Directive 97/23/EC of the European Parliament and of the Council (repealed)Show full title

ANNEX I U.K. ESSENTIAL SAFETY REQUIREMENTS

PRELIMINARY OBSERVATIONS U.K.

1. The obligations arising from the essential requirements listed in this Annex for pressure equipment also apply to assemblies where the corresponding hazard exists. U.K.

2. The essential requirements laid down in the Directive are compulsory. The obligations laid down in these essential requirements apply only if the corresponding hazard exists for the pressure equipment in question when it is used under conditions which are reasonably foreseeable by the manufacturer. U.K.

3. The manufacturer is under an obligation to analyse the hazards in order to identify those which apply to his equipment on account of pressure; he must then design and construct it taking account of his analysis. U.K.

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

1. GENERAL U.K.

1.1. Pressure equipment must be designed, manufactured and checked, and if applicable equipped and installed, in such a way as to ensure its safety when put into service in accordance with the manufacturer's instructions, or in reasonably foreseeable conditions. U.K.

1.2. In choosing the most appropriate solutions, the manufacturer must apply the principles set out below in the following order: U.K.

• eliminate or reduce hazards as far as is reasonably practicable,

• apply appropriate protection measures against hazards which cannnot be eliminated,

• where appropriate, inform users of residual hazards and indicate whether it is necessary to take appropriate special measures to reduce the risks at the time of installation and/or use.

1.3. Where the potential for misuse is known or can be clearly foreseen, the pressure equipment must be designed to prevent danger from such misuse or, if that is not possible, adequate warning given that the pressure equipment must not be used in that way. U.K.

2. DESIGN U.K.

2.1. General U.K.

The pressure equipment must be properly designed taking all relevant factors into account in order to ensure that the equipment will be safe throughout its intended life.

The design must incorporate appropriate safety coefficients using comprehensive methods which are known to incorporate adequate safety margins against all relevant failure modes in a consistent manner.

2.2. Design for adequate strength U.K.

2.2.1. The pressure equipment must be designed for loadings appropriate to its intended use and other reasonably foreseeable operating conditions. In particular, the following factors must be taken into account: U.K.

• internal/external pressure,

• ambient and operational temperatures,

• static pressure and mass of contents in operating and test conditions,

• traffic, wind, earthquake loading,

• reaction forces and moments which result from the supports, attachments, piping, etc.,

• corrosion and erosion, fatigue, etc.,

• decomposition of unstable fluids.

Various loadings which can occur at the same time must be considered, taking into account the probability of their simultaneous occurence.

2.2.2. Design for adequate strength must be based on: U.K.

• as a general rule, a calculation method, as described in 2.2.3, and supplemented if necessary by an experimental design method as described in 2.2.4, or

• an experimental design method without calculation, as described in 2.2.4, when the product of the maximum allowable pressure PS and the volume V is less than 6 000 bar·L or the product PS·DN less than 3 000 bar.

2.2.3. Calculation method U.K.

(a) Pressure containment and other loading aspects U.K.

The allowable stresses for pressure equipment must be limited having regard to reasonably foreseeable failure modes under operating conditions. To this end, safety factors must be applied to eliminate fully any uncertainty arising out of manufacture, actual operational conditions, stresses, calculation models and the properties and behaviour of the material.

These calculation methods must provide sufficient safety margins consistent, where applicable, with the requirements of section 7.

The requirements set out above may be met by applying one of the following methods, as appropriate, if necessary as a supplement to or in combination with another method:

• design by formula,

• design by analysis,

• design by fracture mechanics;

(b) Resistance U.K.

Appropriate design calculations must be used to establish the resistance of the pressure equipment concerned.

In particular:

• the calculation pressures must not be less than the maximum allowable pressures and take into account static head and dynamic fluid pressures and the decomposition of unstable fluids. Where a vessel is separated into individual pressure-containing chambers, the partition wall must be designed on the basis of the highest possible chamber pressure relative to the lowest pressure possible in the adjoining chamber,

• the calculation temperatures must allow for appropriate safety margins,

• the design must take appropriate account of all possible combinations of temperature and pressure which might arise under reasonably foreseeable operating conditions for the equipment,

• the maximum stresses and peak stress concentrations must be kept within safe limits,

• the calculation for pressure containment must utilize the values appropriate to the properties of the material, based on documented data, having regard to the provisions set out in section 4 together with appropriate safety factors. Material characteristics to be considered, where applicable, include:

  • yield strength, 0,2 % or 1,0 % proof strength as appropriate at calculation temperature,

  • tensile strength,

  • time-dependent strength, i.e. creep strength,

  • fatigue data,

  • Young's modulus (modulus of elasticity),

  • appropriate amount of plastic strain,

  • impact strength,

  • fracture toughness,

• appropriate joint factors must be applied to the material properties depending, for example, on the type of non-destructive testing, the materials joined and the operating conditions envisaged,

• the design must take appropriate account of all reasonably foreseeable degradation mechanisms (e.g. corrosion, creep, fatigue) commensurate with the intended use of the equipment. Attention must be drawn, in the instructions referred to in section 3.4, to particular features of the design which are relevant to the life of the equipment, for example:

  • for creep: design hours of operation at specified temperatures,

  • for fatigue: design number of cycles at specified stress levels,

  • for corrosion: design corrosion allowance;

(c) Stability aspects U.K.

Where the calculated thickness does not allow for adequate structural stability, the necessary measures must be taken to remedy the situation taking into account the risks from transport and handling.

2.2.4. Experimental design method U.K.

The design of the equipment may be validated, in all or in part, by an appropriate test programme carried out on a sample representative of the equipment or the category of equipment.

The test programme must be clearly defined prior to testing and accepted by the notified body responsible for the design conformity assessment module, where it exists.

This programme must define test conditions and criteria for acceptance or refusal. The actual values of the essential dimensions and characteristics of the materials which constitute the equipment tested shall be measured before the test.

Where appropriate, during tests, it must be possible to observe the critical zones of the pressure equipment with adequate instrumentation capable of registering strains and stresses with sufficient precision.

The test programme must include:

(a)

A pressure strength test, the purpose of which is to check that, at a pressure with a defined safety margin in relation to the maximum allowable pressure, the equipment does not exhibit significant leaks or deformation exceeding a determined threshold.

The test pressure must be determined on the basis of the differences between the values of the geometrical and material characteristics measures under test conditions and the values used for design purposes; it must take into account the differences between the test and design temperatures;

(b)

where the risk of creep or fatigue exists, appropriate tests determined on the basis of the service conditions laid down for the equipment, for instance hold time at specified temperatures, number of cycles at specified stress-levels, etc.;

(c)

where necessary, additional tests concerning other factors referred to in 2.2.1 such as corrosion, external damage, etc.

2.3. Provisions to ensure safe handling and operation U.K.

The method of operation specified for pressure equipment must be such as to preclude any reasonably foreseeable risk in operation of the equipment. Particular attention must be paid, where appropriate, to:

• closures and openings,

• dangerous discharge of pressure relief blow-off,

• devices to prevent physical access whilst pressure or a vacuum exists,

• surface temperature taking into consideration the intended use,

• decomposition of unstable fluids.

