations of the control bodies shall send copies thereof to the Ministry of Industry and Energy, expressly indicating the procedures referred to in Article 8 and the tasks of the specific to those designated by those bodies, for the purpose of dissemination and eventual communication to the other competent authorities, as well as to the European Commission and the other Member States, subject to the allocation of the corresponding identification numbers by the Commission.

3. The control bodies shall be inspected on a regular basis, for the purpose of verifying that they faithfully fulfil their duties in relation to the application of this Royal Decree.

Where, by means of a negative report by an accreditation entity, or by other means, it is established that a control body no longer meets the minimum criteria referred to in paragraph 1, the authorisation shall be withdrawn. The General Administration of the State shall immediately inform the other Member States and the European Commission thereof.

4. The Ministry of Industry and Energy shall publish, by means of a decision of the competent industrial safety management centre, for information, the list of control bodies notified by the EC Member States.

5. Where a Spanish inspection body decides to refuse or withdraw an EC examination certificate of type or suitability for file, it shall proceed as laid down in Article 16 of Law 21/1992 of 16 July. The competent authority in the field of industry which has intervened in the above procedure shall inform the Ministry of Industry and Energy of any decision confirming that of the inspection body.

Article 10.

1. The CE marking of conformity is composed of the initials CE. The CE marking model to be used is set out in Annex X. The CE marking shall be followed by the identification number of the notified body in case of intervention in the production control phase.

2. The CE marking shall be affixed to the devices, protective systems and devices referred to in Article 1 (2) in a clear, visible, legible and indelible manner, in addition to the provisions of paragraph I. 1.5. of Annex II.

3. It shall be prohibited to place in the apparatus, protective systems and devices referred to in Article 1 (2) marked as such that they may mislead third parties in relation to the meaning or logo of the CE marking. Any other marking may be affixed to equipment, protective systems and devices referred to in Article 1 (2), provided that the visibility and legibility of the CE marking is not reduced.

Article 11.

Without prejudice to Article 7, where an Autonomous Community establishes that the CE marking has been affixed unduly, the manufacturer or his authorised representative established in the European Community shall be responsible for the the obligation to restore the conformity of the product as regards the provisions on the CE marking, and to put an end to such an infringement under the conditions laid down in the legislation in force.

Should non-compliance persist, the Autonomous Community shall take all necessary measures to restrict or prohibit the placing on the market of the product concerned or to withdraw it from the market, in accordance with the set out in Article 7.

Additional disposition first.

Any decision of the public authorities adopted pursuant to this Royal Decree that would impose a restriction on the marketing and/or putting into service of a machine or a safety component it will provide a precise basis for the information and will be communicated to the person concerned as soon as possible, indicating the resources and time limits for bringing them, as laid down in the legislation in force.

Additional provision second.

The Minister of Industry and Energy is empowered to make the necessary provisions for the development and enforcement of this Royal Decree.

Single transient disposition.

Subject to the provisions of Article 2 and the final provision, the placing on the market and putting into service of protective equipment and systems in accordance with the rules shall be permitted until 30 June 2003. Existing national at 23 March 1994.

Single repeal provision.

At the entry into force of this Royal Decree any provision of equal or lower rank shall be abrogated that objects to the provisions of the present Royal Decree.

Single end disposition.

This Royal Decree shall enter into force on the day following that of its publication in the "Official Gazette of the State", with effect from 1 March 1996.

Dado en Madrid a 1 de marzo de 1996.

JOHN CARLOS R.

The Minister of Industry and Energy,

JUAN MANUEL EGUIAGARAY UCELAY

ANNEX I

Criteria that determine the classification of appliances in categories

1. Group of appliances I

(a) Category M 1 comprises appliances designed, and, if necessary, equipped with special means of protection, so that they can operate within the operational parameters determined by the manufacturer and ensure a very high level of protection.

The apparatus of this category is intended for use in underground work in mines and in the parts of its surface installations where there is a danger due to the grisu and/or explosive powders.

Appliances in this category must remain operational in the presence of explosive atmospheres, even in the event of infrequent damage and are characterised by means of protection such that:

1. Or in case of failure of one of the means of protection, at least one second independent means ensures the level of protection required.

2. Or in case two separate faults occur on each other, the required level of protection is assured.

The apparatus in this category of conformity shall comply with the additional requirements referred to in point II.1.1. of Annex II.

(b) Category M 2 comprises appliances designed to be able to operate under the practical conditions laid down by the manufacturer and based on a high level of protection.

The apparatus of this category is intended to be used in underground work in the mines and in the parts of its surface installations where there may be danger due to the flail or combustible dusts.

In case there are signs of a potentially explosive atmosphere, the power supply of these devices should be cut.

The means of protection relating to equipment in this category shall ensure the level of protection required during normal operation, including under more stringent operating conditions, in particular those resulting from the operation of the equipment. an intense use of the apparatus and changing environmental conditions.

The apparatus included in this category of conformity shall meet the additional requirements referred to in paragraph II, 1, 2. of Annex II.

2. Group of apparatus II

(a) Category 1 includes equipment designed to be able to operate within the operational parameters set by the manufacturer and to ensure a very high level of protection.

The apparatus of this category is intended to be used in an environment in which explosive atmospheres due to air mixtures with gases, vapours, mists or mixtures occur in a constant, lasting or frequent manner. polvo-air.

Appliances in this category must ensure the level of protection required, even in case of infrequent failure of the apparatus, and are characterized by means of protection such that:

1. Or in case of failure of one of the means of protection, at least one second independent means ensures the level of protection required.

2. Or in the event that separate failures occur on each other, the required level of protection is assured.

The devices included in this category of conformity shall comply with the requirements referred to in Annex II (II) (2

.

(b) Category 2 includes equipment designed to be able to operate under the practical conditions laid down by the manufacturer and to ensure a high level of protection.

