1.1

The essential requirements to be met by pressure equipment are also applicable to sets of equivalent risk.

1.2

The manufacturer is required to analyse the risks in order to determine which ones apply to its equipment because of the pressure; it must then design and build its equipment taking into account its analysis.

1.3

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

1.4

Pressure equipment shall be designed, manufactured, controlled and, where appropriate, equipped and installed in such a way as to ensure their safety if they are put into service in accordance with the manufacturer's instructions or under reasonable conditions Predictable.

1.5

In order to select the most appropriate solutions, the manufacturer shall apply the following principles in the order in which they are stated:

1.5.1

Remove or reduce risks as much as reasonably possible;

1.5.2

Apply appropriate safeguards against risks that cannot be removed;

1.5.3

Inform, where appropriate, users of residual risks and indicate whether appropriate special measures are required to mitigate risks at the time of installation and/or use.

1.6

In the event of a proven or foreseeable risk of misuse, pressure equipment shall be designed so as to exclude the danger of such incorrect use or, if it is not possible, it should be indicated in an appropriate manner. Pressure equipment should not be used in this way.

2.1 General provision

Pressure equipment shall be properly designed taking into account all relevant factors to ensure the safety of the equipment throughout its intended life. The design includes appropriate safety factors that are based on general methods deemed to use adequate safety margins to prevent all types of failures in a consistent manner.

2.2

Design for appropriate resistance

2.2.1

Pressure equipment shall be designed to withstand loads corresponding to the intended use, as well as for other reasonably foreseeable operating conditions. This includes the following factors:

A.

Internal and external pressures;

B.

Ambient and service temperatures;

C.

Static pressure and the mass of content in terms of employment and testing;

D.

Charges due to circulation, wind and earthquakes;

E.

The forces and moments of reaction caused by the supports, the fixations, the pipes, etc.;

F.

Corrosion and erosion, fatigue, etc.;

G.

The decomposition of unstable fluids.

The different charges which may take place at the same time must be taken into account, taking into account the likelihood of their simultaneous appearance.

2.2.2

The design for appropriate resistance should be based on:

A.

As a general rule, a calculation method as described in c. 2.2.3 and completed if necessary by an experimental design method as described in c. 2.2.4; or

B.

An experimental design method without calculation, as described in c. 2.2.4, when the product of the maximum permissible pressure PS ' V is less than 6000 bar ' Litres or PS product ' DN less than 3000 bars.

2.2.3

Calculation Method:

A.

For pressure containment and other charges:

The allowable stresses of pressure equipment shall be limited in the light of reasonably foreseeable failures in operating conditions. For this purpose, safety factors should be applied to eliminate all uncertainties arising from manufacture, actual conditions of use, constraints, design models and properties. The behaviour of the material.

These calculation methods shall provide adequate safety margins, in accordance with, where appropriate, the requirements of the c. 6.

The above provisions may be satisfied by applying one of the following methods, as appropriate, if necessary as a complement or in combination:

-

Formula design

-

Analysis design

-

Mechanical failure design

B.

For resistance:

The resistance of the pressure equipment under consideration shall be determined by appropriate design calculations.

In particular:

-

Calculation pressures shall not be less than the maximum allowable stresses and shall take into account static and dynamic fluid pressures as well as the decomposition of unstable fluids. When a container is composed of separate and individual pressure confinement compartments, the separation bulkheads shall be designed with the highest possible pressure in a compartment and pressure. As low as possible in the neighboring compartment.

-

Calculation temperatures must provide adequate safety margins.

-

The design shall take due account of all possible combinations of temperature and pressure that may occur under reasonably foreseeable operating conditions of the equipment.

-

Maximum stresses and stress concentration points must be maintained within safe limits.

-

Pressure containment calculations shall use the appropriate values of the material properties, based on demonstrated data, taking into account the provisions set out in c. 4 as well as adequate safety factors. Depending on the case, the characteristics of the material to be considered include:

-

The limit of elasticity, at 0.2 % or, as the case may be, at 1.0 %, at the calculation temperature

-

Tensile strength

-

Resistance to time (resistance to creep)

-

Fatigue endurance (for alternating efforts)

-

The Young module (modulus of elasticity)

-

The appropriate level of plastic stress

-

Resistance to bending by shock

-

Tenacity at failure

-

Appropriate joint coefficients shall be applied to the characteristics of the materials according to, for example, the nature of the non-destructive tests, the properties of the material assemblies and the envisaged operating conditions.

-

The design shall take due account of all reasonably foreseeable degradation mechanisms (such as corrosion, creep, fatigue) corresponding to the intended use of the equipment. The instructions referred to in c. 3.4 shall draw attention to the design features which are decisive for the life of the equipment such as:

-

For creep: the theoretical number of hours of operation at specified temperatures

-

For fatigue: the theoretical number of cycles at specified stress levels

-

For corrosion: the theoretical corrosion tolerance

C.

For stability:

Where the calculated thickness does not provide sufficient structural stability, it is necessary to take the necessary measures to remedy the situation, taking into account the risks associated with transport and handling.

2.2.4

Experimental design method

The design of the equipment may be validated, in whole or in part, by a testing program for a representative sample of equipment or family of equipment.

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

This program must define test conditions and acceptance and rejection criteria. The exact values of the essential dimensions and characteristics of the materials of the equipment tested shall be identified prior to the test.

Where appropriate, during testing, critical areas of pressure equipment shall be capable of being observed with suitable instruments for measuring deformations and stresses with sufficient accuracy. The test program must include:

A.

A pressure resistance test, intended to verify that at a pressure ensuring a safety margin defined in relation to the maximum permissible pressure, the equipment does not show any significant flight or deformation exceeding a threshold Determined.

The test pressure shall be determined by taking into account the differences between the values of the geometrical characteristics and the materials measured in the test conditions and the accepted values for the design; it must also take account of The difference between test and design temperatures.

B.

When the risk of creep or fatigue exists, appropriate tests determined according to the conditions of service provided for the equipment, for example: duration of service at specified temperatures, number of cycles at stress levels Determined, etc.

C.

Where necessary, additional tests for other specific environmental factors referred to in c. 2.2.1 such as corrosion, external aggressions, etc.

2.3 Provisions to ensure safe handling and operation

2.3.1

The operating mode of pressure equipment shall exclude any reasonably foreseeable risk as a result of their use. Special attention should be paid as appropriate, if appropriate:

A.

Closure and opening devices;

B.

Dangerous emissions from safety valves;

C.

Devices for prohibiting physical access as long as pressure or vacuum reigns;

D.

At the surface temperature, taking into account the intended use;

E.

The decomposition of unstable fluids.

2.3.2

In particular, pressure equipment with removable fillers shall be fitted with an automatic or manual device allowing the user to easily ensure that the opening does not pose a hazard. In addition, when this opening can be rapidly maneuvered, the pressure equipment shall be equipped with a device prohibiting the opening as long as the pressure or temperature of the fluid is in danger.

2.4 Means of inspection

2.4.1

Pressure equipment shall be so designed that all inspections necessary for their safety can be carried out.

2.4.2

It is important to provide for means of determining the internal state of the equipment under pressure where necessary to ensure the permanent safety of the equipment, such as eyes enabling physical access to the equipment. The interior of the equipment so that appropriate inspections can be conducted in a safe and ergonomic manner.

2.4.3

Other means of ensuring that the state of the pressure equipment complies with the safety requirements may be used:

A.

When it is too small to allow physical access to the inside;

B.

When the opening of the equipment under pressure may alter the internal condition;

C.

Where it is proved that the substance contained therein does not present a danger to the material of which it is constituted and that no other mechanism of internal degradation is reasonably foreseeable.

2.5 Purging and ventilation

Suitable means for the purge and ventilation of pressure equipment shall be provided as required:

A.

To avoid harmful phenomena, such as belling, collapse under vacuum, corrosion and uncontrolled chemical reactions. All operating and test states, including pressure tests, shall be considered;

B.

To allow for safe cleaning, control and maintenance.

2.6 Corrosion and other chemical attacks

Where appropriate, appropriate overthickness or protection against corrosion or other chemical attacks shall be provided, taking due account of the intended and reasonably foreseeable use.

2.7 Usure

Where equipment is likely to be subject to severe erosion or abrasion, appropriate measures should be taken to:

A.

Minimize these effects through an appropriate design, for example, by providing for over-thicknesses, or through the use of inner liners or coatings;

B.

Allow the replacement of the most affected parts;

C.

Draw attention to the instructions referred to in c. 3.4, on the measures to be taken to ensure that the use of the equipment can continue without danger.

