CE Directive Checklist

(a) Is the product a safety component intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery?

(b) Is the product specific equipment for use in fairgrounds and/or amusement parks?

(c) Is the product machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity?

(d) Is the product a weapon (including firearms);

(e) Is the product one of the the following means of transport:
- agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
- motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers [13], with the exclusion of machinery mounted on these vehicles,
- vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles [14], with the exclusion of machinery mounted on these vehicles,
- motor vehicles exclusively intended for competition, and
- means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;

(f) Is the product a seagoing vessel and mobile offshore unit and machinery installed on board such vessels and/or units?

(g) Is the product machinery specially designed and constructed for military or police purposes?

(h) Is the product machinery specially designed and constructed for research purposes for temporary use in laboratories?

(i) Is the product mine winding gear?

(j) Is the product machinery intended to move performers during artistic performances?

(k) Is the product one of the following products:
- electrical and electronic household appliances intended for domestic use,
- audio and video equipment,
- information technology equipment,
- ordinary office machinery,
- low-voltage switchgear and control gear,
- electric motors;

(l) Is the product one of the following types of high-voltage electrical equipment:
- switch gear and control gear,
- transformers.

(a) water meters intended for the measurement of volumes of clean, cold or heated water in residential, commercial and light industrial use
(b) gas meters and volume conversion devices intended for residential, commercial and light industrial use
(c) active electrical energy meters intended for residential, commercial and light industrial use,
(d) heat meters intended for residential, commercial and light industrial use
(e) measuring systems for continuous and dynamic measurement of quantities of liquids other then water s intended for the continuous and dynamic measurement of quantities (volumes or masses) of liquids other than water
(f) automatic weighing instruments intended to determine the mass of a body by using the action of gravity on that body
(g) taximeters
(h) material measures of length
(i) dimensional measuring instruments:
- Length measuring instrument: A length measuring instrument serves for the determination of the length of ropetype materials (e.g. textiles, bands, cables) during feed motion of the product to be measured
- Area Measuring Instruments: An area measuring instrument serves for the determination of the area of irregular shaped objects, e.g. for leather.
- Multi-dimensional Measuring Instruments: A multi-dimensional measuring instrument serves for the determination of the edge length (length, height, width) of the smallest enclosing rectangular parallelepiped of a product.
(j) exhaust gas analysers intended for inspection and professional maintenance of motor vehicles in use.

A 'construction product' covered by the 'Construction Products Directive' is a product produced and placed on the market for incorporation in a permanent manner in construction works or parts thereof and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works?

(a) playground equipment intended for public use;
(b) automatic playing machines, whether coin operated or not, intended for public use;
(c) toy vehicles equipped with combustion engines;
(d) toy steam engines; and
(e) slings and catapults.

According to the directive 'in vitro diagnostic medical device’ means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

— concerning a physiological or pathological state, or
— concerning a congenital abnormality, or
— to determine the safety and compatibility with potential recipients, or— to monitor therapeutic measures.

Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

According to the Active Implantable Medical Devices Directive, a 'active implantable medical device' is an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software necessary for its proper application intended by the manufacturer to be used for medical purposes for human beings for one or more of the following purposes?

— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means

(a) medicinal products covered by Directive 2001/83/EC. In deciding whether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(b) human blood, blood products, plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells with the exception of devices referred to in paragraph 4a;
(c) transplants or tissues or cells of human origin or to products incor- porating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(d) transplants or tissues or cells of animal origin, unless a device is manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

According to the Medical Devices Directive, a 'medical device' is an instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for medical purposes for human beings for one of the following purposes:

- diagnosis, prevention, monitoring, treatment or alleviation of disease?
- diagnosis, prevention, monitoring, treatment, alleviation or compensation for an injury or handicap
- diagnosis, investigation, replacement or modification of the anatomy or a physiological process?
- designed for the control of conception?

(a) in vitro diagnostic devices;
(b) active implantable devices covered by Directive 90/385/EEC;
(c) medicinal products covered by Directive 2001/83/EC. In decidingwhether a product falls under that Directive or this Directive, particular account shall be taken of the principal mode of action of the product;
(d) cosmetic products covered by Directive 76/768/EEC;
(e) human blood, blood products, plasma or blood cells of humanorigin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells, with the exception of devices referred to in paragraph 4a;
(f) transplants or tissues or cells of human origin nor to productsincorporating or derived from tissues or cells of human origin, with the exception of devices referred to in paragraph 4a;
(g) transplants or tissues or cells of animal origin, unless a device ismanufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

The PPE Directive also covers:
(a) a unit constituted by several devices or appliances which have been integrally combined by the manufacturer for the protection of an individual against one or more potentially simultaneous risks;
(b) a protective device or appliance combined, separably or inseparably, with personal non-protective equipment worn or held by an individual for the execution of a specific activity;
(c) interchangeable PPE components which are essential to its satisfactory functioning and used exclusively for such equipment.