Appliances in this category are intended to be used in an environment where the formation of explosive atmospheres due to gases, vapours, mists or dust in suspension is likely.

The means of protection relating to equipment in this category shall ensure the level of protection required, even in the event of frequent failure or malfunction of the equipment to be normally taken in account.

The apparatus included in this category of conformity shall comply with the additional requirements referred to in Annex II (II.3

.

(c) Category 3 includes equipment designed to be able to operate under the practical conditions laid down by the manufacturer and to ensure a normal level of protection.

The apparatus of this category is intended to be used in an environment where the formation of explosive atmospheres due to gases, vapours, mists or dust in suspension is unlikely and in which, according to all probability, its formation is infrequent and its presence is short-lived.

Appliances in this category will ensure the level of protection required during normal operation.

The apparatus included in this category of conformity shall comply with the additional requirements referred to in Annex II, paragraph II

ANNEX II

Essential safety and health requirements for the design and manufacture of protective equipment and systems for use in potentially explosive atmospheres

Preliminary Observations

The technical knowledge that is the subject of a rapid evolution should be taken into account and implemented without delay, as far as possible.

As regards the devices referred to in Article 1 (2), the essential requirements shall apply only to the extent that they are necessary for the operation and handling of such devices in a manner safe as regards the risks of explosion.

I. Common requirements for appliances and protective systems

1. General requirements.

1. Principles of security integration in the face of explosions.

Protection equipment and systems intended for use in potentially explosive atmospheres should be designed with a view to the integration of security against explosions.

In this sense, the builder will take action to:

a) Avoid preferably, if possible, that the devices and systems of protection produce or release explosive atmospheres themselves.

b) Prevent the ignition of explosive atmospheres taking into account the nature of each electrical or non-electric ignition focus.

(c) If, in spite of everything, there was an explosion which could endanger persons and, where appropriate, domestic animals or goods by direct or indirect effect, stop it immediately or limit it to a level of Sufficient safety of the affected area by fire and the pressure resulting from the explosion.

2. Equipment and protective systems shall be designed and constructed considering possible operating anomalies to avoid maximum hazardous situations.

The possibility of improper use, reasonably foreseeable, should be taken into account.

3. Special Control and Maintenance Conditions.

Equipment and protective systems that are subject to special control and maintenance conditions shall be designed and constructed in accordance with these conditions.

4. The Conditions of the surrounding environment.

Protection equipment and systems shall be designed and constructed in accordance with the conditions of the surrounding or foreseeable environment.

5. Marking.

Each protective apparatus and system shall, at least in indelible and legible form, present the following indications:

a) The name and address of the manufacturer.

b) The CE marking (cf. point A of Annex X).

c) The designation of the string or type.

d) The serial number, if any.

e) The year of manufacture.

f) The specific marking of explosion protection , followed by the equipment group and category symbol.

g) For the group of apparatus II, the letter "G" (concerning explosive atmospheres due to gases, vapours or mists) and/or the letter "D" concerning explosive atmospheres due to the presence of dust.

On the other hand, and whenever deemed necessary, they must also present any indication that is indispensable for the safe use of the apparatus.

6. Instructions:

A) Each protection apparatus and system shall be accompanied by instructions containing at least the following information:

1. The reminder of the intended indications for marking, except for the serial number (cf. paragraph 1.5.), which will be supplemented eventually with those indications that facilitate maintenance (such as, for example, the importer's address, the repairer, etc.)

2. Instructions to enable the risk to proceed without risk:

For service, utilization, assembly and disassembly, maintenance (repair included), installation, adjustment.

(a) Where appropriate, the indication of the hazardous areas located in front of the pressure discharge devices.

b) Where appropriate, the training instructions.

(c) The information necessary to determine with knowledge of the case whether an apparatus of a given category or a protection system can be used safely at the place and under the conditions laid down.

d) The electrical and pressure parameters, maximum surface temperatures or other limit values.

(e) Where appropriate, the special conditions of use, including indications as to a possible misuse of the apparatus which is foreseeable as shown by the experience.

B) The instruction manual shall be drawn up in one of the Community languages by the manufacturer or his authorised representative established in the Community.

Each protection apparatus or system shall be accompanied, at the time of its entry into service, of the original manual and its translation into the language or languages of the country of use.

The translation shall be carried out by the manufacturer or his authorised representative established within the Community, or by the person responsible for the introduction of the apparatus or the protection system in the linguistic area concerned.

However, when it is to be used by specialised personnel depending on the manufacturer or his representative, the instruction manual may be written in only one of the Community languages which is understood by such staff.

C) The instructions shall include the drawings and schemes necessary for the putting into service, maintenance, inspection, verification of the correct operation and, where appropriate, repair of the appliance or of the protection system, as well as all instructions that are useful, especially in the field of safety.

D) Any documentation of the presentation of the appliance or of the protection system shall coincide with the instructions as regards the safety aspects.

2. Selection of materials.

1. The materials used for the construction of protective equipment and systems shall not cause an explosion to be triggered, taking into account the foreseeable operating conditions.

2. Within the limit of the conditions of use provided for by the manufacturer, there shall be no reaction between the materials used and the potentially explosive atmosphere, which may give rise to a decrease in the ability to prevent explosions.

3. The materials must be chosen taking into account that the foreseeable changes of their characteristics and the combination compatible with other materials do not lead to a reduction of the guaranteed protection, in particular with regard to corrosion resistance, wear resistance, electrical conductivity, shock resistance, ageing and the effects of temperature variations.

3. Design and manufacture.

1. Equipment and protective systems shall be designed and constructed in the light of technological knowledge in the field of protection against explosions in order to enable them to operate safely during their operation. foreseeable duration.