In particular, pressure equipment fitted with an access door must be equipped with an automatic or manual device enabling the user easily to ascertain that the opening will not present any hazard. Furthermore, where the opening can be operated quickly, the pressure equipment must be fitted with a device to prevent it being opened whenever the pressure or temperature of the fluid presents a hazard.

2.4. Means of examination U.K.

(a)

Pressure equipment must be designed and constructed so that all necessary examinations to ensure safety can be carried out;

(b)

Means of determining the internal condition of the equipment must be available, where it is necessary to ensure the continued safety of the equipment, such as access openings allowing physical access to the inside of the pressure equipment so that appropriate examinations can be carried out safely and ergonomically;

(c)

Other means of ensuring the safe condition of the pressure equipment may be applied:

• where it is too small for physical internal access, or

• where opening the pressure equipment would adversely affect the inside, or

• where the substance contained has been shown not to be harmful to the material from which the pressure equipment is made and no other internal degradation mechanisms are reasonably foreseeable.

2.5. Means of draining and venting U.K.

Adequate means must be provided for the draining and venting of pressure equipment where necessary:

• to avoid harmful effects such as water hammer, vacuum collapse, corrosion and uncontrolled chemical reactions. All stages of operation and testing, particularly pressure testing, must be considered,

• to permit cleaning, inspection and maintenance in a safe manner.

2.6. Corrosion or other chemical attack U.K.

Where necessary, adequate allowance or protection against corrosion or other chemical attack must be provided, taking due account of the intended and reasonably foreseeable use.

2.7. Wear U.K.

Where severe conditions of erosion or abrasion may arise, adequate measures must be taken to:

• minimize that effect by appropriate design, e.g. additional material thickness, or by the use of liners or cladding materials,

• permit replacement of parts which are most affected,

• draw attention, in the instructions referred to in 3.4, to measures necessary for continued safe use.

2.8. Assemblies U.K.

Assemblies must be so designed that:

• the components to be assembled together are suitable and reliable for their duty,

• all the components are properly integrated and assembled in an appropriate manner.

2.9. Provisions for filling and discharge U.K.

Where appropriate, the pressure equipment must be so designed and provided with accessories, or provision made for their fitting, as to ensure safe filling and discharge in particular with respect to hazards such as:

(a)

on filling:

• overfilling or overpressurization having regard in particular to the filling ratio and to vapour pressure at the reference temperature,

• instability of the pressure equipment;

(b)

on discharge: the uncontrolled release of the pressurized fluid;

(c)

on filling or discharge: unsafe connection and disconnection.

2.10. Protection against exceeding the allowable limits of pressure equipment U.K.

Where, under reasonably foreseeable conditions, the allowable limits could be exceeded, the pressure equipment must be fitted with, or provision made for the fitting of, suitable protective devices, unless the equipment is intended to be protected by other protective devices within an assembly.

The suitable device or combination of such devices must be determined on the basis of the particular characteristics of the equipment or assembly.

Suitable protective devices and combinations thereof comprise:

(a)

safety accessories as defined in Article 1, section 2.1.3,

(b)

where appropriate, adequate monitoring devices such as indicators and/or alarms which enable adequate action to be taken either automatically or manually to keep the pressure equipment within the allowable limits.

2.11. Safety accessories U.K.

2.11.1. Safety accessories must: U.K.

• be so designed and constructed as to be reliable and suitable for their intended duty and take into account the maintenance and testing requirements of the devices, where applicable,

• be independent of other functions, unless their safety function cannot be affected by such other functions,

• comply with appropriate design principles in order to obstain suitable and reliable protection. These principles include, in particular, fail-safe modes, redundancy, diversity and self-diagnosis.

2.11.2. Pressure limiting devices U.K.

These devices must be so designed that the pressure will not permanently exceed the maximum allowable pressure PS; however a short duration pressure surge in keeping with the specifications laid down in 7.3 is allowable, where appropriate.

2.11.3. Temperature monitoring devices U.K.

These devices must have an adequate response time on safety grounds, consistent with the measurement function.

2.12. External fire U.K.

Where necessary, pressure equipment must be so designed and, where appropriate, fitted with suitable accesssories, or provision made for their fitting, to meet damage-limitation requirements in the event of external fire, having particular regard to its intended use.

3. MANUFACTURING U.K.

3.1. Manufacturing procedures U.K.

The manufacturer must ensure the competent execution of the provisions set out at the design stage by applying the appropriate techniques and relevant procedures, especially with a view to the aspects set out below.

3.1.1. Preparation of the component parts U.K.

Preparation of the component parts (e.g. forming and chamfering) must not give rise to defects or cracks or changes in the mechanical characteristics likely to be detrimental to the safety of the pressure equipment.

3.1.2. Permanent joining U.K.

Permanent joints and adjacent zones must be free of any surface or internal defects detrimental to the safety of the equipment.

The properties of permanent joints must meet the minimum properties specified for the materials to be joined unless other relevant property values are specifically taken into account in the design calculations.

For pressure equipment, permanent joining of components which contribute to the pressure resistance of equipment and components which are directly attached to them must be carried out by suitably qualified personnel according to suitable operating procedures.

For pressure equipment in categories II, III and IV, operating procedures and personnel must be approved by a competent third party which, at the manufacturer's discretion, may be:

• a notified body,

• a third-party organization recognized by a Member State as provided for in Article 13.

To carry out these approvals the third party must perform examinations and tests as set out in the appropriate harmonized standards or equivalent examinations and tests or must have them performed.

3.1.3. Non-destructive tests U.K.

For pressure equipment, non-destructive tests of permanent joints must be carried out by suitable qualified personnel. For pressure equipment in categories III and IV, the personnel must be approved by a third-party organization recognized by a Member State pursuant to Article 13.

3.1.4. Heat treatment U.K.

Where there is a risk that the manufacturing process will change the material properties to an extent which would impair the safety of the pressure equipment, suitable heat treatment must be applied at the appropriate stage of manufacture.

3.1.5. Traceability U.K.

Suitable procedures must be established and maintained for identifying the material making up the components of the equipment which contribute to pressure resistance by suitable means from receipt, through production, up to the final test of the manufactured pressure equipment.

3.2. Final assessment U.K.

Pressure equipment must be subjected to final assessment as described below.

3.2.1. Final inspection U.K.

Pressure equipment must undergo a final inspection to assess visually and by examination of the accompanying documents compliance with the requirements of the Directive. Test carried out during manufacture may be taken into account. As far as is necessary on safety grounds, the final inspection must be carried out internally and externally on every part of the equipment, where appropriate in the course of manufacture (e.g. where examination during the final inspection is no longer possible).

3.2.2. Proof test U.K.

Final assessment of pressure equipment must include a test for the pressure containment aspect, which will normally take the form of a hydrostatic pressure test at a pressure at least equal, where appropriate, to the value laid down in 7.4.

