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    PED 97/23/CE Directive The Pressure Equipment Directive, 97/23/EC, commonly known as the PED Directive, was issued by the European Union and implemented in Italy with Legislative Decree N° 93/2000. This Directive regulates the design and construction of pressure equipment subject to a relative pressure greater than 0.5 bar. The main new features introduced by PED are: ã  The regulation of pressure equipment design and construction, including reference to European Harmonised Standards (e.g. EN 13445 for flameless pressure vessels, EN 12952 for water tube boilers, EN 12953 for fire tube boilers, EN 13480 for piping), with a choice of which code is to be applied both in the engineering phase as well as the construction and monitoring phase. This is carried out by placing technical limitations related to the elastic properties, the efficiency of the welded  joints and tenacity of the materials used. ã  The identification of the manufacturer as the responsible for all construction phases, from design to manufacturing to final testing. The manufacturer must also ensure that the pressure risk is adequately addressed in all stages even after the final inspection, such as transport, installation, commissioning, operation, maintenance and disposal. ã  The identification of a Notified Body, as the responsible for certain phases of Certification, depending on the Module of the Directive chosen by the Manufacturer Each item of pressure equipment: 1. must be classified based on the pressure, the volume (or the diameter in the case of pipes) and the type of fluid contained. 2. must be subjected to an inspection of compliance  with the minimum safety requirements with varying degrees of severity depending on the possible risk for safety purposes. 3. must be equipped with a user instructions manual  wherein the manufacturer should: indicate any potential risks of their product; make the user aware of any precautions to be taken; indicate any inspections and maintenance that is required and how often in order to keep the product itself safe over time. PRESSURE EQUIPMENT Pressure equipment are: 1. VESSELS Housing designed and built to contain fluids under pressure. This includes its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed by more than one chamber. The following examples of products are classified as vessels: ã  Compressors, pressure vessels, condensers, gas or steam vessels, reactors, heat exchangers, LPG spheres ã  Tanks, reactors installed in production equipment, fire extinguishers ã  Steam Generators ã  Vessels for liquefied gases (cryogenic tanks) 2. PIPING Piping components intended for the transport of fluids when connected together for integration into a pressure system. This includes a pipe or system of pipes, tubing, fittings, expansion joints, hoses, or other pressure-bearing components as appropriate; heat exchangers consisting of pipes for the purpose of cooling or heating air are considered as piping. For example: ã  dismantling joints, expansion joints ã  flanges, fittings, etc. Not included are for example hydraulic tubing for oil or gas.    3. SAFETY ACCESSORIES Devices designed to protect pressure equipment against the allowable limits being exceeded. Such devices include: ã  devices for direct pressure limitation, such as safety valves and bursting discs, buckling rods, Controlled Safety Pressure Relief Systems and ã  limiting devices which either activate the means for correction or provide for shutdown or shutdown and lock out, such as pressure switches, temperature switches or fluid level and equipment for Safety Related Measurement, Control and Regulation. 4. PRESSURE ACCESSORIES: Devices with an operational function and having pressure-bearing housings. For example: ã  Valves (shut-off, regulator) ã  Vents, check valves 5. ASSEMBLIES: Several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole. HAZARDS AND RISK ASSESSMENT PRINCIPLES The PED requires manufacturers to identify the risk level of the equipment built. They are required to assess hazards due to pressure and then to design and build the equipment with this analysis in mind. The danger level is related to the concept of energy stored in the equipment. The stored energy is evaluated using the following parameters: ã  Maximum allowable pressure (PS): maximum pressure in bar for which the equipment is designed, according to the manufacturer specifications; ã  dimensions: o  volume V in litres in the case of containers (full volume including accessories attached permanently, excluding the volume of permanent internal parts) o  diameter DN in mm in the case of tubing ã  minimum/maximum permissible temperature (TS): minimum/maximum temperatures for which the equipment has been designed, according to manufacturer specifications ã  fluid type: gas, liquids, steam whether by themselves or mixtures thereof. These can be divided into o   Fluid Group 1 : dangerous media. The following fluids are included in this category:   Explosive   Extremely flammable   Highly flammable   