2. The assembly or replacement components intended for protection equipment and systems shall be designed and constructed in such a way as to have a proper functioning safety for the use for which they are intended for protection against explosions, provided that they are mounted in accordance with the manufacturer's instructions.

3. No Mode of Closed Construction and Prevention of Tightness Defects.

Appliances that may cause flammable gases or powders shall only, as far as possible, have closed cavities.

Must have openings or defects of tightness, these must be, as far as possible, such that gas or dust emissions cannot produce explosive atmospheres on the outside.

The filling and emptying holes must be designed and equipped in such a way as to limit, as far as possible, the emission of flammable materials during these operations.

4. ° Dust formation.

Protective devices and systems used in areas where dust is present must be designed in such a way that the dust deposits forming on the surface of the dust do not become inflamed.

As a general rule, dust formation should be limited as much as possible. Protective equipment and systems must be able to be easily cleaned.

The surface temperatures of the pieces of the apparatus must be markedly lower than the temperatures of incandescent dust deposited.

The thickness of the deposited dust layer should be taken into account and, where appropriate, take measures to limit temperatures and prevent heat from accumulating.

5. Additional means of protection.

Protection equipment and systems which may be exposed to all types of external hazards shall, if necessary, be provided with complementary means of protection.

Appliances must be able to withstand the conditions in which they work without affecting explosion protection.

6. Open without danger.

When protective devices and systems are housed in a box or a wrapper that forms part of the explosion protection itself, they must not be able to be opened more than with the help of a special tool or by means of appropriate protective measures.

7. Protection against other risks.

Protective devices and systems must be designed and constructed in such a way that:

a) Avoid the hazards of injuries or other damage that may occur from direct or indirect contacts.

b) No surface temperatures of accessible parts or radiators that would cause danger.

c) The dangers of non-electric nature and revealed by the experience are removed.

d) Expected overload conditions do not lead to a dangerous situation.

Where, for appliances and systems of protection, the risks referred to in this paragraph are covered, in whole or in part, by other Community Directives, this Directive shall not apply or cease to apply. for such equipment and systems of protection and for such risks from the implementation of such specific directives.

8. º Overloading of appliances.

From the moment they are designed, the dangerous overloads of the devices must be avoided by means of integrated measuring, control and adjustment devices, in particular by means of superintensity limiters, temperature, differential pressure switches, volumetric indicators, time relays, revolutions and/or similar surveillance devices.

9. Anti-Flagrant Envelope Systems.

If the parts that can inflame an explosive atmosphere are enclosed in a wrapper, it must be ensured that this resists the pressure generated by an internal explosion of an explosive mixture and that prevents the transmission of the explosion to the atmosphere around the envelope.

4 Potential ignition foci.

1. º Hazards derived from various ignition foci.

No potential ignition hotspots such as sparks, flames, electric arcs, high surface temperatures, acoustic energy emissions, optical radiation, electromagnetic waves or other sources of ignition should occur. type.

2. º Hazards originating from static electricity.

By means of appropriate measures, electrostatic charges liable to cause dangerous discharges should be avoided.

3. º Hazards derived from parasitic and leakage electrical currents.

It shall be prevented from producing, in the conductive parts of the apparatus, parasitic or leakage electrical currents which give rise, for example to dangerous corrosions, to the heating of the surfaces or to the formation of capable sparks. of causing an ignition.

4. º Hazards derived from excessive heating.

The design shall be such as to avoid, as far as possible, excessive overheating due to the rubbing or shock that may occur, for example, between materials in rotating parts or in the introduction of foreign bodies.

5. º Hazards derived from pressure balancing.

From the moment of design, by means of integrated measuring, control or adjustment devices, the balancing of pressures must be carried out in such a way that they do not trigger shock waves or compressions that may cause a ignition.

5. Hazards due to external disruptive influences.

1. Equipment and protective systems must be designed and constructed in such a way that they can safely fulfil the function for which they are intended, even in the presence of changing environmental conditions, parasitic stresses, humidity, vibrations, pollution or other external disruptive influences, taking into account the limits of the operating conditions laid down by the manufacturer.

2. The parts of the apparatus must be adapted to the expected mechanical and thermal stresses and resist the aggressive action of the present or foreseeable substances.

6. Requirements for the team that contributes to security.

1. Safety devices shall operate independently of the measurement and control necessary for the operation.

As far as possible, it should be detected through appropriate technical means, any failure of a safety device, with sufficient speed to ensure that there is a minimum probability of occurrence of a situation. dangerous.

The positive safety principle "fail-safe" should be applied as a general rule.

By general rule, security-related controls must act directly on the corresponding control organs without passing through the logical equipment.

2. In case of failure of the safety devices, the protective equipment or systems shall, as far as possible, be put in a safe position.

3. The emergency stop controls of the security devices shall, as far as possible, have a blocking system against the resumption of operation. Any new commissioning order may only have an effect on normal operation, if previously, the blocking system against the resumption of operation has been intentionally repositioned.

4. Command and visual representation devices.

If control and visual display devices are used, they must be designed according to ergonomic principles to provide maximum use safety as far as explosion risks are concerned.

5. º Requirements for devices intended for protection against explosions that have a function of measurement.

Devices having a measurement function, in so far as they are used with devices used in potentially explosive atmospheres, shall be designed and constructed in accordance with their foreseeable capabilities. operation and its special conditions of use.

6. º In case of need, the accuracy of reading and the operating capacity of devices having a measurement function must be controlled.

7. The design of devices having a measurement function shall take into account a safety coefficient which ensures that the alarm threshold is sufficiently far removed from the explosiveness and/or the limits of the inflammation of the atmosphere to be analysed, taking into account, in particular, the operating conditions of the installation and the deviations of the measurement system.

8. º Risks derived from logical equipment.

