Source: https://www.ibf.at/fachbeitraege/article/2019/11/12/neuer-leitfaden-guide-22-zur-maschinenrichtlinie-200642eg/
Timestamp: 2020-02-24 05:43:39
Document Index: 385256110

Matched Legal Cases: ['§42', '§418', '§419', '§417', '§418', '§46', '§49', '§64', '§67', '§90', 'Art 2', '§388', '§417', '§ 385', '§417', '§64', '§140', '§49', '§46', '§35', '§38', '§42', '§184', '§88', '§418', '§ 417', '§ 418', '§388', 'Art 2', '§42', 'Art 1', '§42', 'Art 2']

Neuer Leitfaden (Guide) 2.2 zur Maschinenrichtlinie 2006/42/EG - Fachbeiträge und News zur CE-Kennzeichnung | ibf.at Statistiken Marketing
Die EU-Kommission hat den Leitfaden zur Maschinenrichtlinie überarbeitet und am 6.11.2019 in der neuen Version 2.2 veröffentlicht.
Der neue Leitfaden 2.2 enthält an einigen Stellen Änderungen gegenüber dessen Vorgängerversion 2.1. Dies Änderungen sind jedoch nicht so umfangreich, wie die Änderungen der Version 2.1 gegenüber der Version 2.
Die aus unserer sicht wichtigsten Änderungen sind:
Erläuterungen bzgl. Sicherheitsbauteilen und "Logikeinheiten für Sicherheitsfunktionen" ("logic units")
Ergänzungen in §42 (Sicherheitsbauteile), insb. bzgl. Safety-Software
Zwei zusätzliche Paragrafen (§418 und §419) bzgl. "Control Units (Circuit Boards)" und "Logic Units"
Ergänzung mehrerer Paragraphen mit Verweisen auf §417 und §418
Unvollständige Maschinen: Hinweise bzgl. der Mitlieferung von Steuerungsboards (§46)
Einrichtungen für die Verwendung auf Jahrmärkten und Vergnügungsparks: Konkretere Erläuterungen anhand von Beispielen (§49)
Haushaltsgeräte für den häuslichen Gebrauch: Hinweise bzgl. elektrisch betriebener Möbel (§64)
Abgrenzung von 3D-Druckern und ähnlichen Maschinen von "gewöhnlichen Büromaschinen" (§67)
Zum Teil neue Formulierung zur Abgrenzung von Richtlinien (§90)
MRL ⇔ LVD (Niederspannungsrichtlinie)
MRL ⇔ Verordnung 167/201348 (Land und forstwirtschaftliche Fahrzeuge)
Hinweis bzgl. der vernünftigerweise vorhersehbaren Fehlanwendung bei der Wahl von Betriebsarten.
Tabellarische Darstellung der wichtigsten Neuerungen der Version 2.2 gegenüber Version 2.1
Bitte beachten Sie, dass der neue Leitfaden bis jetzt nur auf Englisch verfügbar ist. Jeweils den gesamten Inhalt der zum Teil sehr umfangreichen Paragraphen hier anzuführen scheint nicht zweckdienlich. Wo immer erforderlich wird aber jener Teil angeführt, der für die Einbettung der neuen Inhalte in den Kontext des Leitfadens aus unserer Sicht erforderlich ist. Die neuen Inhalte sind fett hervorgehoben, Anmerkungen des Autors kursiv.
Titel (Version 2.1)
Neue Anmerkungen bzgl. Safety-Software und "control units/boards":
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.
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).
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.
[16] EN 13814:2004 Fairground and amusement park machinery and structures - Safety; EN 13782:2005 Temporary structures - Tents - Safety.
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).
30 OJ L 169, 12.7.1993, p. 1.
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.
Spezielle EU-Rechtsvorschriften, die statt der Maschinenrichtlinie auf in ihren Anwendungsbereich fallende Maschinen zur Anwendung kommen
Der Abschnitt (Zeile 1 in der Tabelle) bzgl. der Niederspannungsrichtlinie wurde komplett neu formuliert:
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
Abschnitt bzgl. Verordnung (EU) Nr. 167/201348 über land- und forstwirtschaftliche Fahrzeuge (geringfügige Anpassung):
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.
