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:
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.
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.
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:
Compressors, pressure vessels, condensers, gas or steam vessels, reactors, heat exchangers,
LPG spheres
Tanks, reactors installed in production equipment, fire extinguishers
Steam Generators
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:
dismantling joints, expansion joints
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:
devices for direct pressure limitation, such as safety valves and bursting discs, buckling rods,
Controlled Safety Pressure Relief Systems and
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:
Valves (shut-off, regulator)
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:
Maximum allowable pressure (PS): maximum pressure in bar for which the equipment is designed,
according to the manufacturer specifications;
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
minimum/maximum permissible temperature (TS): minimum/maximum temperatures for which the
equipment has been designed, according to manufacturer specifications
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.
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:
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;
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;
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




REQUIRED DOCUMENTATION
The PED requires stringent documentation of all equipment and pressure assemblies that exceed 0.5 bar.

DOCUMENT TYPE ISSUED BY MODULE CATEGORY
Declaration of
Conformity
Manufacturer
A, A1, C1, D, D1, E, E1,
F, G, H, H1
I, II, III, IV
Certificate of CE type
examination
Notified Body B III, IV
Certificate of CE
examination of design
Notified Body B1 III
Certificate of CE
examination of the
project
Notified Body H1 IV
Certificate of Conformity Notified Body F, G III, IV
Quality system
Assessment notification
Notified Body D, D1, E, E1, H, H1 II, III, IV

A substantial part of the documentation required is collected in the " Technical File" . We have listed some of
the contents below.

Regarding the design:
1. Risk analysis and assessment;
2. Report on design;
3. Drawings;

Regarding the materials:
1. Description of materials;
2. Specifications required;
3. Certification of materials;
4. Tests on the materials used;

Regarding the manufacturing:
1. Description of manufacturing processes;
2. Operator qualifications;
3. Welding qualifications;
4. Report on process control management;

Regarding the implementation:
1. Final inspection report;

In addition to the technical dossier, the manufacturer must also draw up a user manual and a maintenance
log for the user.



ASSEMBLY ASSESSMENT
New assemblies
New assemblies must follow the Directive and therefore must be subject to an assessment of conformity and
bear the CE mark.
Who builds and sells such assemblies is the manufacturer, pursuant to the Directive, and therefore is under
all the obligations set out by the same.

Assemblies pre-existing the Directive, which do not require any intervention
These assemblies may continue to be operated without additional expense to the user except the re-
classification according to the new categories of risk listed in the Directive and the execution of a series of
checks to define the state of preservation.

Assemblies pre-existing the Directive, which are subjected to modification
The Directive states that, following any modification, the equipment should be subjected to a verification of
compliance: therefore the party in charge of this modification (except in the case in which the product user
assumes full responsibility) is the assembly manufacturer with all consequent obligations.

Assemblies pre-existing the Directive, which are subjected to component replacement
This is the most common and most complex situation. Notwithstanding the fact that the substitute component
must be CE marked, the problem is represented by the inclusion of this component in the assembly.
If the user does not assume full responsibility, the party responsible for replacement is required by the
Directive to operate according to the Directive, and therefore we will be faced with two options:
1. CE mark the whole assembly (as in the case of a modification)
2. CE mark the individual substitution piece.
In the latter case, however, the Notified Body responsible must be provided with proper documentation
attesting the fact that the existing part and the part replaced are mutually compatible; as a minimum, this will
require a risk analysis of the whole.
The choice of which path to take will depend on the specific case and the decision should be taken
necessarily in agreement with the user of the assembly.

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CTAI, TV Rheinland Partner, Notified Body, can offer all services necessary for the application steps of the
Directive and in particular:
- Technical File Examination
- Inspections of materials and components
- Special approvals of materials
- Qualifications of working processes (e.g., permanent joints) and of the workers
- Qualifications of operators of Non-Destructive Testing
- Certificate for Modules A1, D1, E1
- Certificate for EC type examination, Module B
- Certificate for EC design examination, Module B1
- Certificate of Conformity to Type, Module C1
- Certificate for production quality assurance, Module D
- Certificate for product quality assurance, Module E
- Single product verification, Module F
- Single product EC verification, Module F
- Certificate for full quality assurance, Module H
- Full quality assurance certificate with production control, Module H1

We can also provide the manufacturer with support for the following services:
- Identification of the applicable requirements of the Directive, and the relevant harmonised and/or non-
harmonised standards
- Choice of the application Modules of the Directive
- Execution of compliance testing in affiliated laboratories
- Consultancy for risk analysis and the development of the Technical File as required by the Directive
- Training courses on the application of the Directive