In the design of devices, protection systems, and security devices controlled by software, the risks resulting from failures in the program must be taken into account.

7. System security requirements.

1. When equipment and protective systems included in automatic processes are removed from the intended operating conditions, they must be able to be disconnected manually, provided that this is not contrary to the good security conditions.

2. The stored energy shall be dissipated as quickly and safely as possible when the emergency disconnect devices are actuated so that it no longer constitutes a hazard.

The above does not apply to energy stored by electrochemical via.

3. º Hazards derived from a power outage

Equipment and protective systems in which a power outage can lead to the spread of new hazards should be able to be kept in a safe working situation, irrespective of the rest of the installation.

4. º Risks derived from connection parts.

Equipment and protective systems shall be equipped with appropriate cable and duct inputs.

When protective equipment and systems are intended to be used in combination with other protective equipment and systems, the interfaces shall be safe.

5. Placement of alarm devices that are part of the apparatus.

When an appliance or a protective system has detection or alarm devices intended to control the formation of explosive atmospheres, the necessary indications must be provided in order to be able to place such devices in the appropriate places.

II. Additional requirements for appliances

1. Requirements applicable to equipment in group I.

1. º Requirements applicable to equipment of category M 1 of group I.

(a) The apparatus must be designed and constructed in such a way that ignition bulbs are not activated even in the event of a rare failure.

They will be provided with means of protection so that:

1. In case of failure of one of these means of protection, at least one second independent means ensures the level of protection required;

2. In the event of two separate faults occurring from each other, the required level of protection is assured.

If necessary, they shall be provided with special supplementary protection means.

They must remain operational in the presence of explosive atmospheres.

(b) Whenever necessary, the apparatus must be manufactured in such a way that it cannot enter dust inside.

c) In order to avoid the ignition of the suspended dust, the surface temperatures of the parts of the apparatus shall be clearly below the ignition temperature of the foreseeable dust-air mixture.

(d) The apparatus must be designed in such a way that it is only possible to open those parts thereof which may constitute ignition bulbs, in the absence of energy or in intrinsic safety conditions. When it is not possible to disable the apparatus, the manufacturer shall affix a warning label to the opening of such parts of the apparatus.

If necessary, they will be provided with appropriate complementary locking systems.

2. º Requirements applicable to appliances in the M2 conformity category of the group of appliances I.

(a) Equipment shall be provided with protective measures so that ignition bulbs cannot be activated during normal operation even under strict operating conditions, in particular those resulting from an operation. intense use of the apparatus and variable environmental conditions.

In case there are signs of explosive atmospheres, the power supply of the devices must be cut.

(b) The apparatus must be designed in such a way that it is only possible to open those parts thereof which may constitute ignition bulbs, in the absence of energy or by appropriate locking mechanisms. When it is not possible to disable the apparatus, the manufacturer shall affix a warning label to the opening of such parts of the apparatus.

(c) As regards protection measures against explosions due to the presence of dust, the corresponding requirements of category M 1 shall be complied with.

2. Requirements applicable to equipment in category 1 of Group II.

1. Explosive Atmospheres due to the presence of gases, vapors or mists.

(a) The apparatus must be designed and constructed in such a way as to avoid activation of ignition bulbs, including those resulting from an infrequent failure of the apparatus.

They will be provided with means of protection so that:

1. In case of failure of one of the means of protection, at least one second independent means ensures the level of protection required.

2. In the event of two separate failures occurring on each other, the required level of protection is assured.

(b) For devices whose surfaces may be reheated, it must be ensured that, in the worst case, the maximum surface temperature indicated is not exceeded.

The temperature rise resulting from the accumulation of heat and chemical reactions shall also be taken into account.

(c) The apparatus must be designed in such a way that the opening of different parts of the apparatus which may constitute ignition foci is only possible in the absence of energy or in intrinsic safety conditions. When it is not possible to disable the apparatus, the manufacturer shall affix a warning label to the opening of such parts of the apparatus.

If necessary, they shall be provided with appropriate additional locking mechanisms.

2. Explosive atmospheres due to the presence of dust-air mixtures.

(a) The apparatus must be designed and constructed in such a way as to avoid the ignition of dust-air mixtures, even resulting from an infrequent breakdown of the apparatus.

They will be provided with means of protection so that:

1. In case of failure of one of the means of protection, at least one second independent means ensures the level of protection required.

2. In the event of two separate failures occurring on each other, the required level of protection is assured.

(b) Where necessary, appliances must be manufactured in such a way that dust can only be introduced or evacuated for the intended purpose.

The cable and connection parts entries must also satisfy this requirement.

(c) To avoid ignition of the suspended dust, the surface temperatures of the different parts of the apparatus shall be markedly lower than the ignition temperature of the foreseeable dust-air mixture.

(d) With regard to the non-danger opening of the different parts of the apparatus, the requirement of paragraph 2.1. (c) shall apply.

3 Requirements for equipment in category 2 of Group II.

1. Explosive Atmospheres due to the presence of gases, vapors or mists.

(a) The apparatus shall be designed and constructed in such a way as to avoid ignition bulbs, even in the event of frequent breakdowns or malfunction to be taken into account.

(b) The parts of the apparatus must be designed and constructed in such a way as to ensure that the surface temperatures are not exceeded, even if the hazard is caused by abnormal situations provided by the manufacturer.

(c) The apparatus must be designed in such a way that the opening of the parts thereof which are capable of constituting ignition foci is only possible in the absence of energy or by appropriate locking mechanisms. When it is not possible to disable the apparatus, the manufacturer shall affix a warning label to the opening of such parts of the apparatus.

2. Explosive atmospheres due to the presence of dust-air mixtures.

(a) The apparatus must be designed and constructed in such a way as to prevent the ignition of dust-air mixtures, including that resulting from an infrequent breakdown of the apparatus or operating failures to be normally taken in account.