For category I series-produced pressure equipment, this test may be performed on a statistical basis.

Where the hydrostatic pressure test is harmful or impractical, other tests of a recognized value may be carried out. For tests other than the hydrostatic pressure test, additional measures, such as non-destructive tests or other methods of equivalent validity, must be applied before those tests are carried out.

3.2.3. Inspection of safety devices U.K.

For assemblies, the final assessment must also include a check of the safety devices intended to check full compliance with the requirements referred to in 2.10.

3.3. Marking and labelling U.K.

In addition to the CE marking referred to in Article 15, the following information must be provided:

(a)

for all pressure equipment:

• the name and address or other means of identification of the manufacturer and, where appropriate, of his authorized representative established within the Community,

• the year of manufacture,

• identification of the pressure equipment according to its nature, such as type, series or batch identification and serial number,

• essential maximum/minimum allowable limits;

(b)

depending on the type of pressure equipment, further information necessary for safe installation, operation or use and, where applicable, maintenance and periodic inspection such as:

• the volume V of the pressure equipment in L,

• the nominal size for piping DN,

• the test pressure PT applied in bar and date,

• safety device set pressure in bar,

• output of the pressure equipment in kW,

• supply voltage in V (volts),

• intended use,

• filling ratio kg/L,

• maximum filling mass in kg,

• tare mass in kg,

• the product group;

(c)

where necessary, warnings fixed to the pressure equipment drawing attention to misuse which experience has shown might occur.

The CE marking and the required information must be given on the pressure equipment or on a dataplate firmly attached to it, with the following exceptions:

• where applicable, appropriate documentation may be used to avoid repetitive marking of individual parts such as piping components, intended for the same assembly. This applies to CE marking and other marking and labelling referred to in this Annex;

• where the pressure equipment is too small, e.g. accessories, the information referred to in (b) may be given on a label attached to that pressure equipment;

• labelling or other adequate means may be used for the mass to be filled and the warnings referred to in (c), provided it remains legible for the appropriate period of time.

3.4. Operating instructions U.K.

(a)

When pressure equipment is placed on the market, it must be accompanied, as far as relevant, with instructions for the user, containing all the necessary safety information relating to:

• mounting including assembling of different pieces of pressure equipment,

• putting into service,

• use,

• maintenance including checks by the user;

(b)

Instructions must cover information affixed to the pressure equipment in accordance with 3.3, with the exception of serial identification, and must be accompanied, where appropriate, by the technical documents, drawings and diagrams necessary for a full understanding of these instructions;

(c)

If appropriate, these instructions must also refer to hazards arising from misuse in accordance with 1.3 and particular features of the design in accordance with 2.2.3.

4. MATERIALS U.K.

Materials used for the manufacture of pressure equipment must be suitable for such application during the scheduled lifetime unless replacement is foreseen.

Welding consumables and other joining materials need fulfil only the relevant requirements of 4.1, 4.2 (a) and the first paragraph of 4.3, in an appropriate way, both individually and in a joined structure.

4.1. Materials for pressurized parts must: U.K.

(a)

have appropriate properties for all operating conditions which are reasonably foreseeable and for all test conditions, and in particular they should be sufficiently ductile and tough. Where appropriate, the characteristics of the materials must comply with the requirements of 7.5. Moreover, due care should be exercised in particular in selecting materials in order to prevent brittle-type fracture where necessary; where for specific reasons brittle material has to be used appropriate measures must be taken;

(b)

be sufficiently chemically resistant to the fluid contained in the pressure equipment; the chemical and physical properties necessary for operational safety must not be significantly affected within the scheduled lifetime of the equipment;

(c)

not be significantly affected by ageing;

(d)

be suitable for the intended processing procedures;

(e)

be selected in order to avoid significant undesirable effects when the various materials are put together.

4.2.

(a)

The pressure equipment manufacturer must define in an appropriate manner the values necessary for the design calculations referred to in 2.2.3 and the essential characteristics of the materials and their treatment referred to in 4.1;

(b)

the manufacturer must provide in his technical documentation elements relating to compliance with the materials specifications of the Directive in one of the following forms:

• by using materials which comply with harmonized standards,

• by using materials covered by a European approval of pressure equipment materials in accordance with Article 11,

• by a particular material appraisal;

(c)

for pressure equipment in categories III and IV, particular appraisal as referred to in the third indent of (b) must be performed by the notified body in charge of conformity assessment procedures for the pressure equipment.

4.3. The equipment manufacturer must take appropriate measures to ensure that the material used conforms with the required specification. In particular, documentation prepared by the material manufacturer affirming compliance with a specification must be obtained for all materials. U.K.

For the main pressure-bearing parts of equipment in categories II, III and IV, this must take the form of a certificate of specific product control.

Where a material manufacturer has an appropriate quality-assurance system, certified by a competent body established within the Community and having undergone a specific assessment for materials, certificates issued by the manufacturer are presumed to certify conformity with the relevant requirements of this section.

SPECIFIC PRESSURE EQUIPMENT REQUIREMENTS U.K.

In addition to the applicable requirements of sections 1 to 4, the following requirements apply to the pressure equipment covered by sections 5 and 6.

5. FIRED OR OTHERWISE HEATED PRESSURE EQUIPMENT WITH A RISK OF OVERHEATING AS REFERRED TO IN ARTICLE 3 (1) U.K.

This pressure equipment includes:

• steam and hot-water generators as referred to in Article 3, section 1.2, such as fired steam and hot-water boilers, superheaters and reheaters, waste-heat boilers, waste incineration boilers, electrode or immersion-type electrically heated boilers, pressure cookers, together with their accessories and where applicable their systems for treatment of feedwater and for fuel supply, and

• process-heating equipment for other than steam and hot water generation falling under Article 3, section 1.1, such as heaters for chemical and other similar processes and pressurized food-processing equipment.

This pressure equipment must be calculated, designed and constructed so as to avoid to minimize risks of a significant loss of containment from overheating. In particular it must be ensured, where applicable, that:

(a)

appropriate means of protection are provided to restrict operating parameters such as heat input, heat take-off and, where applicable, fluid level so as to avoid any risk of local and general overheating,

(b)

sampling points are provided where required to allow evaluation of the properties of the fluid so as to avoid risks related to deposits and/or corrosion,

(c)

adequate provisions are made to eliminate risks of damage from deposits,

(d)

means of safe removal of residual heat after shutdown are provided,

(e)

steps are taken to avoid a dangerous accumulation of ignitable mixtures of combustible substances and air, or flame blowback.