2.8 Sets

The sets shall be so designed that:

A.

The elements to be assembled are adapted and reliable in their conditions of service;

B.

All the elements are properly integrated and properly assembled.

2.9 Filling and Dump

Where appropriate, pressure equipment shall be designed and equipped with appropriate accessories, or intended to be equipped, to ensure safe filling and emptying, in particular as regards the following risks:

2.9.1

When filling:

A.

Over-filling or overpressure, in particular with regard to the filling rate and the vapour pressure at the reference temperature;

B.

Instability of pressure equipment.

2.9.2

When emptying:

Uncontrolled exhaust of the fluid under pressure;

2.9.3

Both when filling and emptying:

Connections and disconnections presenting risks.

2.10 Protection against exceeding the allowable limits of pressure equipment

2.10.1

Where, under reasonably foreseeable conditions, the permissible limits could be exceeded, pressure equipment shall be equipped or provided for in order to be equipped with adequate protective devices, unless protection is provided for Be provided by other integrated protective devices as a whole.

2.10.2

The appropriate device or combination of the appropriate devices shall be determined on the basis of the particularities of the equipment or the set and its operating conditions.

2.10.3

Protective devices and their combinations include:

A.

Security accessories;

B.

Appropriate control devices, such as indicators or alarms, that allow for automatic or manual action to be taken to keep the equipment under pressure within the limits Eligible.

2.11 Security Accessories

2.11.1

Security accessories must:

A.

Be designed and constructed in such a way as to be reliable and adapted to the conditions of service provided for and to take into account, where appropriate, the requirements for maintenance and testing of the devices;

B.

Be independent of other functions unless their security function can be affected by other functions;

C.

Follow the appropriate design principles to ensure adequate and reliable protection. These principles include positive security (fail safe), redundancy, diversity and self-control.

2.11.2

Pressure limitation devices

These devices shall be designed so that the pressure does not permanently exceed the maximum allowable pressure PS; however, a short pressure of short duration shall be permitted in accordance with, where appropriate, the requirements of the c. 6.3.

2.11.3

Temperature Monitoring Devices

These devices must have adequate reaction time for safety reasons and compatible with the measurement function.

2.12 Outside Feu

If necessary, the pressure equipment shall be designed and, where appropriate, equipped with the appropriate or intended accessories to be equipped to meet the requirements for damage limitation in the case of external fire, In particular the use to which they are intended.

3.1 Manufacturing Process

The manufacturer shall ensure the proper implementation of the provisions taken at the design stage by applying the appropriate techniques and methods, in particular as regards the following elements:

3.1.1

Preparing components

The preparation of components (e.g., forming and chamfering) shall not result in defects, cracks or modifications of mechanical properties which may affect the safety of the equipment under pressure.

3.1.2

Permanent Assemblies

Permanent assemblies and adjacent areas shall be free of surface or internal defects detrimental to the safety of the equipment.

The properties of the permanent assemblies must correspond to the minimum properties specified for the materials to be assembled, unless other corresponding property values are specifically taken into account in the calculations of Design.

For pressure equipment, the permanent assemblies of the parts which contribute to the resistance to the pressure of the equipment and the parts directly attached thereto shall be carried out by qualified personnel to the degree of fitness Appropriate and according to qualified operating procedures.

Operating procedures and personnel shall be approved for pressure equipment of categories II, III and IV by a competent third party, at the choice of the manufacturer:

A.

A conformity assessment body;

B.

An inspection service as provided for in s. 16, para. 1.

In order to carry out these approvals, the said third party shall carry out or have carried out the examinations and tests provided for in the technical standards referred to in Art. 6 appropriate or equivalent tests and tests.

3.1.3

Non-destructive testing

For pressure equipment, non-destructive testing of permanent assemblies shall be carried out by qualified personnel to the appropriate degree of fitness. For Category III and IV pressure equipment such personnel shall have been approved by a third party entity recognized under Art. 16.

3.1.4

Thermal Treatment

Where there is a risk that the manufacturing process may modify material properties to a degree that would compromise the integrity of the pressure equipment, appropriate thermal treatment shall be applied to the appropriate step of the Manufacturing.

3.1.5

Traceability

Adequate procedures shall be established and maintained for the identification of the materials of the parts of the equipment which contribute to the pressure resistance by appropriate means, from reception to production, Until the final test of the manufactured pressure equipment.

3.2 Final check

Pressure equipment shall be subject to the final verification as described below:

3.2.1

Final Review

Pressure equipment shall be subject to a final examination designed to verify, visually and through the control of accompanying documents, compliance with the requirements of the order. In this case, account may be taken of the controls which have been carried out during the manufacturing process. In so far as safety is necessary, the final examination shall be carried out both inside and outside all parts of the equipment, if any during the manufacturing process (for example, if the inspection is no longer possible in the Final exam).

3.2.2

Pressure resistance test

The final verification of pressure equipment shall include a pressure resistance test which normally takes the form of a hydrostatic pressure test at a pressure of at least equal, where appropriate, to the value fixed at the Ch. 6.4.

For Category I equipment, manufactured in series, this test can be performed on a statistical basis.

In the event that the hydrostatic pressure test is harmful or cannot be carried out, further tests of a recognized value may be performed. For tests other than the hydrostatic pressure test, additional measures, such as non-destructive testing or other methods of equivalent effectiveness, shall be implemented prior to these tests.

3.2.3

Review of security arrangements

For packages, the final check also includes a review of security accessories to verify that the requirements referred to in c. 2.10 have been fully respected.

3.3 Marking and labelling

When labelling and marking the following information should be provided:

3.3.1

For all pressure equipment:

A.

The name and address of the person in charge of the release or any indications allowing for identification;

B.

The year of manufacture;

C.

The identification of pressure equipment according to its nature, for example the type, the identification of the series or lot, and the manufacturing number;

D.

Maximum permissible maximum/minimum limits.

3.3.2

Provided, according to the type of pressure equipment, additional information necessary for the safety of the installation, operation or use and, where appropriate, maintenance and periodic inspection, such as:

A.

Volume V of pressure equipment, expressed in I;

B.

The nominal pipe size DN;

C.

The applied PT test pressure, expressed in bar, and the date;

D.

The starting pressure of the safety device, expressed in bar;

E.

The power of the pressure equipment, expressed in kW;

F.

The supply voltage expressed in V (volts);

G.

Intended use;

H.

The loading rate, expressed in kg/l;

I.

The maximum filling mass, expressed in kg;

J.

Tare, expressed in kg;

K.

The product group.

3.3.3

Where appropriate, warnings on pressure equipment, which draw attention to the errors of use highlighted by the experiment.

3.3.4

The required information shall be affixed to the equipment under pressure or on a plate firmly fixed on them, with the exception of the following:

A.

Where appropriate, an appropriate document may be used to avoid repeated marking of individual elements such as piping components for the same set. This shall apply to all markings and labelling referred to in this Annex.

B.

When the equipment under pressure is too small, for example for accessories, the information referred to in c. 3.3.2 may be indicated on a label attached to the pressure equipment.

C.

A label or other suitable means may be used for the identification of the filling mass and to indicate the warnings referred to in the c. 3.3.3, as long as it remains legible within the appropriate time frame.

3.4 Instructions Notice

3.4.1

When put into circulation, the pressure equipment must be accompanied by a notice of instructions to the user containing all the relevant safety information with regard to:

A.

Assembly, including the assembly of various pressure equipment;

B.

Commissioning; and

C.

Use;

D.

Maintenance, including user controls.

3.4.2

The instructions shall return the information provided on the pressure equipment in application of the ch. 3.3, with the exception of the identification of the series, and shall be accompanied, where appropriate, by the technical documentation and the plans and schemes necessary for a good understanding of these instructions.

3.4.3

Where appropriate, the instructions must also draw attention to the dangers of incorrect use in accordance with the ch. 1.3 and the particular characteristics of the design according to the c. 2.2.3.

Materials used in the manufacture of pressure equipment shall be suitable for such use during their intended life, unless their replacement is provided for.

Welding materials and other assembly materials shall only fulfil the corresponding obligations of the hh. 4.1, 4.2.1 and 4.3.1, in an appropriate manner, both individually and when assembled.

4.1 Materials for pressure parts shall:

4.1.1

They shall have characteristics adapted to all reasonably foreseeable conditions of service and test conditions, and in particular to be sufficiently ductile and tenacious. Where applicable, the characteristics of these materials shall meet the requirements set out in c. 6.5. In addition, proper selection of materials should be carried out in such a way as to prevent a breakdown of fragility when necessary; when the use of a fragile material is necessary

4.1.2

For special reasons, appropriate measures must be taken.