(a) PPE designed and manufactured specifically for use by the armed forces or in the maintenance of law and order (helmets, shields, etc.).
(b) PPE for self-defence (aerosol canisters, personal deterrent weapons, etc.).
(c) PPE designed and manufactured for private use against:
— adverse atmospheric conditions (headgear, seasonal clothing, footwear, umbrellas, etc.),
— damp and water (dish-washing gloves, etc.),
— heat (gloves etc.).
(d) PPE intended for the protection or rescue of persons on vessels or aircraft, not worn all the time.
(e) Helmets and visors intended for users of two- or three-wheeled motor vehicles.

- 'appliance' = appliance burning gaseous fuels used for cooking, heating, hot water production, refrigeration, lighting or washing and having, where applicable, a normal water temperature not exceeding 105 °C. Forced draught burners and heating bodies to be equipped with such burners shall also be considered as appliances;
- ‘fitting’ = safety devices, controlling devices or regulating devices and sub-assemblies, other than forced draught burners and heating bodies to be equipped with such burners, separately marketed for trade use and designed to be incorporated into an appliance burning gaseous fuel or assembled to constitute such an appliance;

(a) vessels specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
(b) vessels specifically intended for installation in or the propulsion of ships and aircraft;
(c) fire extinguishers.

'Vessel’ = a housing designed and built to contain fluids under pressure including its direct attachments up to the coupling point connecting it to other equipment. A vessel may be composed of more than one chamber.
‘Piping’ = piping components intended for the transport of fluids, when connected together for integration into a pressure system. Piping includes in particular 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 shall be considered as piping.
‘Safety accessory’ = a device designed to protect pressure equipment against the allowable limits being exceeded. Such devices include:
— devices for direct pressure limitation, such as safety valves, bursting disc safety devices, buckling rods, controlled safety pressure relief systems (CSPRS), and
— limiting devices, which either activate the means for correc- tion or provide for shutdown or shutdown and lockout, such as pressure switches or temperature switches or fluid level switches and ‘safety related measurement control and regulation (SRMCR)’ devices.
'Pressure accessories’ = device with an operational function and having pressure-bearing housings.
‘Assembly’ = several pieces of pressure equipment assembled by a manufacturer to constitute an integrated and functional whole.

3.1. pipelines comprising piping or a system of piping designed for the conveyance of any fluid or substance to or from an installation (onshore or offshore) starting from and including the last isolation device located within the confines of the installation, including all the annexed equipment designed specifically for pipelines. This exclusion does not apply to standard pressure equipment such as may be found in pressure reduction stations or compression stations;
3.2. networks for the supply, distribution and discharge of water and associated equipment and headraces such as penstocks, pressure tunnels, pressure shafts for hydroelectric installations and their related specific accessories;
3.3. equipment covered by Directive 87/404/EEC on simple pressure vessels;
3.4. equipment covered by Council Directive 75/324/EEC of 20 May 1975 on the approximation of the laws of the Member States relating to aerosol dispensers;
3.5. equipment intended for the functioning of vehicles defined by the following Directives and their Annexes:
— Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers,
— Council Directive 74/150/EEC of 4 March 1974 on the approximation of the laws of the Member States relating to the type-approval of wheeled agricultural or forestry tractors,
— Council Directive 92/61/EEC of 30 June 1992 relating to the type-approval of two or three-wheel motor vehicles;
3.6. equipment classified as no higher than category I under Article 9 of this Directive and covered by one of the following Directives:
— Council Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery,
— European Parliament and Council Directive 95/16/EC of 29 June 1995 on the approximation of the laws of the Member States relating to lifts,
— Council Directive 73/23/EEC of 19 February 1973 on the harmonization of the laws of the Member States relating to electrical equipment designed for use within certain voltage limits,
— Council Directive 93/42/EEC of 14 June 1993 concerning medical devices,
— Council Directive 90/396/EEC of 29 June 1990 on the approximation of the laws of the Member States relating to appliances burning gaseous fuels,
— Directive 94/9/EC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres;
3.7. equipment covered by Article 223 (1) (b) of the Treaty;
3.8. items specifically designed for nuclear use, failure of which may cause an emission of radioactivity;
3.9. well-control equipment used in the petroleum, gas or geothermal exploration and extraction industry and in underground storage which is intended to contain and/or control well pressure. This comprises the wellhead (Christmas tree), the blow out preventers (BOP), the piping manifolds and all their equipment upstream;
3.10. equipment comprising casings or machinery where the dimensioning, choice of material and manufacturing rules are based primarily on requirements for sufficient strength, rigidity and stability to meet the static and dynamic operational effects or other operational characteristics and for which pressure is not a significant design factor.
Such equipment may include:
— engines including turbines and internal combustion engines,
— steam engines, gas/steam turbines, turbo-generators, compressors, pumps and actuating devices;
3.11. blast furnaces including the furnace cooling system, hot-blast recuperators, dust extractors and blast-furnace exhaust-gas scrubbers and direct reducing cupolas, including the furnace cooling, gas converters and pans for melting, re-melting, de-gassing and casting of steel and non-ferrous metals;
3.12. enclosures for high-voltage electrical equipment such as switchgear, control gear, transformers, and rotating machines;
3.13. pressurized pipes for the containment of transmission systems, e.g. for electrical power and telephone cables;
3.14. ships, rockets, aircraft and mobile off-shore units, as well as equipment specifically intended for installation on board or the propulsion thereof;
3.15. pressure equipment consisting of a flexible casing, e.g. tyres, air cushions, balls used for play, inflatable craft, and other similar pressure equipment;
3.16. exhaust and inlet silencers;
3.17. bottles or cans for carbonated drinks for final consumption;
3.18. vessels designed for the transport and distribution of drinks having a PS·V of not more than 500 bar·L and a maximum allowable pressure not exceeding 7 bar;
3.19. equipment covered by the ADR (1), the RID (2), the IMDG (3) and the ICAO Convention;
3.20. radiators and pipes in warm water heating systems;
3.21. vessels designed to contain liquids with a gas pressure above the liquid of not more than 0,5 bar.