6. PIPING AS REFERRED TO IN ARTICLE 3, SECTION 1.3 U.K.

Design and construction must ensure:

(a)

that the risk of overstressing from inadmissible free movement or excessive forces being produced, e.g. on flanges, connections, bellows or hoses, is adequately controlled by means such as support, constraint, anchoring, alignment and pre-tension;

(b)

that where there is a possibility of condensation occurring inside pipes for gaseous fluids, means are provided for drainage and removal of deposits from low areas to avoid damage from water hammer or corrosion;

(c)

that due consideration is given to the potential damage from turbulence and formation of vortices; the relevant parts of 2.7 are applicable;

(d)

that due consideration is given to the risk of fatigue due to vibrations in pipes;

(e)

that, where fluids of Group 1 are contained in the piping, appropriate means are provided to isolate ‘take-off’ pipes the size of which represents a significant risk;

(f)

that the risk of inadvertent discharge is minimized; the take-off points must be clearly marked on the permanent side, indicating the fluid contained;

(g)

that the position and route of underground piping is at least recorded in the technical documentation to facilitate safe maintenance, inspection or repair.

7. SPECIFIC QUANTITATIVE REQUIREMENTS FOR CERTAIN PRESSURE EQUIPMENT U.K.

The following provisions apply as a general rule. However, where they are not applied, including in cases where materials are not specifically referred to and no harmonized standards are applied, the manufacturer must demonstrate that appropriate measures have been taken to achieve an equivalent overall level of safety.

This section is an integral part of Annex I. The provisions laid down in this section supplement the essential requirements of sections 1 to 6 for the pressure equipment to which they apply.

7.1. Allowable stresses U.K.

7.1.1. Symbols U.K.

R_e/t, yield limit, indicates the value at the calculation temperature of:

• the upper flow limit for a material presenting upper and lower flow limits,

• the 1,0 % proof strength of austenitic steel and non-alloyed aluminium,

• the 0,2 % proof strength in other cases.

R_m/20 indicates the minimum value of the ultimate strength 20 °C.

R_m/t designates the ultimate strength at the calculation temperature.

7.1.2. The permissible general membrane stress for predominantly static loads and for temperatures outside the range in which creep is significant must not exceed the smaller of the following values, according to the material used: U.K.

• in the case of ferritic steel including normalized (normalized rolled) steel and excluding fine-grained steel and specially heat-treated steel, ²/³ of R_e/t and ⁵/₁₂ of R_m/20;

• in the case of austenitic steel:

  • if its elongation after rupture exceeds 30 %, ²/³ of R_e/t

  • or, alternatively, and if its elongation after rupture exceeds 35 %, ⁵/⁶ of R_e/t and ¹/³ of R_m/t;

• in the case of non-alloy or low-alloy cast steel, ¹⁰/₁₉ of R_e/t and ¹/³ of R_m/20;

• in the case of aluminium, ²/³ of R_e/t;

• in the case of aluminium alloys excluding precipitation hardening alloys ²/³ of R_e/t and ⁵/₁₂ of R_m/20.

7.2. Joint coefficients U.K.

For welded joints, the joint coefficient must not exceed the following values:

• for equipment subject to destructive and non-destructive tests which confirm that the whole series of joints show no significant defects: 1,

• for equipment subject to random non-destructive testing: 0,85,

• for equipment not subject to non-destructive testing other than visual inspection: 0,7.

If necessary, the type of stress and the mechanical and technological properties of the joint must also be taken into account.

7.3. Pressure limiting devices, particularly for pressure vessels U.K.

The momentary pressure surge referred to in 2.11.2 must be kept to 10 % of the maximum allowable pressure.

7.4. Hydrostatic test pressure U.K.

For pressure vessels, the hydrostatic test pressure referred to in 3.2.2 must be no less than:

• that corresponding to the maximum loading to which the pressure equipment may be subject in service taking into account its maximum allowable pressure and its maximum allowable temperature, multiplied by the coefficient 1,25, or

• the maximum allowable pressure multiplied by the coefficient 1,43, whichever is the greater.

7.5. Material characteristics U.K.

Unless other values are required in accordance with other criteria that must be taken into account, a steel is considered as sufficiently ductile to satisfy 4.1 (a) if, in a tensile test carried out by a standard procedure, its elongation after rupture is no less than 14 % and its bending rupture energy measured on an ISO V test-piece is no less than 27 J, at a temperature not greater than 20 °C but not higher than the lowest scheduled operating temperature.

ANNEX II U.K. CONFORMITY ASSESSMENT TABLES

1. The references in the tables to categories of modules are the following: U.K.

Ι

=

Module A

II

=

Module A1, D1, E1

III

=

Modules B1 + D, B1 + F, B + E, B + C1, H

IV

=

Modules B + D, B + F, G, H1

2. The safety accessories defined in Article 1, Section 2.1.3, and referred to in Article 3, Section 1.4, are classified in category IV. However, by way of exception, safety accessories manufactured for specific equipment may be classified in the same category as the equipment they protect. U.K.

3. The pressure accessories defined in Article 1, Section 2.1.4, and referred to in Article 3, Section 1.4, are classified on the basis of: U.K.

• their maximum allowable pressure PS, and

• their volume V or their nominal size DN, as appropriate, and

• the group of fluids for which they are intended,

and the appropriate table for vessels or piping is to be used to determine the conformity assessment category.

Where both the volume and the nominal size are considered appropriate in the second indent, the pressure accessory must be classified in the highest category.

4. The demarcation lines in the following conformity assessment tables indicate the upper limit for each category. U.K.

Exceptionally, vessels intended to contain an unstable gas and falling within categories I or II on the basis of table 1 must be classified in category III.

Exceptionally, portable extinguishers and bottles for breathing equipment must be classified at least in category III.

Exceptionally, assemblies intended for generating warm water as referred to in Article 3, Section 2.3, must be subject either to an EC design examination (Module B1) with respect to their conformity with the essential requirements referred to in Sections 2.10, 2.11, 3.4, 5 (a) and 5 (d) of Annex I, or to full quality assurance (Module H).

Exceptionally, the design of pressure-cookers must be subject to a conformity assessment procedure equivalent to at least one of the category III modules.

Exceptionally, piping intended for unstable gases and falling within categories I or II on the basis of Table 6 must be classified in category III.

Exceptionally, all piping containing fluids at a temperature greater than 350 °C and falling within category II on the basis of Table 7 must be classified in category III.

ANNEX III U.K. CONFORMITY ASSESSMENT PROCEDURES

The obligations arising from the provisions on pressure equipment in this Annex also apply to assemblies.

Module A (internal production control) U.K.

1. This module describes the procedure whereby the manufacturer or his authorized representative established within the Community who carries out the obligations laid down in section 2 ensures and declares that pressure equipment satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. U.K.

2. The manufacturer must draw up the technical documentation described in section 3 and either the manufacturer or his authorized representative established within the Community must keep it at the disposal of the relevant national authorities for inspection purposes for a period of ten years after the last of the pressure equipment has been manufactured. U.K.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain: U.K.

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• a list of the standards referred to in Article 5, applied in full or in part, and a description of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports.

4. The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity with the technical documentation. U.K.

5. The manufacturer must take all measures necessary to ensure that the manfacturing process requires the manufactured pressure equipment to comply with the technical documentation referred to in section 2 and with the requirements of the Directive which apply to it. U.K.

Module A1 (internal manufacturing checks with monitoring of the final assessment) U.K.

In addition to the requirements of module A, the following applies.