(b) With regard to surface temperatures, the requirement of paragraph 2.2. c.) shall apply.)

(c) With regard to dust protection, the requirement of paragraph 2.2. (b) shall apply.

(d) With regard to the non-danger opening of the parts of the apparatus, the requirement of paragraph 3.1. (c) shall apply.

4. Requirements applicable to equipment in category 3 of Group II.

1. Explosive Atmospheres due to the presence of gases, vapors or mists.

(a) The apparatus must be designed and constructed in such a way as to avoid foreseeable ignition outbreaks in the case of normal operation.

(b) The surface temperatures that appear shall not exceed, under the intended operating conditions, the maximum surface temperatures indicated. It shall only be tolerable to exceed those temperatures exceptionally when the manufacturer takes additional special protective measures.

2. Explosive atmospheres due to the presence of dust-air mixtures.

(a) The apparatus must be designed and constructed in such a way that the foreseeable ignition foci in the case of normal operation do not present a danger of inflammation of the dust-air mixtures.

(b) As far as surface temperatures are concerned, the requirement of paragraph 2.2. (c) shall apply.

(c) Equipment, including cable entries and intended connection parts, shall be manufactured with the size of dust particles present in order to prevent the formation of dust-air mixtures. explosive and the dangerous accumulation of dust inside.

III. Additional requirements for protection systems

1. General requirements.

(a) Protection systems shall have such dimensions as to reduce the effects of explosions to a sufficient level of safety.

(b) Protection systems must be designed and placed in such a way as to prevent explosions from being transmitted by dangerous reactions in the chain or by the jet of flames, and that the incipient explosions become on detonations.

(c) In the event of an interruption of the energy supply, the protection systems shall maintain their operating capacity for an appropriate period in order to avoid dangerous situations.

d) Protection systems should not have malfunction due to external disruptive influences.

2. Studies and design.

a) Characteristics of the materials.

The maximum pressure and temperature to be taken into account to study the strength of the materials will be the foreseeable pressure during an explosion in extreme conditions of use and the effect of foreseeable warming due to the flames.

(b) In the event of an explosion, the protective systems designed to withstand or contain the explosions shall withstand the shock wave without losing the integrity of the system.

(c) Accessories connected to the protection systems shall withstand the maximum expected explosion pressure without losing their operating capacity.

(d) In the study and design of the protection systems, account shall be taken of the reactions caused by the pressure on the peripheral equipment and on the pipes connected thereto.

e) Download devices.

When it is foreseeable that the protection systems used are exposed to situations in which their resistance is exceeded, appropriate discharge devices, which do not involve any of these, should be provided at the time of design. danger to the staff located in the vicinity.

f) Explosion suppression systems

The explosion suppression systems should be studied and designed in such a way that, in the event of an incident, they control the incipient explosion as soon as possible and oppose it in the most appropriate manner, taking into account the maximum pressure increase and maximum pressure of the pressure.

g) Disconnect systems.

The disconnection systems intended to isolate certain devices in the event of an incipient explosion, with the help of appropriate devices and in the shortest possible time, shall be studied and designed in such a way as to which remain watertight to the transmission of the internal flame and retain their mechanical strength in the service conditions.

(h) Protection systems shall be able to be integrated into circuits with an appropriate alarm threshold so that, if necessary, there is an interruption of the arrival and evacuation of products as well as a disconnection from the parts of appliances which do not have guarantees of being able to operate safely.

ANNEX III

Module: EC type examination

1. This module describes the part of the procedure by which a notified body checks and certifies that a representative of the production concerned complies with the requirements of the Directive which are applicable.

2. The manufacturer, or his authorised representative established in the Community, shall submit the application for the 'EC type' examination to the notified body of his choice.

The request will include:

(a) The name and address of the manufacturer, and if the application is submitted by an authorised representative, including the name and address of the authorised representative.

b) A written statement specifying that the same application has not been submitted to any other notified body.

c) The technical documentation described in paragraph 3.

The applicant shall make available to the notified body a copy of the product representative of the production concerned, hereinafter referred to as 'type'. The notified body may request other copies, if required by the test programme.

3. The technical documentation shall allow the conformity of the product with the requirements of the Directive to be assessed. Whenever necessary for such assessment, it shall cover the design, manufacture and operation of the product and include, to the extent necessary for the assessment:

a) A general description of the type.

b) Design and manufacturing plants and schemes of components, subassemblies, circuits, etc.

c) The descriptions and explanations necessary for the understanding of the plans and schemes and the operation of the product.

(d) A list of the rules referred to in Article 5, whether or not they have been fully applied, and a description of the solutions adopted to meet the essential requirements, where the rules have not been applied to Those referred to in Article 5.

e) The results of the design calculations performed and the examinations performed, etc.

f) The test reports.

4. The notified body.

(a) examine the technical documentation, verify that the type has been manufactured in accordance with the technical documentation and establish the elements that have been designed in accordance with the applicable rules of the those referred to in Article 5 and the elements whose design is not supported by the relevant provisions of those rules.

(b) Realise or make appropriate checks and tests necessary to check whether the solutions adopted by the manufacturer meet the essential requirements of the Directive where the standards have not been applied to the referred to in Article 5.

(c) Realize or make the appropriate checks and tests necessary to check whether the manufacturer who has chosen to apply the relevant rules has actually applied them.

(d) You shall agree with the applicant on the place where the necessary checks and tests will be carried out.

5. If the type complies with the provisions of the Directive, the notified body shall issue to the applicant an 'EC type' examination certificate. The certificate shall include the name and address of the manufacturer, the control findings, and the data necessary to identify the approved type.

A list of significant parts of the technical documentation shall be attached to the certificate and a copy shall be kept by the notified body.