4.1.3

They should not be significantly sensitive to aging.

4.1.4

They must be suitable for the intended processing methods.

4.1.5

They shall be chosen so as to avoid significant adverse effects when different materials are assembled.

4.2

4.2.1

The manufacturer of the pressure equipment shall properly define the necessary values for the design calculations referred to in the c. 2.2.3, as well as the essential characteristics of the materials and their implementation referred to in c. 4.1.

4.2.2

The manufacturer shall attach, in the technical documentation, the elements relating to compliance with the requirements of the Ordinance relating to materials in one of the following forms:

A.

By the use of materials in accordance with technical standards in art. 6;

B.

By the use of materials approved for equipment under pressure pursuant to Art. 15;

C.

By a particular assessment of materials.

4.2.3

For Category III and IV pressure equipment, the particular assessment shall be carried out by the conformity assessment body in charge of the conformity assessment procedures of the pressure equipment.

4.3

4.3.1

The manufacturer of the equipment shall take appropriate measures to ensure that the material used complies with the requirements. In particular, documents prepared by the manufacturer of the material certifying conformity with a given prescription must be obtained for all materials.

4.3.2

For the main parts under pressure of the equipment of categories II, III and IV, the certificate according to c. 4.3.1 must be a product-specific certificate.

4.3.3

Where a manufacturer of materials has an appropriate quality assurance system, certified by a competent body established in Switzerland and which has been the subject of a specific assessment for the materials, the certificates issued by the manufacturer shall be The alleged compliance with the corresponding requirements of the ch. 4.3.

In addition to the requirements set out in sections 1 to 4, the following requirements apply to pressure equipment referred to in sections 5.1 and 5.2.

5.1 Pressure equipment subjected to the action of the flame or to a heat input which is in danger of overheating, as referred to in Article 5 (1). 2, let. A to e, h and i

5.1.1

Included in this category of pressure equipment are:

A.

Treatment of the water supply, fuel supply;

B.

Heating appliances for industrial purposes using other fluids than steam and overheated water that are covered by s. 5, let. A and b, such as heating devices for the chemical and other comparable industries, pressure equipment for the processing of foodstuffs.

5.1.2

These pressure equipment are calculated, designed and constructed in such a way as to avoid or reduce the risk of a significant loss of containment due to overheating. In particular, it is necessary to ensure that:

A.

Appropriate protective devices are provided to limit operating parameters such as heat input and discharge and, where appropriate, the fluid level to avoid any risk of localized or generalized overheating;

B.

Sampling figures are provided where necessary to assess the properties of the fluid in order to avoid any risk associated with depositing or corrosion;

C.

Appropriate arrangements are made to eliminate the risk of damage from deposits;

D.

Safe means are provided for the disposal of residual heat after the stop;

E.

Provision is made to avoid a dangerous buildup of flammable mixtures of fuels and air or a flashback.

5.2 Tuyautery within the meaning of Art. 5, para. 2, let. D and e

Design and construction must ensure:

A.

That the risk of overload due to excessive games or excessive forces, for example at the level of brides, connections, bellows and flexible hoses, is adequately controlled by means such as supports, reinforcements, Fasteners, alignment, and prestressing

B.

That in cases where there is a risk of condensation inside the pipes for gaseous fluids, the drainage and disposal of the deposits in the low figures are provided to avoid belling or corrosion;

C.

The potential damage caused by turbulence and eddies is duly taken into account. The relevant provisions of the c. 2.7 are applicable;

D.

The risk of vibration fatigue in the pipes is properly taken into account;

E.

That when the piping contains group 1 fluids, appropriate means are provided for the isolation of shipping pipes that pose significant risks as a result of their size;

F.

The risk of inadvertent discharge is reduced to a minimum; the shipping figures shall contain, on their fixed part, the clear indication of the fluid content;

G.

The location and path of pipes and underground pipes are at least recorded in the technical documentation to facilitate safe maintenance, inspection or repair.

The following provisions are generally applicable. However, where they are not applied, including in cases where the materials are not specifically targeted and the technical standards in s. 6 are not applied, the manufacturer must justify the implementation of appropriate provisions to achieve an equivalent overall level of safety.

6.1 Eligible Constraints

6.1.1

Symbols

A.

R _{E, t} (elasticity limit), means the value at the calculation temperature, as the case may be, of:

-

The upper limit of flow for a material with lower and upper limits of headwater;

-

The conventional elasticity limit of 1.0 % for austenitic steel and non-alloy aluminum;

-

The conventional limit of elasticity at 0.2 % in other cases

B.

R _{M, 20} The minimum value of the tensile strength at 20 C;

C.

R _{M, t} Is the tensile strength at the calculation temperature.

6.1.2

The general permissible membrane stress for static-dominated loads and for temperatures outside the range where the creep phenomena are significant must not be greater than the smallest of the values Below, depending on the material used:

A.

In the case of ferritic steel, including standard steel (rolled steel) and the exclusion of fine-grained steels and steel that have undergone special heat treatment: ² / ₃ Of R _{E, t} And ⁵ / ₁₂ Of R _{M, 20} ;

B.

In the case of austenitic steel:

-

If its elongation after rupture is greater than 30 %: ⁵ / ₆ Of R _{E, t}

-

Or, alternatively, and if its elongation after rupture is greater than 35 %: ⁵ / ₆ Of R _{E, t} And ¹ / ₃ Of R _{M, t}

C.

In the case of non-alloy or weakly alloyed steel: ¹⁰ / ₁₉ Of R _{E, t} And ¹ / ₃ Of R _{M, 20} ;

D.

For aluminum: ² / ₃ Of R _{E, t} ;

E.

In the case of aluminum alloys that cannot be soaked: ² / ₃ Of R _{E, t} And ⁵ / ₁₂ Of R _{M, 20}

6.2 Joint Coefficients

6.2.1

For welded joints, the joint coefficient shall be equal to the following value:

A.

For equipment subject to destructive and non-destructive controls so as to ensure that all joints do not have significant defects: 1;

B.

For equipment subject to non-destructive testing by survey: 0.85;

C.

For equipment not subject to non-destructive testing other than visual inspection: 0.7.

6.2.2

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

6.3 Pressure limiting devices, in particular for pressure equipment

The temporary overpressure referred to in c. 2.11.2 shall be limited to 10 % of the maximum permissible pressure.

6.4 Hydrostatic test pressure

For pressure equipment, the hydrostatic test pressure referred to in c. 3.2.2 must be the highest of the following values:

A.

The pressure corresponding to the maximum load that the equipment in service can withstand, given its maximum permissible pressure and its maximum permissible temperature, multiplied by the coefficient 1.25; or

B.

The maximum permissible pressure multiplied by the coefficient 1.43.

6.5 Materials Characteristics

Unless other values are required under other criteria which must be taken into account, a steel is considered to be sufficiently ductile to satisfy the c. 4.1.1. If its elongation after failure in a tensile test carried out according to a standard procedure is at least equal to 14 % and its shock bending energy on ISO V test tube is at least 27 J, at a temperature of not more than 20 ° C, But not higher than the lowest operating temperature expected.

1

Safety accessories are classified as Category IV. However, by exception, safety accessories that are manufactured for specific equipment may be classified in the same category as the equipment to be protected.

2

Pressure accessories are classified according to:

A.

Their maximum allowable pressure PS;

B.

Their own volume V or nominal size DN; as applicable; and

C.

The group of fluids to which they are intended.

The corresponding table for containers or pipes shall be applied to specify the conformity assessment category.

In cases where both the volume and the nominal size are considered to be appropriate for the purposes of the application of the let. B, the pressure accessory shall then be classified in the highest category.

3

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

Exception: containers intended to contain an unstable gas and which fall under categories I or II in accordance with Table 1, must be classified in category III.

Exception: portable fire extinguishers and respirators should be classified at least in Category III.

Exception: sets for the production of hot water referred to in s. 5, para. 2, let. F and art. 10, are subject to a design review (module B1) in order to monitor their compliance with the essential requirements set out in the c. 2.10, 2.11, 3.4, 5.1, let. A and d, of Annex 1, of a comprehensive quality assurance system (module H).

Exception: self-censors are subject to design control in accordance with a verification procedure corresponding to at least one of the modules in category III.

Exception: pipes for unstable gases which fall under categories I or II under this table must be classified as Category III.

Exception: all piping containing fluids at a temperature above 350 °C and which falls under Category II under this table shall be classified in Category III.

The obligations arising from the provisions set out in this Annex for pressure equipment shall also apply to sets.