(a) any boat or partly completed boats of any type intended for sports and leisure purposes of hull length from 2,5 meters to 24 meters, regardless of the means of propulsion;
(b) a vessel less than 4 m in length which uses an internal combustion engine having a water jet pump as its primary source of propulsion and designed to be operated by a person or persons sitting, standing or kneeling on, rather than within the confines of, a hull;
(c) Ignition-protected equipment for inboard and stern drive engines;
(d) Start-in-gear protection devices for outboard engines.
(e) Steering wheels, steering mechanisms and cable assemblies.
(f) Fuel tanks intended for fixed installations and fuel hoses.
(g) Prefabricated hatches and portlights.
(h) propulsion engines which are installed or specifically intended for installation on or in recreational craft and personal watercraft;
(i) propulsion engines installed on or in these craft that are subject to a ‘major engine modification’;
(j) outboard engines and stern drive engines with integral exhausts intended for installation on recreational craft;

(i) craft intended solely for racing, including rowing racing boats and training rowing boats, labelled as such by the manufacturer;
(ii) canoes and kayaks, gondolas and pedalos;
(iii) sailing surfboards;
(iv) surfboards, including powered surfboards;
(v) original historical craft and individual replicas thereof designed before 1950, built predominantly with the original materials and labelled as such by the manufacturer;
(vi) experimental craft, provided that they are not subsequently placed on the Community market;
(vii) craft built for own use, provided that they are not subse- quently placed on the Community market during a period of five years;
(viii) craft specifically intended to be crewed and to carry passen- gers for commercial purposes, without prejudice to paragraph 3(a), in particular those defined in Council Directive 82/714/ EEC of 4 October 1982 laying down technical requirements for inland waterway vessels (1), regardless of the number of passengers;
(ix) submersibles;
(x) air cushion vehicles;
(xi) hydrofoils;
(xii) External combustion steam powered craft, fuelled by coal, coke, wood, oil or gas;
(b) with regard to paragraph 1(b):
(i) propulsion engines installed or specifically intended for instal- lation on the following:
— craft intended solely for racing and labelled as such by the manufacturer,
— experimental craft, provided that they are not subsequently placed on the Community market,
— craft specifically intended to be crewed and to carry passengers for commercial purposes, without prejudice to paragraph 3(a), in particular those defined in Directive 82/ 714/EEC, regardless of the number of passengers,
— submersibles,
— air cushion vehicles,
— hydrofoils;
(ii) original and individual replicas of historical propulsion engines, which are based on a pre-1950 design, not produced in series and fitted on craft referred to in paragraph 2(a)(v) and (vii);
(iii) propulsion engines built for own use provided that they are not subsequently placed on the Community market during a period of five years;
(c) with regard to paragraph 1(c):
— all craft referred to in point (b) of this paragraph,
— craft built for own use, provided that they are not subsequently placed on the Community market during a period of five years.

'lift' a lifting appliance serving specific levels, having a carrier moving along guides which are rigid and inclined at an angle of more than 15 degrees to the horizontal, intended for the transport of:
— persons,
— persons and goods,
— goods alone if the carrier is accessible, that is to say a person may enter it without difficulty, and fitted with controls situated inside the carrier or within reach of a person inside the carrier.

'safety components':
(a) Devices for locking landing doors.
(b) Devices to prevent falls referred to in Section 3.2 of Annex I to prevent the car from falling or unchecked upward movements.
(c) Overspeed limitation devices.
(d)(i) Energy-accumulating shock absorbers:
— either non-linear,
— or with damping of the return movement.
(ii) Energy-dissipating shock absorbers.
(e) Safety devices fitted to jacks of hydraulic power circuits where these are usedas devices to prevent falls.
(f) Electric safety devices in the form of safety switches containing electroniccomponents.

(a) lifting appliances whose speed is not greater than 0,15 m/s,
(b) construction site hoists,
(c) cableways, including funicular railways,
(d) lifts specially designed and constructed for military or police purposes,
(e) lifting appliances from which work can be carried out,
(f) mine winding gear,
(g) lifting appliances intended for lifting performers during artistic performances,
(h) lifting appliances fitted in means of transport,
(i) lifting appliances connected to machinery and intended exclusively for access to workstations including maintenance and inspection points on the machinery,
(j) rack and pinion trains,
(k) escalators and mechanical walkways.