If the notified body refuses to issue the certificate to the manufacturer or its representative established in the Community, it shall give reasons for its decision in detail.

A resource procedure must be set.

6. The applicant shall inform the notified body which has the technical documentation relating to the EC type-certificate of any modification of the approved product which is to receive a new approval, if such modifications may affect their compliance with the essential requirements or with the intended conditions of use of the product. This new approval will be issued as a supplement to the original "EC type" examination certificate.

7. Each notified body shall communicate to the other notified bodies the relevant information on the 'EC type' examination certificates and their allowances issued and withdrawn.

8. The other notified bodies may receive copies of the type examination certificates and/or their supplements. The annexes to the certificates shall be made available to the other notified bodies.

9. The manufacturer or his authorised representative established within the Community shall keep a copy of the EC type-examination certificates and their supplements together with the technical documentation for a period of at least 10 years from the last date of manufacture of the protective apparatus or system.

Where neither the manufacturer nor his representative is established in the Community, the obligation to keep the technical documentation shall be the responsibility of the person responsible for placing the product on the market community.

ANNEX IV

Module: Production Quality Assurance

1. This module describes the procedure whereby the manufacturer who fulfils the obligations of paragraph 2 ensures and declares that the products concerned are in conformity with the type described in the EC type-examination certificate and comply with the requirements of the requirements of the Directive which apply to them. The manufacturer or his authorised representative established within the Community shall affix the CE marking to each appliance and make a written declaration of conformity. The CE marking shall be accompanied by the identification number of the notified body responsible for the supervision referred to in paragraph 4

2. The manufacturer shall apply an approved production quality system and carry out the inspection and testing of the finished products referred to in paragraph 4.

3. Quality system.

(a) The manufacturer shall submit, for the appliances concerned, an application for the assessment of his quality system to the notified body of his choice.

This request will include:

1. All relevant information according to the category of products in question.

2. The documentation for the quality system.

3. The technical documentation of the approved type and a copy of the "CE" examination certificate of type.

(b) The quality system shall ensure that the products are in conformity with the type described in the EC type-examination certificate and comply with the requirements of the Directive applicable to them.

All the elements, requirements and provisions adopted by the manufacturer shall be included in a documentation carried out in a systematic and orderly manner in the form of written measures, procedures and instructions. The documentation relating to the quality system shall allow for a uniform interpretation of quality programmes, plans, manuals and dossiers.

In particular, it will include an appropriate description of:

1. The quality objectives, the organization chart, and the responsibilities and competencies of the management staff as regards the quality of the devices.

2. The manufacturing procedures, quality assurance and quality assurance techniques and the systematic activities to be carried out.

3. º The tests and tests that will be performed before, during, and after manufacturing, and the frequency with which they will be performed.

4. Quality dossiers such as inspection reports and test and calibration data, reports on the qualification of the affected staff, etc.

5. The means to monitor the achievement of the required quality of products and the effective functioning of the quality system.

(c) The notified body shall evaluate the quality system to determine whether it meets the requirements referred to in paragraph (b). Where the quality system complies with the relevant harmonised standard, compliance with those requirements shall be assumed. At least one of the members of the audit team shall have experience in the assessment of the technology of the apparatus in question. The assessment procedure shall include an inspection visit to the manufacturer's premises.

The decision to be taken will be notified to the manufacturer. The notification shall include the findings of the control and the reasoned assessment decision.

(d) The manufacturer shall undertake to comply with the obligations arising from the approved quality system and to maintain it in a manner that continues to be appropriate and effective.

The manufacturer, or its representative, shall keep the notified body that has approved the quality system informed of any adaptation provided for therein.

The notified body shall evaluate the proposed modifications and decide whether the modified quality system still complies with the requirements set out in paragraph (b) or if a new assessment is required.

The notified body shall notify the manufacturer of its decision. It shall notify the manufacturer of its decision. This notification shall include the findings of the control and the reasoned assessment decision.

4. Supervision under the responsibility of the notified body.

(a) The purpose of the supervision is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

(b) The manufacturer shall allow access by the notified body to the places of manufacture, inspection, testing and storage to enable it to carry out the relevant inspections, and shall provide it with all the necessary information, in particular:

1. The documentation on the quality system.

2. Quality dossiers, such as inspection reports and test and calibration data, reports on the qualification of affected staff, etc.

(c) The notified body shall carry out periodic audits to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

(d) In addition, the notified body may make unannounced visits to the manufacturer. In the course of such visits, the notified body may carry out or carry out tests in order to verify, if deemed necessary, the proper functioning of the quality system. It shall submit to the manufacturer an inspection report and, if evidence has been carried out, a report on the evidence.

5. For at least 10 years from the last date of manufacture of the product, the manufacturer shall have at the disposal of the national authorities:

1. The documentation referred to in point 3.a) 2. º

2. The adaptations referred to in the second subparagraph of paragraph 3.4.

3. º The decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.d) and paragraphs 4.c) and 4.d).

6. Each notified body shall communicate to the other notified bodies the relevant information concerning approvals of quality systems issued and withdrawn.

ANNEX V

Module: Product Verification

1. This module describes the procedure whereby the manufacturer or his authorised representative established in the Community ensures and declares that the apparatus to which the provisions of paragraph 3 have been applied are in conformity with the type described in the 'EC type' examination certificate and comply with the relevant requirements of this Directive.

2. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the appliances with the type described in the EC type-examination certificate and with the requirements of the Directive applicable to them. The manufacturer or his authorised representative established within the Community shall affix the CE marking of each appliance and draw up a declaration of conformity.

3. The notified body shall carry out appropriate examinations and tests in order to verify the conformity of the apparatus with the relevant requirements of the Directive by means of control and testing of each appliance, as specified in paragraph 4.