1

This module describes the procedure by which the manufacturer, assures and declares that the pressure equipment meets the requirements of the applicable order. The manufacturer shall prepare a declaration of conformity in writing.

2

The manufacturer shall prepare the technical documentation.

Where the manufacturer is not established in Switzerland, the obligation to keep the technical documentation is the responsibility of the person putting the equipment under pressure in circulation.

3

The technical documentation shall permit the assessment of the conformity of the equipment under pressure with the requirements of the order applicable to it. To the extent necessary for this evaluation, it shall cover the design, manufacture and operation of the equipment under pressure and contain:

A.

A general description of the pressure equipment;

B.

Design and manufacturing plans, as well as diagrams of components, subassemblies, circuits, etc.;

C.

The descriptions and explanations necessary to understand the said plans and diagrams and the operation of the equipment under pressure;

D.

A list of the standards referred to in s. 6, applied in whole or in part, and a description of the solutions adopted to meet the essential requirements of the order when the standards referred to in s. 6 have not been applied;

E.

Results of design calculations, checks carried out, etc.;

F.

Test reports.

4

The manufacturer, or the person responsible for the release, shall retain, together with the technical documentation, a copy of the declaration of conformity.

5

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the pressure equipment manufactured with the technical documentation referred to in the c. 2 and with the requirements of the order that apply to it.

In addition to the requirements of Module A, the following provisions shall apply:

1

The final audit is monitored in the form of ad hoc visits to the conformity assessment body chosen by the manufacturer. During these visits, the conformity assessment body shall:

A.

Ensure that the manufacturer does the final check in accordance with the c. 3.2 of Schedule 1;

B.

Proceed with the sampling at the manufacturing or storage of pressure equipment for control purposes. It shall appreciate the number of equipment to be removed and the need to carry out or cause to be carried out on such pressure equipment taken or part of the final check.

2

In the event that one or more pressure equipment is not in conformity, the conformity assessment body shall take appropriate measures.

3

The manufacturer shall, under the responsibility of the conformity assessment body, affix the identification number of the conformity assessment body to each equipment under pressure.

1

This module describes the part of the procedure by which a conformity assessment body finds and certifies that a copy, representative of the production concerned, complies with the provisions of the order applicable to it.

2

The application for a type examination shall be submitted by the manufacturer, or by his authorised representative in Switzerland, to a conformity assessment body of his choice. The application includes:

A.

The name and address of the person responsible for the release;

B.

A written statement that the same application has not been filed with another conformity assessment body;

C.

The technical documentation described in c. 3.

The applicant shall make available to the conformity assessment body a representative copy of the production concerned, hereinafter referred to as 'the type'. The conformity assessment body may request other copies if the programme Testing requires it.

A type 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 shall permit the assessment of the conformity of the equipment under pressure with the requirements of the order applicable to it. It shall, to the extent necessary for the evaluation, cover the design, manufacture and operation of the equipment under pressure and contain:

A.

A general description of the type;

B.

Design and manufacturing plans, as well as diagrams of components, subassemblies, circuits, etc.;

C.

The descriptions and explanations necessary to understand the said plans and diagrams and the operation of the equipment under pressure;

D.

A list of the standards referred to in s. 6, applied in whole or in part, and the descriptions of the solutions selected to meet the requirements of the order when the standards referred to in s. 6 have not been applied;

E.

The results of the design calculations carried out, the checks carried out;

F.

Test reports;

G.

The elements relating to the tests provided for in the manufacture;

H.

Elements relating to qualifications or approvals required under c. 3.1.2 and 3.1.3 of Annex 1.

4

The conformity assessment body

4.1

The conformity assessment body shall examine the technical documentation, verify that the type has been manufactured in accordance with the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the standards referred to in Art. 6, as well as those elements whose design does not rely on the provisions of those standards.

4.2

In particular, it is responsible for:

A.

It reviews the technical documentation for design and manufacturing processes.

B.

It shall evaluate the materials used when they are not in conformity with the technical standards referred to in Art. 6 applicable or approval of material for pressure equipment and verifies the certificate by the manufacturer of material in accordance with the c. 4.3 of Schedule 1.

C.

It shall act on the operating methods of permanent assembly of the parts, or verify that they have been approved previously, in accordance with c. 3.1.2 of Schedule 1.

D.

It verifies that personnel for permanent assembly of parts and non-destructive tests are qualified or approved in accordance with c. 3.1.2 or 3.1.3 of Schedule 1.

4.3

It shall carry out or carry out the appropriate tests and tests necessary to verify whether the solutions adopted by the manufacturer satisfy the essential requirements of the order when the standards referred to in Art. 6 were not applied.

4.4

It shall carry out or carry out the appropriate checks and tests necessary to verify whether, in cases where the manufacturer has chosen to apply the relevant standards, they have actually been applied.

4.5

The applicant should be provided with the place where the necessary checks and tests will be carried out.

5

Where the type complies with the corresponding provisions of the order, the conformity assessment body shall issue a type examination certificate to the applicant. The certificate, for a period of validity of ten years renewable, shall contain the name and address of the manufacturer, the conclusions of the control and the data necessary for the identification of the approved type.

A list of relevant parts of the technical documentation is attached to the certificate and a copy is retained by the conformity assessment body.

If the conformity assessment body refuses to issue a type examination certificate to the manufacturer, or to its representative in Switzerland, the conformity assessment body shall give reasons for the refusal in detail.

6

The applicant shall inform the conformity assessment body, which shall hold the technical documentation relating to the type examination certificate of all modifications of the approved pressure equipment, which shall be the subject of a new Approval where they may call into question the compliance of the equipment under pressure with the essential requirements or conditions of use. This new approval shall be issued in the form of a supplement to the initial type examination certificate.

7

Each conformity assessment body shall provide the SECO with relevant information concerning the type examination certificates it has withdrawn and, on request, those which it has issued.

Each conformity assessment body shall also communicate to the other conformity assessment bodies the relevant information concerning the type examination certificates it has withdrawn or refused.

8

Other conformity assessment bodies may obtain copies of the type examination certificates and/or their supplements. The annexes to the certificates are to be made available to other conformity assessment bodies.

9

The manufacturer, or the person responsible for putting into circulation, shall retain with the technical documentation a copy of the examination certificates of type and their supplements for a period of ten years from the date of manufacture of the last equipment Under pressure.

Where the manufacturer is not established in Switzerland, the obligation to keep the technical documentation shall be the responsibility of the person responsible for the placing of the pressure equipment in circulation in Switzerland.

1

This module describes the part of the procedure by which a conformity assessment body finds and certifies that the design of pressure equipment meets the requirements of the applicable order.

The experimental design method, provided for in c. 2.2.4 of Schedule 1, cannot be used in this module.

2

The manufacturer, or his authorised representative in Switzerland, shall submit a request for examination of the design to a single conformity assessment body. The application includes:

A.

The name and address of the manufacturer, as well as the name and address of the representative established in Switzerland if the application is made by the manufacturer;

B.

A written statement that the same application has not been filed with another conformity assessment body;

C.

The technical documentation described in c. 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 shall permit the assessment of the conformity of the equipment under pressure with the requirements of the order applicable to it. It shall, to the extent necessary for the evaluation, cover the design, manufacture and operation of the equipment under pressure and contain:

A.

A general description of the pressure equipment;

B.

Design and manufacturing plans, as well as diagrams of components, subassemblies, circuits, etc.;

C.

The descriptions and explanations necessary to understand the said plans and diagrams and the operation of the equipment under pressure;

D.

A list of the standards referred to in s. 6, applied in whole or in part, and the descriptions of the solutions selected to meet the essential requirements of the order when the standards referred to in s. 6 have not been applied;

E.

The necessary proof of the adequacy of the solutions chosen for the design, in particular where the standards referred to in s. 6 have not been fully implemented. This evidence must include the results of tests performed by or on behalf of the manufacturer's appropriate laboratory;

F.

Results of design calculations performed, controls carried out, etc.;

G.

Elements relating to qualifications or approvals required by c. 3.1.2 and 3.1.3 of Annex 1.

4 The conformity assessment body

4.1

The conformity assessment body shall review the technical documentation and identify the elements which have been designed in accordance with the applicable provisions of the standards referred to in Art. 6, as well as those elements whose design does not rely on the provisions of those standards. In particular, the conformity assessment body shall:

A.

It evaluates materials when they do not comply with the technical standards referred to in s. 6 applicable or approval of materials for pressure equipment.

B.

It shall act on the operating methods of permanent assembly of the parts, or verify that they have been approved previously, in accordance with c. 3.1.2 of Schedule 1.

