Controltest

Conformity Assessment

Controltest Ltd is a Notified by European Commission Body number 2413 for Conformity Assessment of:
 
2010/35/ EU – „Transportable Pressure Equipment Directive /ТРЕD/”.
 
Контролтест ООД е нотифициран да изваршва :
  • Type assessment of transportable pressure equipment /TPE/
  • Initial check of transportable pressure equipment /TPE/
  • Supervision of manufacturing of transportable pressure equipment /TPE/
  • Supervision of in-house inspection services and delegation of certain rights, which can be performed under our Notification
  • Periodic checks of transportable pressure equipment /TPE/
  • Intermediate checks of transportable pressure equipment /TPE/
  • Exceptional checks of transportable pressure equipment /TPE/
  • Reassessment of conformity of transportable pressure equipment /TPE/
Оценявяне на съответствието се извършва на следното транспортируемо обурудване под налягане:
  • Cylinders  - Chapter 6.2.      ADR, RID, ADN
  • Tubes  - Chapter 6.2.      ADR,RID, ADN
  • Pressure drums - Chapter 6.2.      ADR, RID, ADN
  • Barrel - Chapter 6.2.      ADR, RID, ADN
  • Bundles of cylinders  - Chapter 6.2.      ADR, RID, ADN
  • Closed cryogenic receptacles - Chapter 6.2.      ADR, RID, ADN
  • UN multiple-element gas containers (MEGCs) - Chapter 6.7.5.   ADR, RID, ADN
  • Portable tanks  - Chapter 6.7.3.   ADR, RID, ADN
  • Tanks - Chapter 6.8.      ADR, RID, ADN
  • Multiple-element gas containers (MEGCs) - Chapter 6.8.      ADR, RID, ADN
With the stated above we cover the full scope of activities for implementation of 2010/35/EU Transportable pressure equipment, ADR, RID, ADN and standards, concerning the design, manufacture , testing and conformity assessment of Transportable pressure equipment
 
2014/68/EU – „Pressure Equipment Directive /РЕD/”
 
The Pressure Equipment Directive (PED) is a European Union Directive applicable to the design, manufacture and conformity assessment of pressure equipment and assemblies of pressure equipment with a maximum allowable pressure greater than 0.5 bar.
The basic purpose of the PED is to ensure that pressure equipment used in the European Economic Area1 (EEA) is safe. Additionally, because the requirements of the Directive are common to all states within the EEA, all equipment complying with the PED may be sold and used anywhere within the EEA.
PED requires the level of hazard of pressure equipment to be assessed and classified into 1 of 5 categories.
  • SEP (Sound engineering practice)  
  • Category I
  • Category II
  • Category III
  • Category IV
The higher the level of hazard, the more extensive the level of quality assurance required during the design, manufacture and testing of the equipment.
Determining the Hazard Category
When the PED category has been established for equipment, the conformity assessment requirements can be defined. Тhe conformity assessment is the quality assurance required to validate the design, manufacture, testing and inspection of the equipment. The higher the equipment PED category, the higher the level of hazard and therefore the more extensive the quality assurance requirements are.
The PED category defines the required conformity assessment module. Where multiple module choices apply, the equipment manufacturer may select the module(s) best suited to their particular requirement.
 
Types of Pressure Equipment
 
The PED defines 6 types of pressure equipment:
1. Vessel
2. Fired or otherwise heated pressure equipment with the risk of overheating (generator of steam or super- heated water at temperatures higher than 110 °C)
3. Piping
4. Safety accessories
5. Pressure accessories
6. Assemblies
   