Hinweis bzgl. vernünftigerweise vorhersehbarer Fehlanwendung:
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.
Änderung einer Fußnote.
Kategorien von Maschinen, auf die eines der Konformitätsbewertungsverfahren unter Beteiligung einer notifizierten Stelle Anwendung finden kann
Änderungen Betreffend Nummer 21 («Logikeinheiten für Sicherheitsfunktionen.»)
Zusätzliche Anmerkung: Auch im Leitfaden Version 2.2 wird der unten angeführte Text rot geschrieben, ohne das genauer erläutert wird, weshalb hier von der üblichen Formatierung abgewichen wird.
Item 21 [Fett, da Überschrift, Anm.]
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.
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.
To be considered a logic unit to ensure a safety function, the component delivering its logic shall be complex. However, the way the logic is processed is independent of the technology, and can include mechanical, electronic and other systems that may be developed in the future.
Where the logic is delivered by simple devices like electromechanical sensors or switching devices, which just transform an input signal into an output signal, they are not to be considered as logic units.
But where an input signal (or signals) is transformed into an output signal by a complex component, e.g. an electronic chip or complex mechanical component that processes the signal(s), it will be considered a logic unit to ensure a safety function. Such complex components may also simultaneously monitor themselves or other components, but a monitoring function is not essential for the component to be considered a logic unit.
The table in section §418 indicates which safety components are considered to be logic units to ensure safety functions (LUTESF), and devices which are not considered LUTESF.
Anhänge des Leitfadens (komplett neu)
§ 417 Status of machinery control units under the Machinery Directive
Machinery rely on their control units for their function, which often includes ensuring safety, where failure could result in serious injury or even death. Control units/circuit boards may be placed on the market in a number of ways which affect their status under the Machinery Directive, and the extent to which conformity assessment, the preparation of a technical file and supporting information is required. A number of compliance scenarios are presented here in this table covering the range of situations commonly found so that the legal status of machinery control units/boards when placed on the market either on their own or as part of another product is clear.
§ 418 Table of safety components which are considered to be logic units
The following non-exhaustive list with accompanying explanatory notes indicate which safety components are considered to be logic units to ensure safety functions in the scope of Annex VI, Item 21, and which are NOT considered to be logic units to ensure safety functions (see also the comments at §388 item 21 on categories of machinery that may be subject to one of the conformity assessment procedures involving a Notified Body).
It must be remembered that Logic Units to Ensure Safety Functions must be a Safety Component as defined by Art 2 (c) (see §42), that is a component:
which is not necessary in order for the machinery to function, or for which normalcomponents may be substituted in order for the machinery to function.
The definition of a safety component covers both the intended function and manner in which the product is placed on the market.
Even if a device delivers a safety function, where it is part of a product –so not placed independently on the market, or only intended to be used as a spare part to replace identical components and supplied by the manufacturer of the original machinery (the limited exclusion of Art 1(2)a), it is not a safety component as defined, and cannot be a logic unit in the scope of Annex IV & V.
The control system as a whole, which must fulfil EHSR 1.2.1, is not to be considered as a logic unit.
A partly completed machine (PCM) is not a safety component by definition, and so not a logic unit (although a PCM may incorporate a safety component, which may be a logic unit).
Safety-related application software is in itself not considered to be a logic unit, as it is not a safety component, and in any case will always be dependent on a physical component to perform its function (see §42: safety components).
Simple devices like electromechanical sensors or switching devices which just transform an input signal into an output signal are not to be considered as logic units.
Certain devices such as contactors, contact expansion modules used to enhance safety switchgear, and devices for under-voltage release for supply disconnecting devices are not considered to be safety components (unless they meet the definition of a safety component as defined by Art 2c and are marketed as such), even though they are components specially constructed (eg with high reliability levels) specifically for use in safety related applications.
Protective devices designed to detect the presence of persons, including domestic animals (item 2, Annex V) are already covered by Annex IV (item 19), and so are not considered as logic units (item 21).
Edition 2.2 – November 2019 (PDF)