C.

It verifies that personnel for permanent assembly of parts and non-destructive testing are qualified or approved in accordance with c. 3.1.2 and 3.1.3 of Annex 1.

4.2

It shall carry out the examinations necessary to verify whether, where the standards referred to in Art. 6 have not been applied, the solutions chosen by the manufacturer satisfy the essential requirements of the order.

4.3

It shall carry out or carry out the examinations necessary to ascertain whether, in cases where the manufacturer has chosen to apply the relevant standards, they have actually been applied.

5

Where the design complies with the applicable provisions of the order, the conformity assessment body shall issue a design examination certificate to the applicant. The certificate shall contain the name and address of the applicant, the conclusions of the examination, the conditions of its validity, the data necessary for the identification of the approved design.

A list of relevant parts of the technical documentation is attached to the certificate and a copy is retained by the conformity assessment body.

If the conformity assessment body refuses to issue a design examination certificate to the manufacturer, or to its representative established in Switzerland, the conformity assessment body shall give reasons for this refusal in detail.

6

The applicant shall inform the conformity assessment body, which has the technical documentation relating to the design examination certificate of all amendments to the approved design, which must be the subject of a New approval where they may call into question the conformity of the equipment under pressure with the essential requirements or the conditions of intended use. This new approval shall be issued in the form of a supplement to the original design examination certificate.

7

Each conformity assessment body shall provide the SECO with relevant information concerning the design examination certificates which it has withdrawn and, upon request, those which it has issued.

Each conformity assessment body shall also communicate to the other conformity assessment bodies the relevant information concerning the design examination certificates which it has withdrawn or refused.

8

Other conformity assessment bodies may, upon request, obtain relevant information concerning:

A.

The awards of the design examination certificates and additions thereto;

B.

Withdrawal of design examination certificates and additions to them.

9

The manufacturer, or the person responsible for the release, shall retain the technical documentation referred to in c. 3 a copy of the design examination certificates and their supplements for a period of ten years from the date of manufacture of the last pressure equipment.

Where the manufacturer is not established in Switzerland, the obligation to keep the technical documentation is the responsibility of the person placing the product in circulation.

1

This module describes the part of the procedure by which the manufacturer of the pressure equipment or the person responsible for the release ensures and declares that the pressure equipment complies with the type described in the certificate Of a type examination and meets the requirements of the applicable order. The manufacturer shall prepare a declaration of conformity in writing.

2

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the pressure equipment manufactured with the type described in the type examination certificate and with the requirements of the order that are Applicable.

3

The manufacturer shall keep a copy of the declaration of conformity for a period of ten years from the date of manufacture of the last pressure equipment.

Where the manufacturer is not established in Switzerland, the obligation to retain the technical documentation shall be the responsibility of the person responsible for the release.

4

The final audit is monitored in the form of ad hoc visits by a conformity assessment body chosen by the manufacturer. During these visits, the conformity assessment body shall:

A.

Ensure that the manufacturer does the final check in accordance with the c. 3.2 of Schedule 1;

B.

Carry out the sampling at the places of manufacture or storage of pressure equipment for control purposes; the conformity assessment body shall assess the number of equipment to be removed and the need to carry out or to do so Perform on these devices under pressure all or part of the final check.

In the event that one or more pressure equipment is not in conformity, the conformity assessment body shall take appropriate measures.

The manufacturer shall, under the responsibility of the conformity assessment body, affix the identification number of the conformity assessment body to each equipment under pressure.

1

This module describes the procedure by which the manufacturer insures and declares that the pressure equipment concerned conforms to the type described in the type examination certificate, or in the design examination certificate, and satisfy The requirements of the order that apply to them.

The manufacturer shall prepare a declaration of conformity in writing.

2

The manufacturer shall apply, for the production, final inspection and testing, a certified quality system in accordance with the c. 3 and shall be subject to the supervision referred to in c. 4.

3 Quality system

3.1

The manufacturer shall submit a request for the assessment of its quality system to a conformity assessment body of its choice. The application includes:

A.

All relevant information on the pressure equipment in question;

B.

Documentation of the quality system;

C.

Technical documentation related to the approved type and a copy of the type examination certificate or design examination certificate.

3.2

The quality system shall ensure the conformity of the equipment under pressure with the type described in the type examination certificate, or in the design examination certificate, and with the requirements of the order applicable to it.

All elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of written measures, procedures and instructions. This quality system documentation should allow for a consistent interpretation of programs, plans, manuals and quality records. In particular, it includes an adequate description:

A.

Quality objectives, the organisation chart and the responsibilities and powers of the staff in the field of quality of pressure equipment;

B.

Systematic techniques, procedures and measures that will be implemented for manufacturing as well as for quality control and quality assurance, including the permanent assembly operating procedures for parts approved in accordance with c. 3.1.2 of Annex 1;

C.

Checks and tests which will be carried out before, during and after manufacture, (with indication of the frequency) to which they will take place;

D.

Quality records such as inspection reports and test data, calibration data, reports on the qualifications or approvals of relevant personnel, including personnel for the permanent assembly of the Parts and non-destructive testing in accordance with c. 3.1.2 and 3.1.3 of Annex 1;

E.

Monitoring means to monitor the achievement of the quality required and the effective functioning of the quality system.

3.3

The conformity assessment body shall evaluate the quality system in order to determine whether it meets the requirements referred to in c. 3.2. Elements of the quality system conforming to the technical standard referred to in Art. 6 relevant are presumed to be in accordance with the corresponding requirements referred to in c. 3.2.

The audit team will have at least one member experienced in the evaluation of the equipment technology under pressure. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

3.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to ensure that it remains adequate and effective.

Manufacturer informs l l ' Conformity assessment body which has approved the quality system of any project to adapt it.

L ' The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality system will still meet the requirements referred to in the c. 3.2 or if re-evaluation is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4 Monitoring under the responsibility of ' Conformity assessment body

4.1

The purpose of the monitoring is to ensure that the manufacturer properly fulfils the obligations arising from the approved quality system.

4.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the places of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

A.

Documentation of the quality system;

B.

Quality records such as inspection reports and test data, calibration data, reports on qualifications of personnel involved, etc.

4.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer. The frequency of periodic audits is such that a full re-evaluation is conducted every three years.

4.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. The need for these additional visits and their frequency will be determined on the basis of a system of control over visits managed by the conformity assessment body. In particular, the following factors will be taken into account in the visit control system:

A.

The equipment category;

B.

Results of previous monitoring visits;

C.

The need to follow up on corrective measures;

D.

The special conditions for approval of the system, if any;

E.

Significant changes in the organization of manufacturing, measures or techniques.

On the occasion of such visits, the conformity assessment body may, if necessary, carry out or have carried out tests intended to verify the proper functioning of the quality system. It provides the manufacturer with a visitation report and, if tested, a test report.

5

The manufacturer shall make available to the inspection bodies for a period of ten years from the date of manufacture of the last pressure equipment:

A.

The documentation referred to in c. 3.1 let. B;

B.

Adaptations referred to in c. 3.4 al. 2;

C.

The decisions and reports of the conformity assessment body referred to in c. The last subparagraph and 3.4 last paragraph, as well as the c. 4.3 and 4.4.

6

Each conformity assessment body shall provide the SECO with relevant information concerning the quality system approvals it has withdrawn and, upon request, those which it has issued.

Each conformity assessment body shall also inform other conformity assessment bodies of the relevant information concerning quality system approvals which it has withdrawn or refused.

1

This module describes the procedure by which the manufacturer assures and declares that the pressure equipment concerned meets the requirements of the applicable order. The manufacturer shall prepare a declaration of conformity in writing.

2

The manufacturer establishes the following technical documentation:

The technical documentation shall be used to assess the compliance of the equipment under pressure with the corresponding requirements of the order. To the extent necessary for this evaluation, it shall cover the design, manufacture and operation of the equipment under pressure and contain:

A.

A general description of the pressure equipment;

B.

Design and manufacturing plans, as well as diagrams of components, subassemblies, circuits, etc.;

C.

The descriptions and explanations necessary to understand the said plans and diagrams and the operation of the equipment under pressure;

D.

A list of the standards referred to in s. 6, applied in whole or in part, and the descriptions of the solutions selected to meet the essential requirements of the order when the standards referred to in s. 6 have not been applied;

E.

Results of design calculations performed, controls carried out, etc.;

F.

Test reports.

3

The manufacturer shall apply, for the production, final inspection and testing, a certified quality system in accordance with the c. 4 and is subject to the supervision referred to in c. 5

4 Quality system

4.1

The manufacturer shall submit a request for the assessment of its quality system to a conformity assessment body of its choice. The application includes:

A.