Final assessment must be performed by the manufacturer and monitored by means of unexpected visits by a notified body chosen by the manufacturer.

During such visits, the notified body must:

• establish that the manufacturer actually performs final assessment in accordance with section 3.2 of Annex I,

• take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body assesses the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of the final assessment of the pressure equipment samples.

Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment.

Module B (EC type-examination) U.K.

1. This module describes the part of the procedure by which a notified body ascertains and attests that a representative example of the production in question meets the provisions of the Directive which apply to it. U.K.

2. The application for EC type-examination must be lodged by the manufacturer or by his authorized representative established within the Community with a single notified body of his choice. U.K.

The application must include:

• the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,

• a written declaration that the same application has not been lodged with any other notified body,

• the technical documentation described in section 3.

The applicant must place at the disposal of the notified body a representative example of the production envisaged, hereinafter called ‘type’. The notified body may request further examples should the test programme so require.

A type may cover several versions of pressure equipment provided that the differences between the versions do not affect the level of safety.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain: U.K.

• a general description of the type,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports,

• information concerning the tests provided for in manufacture,

• information concerning the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.

4. The notified body must: U.K.

4.1. examine the technical documentation, verify that the type has been manufactured in conformity with it and identify the components designed in accordance with the relevant provisions of the standards referred to in Article 5, as well as those designed without applying the provisions of those standards. U.K.

In particular, the notified body must:

• examine the technical documentation with respect to the design and the manufacturing procedures,

• assess the materials used where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with section 4.3 of Annex I,

• approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with section 3.1.2 of Annex I,

• verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 or 3.1.3 of Annex I.

4.2. perform or have performed the appropriate examinations and necessary tests to establish whether the solutions adopted by the manufacturer meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied. U.K.

4.3. perform or have performed the appropriate examinations and necessary tests to establish whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied. U.K.

4.4. agree with the applicant the location where the examinations and necessary tests are to be carried out. U.K.

5. Where the type satisfies the provisions of the Directive which apply to it, the notified body must issue an EC type-examination certificate to the applicant. The certificate, which should be valid for ten years and be renewable, must contain the name and address of the manufacturer, the conclusions of the examination and the necessary data for identification of the approved type. U.K.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the notified body refuses to issue an EC type-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical documentation concerning the EC type-examination certificate of all modifications to the approved pressure equipment; these are subject to additional approval where they may affect conformity with the essential requirements or the prescribed conditions for use of the pressure equipment. This additional approval must be given in the form of an addition to the original EC type-examination certificate. U.K.

7. Each notified body must communicate to the Member States the relevant information concerning EC type-examination certificates which it has withdrawn, and, on request, those it has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the EC type-examination certificates it has withdrawn or refused.

8. The other notified bodies may receive copies of the EC type-examination certificates and/or their additions. The annexes to the certificates must be held at the disposal of the other notified bodies. U.K.

9. The manufacturer, or his authorized representative established within the Community, must keep with the technical documentation copies of EC type-examination certificates and their additions for a period of ten years after the last of the pressure equipment has been manufactured. U.K.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

Module B1 (EC design-examination) U.K.

1. This module describes the part of the procedure whereby a notified body ascertains and attests that the design of an item of pressure equipment meets the provisions of the Directive which apply to it. U.K.

The experimental design method provided for in section 2.2.4 of Annex I may not be used in the context of this module.

2. The manufacturer, or his authorized representative established within the Community, must lodge an application for EC design examination with a single notified body. U.K.

The application must include:

• the name and address of the manufacturer and, if the application is lodged by the authorized representative, his name and address as well,

• a written declaration that the same application has not been lodged with any other notified body,

• the technical documentation described in section 3.

The application may cover several versions of the pressure equipment provided that the differences between the versions do not affect the level of safety.

3. The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain: U.K.

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• the necessary supporting evidence for the adequacy of the design solution, in particular where the standards referred to in Article 5 have not been applied in full; this supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf,

• results of design calculations made, examinations carried out, etc.,

• information regarding the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I.

4. The notified body must: U.K.

4.1. examine the technical documentation and identify the components which have been designed in accordance with the relevant provisions of the standards referred to in Article 5, as well as those which have been designed without applying the relevant provisions of those standards. U.K.

In particular, the notified body must:

• assess the materials where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials,

• approve the procedures for the permanent joining of pressure equipment parts, or check that they have been previously approved in accordance with section 3.1.2 of Annex I,

• verify that the personnel undertaking the permanent joining of pressure equipment parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 and 3.1.3 of Annex I.

4.2. perform the necessary examinations to establish whether the solutions adopted by the manufacturer meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied. U.K.

4.3. perform the necessary examinations to establish whether, where the manufacturer has chosen to apply the relevant standards, these have actually been applied. U.K.

5. Where the design meets the provisions of the Directive which apply to it, the notified body must issue an EC design-examination certificate to the applicant. The certificate must contain the name and address of the applicant, the conclusions of the examination, conditions for its validity and the necessary data for identification of the approved design. U.K.

A list of the relevant parts of the technical documentation must be annexed to the certificate and a copy kept by the notified body.

If the notified body refuses to issue an EC design-examination certificate to the manufacturer or to his authorized representative established within the Community, that body must provide detailed reasons for such refusal. Provision must be made for an appeals procedure.

6. The applicant must inform the notified body that holds the technical documentation concerning the EC design-examination certificate of all modifications to the approved design; these are subject to additional approval where such changes may affect the conformity of the pressure equipment with the essential requirements of the Directive or the prescribed conditions for use of the equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate. U.K.

7. Each notified body must communicate to the Member States the relevant information concerning EC design-examination certificates which it has withdrawn, and, on request, those it has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

8. The other notified bodies may on request obtain the relevant information concerning: U.K.

• the EC design-examination certificates and additions granted,

• the EC design-examination certificates and additions withdrawn.

9. The manufacturer, or his authorized representative established within the Community, must keep with the technical documentation referred to in section 3 copies of EC design-examination certificates and their additions for a period of ten years after the last of the pressure equipment has been manufactured. U.K.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the product on the Community market.

Module C1 (conformity to type) U.K.

1. This module describes that part of the procedure whereby the manufacturer, or his authorized representative established within the Community, ensures and declares that pressure equipment is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. U.K.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process requires the manufactured pressure equipment to comply with the type as described in the EC type-examination certificate and with the requirements of the Directive which apply to it. U.K.

3. The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity for a period of ten years after the last of the pressure equipment has been manufactured. U.K.

Where neither the manufacturer nor his authorized representative is established within the Community, the obligation to keep the technical documentation available is the responsibility of the person who places the pressure equipment on the Community market.

4. Final assessment must be subject to monitoring in the form of unexpected visits by a notified body chosen by the manufacturer. U.K.

During such visits, the notified body must:

• establish that the manufacturer actually performs final assessment in accordance with section 3.2 of Annex I,

• take samples of pressure equipment at the manufacturing or storage premises in order to conduct checks. The notified body must assess the number of items of equipment to sample and whether it is necessary to perform, or have performed, all or part of final assessment on the pressure equipment samples.