The manufacturer or his representative shall keep a copy of the declaration of conformity for a period of at least 10 years from the last date of manufacture of the appliance.

4. Verification by control and test of each appliance.

(a) One shall be examined by all apparatus and the appropriate tests as defined in the relevant standard or standards referred to in Article 5 shall be carried out or equivalent tests shall be carried out to verify their conformity with the the type described in the EC type-examination certificate and with the requirements of the Directive applicable to them.

(b) The notified body shall affix or stamp its identification number on each approved appliance, and shall issue in writing a certificate of conformity concerning the tests carried out.

(c) The manufacturer, or his/her representative, shall submit the certificates of conformity of the notified body, if required.

ANNEX VI

Module: Type compliance

1. This module describes the part of the procedure whereby the manufacturer or his authorised representative established in the Community ensures and declares that the apparatus is in conformity with the type described in the EC type-examination certificate and complies with the requirements of the requirements of the Directive which apply to it. The manufacturer or his authorised representative established within the Community shall affix the CE marking of each appliance and make a written declaration of conformity.

2. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the products manufactured with the type described in the EC type-examination certificate, as well as the corresponding requirements of the Directive.

3. The manufacturer or his representative shall keep a copy of the declaration of conformity for a period of at least 10 years from the last date of manufacture of the apparatus. Where neither the manufacturer nor his authorised representative is established within the Community, the obligation to keep the technical documentation available shall be the responsibility of the person responsible for placing the appliance or system of protection on the market. community.

For each device manufactured, the manufacturer shall perform, or perform, the tests relating to the technical aspects of the explosion protection. The tests shall be carried out under the responsibility of a notified body chosen by the manufacturer.

The manufacturer shall, under the responsibility of the notified body, affix the latter's identification number during the manufacturing process.

ANNEX VII

Module: Product Quality Assurance

1. This module describes the procedure whereby the manufacturer who fulfils the obligations of paragraph 2 ensures and declares that the apparatus is in conformity with the type described in the EC type-examination certificate. The manufacturer or his authorised representative established within the Community shall affix the CE marking to each appliance and make a written declaration of conformity. The CE marking shall be accompanied by the identification number of the notified body responsible for the supervision referred to in paragraph 4

2. The manufacturer shall use a quality system approved for the final inspection of the apparatus and for testing as specified in paragraph 3 and shall be subject to the supervision referred to in paragraph 4.

3. Quality system.

(a) The manufacturer shall submit an application for the assessment of his quality system to the notified body of his choice for the appliances.

This request will include:

1. All relevant information according to the category of the corresponding apparatus.

2. The documentation for the quality system.

3. The technical documentation of the approved type and a copy of the "CE" examination certificate of type.

(b) According to the quality system, the apparatus shall be examined and appropriate tests shall be carried out in accordance with the relevant standard (s) referred to in Article 5, or equivalent tests, in order to verify their conformity. with the relevant requirements of the Directive. All the elements, requirements and provisions adopted by the manufacturer shall appear in a systematic and rational documentation in the form of written measures, procedures and instructions. This quality system documentation will allow for a uniform interpretation of quality programmes, plans, manuals and quality records.

In particular, an appropriate description of:

1. The quality objectives, the organization chart and the responsibilities of the management personnel and their competencies regarding the quality of the products.

2. º The controls and tests to be performed after manufacturing.

3. The means to verify the effective operation of the quality system.

4. º Quality dossiers, such as inspection reports and test data, calibration data, reports on the qualification of affected staff, etc.

(c) The notified body shall evaluate the quality system to determine whether it meets the requirements specified in subparagraph (b) and shall of course comply with those requirements in the case of quality systems which apply the relevant harmonised standard.

At least one of the members of the audit team should have experience in evaluating the technology of the product concerned. The assessment procedure shall include an inspection visit to the manufacturer's premises.

The decision to be taken will be notified to the manufacturer. The notification shall include the conclusions of the control and the reasoned assessment decision.

(d) The manufacturer shall undertake to comply with the obligations arising from the approved quality system and to maintain it in a manner that continues to be appropriate and effective.

The manufacturer or his representative must inform the notified body that he has approved the quality system of any project adaptation of that system.

The notified body shall assess the proposed amendments and decide whether the modified quality system meets the requirements referred to in subparagraph (b) or whether a new assessment is necessary.

The body must notify the manufacturer of its decision. The notification shall include the findings of the control and the reasoned assessment decision.

4. Supervision under the responsibility of the notified body.

(a) The purpose of the supervision is to ensure that the manufacturer duly fulfils the obligations imposed on him by the approved quality system.

(b) The manufacturer shall allow the notified body access to the inspection, testing and storage facilities so that it can carry out the necessary inspections and provide it with all the necessary information, special:

1. The documentation on the quality system.

2. The Technical Documentation.

3. Quality dossiers such as inspection reports and test and calibration data, reports on the qualification of the affected staff, etc.

(c) The body shall carry out periodic audits in order to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report to the manufacturer.

(d) The notified body may, on the other hand, make unannounced inspection visits to the manufacturer. In the course of such visits, the notified body may carry out or carry out tests in order to verify, if deemed necessary, the proper functioning of the quality system; it shall submit to the manufacturer an inspection report and, if evidence has been carried out, the report of the tests.

5. For a period of at least 10 years from the last date of manufacture of the apparatus, the manufacturer shall have at the disposal of the authorities:

(a) The documentation referred to in paragraph 3.a) .3. º

(b) The adaptations referred to in the second subparagraph of paragraph 3.d).

(c) Decisions and reports of the notified body referred to in the last subparagraph of paragraph 3.d) and in paragraphs 4.c) and 4.d).

6. Each notified body shall communicate to the other notified body the information relevant to the approvals of quality systems issued and withdrawn.