All relevant information on the pressure equipment in question;

B.

Documentation of the quality system.

4.2

The quality system ensures the conformity of the equipment under pressure with the requirements of the order that are applicable to it.

All elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of written measures, procedures and instructions. This quality system documentation should allow for a consistent interpretation of programs, plans, manuals and quality records. In particular, it includes an adequate description:

A.

Quality objectives, the organisation chart and the responsibilities and powers of the staff in the field of quality of pressure equipment;

B.

Systematic techniques, procedures and measures that will be implemented for manufacturing as well as for quality control and quality assurance, including the permanent assembly operating procedures for parts approved in accordance with c. 3.1.2 of Annex 1;

C.

Tests and tests to be carried out before, during and after manufacture, with an indication of the frequency with which they will take place;

D.

Quality records such as inspection reports and test data, calibration data, reports on the qualifications or approvals of relevant personnel, including personnel for the permanent assembly of the Parts in accordance with c. 3.1.2 of Annex 1;

E.

Monitoring means to monitor the achievement of the quality required and the effective functioning of the quality system.

4.3

The conformity assessment body shall evaluate the quality system in order to determine whether it meets the requirements referred to in c. 4.2. Elements of the quality system conforming to the technical standard referred to in Art. 6 are deemed to be in compliance with the requirements.

The audit team will have at least one member experienced in the evaluation of the equipment technology under pressure. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to ensure that it remains adequate and effective.

The manufacturer of the pressure equipment or the person who puts it into circulation shall inform the conformity assessment body which has approved the quality system of any project to adapt it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality system will still meet the requirements referred to in c. 4.2 or if re-evaluation is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

5 Monitoring under the responsibility of the conformity assessment body

5.1

The purpose of the monitoring is to ensure that the manufacturer properly fulfils the obligations arising from the approved quality system.

5.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the places of manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

A.

Documentation of the quality system;

B.

Quality records such as inspection reports and test data, calibration data, reports on qualifications of personnel involved, etc.

5.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer. The frequency of periodic audits is such that a full re-evaluation is conducted every three years.

5.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. The need for these additional visits and their frequency will be determined on the basis of a system of control over visits managed by the conformity assessment body. In particular, the following factors will be taken into account in the visit control system:

A.

The equipment category;

B.

Results of previous monitoring visits;

C.

The need to follow up on corrective measures;

D.

The special conditions for approval of the system, if any;

E.

Significant changes in the organization of manufacturing, measures or techniques.

On the occasion of such visits, the conformity assessment body may, if necessary, carry out or have carried out tests intended to verify the proper functioning of the quality system. It provides the manufacturer with a visitation report and, if tested, a test report.

6

The manufacturer shall make available to the inspection bodies for a period of ten years from the date of manufacture of the last pressure equipment:

A.

The technical documentation referred to in c. 2;

B.

The documentation referred to in c. 4.1 let. B;

C.

Adaptations referred to in c. 4.4. 2;

D.

The decisions and reports of the conformity assessment body referred to in c. The last subparagraph and 4.4 last paragraph, and the c. 5.3 and 5.4.

7

Each conformity assessment body shall provide the SECO with relevant information concerning the quality system approvals it has withdrawn and, upon request, those which it has issued.

Each conformity assessment body shall also inform other conformity assessment bodies of the relevant information concerning quality system approvals which it has withdrawn or refused.

1

This module describes the procedure by which the manufacturer assures and declares that the pressure equipment complies with the type described in the standard examination certificate and satisfies the requirements of the applicable order. The manufacturer shall prepare a declaration of conformity in writing.

2

The manufacturer shall apply, for the final inspection of the pressure equipment and the tests, a certified quality system in accordance with the c. 3 and shall be subject to the supervision referred to in c. 4.

3

Quality System

3.1

The manufacturer shall submit a request for assessment of the quality system to a conformity assessment body. The application shall include:

A.

All relevant information on the pressure equipment in question;

B.

Documentation of the quality system;

C.

Technical documentation for the approved type and a copy of the type examination certificate.

3.2

Under the quality system, each pressure equipment is examined and the appropriate tests defined in the relevant standard (s) referred to in s. 6 or equivalent tests and, in particular, the final verification referred to in c. 3.2 of Schedule 1 is carried out to verify its compliance with the corresponding requirements of the order. All elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of written measures, procedures and instructions. This quality system documentation should allow for a consistent interpretation of programs, plans, manuals and quality records. In particular, it includes an adequate description:

A.

Quality objectives, the organisation chart and the responsibilities and powers of the staff in the field of quality of pressure equipment;

B.

Tests and tests to be carried out after manufacture;

C.

Monitoring means to monitor the effective functioning of the quality system;

D.

Quality records such as inspection reports and test data, calibration data, reports on the qualifications or approvals of relevant personnel, including personnel for the permanent assembly of the Parts and non-destructive testing in accordance with c. 3.1.2 and 3.1.3 of Annex 1.

3.3

The conformity assessment body shall evaluate the quality system in order to determine whether it meets the requirements referred to in c. 3.2. Elements of the quality system conforming to the technical standard referred to in Art. 6 relevant are presumed to be in accordance with the corresponding requirements referred to in c. 3.2.

The audit team will have at least one member experienced in the evaluation of the equipment technology under pressure. The evaluation procedure includes an evaluation visit to the manufacturer's facilities.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

3.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to ensure that it remains adequate and effective.

The manufacturer shall inform the conformity assessment body which has approved the quality system of any project to adapt it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality system will still meet the requirements referred to in c. 3.2 or if re-evaluation is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4 Monitoring under the responsibility of the conformity assessment body

4.1

The purpose of the monitoring is to ensure that the manufacturer properly fulfils the obligations arising from the approved quality system.

4.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the inspection, testing and storage facilities and shall provide it with all necessary information, in particular:

A.

Documentation of the quality system;

B.

Technical documentation;

C.

Quality records such as inspection reports and test data, calibration data, reports on qualifications of personnel involved, etc.

4.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer. The frequency of periodic audits is such that a full re-evaluation is conducted every three years.

4.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. The need for these additional visits and their frequency will be determined on the basis of a system of control over visits managed by the conformity assessment body. In particular, the following factors will be taken into account in the visit control system:

A.

The equipment category;

B.

Results of previous monitoring visits;

C.

The need to follow up on corrective measures;

D.

The special conditions for approval of the system, if any;

E.

Significant changes in the organization of manufacturing, measures or techniques.

On the occasion of such visits, the conformity assessment body may, if necessary, carry out or have carried out tests intended to verify the proper functioning of the quality system. It provides the manufacturer with a visitation report and, if tested, a test report.

5

The manufacturer shall keep at the disposal of the national authorities for a period of ten years from the date of manufacture of the last pressure equipment:

A.

The documentation referred to in c. 3.1 let. B;

B.

Adaptations referred to in c. 3.4 al. 2;

C.

The decisions and reports of the conformity assessment body referred to in c. The last subparagraph and 3.4 last paragraph, as well as the c. 4.3 and 4.4.

6

Each conformity assessment body shall provide the SECO with relevant information concerning the quality system approvals it has withdrawn and, upon request, those which it has issued.

Each conformity assessment body shall also inform other conformity assessment bodies of the relevant information concerning quality system approvals which it has withdrawn or refused.

1

This module describes the procedure by which the manufacturer assures and declares that the pressure equipment meets the requirements of the order that apply to them. The manufacturer shall prepare a declaration of conformity in writing.

2

The manufacturer shall prepare the technical documentation described below.

The technical documentation shall be used to assess the compliance of the equipment under pressure with the corresponding requirements of the order. To the extent necessary for this evaluation, it shall cover the design, manufacture and operation of the equipment under pressure and contain:

A.

A general description of the type;

B.

Design and manufacturing plans, as well as diagrams of components, subassemblies, circuits, etc.;

C.

The descriptions and explanations necessary to understand the said plans and diagrams and the operation of the equipment under pressure;

D.

A list of the standards referred to in s. 6, applied in whole or in part, and the descriptions of the solutions selected to meet the essential requirements of the order when the standards referred to in s. 6 have not been applied;

E.

Results of design calculations performed, controls carried out, etc.;

F.

Test reports.

3

The manufacturer shall apply, for the final inspection of the pressure equipment and the tests, a certified quality system in accordance with the c. 4 and is subject to the supervision referred to in c. 5.

4 Quality system

4.1

The manufacturer shall submit a request for the assessment of its quality system to a conformity assessment body of its choice. The application includes:

A.

