§388 ノーティファイドボディが関与する適合性評価手続のいずれかの対象となりうる機械のカテゴリー

Annex IV sets out the list of categories of machinery that may be subject to one of the two conformity assessment procedures involving a Notified Body: EC type- examination or Full quality assurance. These categories include machinery in the broad sense – see §33: comments on Article 2. Machinery belonging to one of the categories listed in Annex IV may also be subject to the procedure for assessment of conformity with internal checks when it is manufactured in accordance with harmonised standards that cover all of the applicable EHSRs – see §129 and §130: comments on Article 12 (3) and (4).

The list set out in Annex IV is exhaustive, in other words, only the machinery belonging to the categories listed is subject to the conformity assessment procedures set out in Article 12 (3) and (4). Machinery belonging to categories not listed in Annex IV, even if it is similar or presents similar hazards to the categories listed, is subject only to the procedure for assessment of conformity with internal checks – see §128: comments on Article 12 (2).

Items 1 to 8

Item 1 covers only circular saws for working with wood and analogous materials or for working with meat or analogous materials belonging to the categories referred to in items 1.1 to 1.4.

It should also be noted that not all circular saws for working wood are concerned; for example, sawing machinery with a blade moved by hand during cutting (such as some mitre saws) are not referred to in Annex IV.

Materials analogous to wood include, for example, chipboard, fibreboard, plywood (and also these materials when they are covered with plastic or light alloy laminates/edges), cork, bone, rigid rubber or plastic. On the other hand, stone, concrete and similar materials requiring an abrasive type of cutting tool are not considered as materials analogous to wood.

Materials analogous to meat include fish and frozen or deep-frozen food.

Items 1.3, 1.4, 3 and 4 refer to manual loading and/or unloading. Manual loading and/or unloading occurs when the operator places workpieces directly in the feed device or workpiece support device and removes them directly from that device, so that it is possible for the operator to have direct contact with the workpiece while it is in contact with the tool. Machinery is not considered to have manual loading or unloading if it is equipped with a feed device or a device for loading and unloading workpieces (such as, for example, a conveyor) such that the tools are out of reach of the user while the device is being used and the machinery cannot be operated without the device.

Items 1.1, 2, 6 and 7 refer to manual feed or hand fed machinery. Manual feed or hand feed occurs when either the workpiece or the tool is manually moved during machining so that it is possible for the operator to come into contact with the tool. The same applies to the machinery with a manually operated reciprocating saw- bench or carriage referred to in item 1.2.

The combined woodworking machinery referred to in item 5 is machinery designed to carry out any combination of the functions referred to in items 1 to 4 and 7, with manual removal of the workpiece between each operation - see §210: comments on section 1.3.5 of Annex I. Only combined machinery carrying out functions referred to in items 1 to 4 and 7 is subject to item 5 of Annex IV, however such machinery may also carry out other additional functions. Since the necessary protective measures are often common to several or all of the combined functions, the EC type-examination or the assessment of the full quality assurance system for such combined woodworking machinery shall always concern the entire machinery.

The vertical spindle moulding machines referred to in item 7 have one spindle passing through the table and one drive motor situated beneath the table. Routing machinery with a spindle located completely above the table is not covered by item 7.

Item 9

The presses for cold working of metals referred to in item 9 are presses the intended or foreseeable use of which includes the possibility of the operator placing or removing workpieces between the tools with his hands without the use of integrated ancillary handling devices. The term 'cold working' refers to the shaping of metal without heating, usually at room temperature. The term 'metal' refers to material in sheet, rolled or forged form.

Item 9 only applies to presses with movable working parts having both of the two following characteristics:

a travel greater than 6 mm, and

a closing speed greater than 30 mm/s.

When establishing the closing speed of mechanical presses, the highest instantaneous speed reached by the slide (in general, at about the mid-point of its travel) should be taken into consideration.

Item 9 does not cover other kinds of machinery for cold working of metals such as, for example:

sintering presses,

alligator or guillotine shears,

riveting, stapling or stitching machines,

assembly presses,

bending machines,

straightening presses,

turret punch presses,

extruder presses,

drop forging or drop stamping presses,

blow forging presses,

isostatic presses.

