New Guide 2.2 to the Machinery Directive 2006/42/EC

Guide

Title (Version 2.1)

Content

§ 42

New notes on safety software and control "units/boards":

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Safety components are considered to be physical devices (like machinery or interchangeable equipment). Software which performs a safety function and which is placed independently on the market is not considered a ‘safety component’. However, physical components incorporating software and fulfilling the definition at Art 2 (c) are ‘safety components’, and may also be ‘logic units to ensure safety functions’ (item 21, Annex IV – see: §388 Categories of machinery that may be subject to one of the conformity assessment procedures involving a Notified Body).

Many machinery components are critical for the health and safety of persons. However, purely operational components, by virtue of the fourth indent in Article 2 (c) above, are not considered as safety components. Safety components are components intended by the component manufacturer to be fitted to machinery specifically to fulfil a protective role, in addition to any operational duty. Components placed independently on the market that are intended by the component manufacturer for functions that are both safety and operational functions, or that are intended by the component manufacturer to be used either for safety or for operational functions are to be considered as safety components. For example, a hydraulic valve designed and specified as being capable of performing a safety function as well as normal production use, is a “safety component” where other parts of the definition are met. However, a similar valve where the manufacturer markets it only for normal production use would not be considered a safety component. Similarly, a control unit/board delivering safety functions is a “safety component” where the other parts of the definition are met – see §417: Status of machinery control units under the Machinery Directive.

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§ 46

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Machinery Directive does not prescribe requirements for PCM manufacturers to meet the EHSRs of Annex I. However, All EHSRs met by the PCM must be declared on the accompanying Declaration of Incorporation – see § 385: comments on Annex II 1 B. PCMs must be accompanied by assembly instructions which should include the essential information to enable safe incorporation, including, where relevant, for the final machine's control system, the relevant data on safety performance/reliability - see §417: Status of machinery control units under the Machinery Directive. This is particularly important where a control unit/board is an integral part of the PCM and delivers safety functions (note: the control board need not be supplied in the same enclosure as the PCM, but must be marketed as a single PCM product).
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Equipment designed and constructed specifically for use in fairground or amusement parks is excluded from the scope of the Machinery Directive by Article 1 (2) (b). This includes powered seating to contain or restrain a person, or move in response to other stimuli, such as a simulator experience, but only where specifically intended for use in fairgrounds or amusement parks (see also comments on electrically-operated furniture at §64). The design and construction of such equipment specifically intended for use in fairgrounds or amusement is not subject to any EU legislation and may therefore be subject to national regulations. It can be noted that there are two European standards for such equipment [16]. Use of such equipment by workers (for example, during erection, dismantling or maintenance operations) is subject to national provisions implementing Directive 2009/104/EC on use of work equipment by workers at work – see §140: comments on Article 15.

§ 64

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• electrically operated furniture, such as beds, chairs, tables, storage furniture including kitchen furniture, remain subject to the Machinery Directive as they are not household appliances of the types indicated above. This includes electrically operated furniture which ‘entertains’, e.g. by responding to a sound or film track, events in a video game, ‘simulates’ function such as machinery at shows or exhibitions, or provides a non-medical stimuli (e.g. for relaxation), unless the products are specifically intended for use in fairgrounds or amusement parks – see §49 comments on the exclusion of Article 1 (2) b. However, where provided for medical purposes such that they are within scope of the Directive 93/42/EEC (as amended)30 concerning medical devices, that Directive applies instead of the Machinery Directive.
• drives for storage furniture (such as the powered movement of kitchen storage unit doors, flaps, drawers and similar applications) and powered table/desk tops may be placed on the market either as:
  • partly completed machinery according to Article 2 (g) if all the provisions of Article 13 are fully applied (see the comments at §46), or
  • as complete machinery according to Article 2 (a) if all the provisions of Article 5 are applied (see the end of §35 - comments on the definition of machinery).
• electrically operated furniture incorporating multiple drives for the opening or closing of doors, drawers or lift-ups (including those in separate units located in the same room) are not to be considered an assembly of machinery unless the criteria of the fourth indent of Article 2 (a) are fully met (see §38 Assemblies of machinery).