All relevant information on the pressure equipment in question;

B.

Documentation of the quality system.

4.2

Under the quality system, each pressure equipment is examined and the appropriate tests defined in the relevant standard (s) referred to in s. 6 or equivalent tests and, in particular, the final verification referred to in c. 3.2 of Schedule 1 is carried out to verify its compliance with the corresponding requirements of the order. All elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of written measures, procedures and instructions. This quality system documentation should allow for a consistent interpretation of programs, plans, manuals and quality records. In particular, it includes an adequate description:

A.

Quality objectives, the organisation chart and the responsibilities and powers of the staff in the field of quality of pressure equipment;

B.

Permanent assembly operating procedures for parts approved in accordance with c. 3.1.2 of Annex 1;

C.

Tests and tests to be carried out after manufacture;

D.

Monitoring means to monitor the effective functioning of the quality system;

E.

Quality records such as inspection reports and test data, calibration data, reports on the qualifications or approvals of relevant personnel, including personnel for the permanent assembly of the Parts in accordance with c. 3.1.2 of Schedule 1.

4.3

The conformity assessment body shall evaluate the quality system in order to determine whether it meets the requirements referred to in c. 4.2. Elements of the quality system conforming to the technical standard referred to in Art. 6 relevant are presumed to comply with the corresponding requirements.

The audit team will have at least one member experienced in the evaluation of the equipment technology under pressure. The evaluation procedure includes an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to ensure that it remains adequate and effective.

The manufacturer of the pressure equipment or the person who puts it into circulation shall inform the conformity assessment body which has approved the quality system of any project to adapt it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality system will still meet the requirements referred to in c. 4.2 or if re-evaluation is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

5 Monitoring under the responsibility of the conformity assessment body

5.1

The purpose of the monitoring is to ensure that the manufacturer properly fulfils the obligations arising from the approved quality system.

5.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the inspection, testing and storage facilities and shall provide it with all necessary information, in particular:

A.

Documentation of the quality system;

B.

Technical documentation;

C.

Quality records such as inspection reports and test data, calibration data, reports on qualifications of personnel involved, etc.

5.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer. The frequency of periodic audits is such that a full re-evaluation is conducted every three years.

5.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. The need for these additional visits and their frequency will be determined on the basis of a system of control over visits managed by the conformity assessment body. In particular, the following factors will be taken into account in the visit control system:

A.

The equipment category;

B.

Results of previous monitoring visits;

C.

The need to follow up on corrective measures;

D.

The special conditions for approval of the system, if any;

E.

Significant changes in the organization of manufacturing, measures or techniques.

On the occasion of such visits, the conformity assessment body may, if necessary, carry out or have carried out tests intended to verify the proper functioning of the quality system. It provides the manufacturer with a visitation report and, if tested, a test report.

6

The manufacturer shall make available to the inspection bodies for a period of ten years from the date of manufacture of the last pressure equipment:

A.

The technical documentation referred to in c. 2;

B.

The documentation referred to in c. 4.1 let. B;

C.

Adaptations referred to in c. 4.4. 2;

D.

The decisions and reports of the conformity assessment body referred to in c. The last subparagraph and 4.4 last paragraph, and the c. 5.3 and 5.4.

7

Each conformity assessment body shall provide the SECO with the relevant information concerning the quality system approvals it has withdrawn and, upon request, those which it has issued.

Each conformity assessment body shall also communicate to the other conformity assessment bodies the relevant information concerning quality system approvals which it has withdrawn or refused.

1

This module describes the procedure by which the manufacturer insures and declares that the pressure equipment that has been subjected to the provisions of the c. 3 and meets the relevant requirements of the order is consistent with the type described:

A.

In the type examination certificate; or

B.

In the design review certificate

2

The manufacturer shall take all necessary measures to ensure that the manufacturing process ensures the conformity of the pressure equipment manufactured and meets the relevant requirements of the order with the type described:

A.

In the type examination certificate; or

B.

In the design review certificate.

The manufacturer shall prepare a declaration of conformity.

3

The conformity assessment body shall carry out the appropriate tests and tests in order to verify the conformity of the equipment under pressure with the corresponding requirements of the order by checking and testing each product, in accordance with the c. 4.

The manufacturer of the pressure equipment or the person placing it in circulation shall keep a copy of the declaration of conformity for a period of ten years from the date of manufacture of the last pressure equipment.

4 Verification by monitoring and testing of each pressure equipment

4.1

Each pressure equipment shall be examined individually and shall be subject to appropriate tests and tests set out in the relevant standard (s) referred to in s. 6 or equivalent tests and tests to verify compliance with the type and with the requirements of the applicable order. The conformity assessment body shall:

A.

Verifies that personnel for permanent assembly of parts and non-destructive testing are qualified or approved in accordance with c. 3.1.2 and 3.1.3 of Annex 1;

B.

Checks the certificate issued by the material manufacturer in accordance with the c. 4.3 of Schedule 1;

C.

Conducts or makes the final visit and test referred to in Schedule 1 c. 3.2 and shall examine, where appropriate, safety devices.

4.2

The conformity assessment body shall affix or cause its identification number to be affixed to each equipment under pressure and shall establish in writing a certificate of conformity relating to the tests carried out.

4.3

The manufacturer of the pressure equipment or the person placing it in circulation shall ensure that they are able to present on request the certificates of conformity issued by the conformity assessment body.

1

This module describes the procedure by which the manufacturer insures and declares that the pressure equipment that has obtained the certificate referred to in c. 4.1 meets the corresponding requirements of the order. The manufacturer shall prepare a declaration of conformity.

2

The request for verification of the unit shall be made by the manufacturer to a conformity assessment body of its choice. The application includes:

A.

The name and address of the manufacturer and the location of the pressure equipment;

B.

A written statement that the same application has not been filed with another conformity assessment body;

C.

Technical documentation.

3

The technical documentation shall be used to assess compliance with the corresponding requirements of the order and to understand the design, manufacture and operation of the pressure equipment.

The technical documentation includes:

A.

A general description of the pressure equipment;

B.

Design and manufacturing plans, as well as diagrams of components, subassemblies, circuits, etc.;

C.

The descriptions and explanations necessary to understand the said plans and diagrams and the operation of the equipment under pressure;

D.

A list of the standards referred to in s. 6, applied in whole or in part, and the descriptions of the solutions selected to meet the essential requirements of the order when the standards referred to in s. 6 have not been applied;

E.

Results of design calculations performed, controls carried out, etc.;

F.

Test reports;

G.

The appropriate elements relating to the qualification of the manufacturing and control processes, as well as the qualifications or approvals of the corresponding personnel in accordance with the c. 3.1.2 and 3.1.3 of Annex 1.

4

The conformity assessment body shall carry out a review of the design and construction of each pressure equipment and shall carry out the appropriate tests as provided for in the relevant standard (s). Art. 6 of the order, or equivalent tests and tests, to certify its compliance with the corresponding requirements of the order. In particular, the conformity assessment body shall:

A.

Reviews the technical documentation for design and manufacturing processes;

B.

Evaluates materials used when they do not meet the technical standards referred to in s. 6 applicable or approval of material for pressure equipment and verifies the certificate issued by the manufacturer of material in accordance with the c. 4.3 of Schedule 1;

C.

Agings the operating methods of permanent assembly of the parts or verifies that they have been approved previously in accordance with c. 3.1.2 of Annex 1;

D.

Verifies the qualifications or approvals required by the c. 3.1.2 and 3.1.3 of Annex 1;

E.

Proceeds to the final review referred to in c. 3.2.1 of Schedule 1, performs or causes the test referred to in c. 3.2.2 of Annex 1 and shall examine, where appropriate, safety devices.

4.1

The conformity assessment body shall affix or cause its identification number to be affixed to each pressure equipment and shall establish a certificate of conformity for the tests carried out. This certificate is retained for a period of ten years.

4.2

The manufacturer of the pressure equipment or the person placing it in circulation shall ensure that they are able to submit on request the declaration of conformity and the certificate of conformity issued by the conformity assessment body.

1

This module describes the procedure by which the manufacturer assures and declares that the pressure equipment considered meets the requirements of the order that apply to them. The manufacturer shall prepare a written declaration of conformity.

2

The manufacturer shall implement an approved quality system for design, manufacture, final inspection and testing, as specified in the c. 3, and is subject to the supervision referred to in c. 4.

3 Quality system

3.1

The manufacturer shall submit a request for the assessment of its quality system to a conformity assessment body of its choice. The application includes:

A.

All appropriate information for the pressure equipment in question;

B.

Documentation of the quality system.