Items 10 and 11

The plastics and rubber moulding machinery referred to in items 10 and 11 is machinery designed for working polymers, such as thermoplastics and thermosets, or rubber, by injection or compression. Loading and unloading refers only to placing and removal of material or parts in and out of the mould. Loading and unloading is not considered as manual if:

- the machinery is designed to operate only with robot or manipulator equipment, or

- the machinery is fitted with loading and unloading devices such that it is not possible to operate the machinery without those devices.

In all other cases, loading and unloading shall be considered as manual.

Item 12

Locomotives for underground working referred to in item 12.1 are self-powered vehicles running on a track of one or two rails situated above or under the vehicle for use in mines or other underground workings, designed for hauling or transporting persons, materials or mineral. Brake vans are railway vehicles for underground working equipped with a brake which can be applied by the operator.

Hydraulic-powered roof supports referred to in item 12.2 are usually self- advancing supports used to support the roof at a mine face. They include:

one support unit under adjacent control;

several support units under group control;

entire mine face support systems under central control.

Tunnelling machines are not covered by item 12.

Item 13

An explanation of the term 'manual loading' with respect to manually loaded trucks for the collection of household refuse incorporating a compression mechanism referred to in item 13 is given in specific guidance that can be found in section §415. It also shows examples of machinery that is within the scope of item 13 and machinery that is outside the scope of item 13.

In general, the vehicle itself is excluded from the scope of the Machinery Directive, so the machinery referred to in item 13 is the refuse collection and compression equipment mounted on the chassis – see §37: comments on the third indent of Article 2 (a), and §54: comments on Article 1 (2) (e).

Items 14 and 15

The removable mechanical transmission devices referred to in item 14, commonly known as “power take-off (PTO) shafts", are removable components for the transmission of power between self-propelled machinery or a tractor and recipient machinery such as towed agricultural machinery – see § 45: comments on Article 2 (f). Removable mechanical transmission devices must always be placed on the market together with an appropriate guard. Guards for removable mechanical transmission devices may also be placed on the market independently as safety components – such guards are covered by item 15.

Item 16

The vehicle servicing lifts referred to in item 16 are stationary, mobile or movable lifts designed to raise whole vehicles off the ground for the purpose of examining and working on or under the vehicles whilst they are in a raised position. Short stroke vehicle servicing lifts not intended for working under the vehicles are not covered by Item 16.

They include machinery intended for the servicing of vehicles such as, for example, cars, motorcycles, snowmobiles, lorries, buses, trams, rail vehicles, and industrial trucks. They also include assemblies of lifting devices operating in a synchronised system for lifting whole aircraft for inspection or maintenance purposes.

Item 16 does not cover:

jacks that are not designed to raise the whole vehicle off the ground,

lifts intended for the parking of vehicles,

lifts incorporated into vehicle assembly lines.

Item 17

The devices for the lifting of persons or persons and goods referred to in item 17 include the following:

a) machinery with the main function of lifting persons or persons and goods such as, for example:

mobile, mast-climbing or suspended elevating work platforms;

construction site hoists for persons or persons and goods;

lifting devices intended to be connected to machinery such as cranes or wind generators, for access to workstations;

machinery serving fixed landings subject to the Machinery Directive such as home lifts and lifting platforms intended for persons with impaired mobility – see §151: comments on Article 24;

b) devices for lifting persons or persons and goods fitted to machinery with main functions other than lifting persons. Such devices include, for example, elevating operating, driving or control positions on industrial trucks, on rail dependent storage and retrieval equipment, on cranes or on earth-moving machinery.

For such devices, the EC type-examination or the assessment of the full quality assurance system concern the conformity of the devices for lifting persons and not the other functions of the machinery;

c) lifting machinery with main functions other than lifting persons with on-board control positions such as, for example, aircraft ground support equipment, passenger boarding bridges for aircraft, bridge spans for access to ships and climbing frames for the erection of tower cranes;

d) interchangeable equipment for the lifting of persons such as work platforms to be assembled with, for example, variable reach lift trucks, loader cranes or mobile cranes. The conformity assessment must ensure that the assembly of the interchangeable equipment and all the types of basic machinery with which it is intended to be assembled complies with all the relevant EHSRs – see §41: comments on Article 2 (b).