Should one or more of the items of pressure equipment not conform, the notified body must take appropriate measures.

On the responsibility of the notified body, the manufacturer must affix the former's identification number on each item of pressure equipment.

Module D (production quality assurance) U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment concerned is in conformity with the type described in the EC type-examination certificate or EC design-examination certificate and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 4. U.K.

2. The manufacturer must operate an approved quality system for production, final inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4. U.K.

3. Quality system U.K.

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice. U.K.

The application must include:

• all relevant information on the pressure equipment concerned,

• the documentation concerning the quality system,

• the technical documentation for the approved type and a copy of the EC type-examination certificate or EC design-examination certificate.

3.2. The quality system must ensure compliance of the pressure equipment with the type described in the EC type-examination certificate or EC design-examination certificate and with the requirements of the Directive which apply to it. U.K.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

• the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

• the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,

• the means of monitoring the achievement of the required quality and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 3.2. U.K.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient. U.K.

The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body U.K.

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular: U.K.

• the quality system documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. U.K.

4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system: U.K.

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• special conditions linked to the approval of the system, where applicable,

• significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, hold at the disposal of the national authorities: U.K.

• the documentation referred to in the second indent of 3.1;

• the adjustments referred to in the second paragraph of 3.4;

• the decisions and reports from the notified body which are referred to in the last paragraph of 3.3, the last paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module D1 (production quality assurance) U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 3 ensures and declares that the items of pressure equipment concerned satisfy the requirements of the Directive which apply to them. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 5. U.K.

2. The manufacturer must draw up the technical documentation described below. U.K.

The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports.

3. The manufacturer must operate an approved quality system for production, final inspection and testing as specified in section 4 and be subject to surveillance as specified in section 5. U.K.

4. Quality system U.K.

4.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice. U.K.

The application must include:

• all relevant information on the pressure equipment concerned,

• the documentation concerning the quality system.

4.2. The quality system must ensure compliance of the pressure equipment with the requirements of the Directive which apply to it. U.K.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

• the manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

• the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I,

• the means of monitoring the achievement of the required quality and the effective operation of the quality system.

4.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 4.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 4.2. U.K.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

4.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient. U.K.

The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.

If must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

5. Surveillance under the responsibility of the notified body U.K.

5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

5.2. The manufacturer must allow the notified body access for inspection purposes to the locations of manufacture, inspection, testing and storage and provide it with all necessary information, in particular: U.K.

• the quality system documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. U.K.

5.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system: U.K.

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• special conditions linked to the approval of the system, where applicable,

• significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

6. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, hold at the disposal of the national authorities: U.K.

• the technical documentation referred to in section 2,

• the documention referred to in the second indent of 4.1,

• the adjustments referred to in the second paragraph of 4.4,

• the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4, and in 5.3 and 5.4.

7. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module E (product quality assurance) U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment is in conformity with the type as described in the EC type-examination certificate and satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each product and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 4. U.K.

2. The manufacturer must operate an approved quality system for the final pressure equipment inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4. U.K.

3. Quality system U.K.

3.1. The manufacturer must lodge an application for assessment of his quality system for the pressure equipment with a notified body of his choice. U.K.

The application must include:

• all relevant information on the pressure equipment concerned,

• the documentation concerning the quality system,

• the technical documentation for the approved type and a copy of the EC type-examination certificate.

3.2. Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. U.K.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

• the examinations and tests to be carried out after manufacture,

• the means of monitoring the effective operation of the quality system,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 3.2. U.K.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.4. The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient. U.K.

The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body U.K.

4.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular: U.K.

• the quality system documentation,

• the technical documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. U.K.

4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system: U.K.

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• special conditions linked to the approval of the system, where applicable,

• significant changes in manufacturing organization, policy or techniques.

During such visits, the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, hold at the disposal of the national authorities: U.K.

• the documentation referred to in the second indent of 3.1,

• the adjustments referred to in the second paragraph of 3.4,

• the decisions and reports from the notified body which are referred to in the last paragraph of 3.3, the last paragraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn and, on request, those it has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module E1 (product quality assurance) U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 3 ensures and declares that the pressure equipment satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 5. U.K.

2. The manufacturer must draw up the technical documentation described below. U.K.

The technical documentation must enable an assessment to be made of the conformity of the pressure equipment with the requirements of the Directive which apply to it. It must, as far as is relevant for such assessment, cover the design, manufacture and operation of the pressure equipment and contain:

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports.

3. The manufacturer must operate an approved quality system for the final pressure equipment inspection and testing as specified in section 4 and be subject to surveillance as specified in section 5. U.K.

4. Quality system U.K.

4.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice. U.K.

The application must include:

• all relevant information on the pressure equipment concerned,

• the documentation concerning the quality system.

4.2. Under the quality system, each item of pressure equipment must be examined and appropriate tests as set out in the relevant standard(s) referred to in Article 5, or equivalent tests, and particularly final assessment as referred to in section 3.2 of Annex I, must be carried out in order to ensure its conformity with the requirements of the Directive which apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. U.K.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the pressure equipment,

• the procedures used for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

• the examinations and tests to be carried out after manufacture,

• the means of monitoring the effective operation of the quality system,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts in accordance with section 3.1.2 of Annex I.

4.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 4.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 4.2. U.K.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

4.4. The manufacturer must undertake to discharge the obligations arising from the quality system as approved and to ensure that it remains satisfactory and efficient. U.K.

The manufacturer, or his authorized representative established within the Community, must inform the notified body which has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 4.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

5. Surveillance under the responsibility of the notified body U.K.

5.1. The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

5.2. The manufacturer must allow the notified body access for inspection purposes to the locations of inspection, testing and storage and provide it with all necessary information, in particular: U.K.

• the quality system documentation,

• the technical documentation,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

5.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. U.K.

5.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system: U.K.

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• special conditions linked to the approval of the system, where applicable,

• significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

6. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, keep at the disposal of the national authorities: U.K.

• the technical documentation referred to in section 2,

• the documentation referred to in the second indent of 4.1,

• the adjustments referred to in the second paragraph of 4.4,

• the decisions and reports from the notified body which are referred to in the last paragraph of 4.3, the last paragraph of 4.4 and in 5.3 and 5.4.

7. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn and, on request, those is has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module F (product verification) U.K.

1. This module describes the procedure whereby a manufacturer, or his authorized representative established within the Community, ensures and declares that the pressure equipment subject to the provisions of section 3 is in conformity with the type described: U.K.

• in the EC type-examination certificate, or

• in the EC design-examination certificate

and satisfies the requirements of the Directive which apply to it.

2. The manufacturer must take all measures necessary to ensure that the manufacturing process requires the pressure equipment to comply with the type described U.K.

• in the EC type-examination certificate, or

• in the EC design-examination certificate

and with the requirements of the Directive which apply to it.

The manufacturer, or his authorized representative established within the Community, must affix the CE marking to all pressure equipment and draw up a declaration of conformity.

