Directive 94/9/EC: Guidelines on the application
5. EQUIPMENT NOT IN THE SCOPE OF DIRECTIVE 94/9/EC
5.1. Exclusions based on Article 1.4 of Directive 94/9/EC:
- medical devices intended for use in a medical environment;
- equipment and protective systems where the explosion hazard results exclusively from the presence of explosive substances or unstable chemical substances;
- equipment intended for use in domestic and non-commercial environments where potentially explosive atmospheres may only rarely be created, solely as a result of the accidental leakage of fuel gas. The question has also been discussed as to whether this implicitly conveys the meaning that equipment intended for use in domestic and non-commercial environments, where the leakage is not fuel gas, are included within scope. It was agreed by the ATEX Standing Committee as a general rule such types of equipment are excluded from Directive 94/9/EC as they are not intended for use in a potentially explosive atmosphere;
- personal protective equipment covered by Directive 89/686/EEC. There are occasions where personal protective equipment with its own potential sources of ignition is intended for use in potentially explosive atmospheres. This type of personal protective equipment should follow the procedures laid down in Directive 94/9/EC to provide the necessary level of explosion safety (see as well chapter 6);
- seagoing vessels and mobile offshore units together with equipment on board such vessels or units, as they are already covered by the IMO Convention;
- means of transport i.e. vehicles and their trailers intended solely for transporting passengers by air, road, rail or water networks, as well as means of transport in so far as such means are designed for transporting goods by air, by public road or rail networks or by water. Means of transport intended for use in a potentially explosive atmosphere are not excluded;
- equipment covered by Article 296 (1)(b) of the EC Treaty, i.e. designed and manufactured specifically for use by the armed forces or in the maintenance of law and order. Dual-purpose equipment is not excluded.
5.2. Examples for equipment not covered by Directive 94/9/EC
5.2.1. "Simple" products
For "simple" electrical products, European harmonised standards provide a good basis to assess the effectiveness of electrical ignition source and, consequently, to determine whether or not these can be considered effective or not.
In general, many simple mechanical products do not fall under the scope of Directive 94/9/EC as they do not have their own source of ignition (see chapter 3.7.2). Examples without own source of ignition are hand tools such as hammers, spanners, saws and ladders.
Other examples that in most cases have no potential ignition source are given below. However, the manufacturer will need to consider each item in turn with respect to potential ignition hazard to consider whether Directive 94/9/EC applies (see also chapter 3.7.3):
- clockwork time pieces; mechanical camera shutters (metallic);
- pressure relief valves, self-closing doors;
- equipment moved only by human power, a hand operated pump, hand powered lifting equipment, hand operated valves.
The issue of hand operated valves has also been discussed. Given that these will move slowly, with no possibility of forming hot surfaces, as discussed in section 3.7.3 they are not in scope of the Directive. Some designs incorporate polymeric parts, which could become charged, but this is no different from plastic pipes. Given that it is clear that the latter is outside of the scope of Directive 94/9/EC it has been accepted that such valves do not fall within scope.
Some manufacturers have argued that their valves are specially adapted for ATEX, in that they have either selected more conductive polymers, or taken steps to ensure that no metal parts could become charged because they are unearthed. Other manufacturers state that all their valves meet this requirement simply by the way they are constructed, and they see no distinction from valves used to process non-flammable materials. To avoid confusion between those who claim correctly that their valves have no source of ignition, and are out of scope, and those who claim that they have done some very simple design change and wish to claim that their valves are now category 2 or even 1, it has been agreed that valves having characteristics as described above are out of scope. Nevertheless, as discussed in section 3.7.3, where potentially flammable atmospheres exists, users must always consider the electrostatic ignition risks.
The Directive does not regulate the process of installation. Installing such equipment will generally be subject to legal requirements either workplace Directives (see footnote 3, chapter 1) or the domestic legislation of the Member States.
However, the question is frequently asked to distinguish between the responsibilities of manufacturers, building a piece of equipment or an assembly under the ATEX Directive 94/9/EC and those responsibilities of an end user, buying in equipment parts to build an installation. (One might use the analogy of the difference between the manufacturing a discreet piece of equipment which can be placed on the market, such as a television (LVD 2006/95/EC), and equipping a house with all its utilities built into which a range of products will be installed and connected, this would clearly be an installation and come under Workplace Directive 89/391/EEC or other Directives concerning workplace safety.)
A common situation is that pieces of already compliant equipment are placed on the market independently by one or more manufacturer(s), and are not placed on the market by a single legal person as a single functional unit (as described in 22.214.171.124). Combining such equipment and installing at the user's premises is not considered as manufacturing and thus does not result in equipment; the result of such an operation is an installation and is outside the scope of Directive 94/9/EC. The installer has to ensure that the initially compliant pieces of equipment still comply when they are taken into service. For that reason he has to carefully follow all installation instructions of the manufacturers. The Directive does not regulate the process of installation. Installing such equipment will generally be subject to legal requirements of the Member States. An example could be instrumentation consisting of a sensor, a transmitter, a zener barrier and a power supply if provided by several different manufacturers installed under the responsibility of the user.
It is understood that there is not always a clear line between an installation and an assembly.
For assemblies and installations the responsibilities will either fall on the person who places the assembly on the market, or the end-user. Each must draw up a technical file setting out how they have complied with the relevant legislation. Much of the technical content will be the same.
The plant will usually be an installation if:
- the end user, or an installer purchases parts (including ATEX components or equipment) from different manufacturers and they are installed under his responsibility after a full risk assessment has been undertaken;
- the user carries out a whole series of different processes requiring the integration of mainly ATEX compliant equipment and parts on site, and they are installed according to a unique layout;
- the end-user commissions the building of parts of his installation off-site, which may be unique, but certainly not a production run, and which is done under his direct responsibility, or indirectly through a contractor, working under contract to him;
- commissioning tests or adjustments are needed once the plant is built and are carried out under the final responsibility of the end user.
 OJ No L 399, 30.12. 1989, amended by Directive 93/95/EEC, OJ No L 276, 9.11.1993 and Directive 93/68/EEC OJ No L 220, 30.8.1993.