Introduction                                                                                       

Lazaro Ituarte Internacional, S.A. with more than 70 years of experience in the sector, has the dedication and vocation of commitment with the quality of our products. In the occasion of the pressure Equipment Directive 97/23/EC we take the opportunity  to present to our clients and collaborators,  a brief summary with the most important  implications of the present Directive and how they affect the intra-communitarian transactions of pressure equipment.

We wished that this report may be of your interest.

 

1. FREE MOVEMENT IN THE EU                                                        

Background In May 1985, the EU Ministries decided the launch of the Harmonized Norms in order to obtain an open market  for the businesses in Europe. The Directives of the New Approach emphasizes in special requirements (for example, security) which must be fulfilled before trading the product within the European market. The Directives also prescribed how the manufacturers should demonstrate that their products fulfil the essential requirements. These products in fulfilment with European requirements must incorporate the CE Mark.

The Directive 97/23/EC is one of those Directives of New Approach.

2. CE  MARK - NOT ONLY A SIMBOL                                                

 The abbreviation CE means “Conformité Européenne” translated from the French “European Conformity”. This mark allows the free trading of the product within the EU. It also informs that the product fulfils the essential requirements of the applicable Directives.  Mark CE consists of the initials accompanied by the Notified Organism number that guarantees the fulfilment of the Directive by the original manufacturer of the equipment. It has to be placed in a visible place, in legible and indelible form. In the case of our company, our valves are dispatched with abbreviation CE0099 (code 0099 pertaining to AENOR, the Spanish Notified body).

3. 97/23/EC  DIRECTIVE FOR PRESSURE EQUIPMENTS                 

Goal: SAFETY
“New EU Directive Will Improve Safety Standards and Market Access”

The present Directive applies to the design, manufacture and quality assurance of all equipment subject to pressure that can supposedly be of potential risk. A pressure equipment is all type of container destined to the production, storage, transport and use of fluids under pressure. All the equipment under this denomination and whose permissible maximum pressure is superior to 0,5 bar over the atmospheric pressure, are subject to this European Directive. All the pressure equipment will have to:

*     Be safe
*     Fulfil the essential requirements of security covering the design, manufacture and final verification
*     Satisfy the procedures for evaluation of conformity;
*     Use the mark CE and provide various information like manuals, etc.

The lack of fulfilment in the requirements of this Directive: means that the equipment or parts subject to pressure cannot legally be provided or be installed in countries of the European Union;  it could also involve legal and civil sues and monetary or prison sentences.

The norms of the Directive are applicable for all intra-communitarian commerce; that is to say, any transaction in any place of the EU will have to be governed by the Directive.

4. RESPONSIBILITIES                                                                        

Sanctions According to point 3.1.2 of  The guide to the implementation of directives based on the New Approach, “Legal or administrative action may take place against any person in the supply or distribution chain who can be considered responsible for a non-compliant product”

Certificates from original manufacturer The Directive requires that the manufacturers or importers have to inform their clients of all relevant aspects related to the product, for the correct measurement of  the inherent risk of the equipment subject to pressure.

In some cases, the Directives can require that the original manufacturer is identified in the product. However, the certificates of conformity will still have to be issued by the original manufacturer in all cases, ie. An European manufacturer importing valves from China will have to present original Chinese Certificates. Also the equipment must be marked with the CE number of the original manufacturer (extra communitarian in the case of imports).

5. PRESSURE EQUIPMENT CLASIFICATION                                     

The pressure equipments are classified by categories according to Annexe II of the Directive and based on:

*     P x V (permissible Maximum Pressure multiplied by flowed Volume)
*     According to ascending level of hazard

6. CONFORMITY ASSESMENT PROCEDURES                                 

The Certificate of Conformity, a document which must be accompanying all valves, is an indispensable requirement to commercialise pressure equipments in Europe. It is also an approval of vessel’s adjustment to the essential security requirements.

Example: gate valve Class 300# and size 8”. Fluid of application: natural gas (dangerous fluid according to the Directive). As per as table 1 of Annex II of Directive 97/23/EC corresponds a category IV based on its PxV and type of fluid. This valve must be marked by some of the following procedures of conformity evaluation:

  1. Procedures B+D: the Notified Body (like AENOR, Lloyd’s...) must conduct a CE type examination for the valve gate Class 300 and size 8”and in addition, to verify the QA System. The manufacturer who does not have the H1 Module, will have to request an inspection of its QA System as well as an inspection of the type of valves (from the phase of design to manufacture and tests that verifies the requirements of the Directive) without this approval, the trading of this valve would be considered an illegal act in Europe.

  2. Procedures B+F: the Notified Body must conduct a CE type examination for the valve gate Class 300 and size 8” and in addition, to verify that the manufacturing of the product (for these valves) adjusts to the type and fulfils the Directive. For a manufacturer who does not have the H1 Module, will have to verify that the valves adjusts to the type examination in presence of a Notified Body. Without this approval, the supply of this valve would be considered an illegal act in Europe.

  3. Procedure G: the Notified Body completely verifies the product: from the design to manufacture and tests. This represents that, the manufacturer will have to conduct in presence of the Notified Body an evaluation for all the valves; one by one. Without this approval, the trading of this valve in Europe would be considered an act illegal.

  4. Procedure H1: the Notified Body guarantees the QA System of the manufacturer, approves the design and manufacturing and controls the final verification. All types of valves made by La'zaro Ituarte Internacional, S.A have been evaluated under this procedure. The H1 module allows the manufacturer to overpass further approvals like in the previous cases, as this procedure is the strictest one.

    *     In order to assure the quality of the pressure equipment of categories III and IV the Notified Body, in its visits without previous notice,  will take samples of the equipment in order to conduct a final verification.

    *     The evaluation of the pressure equipments will include the parts related to the vessel (ie. Safety valves, bypasses…), and the integration of the different elements in one set (actuators) and the general protection of the equipment against exceeds the permissible security limits.

7. CONFORMITY ASSESTMENTS DONE BY LAZARO ITUARTE      

As previously commented, Lazaro Ituarte Internacional, S.A. has carried out in the presence of the Notified Body AENOR (Number 0099) the procedure of conformity evaluation H1 Module for the fulfilment of the PED for all its valves and in all their categories. This procedure consists in a QA System fully approved for the design, manufacture, final inspection and tests; guarantees and declares that the valves and components affected by pressure fulfil the requirements of the Directive.

Lazaro Ituarte Internacional, S.A. presented to AENOR several requests for each design. The Notified Body examined each request and with favourable results, issued certificate of examination CE of design, for each type of valve. Final verification is subject to a reinforced monitoring consisting of visit without previous warnings.

Lazaro Ituarte Internacional, S.A. obtained already 6 certificates CE of Design for its types and models of valves. Finally, Lazaro Ituarte Internacional, S.A. fixes the Mark CE0099 in each valve and does a written declaration of conformity, as per as the law.