Simple pressure vessels are regulated by the Simple Pressure Vessels Regulations S.L. 427.01 which transposes the provisions of Directive 2014/29/EU. These regulations define rules with regards to the placing on the market and putting into service of simple pressure vessels. It establishes essential safety requirements for the protection of the health and safety of persons, and the protection of domestic animals and property regarding the hazards resulting from the leakage or bursting of vessels.
Aim of the Regulations
The regulations cover vessels manufactured in series and subjected to an internal gauge pressure greater than 0.5 bar, made to contain air or nitrogen, and are not intended to be fired. It also covers parts and assemblies contributing to the strength of the vessel under pressure made of certain qualities of steel or aluminium. It excludes vessels designed for nuclear use, vessels installed on ships and aircraft and fire extinguishers.
Categories of vessels
The regulations groups vessels into two main categories according to their capacity which is expressed as the product of the maximum working pressure and its capacity (PS.V), that is, vessels with a capacity exceeding 50 bar.L (further divided into three sub-categories), and vessels with a capacity equal to 50 bar.L or lower.
Obligations of Economic Operators
The regulations define specific requirements for all economic operators which are involved with the placing on the market of vessels namely manufacturers, authorised representatives, importers and distributors. All the parts have an important role in making sure that the product is safe for use as described below.
The obligations of manufacturers are as follows: ensure that vessels exceeding the 50 bar.L, are designed and manufactured in accordance with the essential safety requirements set out in the regulations; ensure that vessels with a 50 bar.L or less are been designed and manufactured in accordance with the sound engineering practice; ensure that vessels exceeding 50 bar.L, has all the necessary technical documentation and that the relevant conformity assessment procedure is carried out; ensure that vessels exceeding 50 bar.L has the EU declaration of conformity drawn up and the CE marking and the inscriptions affixed; ensure that vessels with a 50 bar.L or less, bear all the required inscriptions; retain the technical documentation and the EU declaration of conformity for 10 years after the vessel has been placed on the market; label their vessels with a type and serial or batch identification allowing their identification; indicate on the vessel their name, registered trade name/mark and the postal address at which they can be contacted; provide the instructions and safety information in at lease the Maltese and English language.
An authorised representative is appointed with a written mandate by the manufacturer which includes a list of tasks to be carried out namely to keep the EU declaration of conformity together with the technical documentation for a period of 10 years after the vessel has been placed on the market and to cooperate with the Technical Regulations Division as required.
The obligations of importers are clearly defined in the regulations and to a large extent they are similar to those of the manufacturer. The importer must ensure that the manufacturer has correctly fulfilled his obligations. The importer is not a simple re-seller of vessels but has a key role to play in guaranteeing the compliance of the imported vessels.
The obligations of the distributors are namely to: have a clear indication of a vessels being non-compliant; ensure that vessels bear the CE marking, where applicable and the required inscriptions; vessels are accompanied by the EU declaration of conformity, instructions and safety information
Conformity of Vessel with the Regulations
The regulation deal namely with the presumption of conformity of those vessels which exceeds 50 bar.L through the voluntary application of European harmonized standards (published in the Official Journal of the European Union). Therefore, those vessels which are in conformity with harmonized standards are presumed to be in conformity with the essential health and safety requirements of the regulations. The use of harmonized standards is commonly the preferred option for demonstrating compliance with the regulations.
Vessels whose capacity is equal to 50 bar.L or lower are subject to less requirements than those exceeding the 50 bar.L. This category of vessels is not required to be verified and assessed by a notified body; however, these shall be manufactured in accordance with sound engineering practice.
Conformity assessment procedures
These procedures are defined in the regulations and are applied for vessels which exceed 50 bar.L whereby the manufacturer or his authorised representative ensures and declares that their vessels complies with the regulations before it is placed on the market. A notified body is involved in the process which provide their professional and independent judgements to the manufactures or their authorised representatives to presume conformity with the regulations. Once the appropriate procedure has been carried out, the manufacturer or his authorised representative are responsible to affix the CE marking including other specified marking and to provide a written EU declaration of conformity with their vessel.
EU Declaration of Conformity
The EU declaration of conformity is a legal document drawn up by the manufacturer or his authorised representative declaring that the vessel fulfils the requirements of the regulations. The EU declaration of conformity contains namely, the identification of the vessel/vessel model allowing its traceability, reference to relevant harmonised standards, the name and the identification number of the notified body, and the number of the certificate issued. Schedule IV to the regulations states what the EU declaration of conformity must contain as a minimum.
CE marking and inscriptions
Vessels whose capacity exceed the 50 bar.L must be marked with the CE mark followed by the identification number of the notified body involved in the production control phase, maximum working pressure, maximum and minimum working temperature, capacity of the vessel, name or trade name/mark of the manufacturer including the address, type and serial or batch identification of the vessel, and the last two digits in which the CE marking was affixed.
Vessels whose capacity is equal to 50 bar.L or lower, must not carry the CE mark and the notified body number, however, these must have all the other information required for vessels above the 50 bar.L.