Fluid Group
 
The fluid is hazardous it is a Group 1 fluid, otherwise it is a Group 2 fluid.
Group 1
Group 1 consisting of substances and mixtures, as defined in points (7) and (8) of Article 2 of Regulation (EC) No 1272/2008, that are classified as hazardous in accordance with the following physical or health hazard classes laid down in Parts 2 and 3 of Annex I to that Regulation:
(i) unstable explosives or explosives of Divisions 1.1, 1.2, 1.3, 1.4 and 1.5;
(ii) flammable gases, category 1 and 2;
(iii) oxidising gases, category 1;
(iv) flammable liquids, category 1 and 2;
(v) flammable liquids, category 3 where the maximum allowable temperature is above the flashpoint;
(vi) flammable solids, category 1 and 2;
(vii) self-reactive substances and mixtures, type A to F;
(viii) pyrophoric liquids, category 1;
(ix) pyrophoric solids, category 1;
(x) substances and mixtures which in contact with water emit flammable gases, category 1, 2 and 3;
(xi) oxidising liquids, category 1, 2 and 3;
(xii) oxidising solids, category 1, 2 and 3;
(xiii) organic peroxides types A to F;
(xiv) acute oral toxicity, category 1 and 2;
(xv) acute dermal toxicity, category 1 and 2;
(xvi) acute inhalation toxicity, category 1, 2 and 3;
(xvii) specific target organ toxicity – single exposure, category 1.
EN L 189/182 Official Journal of the European Union 27.6.2014
Group 1 comprises also substances and mixtures contained in pressure equipment with a maximum allowable temperature TS which exceeds the flashpoint of the fluid;
For more information see http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0068&from=EN
Group 2
Group 2 comprises all other fluids including steam.
 
CONFORMITY ASSESSMENT PROCEDURES
Module A:
 (internal production control)
Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations under the preparation of technical documentation, manufacturing, affix CE marking and ensures and declares on his sole responsibility that the PE concerned satisfy the requirements of this Directive (no EU-type examination).
No part of the notified body.
   
Module A2:
 internal production control plus supervised pressure equipment checks at random intervals
Module A2 is the conformity assessment procedure whereby the manufacturer fulfils the obligations under the preparation of technical documentation, manufacturing, final assessment and pressure equipment checks, affix CE marking, and ensures and declares on his sole responsibility that the PE concerned satisfy the requirements of this Directive (no EU-type examination).
The manufacturer shall perform a final assessment of the pressure equipment, monitored by means of unexpected visits by a notified body chosen by the manufacturer.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
Module B:
eu-type examination
EU-Type examination – production type
  • EU-type examination — production type - is the part of a conformity assessment procedure in which a notified body examines the technical design of the PE and supporting evidence plus examination of a specimen, representative of the production envisaged, of the complete pressure equipment.
 Verifies and attests that the technical design of the PE meets the requirements of this Directive.
Where the type meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate – production type to the manufacturer.
EU-Type examination – design type
  • EU-type examination – design type is the part of a conformity assessment procedure in which a notified body examines the technical design of the PE and supporting evidence without examination of a specimen. Verifies and attests that the technical design of the pressure equipment meets the requirements of this Directive.
Where the design meets the requirements of this Directive, the notified body shall issue an EU-type examination certificate — design type to the manufacturer.
   
Module C2:
conformity to type based on internal production control plus supervised pressure equipment checks at random intervals
Module C2 is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations under the manufacturing, final assessment and pressure equipment checks, affix CE marking and ensures and declares on his sole responsibility that the pressure equipment (PE) concerned is in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Directive that apply to it.
A notified body, chosen by the manufacturer, shall carry out checks or have them carried out at random intervals determined by the body, in order to verify the quality of the final assessment and of the internal checks on the PE, taking into account, inter alia, the technological complexity of the PE and the quantity of production.
Where the tests are carried out by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
Module D:
 conformity to type based on quality assurance of the production process
Module D is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations under the manufacturing, final assessment and pressure equipment (PE)checks, affix CE marking and ensures and declares on his sole responsibility that the PE or assembly concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the PE and shall be subject to surveillance under the responsibility of the notified body.
The notified body shall assess the quality system to determine whether it ensure that the PE is in conformity with the type described in the EU-type examination certificate and comply with the requirements of this Directive that apply to it.
Where the quality system is approved by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
Module D1:
quality assurance of the production process
Module D1 is the conformity assessment procedure whereby the manufacturer fulfils the obligations under the preparation of technical documentation and manufacturing and ensures and declares on his sole responsibility that the pressure equipment (PE) concerned satisfy the requirements of this Directive (no EU-type examination).
The manufacturer shall operate an approved quality system for production, final product inspection and testing of the PE and shall be subject to surveillance under the responsibility of the notified body.
The notified body shall assess the quality system to determine whether it ensure that the PE comply with the requirements of this Directive that apply to it.
Where the quality system is approved by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
Module E:
conformity to type based on pressure equipment quality assurance
Module Е is that part of a conformity assessment procedure whereby the manufacturer fulfils the obligations under the manufacturing and ensures and declares on his sole responsibility that the pressure equipment (PE) or assembly concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive that apply to it.
The manufacturer shall operate an approved quality system for the final product inspection and testing of the PE concerned and shall be subject to surveillance under the responsibility of the notified body.
The notified body shall assess the quality system to determine whether ensure compliance of the products with the type described in the EU-type examination certificate and with the applicable requirements of this Directive.
Where the quality system is approved by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
Module E1:
quality assurance of final pressure equipment inspection and testing
Module Е1 is the conformity assessment procedure whereby the manufacturer fulfils the obligations under the preparation of technical documentation and the manufacturing and ensures and declares on his sole responsibility that the PE concerned satisfy the requirements of this Directive (no EU-type examination).
The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the PE with the relevant requirements, and shall include an adequate analysis and assessment of the risk.
The manufacturer shall operate an approved quality system for final product inspection and testing of the PE and shall be subject to surveillance under the responsibility of the notified body.
The notified body shall assess the quality system to determine whether it ensure that the PE comply with the requirements of this Directive that apply to it.
Where the quality system is approved by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process
   