Flammable (where the maximum allowable temperature is above flashpoint)   Very toxic   Toxic   Oxidizing media. o   Fluid Group 2 : non-dangerous media. All other fluids not included in Fluid Group 1. ã  installation and operating conditions Based on Annex II of the Directive, there are 9 tables through which it is possible to define the risk category (I, II, III, IV) depending on: the type of pressure equipment (piping, vessel, accessories); the fluid group (dangerous or non-dangerous fluids); the physical state of the fluid (gas, liquid); and the result of the PS x V calculation, for containers, or PS x DN, for pipes. The equipment acquires the category of highest risk from the risk characteristics of the components that are part of it, with the exception of the safety devices which are automatically classified in category IV, which is the maximum risk category.    RISK CATEGORY Low risk equipment  In case of proven low hazard levels, (as provided in Article 3, paragraph 3 of the Directive), a formal assessment of compliance with minimum safety is not required, however, the equipment must still be designed and constructed in accordance with good engineering practice and must be accompanied by adequate user instructions clearly identifying the manufacturer. The manufacturer is still responsible for the safety of their product. Category I Equipment Low risk equipment and assemblies belong to this category. The formal assessment of compliance with the Directive is carried out by the manufacturer who signs a Declaration of Conformity (available to the client) and affixes the CE marking on the equipment or assembly. Products must be designed and manufactured in accordance with the minimum safety requirements of the Directive and must be accompanied by appropriate user instructions and bear an identification plate containing the data required by the Directive. Category II to IV Equipment Increased risk equipment and assemblies belong to this category. The formal assessment of compliance with the Directive is carried out by a Notified Body or a user inspectorate which, after the assessment, shall issue a Certificate of conformity to the manufacturer. Once the manufacturer has obtained the Certificate, he signs a Declaration of Conformity (available to the client) and affixes the CE marking on the equipment. Products must be designed and manufactured in accordance with the minimum safety requirements of the Directive and must be accompanied by appropriate user instructions and bear an identification plate containing the data required by the Directive. For assemblies, the conformity assessment is performed both on individual items making up the whole (each according to its category), and on the whole assembly. The category of an assembly is the maximum between those of the individual equipment that compose it.     APPLICATION MODULES For category I, which covers the less hazardous equipment, the CE certification is provided without the intervention of the Notified Body: indeed the PED allows self-certification , i.e. the CE marking of the product according to the preparation of a technical file demonstrating how the essential requirements of Annex I of the Directive have been met and also justifying the product belonging to the category, accompanied by a Declaration of Conformity issued by the manufacturer and destined to the purchaser. The requirements are more onerous in the upper classes, up to class IV: ã  Category II: the CE certification by a notified body is mandatory. Without considering the merits of design, the notified body shall carry out the monitoring of production and the methods chosen by the manufacturer; ã  Category III: CE certification by a notified body is mandatory. If a manufacturer has not certified their quality system, including design, the execution of in depth testing on the prototype to be CE certification is mandatory;   ã  Category IV: requires the highest level of control on design and production. Reference is made to the safety equipment (automatically), and to assemblies consisting of vessels + pipes for the use with hazardous fluids at high pressures. Category IV is never reached by Group 2 fluids with a steam pressure lower than 0.5 bar (e.g. water at temperatures below 110 °C), regardless of the size of the equipment. The application Modules according to the Category are summarised in the following table. CATEGORY    APPLICATION MODULE(S)   I  A Internal production control II  A1 D1 E1 Internal production control and final monitoring inspection Production quality assurance Product quality assurance III  B1+D B1+F B+E B+C1 H CE EXAMINATION of design + Production Quality Assurance CE EXAMINATION of production + Product inspection CE TYPE EXAMINATION + Product Quality Assurance CE TYPE EXAMINATION + Conformity of type Full quality assurance IV  B+D B+F G H1 CE TYPE EXAMINATION + Production Quality Assurance CE TYPE EXAMINATION + Product inspection Inspection of single product Quality assurance with the final monitoring
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