3. The notified body must perform the appropriate examinations and tests in order to check the conformity of the pressure equipment with the relevant requirements of the Directive by examining and testing every product in accordance with section 4. U.K.

The manufacturer, or his authorized representative established within the Community, must keep a copy of the declaration of conformity for a period of ten years after the last of the pressure equipment has been manufactured.

4. Verification by examination and testing of each item of pressure equipment U.K.

4.1. Each item of pressure equipment must be individually examined and must undergo appropriate examinations and tests as set out in the relevant standard(s) referred to in Article 5 or equivalent examinations and tests in order to verify that it conforms to the type and the requirements of the Directive which apply to it. U.K.

In particular, the notified body must:

• verify that the personnel undertaking the permanent joining of parts and the non-destructive tests are qualified or approved in accordance with sections 3.1.2 and 3.1.3 of Annex I,

• verify the certificate issued by the materials manufacturer in accordance with section 4.3 of Annex I,

• carry out or have carried out the final inspection and proof test referred to in section 3.2 of Annex I and examine the safety devices, if applicable.

4.2. The notified body must affix its identification number or have it affixed to each item of pressure equipment and draw up a written certificate of conformity relating to the tests carried out. U.K.

4.3. The manufacturer, or his authorized representative established within the Community, must ensure that the certificates of conformity issued by the notified body can be made available on request. U.K.

Module G (EC unit verification) U.K.

1. This module describes the procedure whereby the manufacturer ensures and declares that pressure equipment which has been issued with the certificate referred to in section 4.1 satisfies the requirements of the Directive which apply to it. The manufacturer must affix the CE marking to the pressure equipment and draw up a declaration of conformity. U.K.

2. The manufacturer must apply to a notified body of his choice for unit verification. U.K.

The application must contain:

• the name and address of the manufacturer and the location of the pressure equipment,

• a written declaration to the effect that a similar application has not been lodged with another notified body,

• technical documentation.

3. The technical documentation must enable the conformity of the pressure equipment with the requirements of the Directive which apply to it to be assessed and the design, manufacture and operation of the pressure equipment to be understood. U.K.

The technical documentation must contain:

• a general description of the pressure equipment,

• conceptual design and manufacturing drawings and diagrams of components, sub-assemblies, circuits, etc.,

• descriptions and explanations necessary for an understanding of the said drawings and diagrams and the operation of the pressure equipment,

• a list of the standards referred to in Article 5, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements of the Directive where the standards referred to in Article 5 have not been applied,

• results of design calculations made, examinations carried out, etc.,

• test reports,

• appropriate details relating to the approval of the manufacturing and test procedures and of the qualifications or approvals of the personnel concerned in accordance with sections 3.1.2 and 3.1.3 of Annex I.

4. The notified body must examine the design and construction of each item of pressure equipment and during manufacture perform appropriate tests as set out in the relevant standard(s) referred to in Article 5 of the Directive, or equivalent examinations and tests, to ensure its conformity with the requirements of the Directive which apply to it. U.K.

In particular the notified body must:

• examine the technical documentation with respect to the design and the manufacturing procedures,

• assess the materials used where these are not in conformity with the relevant harmonized standards or with a European approval for pressure equipment materials, and check the certificate issued by the material manufacturer in accordance with section 4.3 of Annex I,

• approve the procedures for the permanent joining of parts or check that they have been previously approved in accordance with section 3.1.2 of Annex I,

• verify the qualifications or approvals required under sections 3.1.2 and 3.1.3 of Annex I,

• carry out the final inspection referred to in section 3.2.1 of Annex I, perform or have performed the proof test referred to in section 3.2.2 of Annex I, and examine the safety devices, if applicable.

4.1. The notified body must affix its identification number or have it affixed to the pressure equipment and draw up a certificate of conformity for the tests carried out. This certificate must be kept for a period of ten years. U.K.

4.2. The manufacturer, or his authorized representative established within the Community, must ensure that the declaration of conformity and certificate of conformity issued by the notified body can be made available on request. U.K.

Module H (full quality assurance) U.K.

1. This module describes the procedure whereby the manufacturer who satisfies the obligations of section 2 ensures and declares that the pressure equipment in question satisfies the requirements of the Directive which apply to it. The manufacturer, or his authorized representative established within the Community, must affix the CE marking to each item of pressure equipment and draw up a written declaration of conformity. The CE marking must be accompanied by the identification number of the notified body responsible for surveillance as specified in section 4. U.K.

2. The manufacturer must implement an approved quality system for design, manufacture, final inspection and testing as specified in section 3 and be subject to surveillance as specified in section 4. U.K.

3. Quality system U.K.

3.1. The manufacturer must lodge an application for assessment of his quality system with a notified body of his choice. U.K.

The application must include:

• all relevant information concerning the pressure equipment in question,

• the documentation concerning the quality system.

3.2. The quality system must ensure compliance of the pressure equipment with the requirements of the Directive which apply to it. U.K.

All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. This quality system documentation must permit a consistent interpretation of the procedural and quality measures such as programmes, plans, manuals and records.

It must contain in particular an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to the quality of the design and to product quality,

• the technical design specifications, including standards, that will be applied and, where the standards referred to in Article 5 are not applied in full, the means that will be used to ensure that the essential requirements of the Directive which apply to the pressure equipment will be met,

• the design control and design verification techniques, processes and systematic measures that will be used when designing the pressure equipment, particularly with regard to materials in accordance with section 4 of Annex I,

• the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic measures that will be used, particularly the procedures for the permanent joining of parts as approved in accordance with section 3.1.2 of Annex I,

• the examinations and tests to be carried out before, during, and after manufacture, and the frequency with which they will be carried out,

• the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications or approvals of the personnel concerned, particularly those of the personnel undertaking the permanent joining of parts and the non-destructive tests in accordance with sections 3.1.2 and 3.1.3 of Annex I,

• the means of monitoring the achievement of the required pressure equipment design and quality and the effective operation of the quality system.

3.3. The notified body must assess the quality system to determine whether it satisfies the requirements referred to in 3.2. The elements of the quality system which conform to the relevant harmonized standard are presumed to comply with the corresponding requirements referred to in 3.2. U.K.

The auditing team must have at least one member with experience of assessing the pressure equipment technology concerned. The assessment procedure must include an inspection visit to the manufacturer's premises.

The decision must be notified to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision. Provision must be made for an appeals procedure.

3.4. The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to ensure that it remains satisfactory and efficient. U.K.

The manufacturer, or his authorized representative established within the Community, must inform the notified body that has approved the quality system of any intended adjustment to the quality system.

The notified body must assess the proposed changes and decide whether the modified quality system will still satisfy the requirements referred to in 3.2 or whether a reassessment is required.

It must notify its decision to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4. Surveillance under the responsibility of the notified body U.K.

4.1. The purpose of this surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system. U.K.

4.2. The manufacturer must allow the notified body access for inspection purposes to the locations of design, manufacture, inspection, testing and storage and provide it with all necessary information, in particular: U.K.