ANNEX VIII

Module: Internal Manufacturing Control

1. This module describes the procedure by which the manufacturer, or his authorised representative established in the Community, who fulfils the obligations laid down in paragraph 2, guarantees and declares that the apparatus in question complies with the requirements of the Directive. which are applicable to you. The manufacturer or his authorised representative established within the Community shall affix the CE marking of each appliance and draw up a written declaration of conformity.

2. The manufacturer shall draw up the technical documentation described in paragraph 3. The manufacturer, or his authorised representative established in the Community, shall keep it at the disposal of the national authorities for inspection purposes for a period of time. at least 10 years after the last date of manufacture of the apparatus.

Where neither the manufacturer nor his representative is established in the Community, the obligation to keep the technical documentation available shall be the responsibility of the person responsible for placing the appliance on the market community.

3. The technical documentation shall enable the conformity of the apparatus to be assessed with the relevant requirements of the Directive. To the extent necessary for this assessment, it shall cover the design, manufacture and operation of the apparatus. The documentation will include:

a) A general description of the appliances.

b) Design and manufacturing plants, as well as components, subassemblies, circuits, and so on.

(c) The descriptions and explanations necessary for the understanding of such plans and schemes and the operation of the apparatus.

(d) A list of the rules that have been applied, in whole or in part, and a description of the solutions adopted to satisfy the safety aspects of this Directive where the standards have not been applied.

e) The results of the design calculations performed, the controls performed, etc.

f) Test reports.

4. The manufacturer or his representative shall, together with the technical documentation, keep a copy of the declaration of conformity.

5. The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the manufactured appliances with the technical documentation referred to in paragraph 2 and with the requirements of the Directive applicable.

ANNEX IX

Module: Verification by Unit

1. This module describes the procedure by which the manufacturer guarantees and declares that the equipment or protective systems which have obtained the certificate referred to in paragraph 2 comply with the requirements of the Directive which apply to them. The manufacturer, or his representative in the Community, shall affix the CE marking of each appliance or system of protection and make a declaration of conformity.

2. The body shall examine the protection apparatus or system and shall carry out appropriate tests as defined in the applicable standard or standards referred to in Article 5, or equivalent tests, in order to verify compliance with the applicable requirements of this Regulation. the Directive.

The notified body shall affix or send its identification number to the approved appliance or system of protection and issue a certificate of conformity concerning the tests carried out.

3. The documentation shall enable the conformity of the protection system or system to be assessed with the requirements of the Directive and the compression of its design, manufacture and operation.

To the extent that is required for evaluation, the documentation will include:

a) General description of the type.

b) Design and manufacturing plants, as well as components, subassemblies, circuits, and so on.

(c) The descriptions and explanations necessary for the compression of such drawings and schemes and the operation of the protection apparatus or system.

(d) A list of the rules referred to in Article 5, whether or not they are fully applied, and a description of the solutions adopted to satisfy the essential requirements, where the rules of the Article 5.

e) The results of the design calculations performed, of the examinations, performed, etc.

f) Test reports.

ANNEX X

A. CE marking:

The CE conformity marking shall be composed of the initials "CE" with the following graphic presentation:

In the case of reducing or extending the size of the marking, the proportions indicated in the graduated scheme preceding these lines must be respected.

The different components of the CE marking shall basically have the same vertical dimension, which shall not be less than 5 mm.

This requirement for minimum dimensions in the case of devices, protective systems or devices referred to in Article 1 (2) of small dimensions may not be met.

B. Content of the EC declaration of conformity.

The "CE" declaration of compliance will contain the following elements:

(a) The name or mark of identification and address of the manufacturer or his authorised representative established in the Community.

(b) The description of the apparatus, the protection system or the device referred to in Article 1 (2

.

(c) Relation of all relevant provisions which comply with the apparatus, the protection system or the device referred to in Article 1 (2).

d) Where appropriate, name, identification number and address of the notified body, and certificate number "EC" of type.

e) Where appropriate, reference to harmonised standards.

f) Where appropriate, rules and technical specifications used.

g) Where appropriate, reference to other applied Community directives.

h) Identification of the signatory to compromise the responsibility of the manufacturer or his authorised representative established in the Community.

ANNEX XI

Minimum criteria to be taken into account for notification of organisms

1. The body, its director and the personnel responsible for carrying out the verification operations may not be the designer, the manufacturer, the supplier or the installer of the equipment, protective systems or devices referred to in this Article. in Article 1 (2) which they control, neither the representative of any of those persons. Neither directly nor as representatives shall be involved in the design, manufacture, marketing or maintenance of such equipment, protective systems or devices referred to in Article 1 (2). This does not preclude the possibility of an exchange of technical information between the manufacturer or the body.

2. The body and the staff responsible for monitoring shall carry out the verification operations with the greatest professional integrity and the greatest technical competence, and shall be outside of any pressure and incitement, especially of type economic, which could influence their judgment or the results of their control, in particular those emanating from persons interested in the results of the verifications.

3. The body must have the necessary staff to perform the technical and administrative tasks relating to the execution of the verifications in a proper manner and must have the necessary means to do so; it must also have access to the material required for the exceptional verifications.

4. The staff responsible for the checks must have:

a) Good technical and professional information.

(b) A satisfactory knowledge of the requirements concerning the controls carried out and a sufficient practical experience of such controls.

(c) The aptitude required to draw up the certificates, minutes and reports in which the checks are carried out.

5. The independence of the staff responsible for monitoring must be ensured. The remuneration of the staff shall not be based on the number of checks carried out or on the results of the staff.

6. The body shall take out civil liability insurance, unless this liability is covered by the State under national law or the controls are carried out directly by the Administration.

7. The staff of the body shall keep the professional secrecy (except in the case of the competent administrative authorities of the State in which its activities are carried out) pursuant to this Royal Decree.