Such interchangeable equipment must be distinguished from equipment that is not assembled with lifting machinery but used exceptionally for lifting persons with machinery designed for lifting goods (according to section 3.1.2 of Annex II to Directive 2009/104/EC) that is not subject to the Machinery Directive – see §10: comments on Recital 7. This distinction is explained in specific guidance that can be found in §416.

The above devices are covered by item 17 when they involve a hazard of falling from a vertical height of more than three metres. The vertical height is to be understood as the vertical distance between the surface of the carrier on which persons or persons and goods are supported in order to be lifted – see §334: comments on section 4.1.1 (g) of Annex I - and the level to which the persons or the carrier itself could fall. That level is usually the ground level or the level of the floor or surface on which the machinery is intended to be installed or used, but could be a lower floor or ground level if the machinery is intended by the manufacturer to be installed next to a drop.

Item 18

The portable cartridge-operated fixing machinery referred to in item 18 is portable machinery operated by explosive cartridges intended for driving fasteners such as nails, threaded studs, eyelets or similar objects into a base material. Item 18 also covers cartridge-operated impact machinery intended for other applications such as, for example, machinery for the hard marking of materials by imprinting or captive bolt pistols for the stunning of animals.

Item 18 does not cover portable fixing or other impact machinery using other sources of energy, such as pneumatic, spring, electromagnetic or gas cartridge- operated machinery.

Item 19

Item 19 covers safety components that detect the presence of persons or parts of persons and that generate an appropriate signal to the control system to reduce risks to the persons detected. The signal may be generated when a person or part of a person goes beyond a predetermined limit (tripping), or when a person is detected in a predetermined zone (presence sensing), or both. Such protective devices include, for example:

pressure sensitive protective devices such as, for example, pressure sensitive mats, floors, edges, bars, bumpers, plates and wires;

active opto-electronic protective devices such as, for example, light curtains, scanning heads, light beam and laser devices;

radar, infrared, ultrasonic and camera-based protective devices.

Item 19 does not cover indirect vision devices such as mirrors or closed circuit television (CCTV).

Item 20

Item 20 covers power-operated moveable guards that correspond to the definition of safety components – see §42: comments on Article 2 (c) – intended to be fitted to presses for the cold working of metal referred to in item 9 or to injection or compression plastics-moulding machinery or rubber moulding machinery with manual loading and/or unloading referred to in items 10 and 11.

Item 21

The logic units to ensure safety functions referred to in item 21 are complex components which:

correspond to the definition of safety components – see §42: comments on Article 2 (c) and

analyse one or several input signals and generate, by a given algorithm, one or more output signals and

are intended to operate in connection with, or as part of, the control system of machinery in order to perform one or more safety functions.

The control system as a whole is not to be considered as a logic unit, although the assessment and design of the control system must fulfil EHSR 1.2.1. such that it can, to the state of the art for the product:

withstand the intended operating stresses and external influences,

faults in the hardware or the software of the control system do not lead to hazardous situations,

errors in the control system logic do not lead to hazardous situations, etc.

– see §184 comments on safety and reliability of control systems.

Items 22 and 23

Items 22 and 23 cover roll-over protective structures (ROPS) and falling-object protective structures (FOPS) that correspond to the definition of safety components - see §42: comments on Article 2 (c).

ROPS and FOPS manufactured by a machinery manufacturer to be fitted to his own machinery are not covered by items 22 and 23.

The same goes for ROPS or FOPS intended to be used as spare parts to replace identical ROPS or FOPS supplied by the manufacturer of the original machinery – see §48: comments on Article 1 (2) (a) – since they are not subject to the Machinery Directive as such.

However, all ROPS and FOPS, whether placed on the market as safety components or manufactured by a machinery manufacturer for his own machinery, must be submitted to appropriate tests – see §315 and §316: comments on sections 3.4.3 and 3.4.4 of Annex I - and the corresponding test reports must be included in the technical file for the machinery to which they are fitted – see §392: comments on Annex VII A 1.

Appropriate tests are also required for tip-over protective structures (TOPS) according to section 3.4.3 of Annex I, but these structures are not covered by item 22 of Annex IV and the related conformity assessment procedures.

It should be noted that FOPS are sometimes referred to in harmonised standards by other terms such as, for example, 'overhead guards' or 'front guards'. All structures intended to be fitted to mobile machinery to protect the operator from falling objects are to be considered as FOPS, regardless of the term used in the standards for the machinery concerned.