• the quality system documentation,

• the quality records provided for in the design part of the quality system, such as results of analyses, calculations, tests, etc.,

• the quality records provided for in the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel concerned, etc.

4.3. The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and provide the manufacturer with an audit report. The frequency of periodic audits must be such that a full reassessment is carried out every three years. U.K.

4.4. In addition the notified body may pay unexpected visits to the manufacturer. The need for such additional visits, and the frequency thereof, will be determined on the basis of a visit control system operated by the notified body. In particular, the following factors must be considered in the visit control system: U.K.

• the category of the equipment,

• the results of previous surveillance visits,

• the need to follow up corrective action,

• special conditions linked to the approval of the system, where applicable,

• significant changes in manufacturing organization, policy or techniques.

During such visits the notified body may, if necessary, carry out or have carried out tests to verify that the quality system is functioning correctly. The notified body must provide the manufacturer with a visit report and, if a test has taken place, with a test report.

5. The manufacturer must, for a period of ten years after the last of the pressure equipment has been manufactured, keep at the disposal of the national authorities: U.K.

• the documentation referred to in the second indent of the second subparagraph of 3.1;

• the adjustments referred to in the second subparagraph of 3.4;

• the decisions and reports from the notified body which are referred to in the last subparagraph of 3.3, the last subparagraph of 3.4, and in 4.3 and 4.4.

6. Each notified body must communicate to the Member States the relevant information concerning the quality system approvals which it has withdrawn, and, on request, those it has issued. U.K.

Each notified body must also communicate to the other notified bodies the relevant information concerning the quality system approvals it has withdrawn or refused.

Module H1 (full quality assurance with design examination and special surveillance of the final assessment) U.K.

1. In addition to the requirements of module H, the following apply: U.K.

(a)

the manufacturer must lodge an application for examination of the design with the notified body;

(b)

the application must enable the design, manufacture and operation of the pressure equipment to be understood, and enable conformity with the relevant requirements of the Directive to be assessed.

It must include:

• the technical design specifications, including standards, which have been applied,

• the necessary supporting evidence for their adequacy, in particular where the standards referred to in Article 5 have not been applied in full. This supporting evidence must include the results of tests carried out by the appropriate laboratory of the manufacturer or on his behalf;

(c)

the notified body must examine the application and where the design meets the provisions of the Directive which apply to it issue an EC design-examination certificate to the applicant. The certificate must contain the conclusions of the examination, the conditions for its validity, the necessary data for identification of the approved design and, if relevant, a description of the functioning of the pressure equipment or accessories;

(d)

the applicant must inform the notified body that has issued the EC design-examination certificate of all modifications to the approved design. Modifications to the approved design must receive additional approval from the notified body that issued the EC design-examination certificate where they may affect conformity with the essential requirements of the Directive or the prescribed conditions for use of the pressure equipment. This additional approval must be given in the form of an addition to the original EC design-examination certificate;

(e)

each notified body must also communicate to the other notified bodies the relevant information concerning the EC design-examination certificates it has withdrawn or refused.

2. Final assessment as referred to in section 3.2 of Annex I is subject to increased surveillance in the form of unexpected visits by the notified body. In the course of such visits, the notified body must conduct examinations on the pressure equipment. U.K.

ANNEX IV U.K. MINIMUM CRITERIA TO BE MET WHEN DESIGNATING THE NOTIFIED BODIES REFERRED TO IN ARTICLE 12 AND THE RECOGNIZED THIRD-PARTY ORGANIZATIONS REFERRED TO IN ARTICLE 13

1. The body, its director and the personnel responsible for carrying out the assessment and verification operations may not be the designer, manufacturer, supplier, installer or user of the pressure equipment or assemblies which that body inspects, nor the authorized representative of any of those parties. They may not become directly involved in the design, construction, marketing or maintenance of the pressure equipment or assemblies, nor represent the parties engaged in these activities. This does not preclude the possibility of exchanges of technical information between the manufacturer of pressure equipment or assemblies and the notified body. U.K.

2. The body and its personnel must carry out the assessments and verifications with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications. U.K.

3. The body must have at its disposal the necessary personnel and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with the inspection and surveillance operations, it must also have access to the equipment required to perform special verifications. U.K.

4. The personnel responsible for inspection must have: U.K.

• sound technical and vocational training,

• satisfactory knowledge of the requirements of the inspections they carry out and adequate experience of such operations,

• the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. The impartiality of the inspection personnel must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of such inspections. U.K.

6. The body must take out liability insurance unless its liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the inspections. U.K.

7. The personnel of the body must observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under the Directive or any provision of national law giving effect to it. U.K.

ANNEX V U.K. CRITERIA TO BE MET WHEN AUTHORIZING USER INSPECTORATES REFERRED TO IN ARTICLE 14

1. The user inspectorate must be organizationally identifiable and have reporting methods within the group of which it is part which ensure and demonstrate its impartiality. It must not be responsible for the design, manufacture, supply, installation, operation or maintenance of the pressure equipment or assemblies, and must not engage in any activities that might conflict with its independence of judgment and integrity in relation to its inspection activities. U.K.

2. The user inspectorate and its personnel must carry out the assessments and verifications with the highest degree of professional integrity and technical competence and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of verifications. U.K.

3. The user inspectorate must have at its disposal the necessary personnel and possess the necessary facilities to enable it to perform properly the technical and administrative tasks connected with the inspection and surveillance operations; it must also have access to the equipment required to perform special verifications. U.K.

4. The personnel responsible for inspection must have: U.K.

• sound technical and vocational training,

• satisfactory knowledge of the requirements of the inspections they carry out and adequate experience of such operations,

• the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.

5. The impartiality of inspection personnel must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of such inspections. U.K.

6. The user inspectorate must have adequate liability insurance unless liability is assumed by the group of which it is part. U.K.

7. The personnel of the user inspectorate must observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) under the Directive or any provision of national law giving effect to it. U.K.

ANNEX VI U.K. CE MARKING

The CE marking consists of the initials ‘CE’ taking the following form:

If the CE marking is reduced or enlarged the proportions given in the above graduated drawing must be respected.

The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm.

ANNEX VII U.K. DECLARATION OF CONFORMITY

The EC declaration of conformity must contain the following particulars:

• name and address of the manufacturer or of his authorized representative established within the Community,

• description of the pressure equipment or assembly,

• conformity assessment procedure followed,

• in the case of assemblies, description of the pressure equipment constituting the assembly, and the conformity assessment procedures followed,

• where appropriate, name and address of the notified body which carried out the inspection,

• where appropriate, a reference to the EC type-examination certificate, EC design-examination certificate or EC certificate of conformity,

• where appropriate, name and address of the notified body monitoring the manufacturer's quality assurance system,

• where appropriate, the references of the harmonized standards applied,

• where appropriate, other technical standards and specifications used,

• where appropriate, the references of the other Community Directives applied,

• particulars of the signatory authorized to sign the legally binding declaration for the manufacturer or his authorized representative established within the Community.