Module F:
conformity to type based on pressure equipment verification
Module F is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations under the manufacturing and ensures and declares on his sole responsibility that the pressure equipment (PE) concerned, on that carry out appropriate examinations and tests are in conformity with the type described in the EU-type examination certificate and satisfies the requirements of this Directive which apply to it.
A notified body chosen by the manufacturer shall carry out the appropriate examinations and tests individually to all pressure equipment in order to check the conformity of the PE with the approved type described in the EU-type examination certificate and with the appropriate requirements of this Directive.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out, and shall affix its identification number or have it affixed under its responsibility to each approved item of PE.
   
Module G:
conformity based on unit verification
MODULE G is the conformity assessment procedure whereby the manufacturer fulfils the obligations under the preparation of technical documentation and manufacturing and ensures and declares on his sole responsibility that the pressure equipment (PE) concerned satisfy the requirements of this Directive (no EU-type examination).
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the conformity of the PE with the relevant requirements and shall include an adequate analysis and assessment of the risk(s).
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured PE with the applicable requirements of this Directive.
A notified body chosen by the manufacturer shall carry out appropriate examinations and tests, set out in the relevant harmonised standard(s) and/or equivalent tests, to check the conformity of the PE with the applicable requirements of this Directive.
The notified body shall issue a certificate of conformity in respect of the examinations and tests carried out and shall affix its identification number to the approved PE, or have it affixed under its responsibility.
   
Module H:
conformity based on full quality assurance
MODULE H is the conformity assessment procedure whereby the manufacturer fulfils the obligations under manufacturing and ensures and declares on his sole responsibility that the PE concerned satisfy the requirements of this Directive (no EU-type examination).
The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the PE and shall be subject to surveillance under the responsibility of the notified body.
The notified body shall assess the quality system to determine whether it ensure that the PE comply with the requirements of this Directive that apply to it.
Where the quality system is approved by a notified body, the manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
Module H1:
conformity based on full quality assurance plus design examination
MODULE H1 is the conformity assessment procedure whereby the manufacturer fulfils the obligations under manufacturing and ensures and declares on his sole responsibility that the pressure equipment (PE) concerned satisfy the requirements of this Directive .
The manufacturer shall operate an approved quality system for design, manufacture, final product inspection and testing of the PE and and shall be subject to surveillance under the responsibility of the notified body.
The notified body shall assess the quality system to determine whether it ensure that the PE comply with the requirements of this Directive that apply to it.
The manufacturer shall lodge an application for examination of the design of each item of PE not covered by a previous design examination to the notified body.
Where the design meets the requirements of this Directive that apply to the PE it shall issue an EU design examination certificate to the manufacturer.
The manufacturer shall, under the responsibility of the notified body, affix the notified body’s identification number during the manufacturing process.
   