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§ 67

The exclusion set out in the fourth indent of Article 1 (2) (k) applies to electrical equipment such as, for example, printers, copiers, fax machines, sorters, binders and staplers.

This exclusion does not concern machinery with similar functions intended for use in industries such as, for example, the printing or paper industries, additive printing machinery for producing 3-dimentional products in home, office, laboratory or similar environments, or production printers (even when for use in office environments).

The exclusion of ordinary office machinery does not extend to electrically powered office furniture which is subject to the Machinery Directive.

§ 90

The section (line 1 in the table) relating to the Low Voltage Directive has been completely reformulated:

Electrical and electronic products that are any of the categories listed in Article 1(2) (k) of Machinery Directive 2006/42/EC (MD) shall comply with the LVD.

Electrical and electronic products that is not in any of the categories listed in Article 1(2) (k) of the MD but meet the definitions of article 2 of the MD, shall comply with the MD. It should be noted that section 1.5.1 of Annex I to the MD requires the electrical aspects of machinery to meet the safety objectives of the LVD. [..] Thus, whilst machinery with an electrical supply, which is not in any of the categories listed in Article 1(2) (k) of MD, shall fulfil the safety objectives of the LVD, the manufacturer’s EC Declaration of conformity shall not refer to the LVD but to the MD

Section relating to Regulation (EU) No 167/201348 on agricultural and forestry vehicles (minor adaptation):

This Regulation covers all identified risks including those previously covered by the Machinery Directive, for agricultural and forestry tractors, and so a complete exclusion from the Machinery Directive could be made. To do this it modified Article 1(2)(e) of the Machinery Directive, removing the reference to the exclusion being only for the risks covered by that Directive. Such tractors supplied under Regulation 167/2013 from 1 January 2016 are completely excluded from the Machinery Directive.

However, there is a two-year transition period where tractors supplied under national legislation implementing Directive 2003/37/EC can still be supplied up to 31 December 2017, and are thus also in scope of the Machinery Directive 2006/42/EC.

Guide

Title

New comments (excerpt)

§ 204

Mode selection

Note regarding reasonably foreseeable misuse:

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The third paragraph of section 1.2.5 permits, as an alternative to a physically lockable selector, that selection of a control or operating mode such as, for example, a setting or maintenance mode, may be restricted to specially trained and authorised operators by other means, such as, for example, an access code.

The means used for restriction of access to the operating modes should achieve the necessary level of safety taking into account the reasonably foreseeable misuse. Where any failure in the means used for mode selection can result in danger, it must be considered an integral part of the safety-related control system.

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Guide

Title

New comments (excerpt)

§ 277

Hygiene requirements for machinery intended for use with foodstuffs or with cosmetics of pharmaceutical products

New comments (excerpt)

§ 388

Amendments concerning point 21 («Logic units for safety functions.»)

 

Item 21 [Bold, as headline, note]
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: 428 - it can 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.
  • Protective devices designed to detect the presence of persons (item 2, Annex V, which are taken to include detecting the presence of domestic animals – see §88: comments on Article 4), are not to be considered as a logic unit as they are already covered by item 19 of Annex IV.

However, the way the logic is executed is technology-independent and may include mechanical, electronic and other systems that will be developed in the future. If the logic is implemented by simple devices, such as electromechanical sensors or switching devices that convert only an input signal into an output signal, they are not considered to be a logic unit. But if an input signal (or signals) is converted into an output signal by a complex device, for example an electronic circuit or a complex mechanical device that processes the signal (or signals), it is considered a logic unit for ensuring safety functions. 

Such complex components can simultaneously monitor themselves or other components. However, a monitoring function is not a prerequisite for the component to be considered a logic unit.