3.2

The quality system shall ensure the conformity of the equipment under pressure with the requirements of the order that apply to it.

All elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and rational manner in the form of written measures, procedures and instructions. This quality system documentation allows for a uniform interpretation of procedural and quality measures such as programmes, plans, manuals and quality files. In particular, it includes an adequate description:

A.

Quality objectives, the organisation chart, and the responsibilities and powers of management in the quality of product design and quality;

B.

Technical design specifications, including the standards that will be applied and, where the standards referred to in s. 6 are not fully implemented, means that will be used to ensure that the essential requirements of the order that apply to pressure equipment are met;

C.

Techniques for the control and verification of the design, processes and systematic actions that will be used in the design of the pressure equipment, in particular as regards the materials referred to in the c. 4 of Annex 1;

D.

The corresponding systematic techniques, procedures and measures which will be implemented for the manufacture, and in particular the operating modes of permanent assembly of the parts approved in accordance with the c. 3.2.2 of Annex 1, as well as for quality control and assurance;

E.

Tests and tests to be carried out before, during and after manufacture, with an indication of the frequency with which they will take place;

F.

Quality records such as inspection reports and test data, calibration data, reports on the qualifications or approvals of relevant personnel, including personnel for the permanent assembly of the Parts and non-destructive testing referred to in c. 3.1.2 and 3.1.3 of Annex 1;

G.

Monitoring means to control the achievement of the design and quality required for pressure equipment and the efficient operation of the quality system.

3.3

The conformity assessment body shall evaluate the quality system in order to determine whether it meets the requirements referred to in c. 3.2. Elements of the quality system conforming to the technical standard referred to in Art. 6 relevant are presumed to comply with the corresponding requirements.

The audit team will have at least one member experienced in the evaluation of the equipment technology under pressure. The evaluation procedure shall include an inspection visit to the manufacturer's premises.

The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

3.4

The manufacturer undertakes to fulfil the obligations arising from the quality system as approved and to ensure that it remains adequate and effective.

The manufacturer shall inform the conformity assessment body which has approved the quality system of any project to adapt it.

The conformity assessment body shall evaluate the proposed amendments and decide whether the modified quality system will still meet the requirements referred to in c. 3.2 or if re-evaluation is required.

It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the monitoring and the reasoned assessment decision.

4 Monitoring under the responsibility of the conformity assessment body

4.1

The purpose of the monitoring is to ensure that the manufacturer properly fulfils the obligations arising from the approved quality system.

4.2

The manufacturer shall authorize the conformity assessment body to access, for inspection purposes, the places of design, manufacture, inspection, testing and storage and shall provide it with all necessary information, in particular:

A.

Documentation of the quality system;

B.

Quality records in the part of the quality system devoted to the design, such as test results, calculations, tests, etc.;

C.

The quality records provided for in the manufacturing quality system, such as inspection reports and test data, calibration data, reports on the qualifications of the personnel involved, etc.

4.3

The conformity assessment body shall conduct periodic audits to ensure that the manufacturer maintains and applies the quality system; it shall provide an audit report to the manufacturer. The frequency of periodic audits is such that a full re-evaluation is conducted every three years.

4.4

In addition, the conformity assessment body may make impromptu visits to the manufacturer. The need for these additional visits and their frequency will be determined on the basis of a system of control over visits managed by the conformity assessment body. In particular, the following factors will be taken into account in the visit control system:

A.

The equipment category;

B.

Results of previous monitoring visits;

C.

The need to follow up on corrective measures;

D.

Where applicable, the special conditions for approval of the system;

E.

Significant changes in the organization of manufacturing, measures or techniques.

On the occasion of such visits, the conformity assessment body may, if necessary, carry out or have carried out tests intended to verify the proper functioning of the quality system. It provides the manufacturer with a visitation report and, if tested, a test report.

5

The manufacturer shall make available to the inspection bodies for a period of ten years from the date of manufacture of the last pressure equipment:

A.

The documentation referred to in c. 3.1, let. B;

B.

Adaptations referred to in c. 3.4, para. 2;

C.

The decisions and reports of the conformity assessment body referred to in c. 3.3, last paragraph, and 3.4, last paragraph, and c. 4.3 and 4.4 ..

6

Each conformity assessment body shall provide the SECO with relevant information concerning the quality system approvals it has withdrawn and, upon request, those which it has issued.

Each conformity assessment body shall also inform other conformity assessment bodies of the relevant information concerning quality system approvals which it has withdrawn or refused.

1

In addition to the provisions of Module H, the following provisions shall also apply:

1.1

The manufacturer shall submit a request for control of the design to the conformity assessment body.

1.2

The application shall provide an understanding of the design, manufacture and operation of the pressure equipment and assess its compliance with the corresponding requirements of the order. It includes:

A.

Technical design specifications, including standards, that have been applied;

B.

The necessary evidence of their suitability, in particular where the standards referred to in s. 6 have not been fully implemented.

This evidence must include the results of tests performed by or on behalf of the manufacturer's appropriate laboratory.

1.3

The conformity assessment body shall examine the application and, where the design complies with the provisions of the relevant order, shall issue to the applicant a certificate of examination of the design. The certificate shall contain the conclusions of the examination, the conditions of its validity, the data necessary for the identification of the approved design and, where appropriate, a description of the operation of the equipment under pressure or its Accessories.

1.4

The applicant shall inform the conformity assessment body which has issued the design examination certificate for all modifications of the approved design. These must be re-approved by the conformity assessment body which has issued the design examination certificate when they can challenge the compliance of the equipment under pressure with the requirements Essential to the order or terms and conditions of use. This new authorisation shall be issued in the form of a supplement to the original design examination certificate.

1.5

Each conformity assessment body shall also communicate to the other conformity assessment bodies the relevant information concerning the design examination certificates it has withdrawn or refused.

2

The final audit referred to in Schedule 1, c. 3.2 is subject to enhanced surveillance in the form of ad hoc visits by the conformity assessment body. As part of these visits, the conformity assessment body shall carry out checks on pressure equipment.

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State 1 ^Er July 2015

1

The user inspection service must have an identifiable structure and have methods of reporting within the group of which it is a member, which guarantees and demonstrates its impartiality. It is not responsible for the design, manufacture, supply, installation, operation or maintenance of pressure equipment or sets and is not engaged in any activity incompatible with the independence of the Judgment and integrity of inspection activities

2

The User Inspection Service and its staff shall carry out the assessment and verification operations with the greatest professional integrity and technical competence and shall be free from all pressures and Incentives, in particular financial incentives, that may influence their judgment or the results of their control, in particular when they come from persons or groups of persons interested in the results of the audits.

3

The user inspectorate must have the necessary staff and resources to properly carry out the technical and administrative tasks related to the execution of controls or supervision; it must also have access to Equipment for performing exceptional audits.

4

Controls staff must have the following:

A.

Good technical and vocational training;

B.

Satisfactory knowledge of the requirements for the controls carried out and a sufficient practice of such controls;

C.

The ability to draw up the certificates, minutes and reports which constitute the materialisation of the checks carried out.

5

The impartiality of the control staff must be ensured. Its remuneration shall not depend on the number of checks it carries out, nor on the results of such controls.

6

The user inspection service must have adequate liability insurance unless this responsibility is assumed by the group of which it is a member.

7

The staff of the Office of the Inspection Service of users shall be bound by professional secrecy (except vis-à-vis the competent authorities) in relation to all that it can learn in the course of its activities, within the framework of The federal order or legislation that serves as the legal basis for the order.

1

The declaration of conformity certifies that the product complies with all the provisions applicable to its release, in particular those relating to essential health and safety requirements and conformity assessment. It is issued by the manufacturer or his authorised representative in Switzerland, in one of the official languages of Switzerland or in English.

2

The declaration of conformity must include the following:

A.

The name and address of the manufacturer or his representative in Switzerland;

B.

The description of the pressure or bagging equipment;

C.

The conformity assessment procedure applied;

D.

For the sets, the description of the pressure equipment which constitutes them and the conformity assessment procedures applied;

E.

Where applicable, the name and address of the conformity assessment body that carried out the monitoring;

F.

Where applicable, a reference to the type examination certificate, the design examination certificate or the certificate of compliance;

G.

Where applicable, the name and address of the conformity assessment body which controls the manufacturer's quality system;

H.

Where applicable, reference to technical standards referred to in s. 6 applied;

I.

Where applicable, other technical specifications that have been used;

J.

Where applicable, references to other Swiss ordinances that have been applied;

K.

The identification of the signatory having received authorisation to engage the manufacturer, or his authorised representative in Switzerland.