     
 
Procedures applicable to conformity assessment
Category  The Conformity Assessment procedures that are applied for the various categories are the following:
I: Модул А
  quality system without quality system
II Module D1 or
Module E,
Module A2
III Module B (design type)+ Модул D,
or
Module B  (production type) + Module E,
or
Module H
Module B (design type) + Module F
or
Module B (production type) + Module C2
IV Module B (production type) + Module D,
or
Module H1
Module B (production type) + Module F,
or
Module G
 
The demarcation lines in the following conformity assessment tables indicate the upper limit for each category.
 
 Table 1
Vessels for compressed gases, liquefied gases or gases dissolved under pressure, vapors or liquids whose vapor pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure, for fluids in Group 1 with a volume greater than 1L and a product of maximum allowable pressure PS (in bar)and volume V (in Liters) greater than 25, or when maximum allowable pressure is greater than 200 bar.
As an exception, vessels intended for unstable gases and falling within category I or II according to the table 1, are classified as category III.
   
 Table 3
Vessels for liquids whose vapor pressure at the maximum allowable temperature is not more than 0,5 bar above normal atmospheric pressure (1 013 mbar), for fluids in Group 1 with a volume V greater than 1L and a product of maximum allowable pressure PS (in bar)and volume V (in Liters) greater than 200, or when maximum allowable pressure is greater than 500 bar. 
 
 
   
 Table 5
Pressure equipment with a volume V greater than 2 l with a risk of overheating by fire or otherwise heated intended for generation of steam or hot water at temperatures higher than 110°C as well as all pressure cookers
As an exception, the design of pressure cookers is subject to a conformity assessment procedure corresponding to at least one of category III modules.
 
 Table 2
Vessels for compressed gases, liquefied gases or gases dissolved under pressure, vapors or liquids whose vapor pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure, for fluids in Group 2 with a volume greater than 1L and a product of maximum allowable pressure PS (in bar)and volume V (in Liters) greater than 50, or when maximum allowable pressure is greater than 1000 bar as well as all portable extinguishers and bottles for breathing apparatus. 
As an exception, portable extinguishers and bottles intended for breathing apparatus are classified at least as category III.
   
Table 4
Vessels for liquids whose vapor pressure at the maximum allowable temperature is not more than 0,5 bar above normal atmospheric pressure, for fluids in Group 2 with a maximum allowable pressure PS greater than 10 bar and a product of maximum allowable pressure PS (in bar)and volume V (in Liters) greater than 10000, or when maximum allowable pressure is greater than 1000 bar.
As an exception, assemblies intended for generating hot water as referred to in Article 4 (2, subparagraph 2) are subject either to EU type-examination (module B – design type) with regard to their conformity with the essential requirements referred to in points 2.10, 2.11, 3.4, 5(a) and 5(d) of Annex I, or to conformity on full quality assurance (module H).
   
Table 6
Piping intended for compressed gases, liquefied gases or gases dissolved under pressure, vapors or liquids whose vapor pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1013mbar), for fluids in Group 1 with a nominal size DN greater than 25mm.
As an exception, piping intended for unstable gases and falling within category I or II according to the table 6, are classified as category III.
 
 Table 7
Piping intended for compressed gases, liquefied gases or gases dissolved under pressure, vapors or liquids whose vapor pressure at the maximum allowable temperature is greater than 0,5 bar above normal atmospheric pressure (1013mbar), for fluids in Group 2 with a nominal size DN greater than 32mm and a product of maximum allowable pressure PS and nominal size DN is greater than 1000.
As an exception, all piping containing fluids at a temperature higher than 350°C and falling within category II according to the table 7, are classified as category III.
   
 Table 8
Piping intended for liquids whose vapor pressure at the maximum allowable temperature is not more than 0,5 bar above normal atmospheric pressure (1013mbar) for fluids in Group 1 with a nominal size DN greater than 25mm and a product of maximum allowable pressure PS and nominal size DN is greater than 2000.
   
 Table 9
Piping intended for liquids whose vapor pressure at the maximum allowable temperature is not more than 0,5 bar above normal atmospheric pressure (1013 mbar) for fluids in Group 2 with a nominal size DN greater than 32mm and a product of maximum allowable pressure PS and nominal size DN is greater than 1000.