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DESCRIPTION
ce markingTRANSCRIPT
Overview of the European Machinery Directive
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Michael Loerzer, President GLOBALNORM group
http://www.psessymposium.org/
7 – 9 October 2013
Austin Texas
Author, presenter
• President – Globalnorm GmbH – Globalconformity GmbH
• Expertise, memberships – TK Regulatory Affairs,
Spectaris – Member of the IEEE
Product Safety Engineering Society, USA
– Chairman Product Conformity Topic Group of the ANP German Committee of Standards Users (DIN ANP TGP)
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AGENDA
• Placing on the market and operation of machinery
• Introduction in the Machinery Directive 2006/42/EC
• Main changes between 98/37/EC and 2006/42/EC
• New scope and definitions
• Specific directives and their application (e. g. ATEX Directive 94/9/EC) for machinery
• New procedure for partly completed machinery
• Conformity assessment procedure for machinery
INTRODUCTION
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Machinery Directive
• European legislation for machine safety
• Adresses manufacturers and/or importers
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Christmas tree stands Paper machine
Current version
• The new version of the Machinery Directive (MD) 2006/42/EC is mandatory since 2009-12-29
• Changed/amended regulations: – Article 1 Scope
– Article 2 Definitions
– Article 5 Placing on the market and putting into service
– Article 7 Presumption of conformity and harmonized standards
– Article 12 Procedures for assessing the conformity of machinery
– Article 13 Procedure for partly completed machinery
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Application of the EU machinery guide
• Published is the 2nd edition (June 2010)
– the citations
– the recitals
– the articles
• Recommendations for the application of the guide
– don´t read the whole guide
– for each article (red-lined text frames) you will find interpretations and guidance
• Link to guide
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KAN Report 40
• Commission for Occupational Health and Safety and Standardization (KAN)
• Publication of a report which shows the regulatory changes between 98/37/EC and 2006/42/EC (red-lined)
• English, french and german
• www.kan.de
• No interpretation of the Directive
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SCOPE AND EXCLUSIONS
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Scope (article 1 section 1)
• Added products are – chains, ropes and webbing – partly completed
machinery
• It is necessary to read Art. 1 together with Art. 2 (definitions), Art. 3 (specific directives) and Art. 24 (amendment of Lift Directive), to understand the whole field of application of the new directive.
• Wide range of products
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Compliance requirements
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Machinery, interchangeable equipment, safety components, lifting accessories,
chains, ropes and webbing and removable mechanical transmission devices
Specific defintions in article 2
Conformity assessment procedure (article 12):
Fulfillment of annex I with risk assessment, technical file, EU declaration of conformity,
CE marking
Partly completed machinery
Article 2 (g): means an assembly which is Almost machinery but which cannot in itself
perform a specific application. A drive system is partly completed machinery. Partly
Completed machinery is only intended to be incorporated into or assembled with other
machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies
Procedure (article 13): Fulfillment of annex I with risk assessment, technical file, declaration of incorporation
Excluded EEE (article 1 section 2 (k))
• This new sub clause defines the borderline between the new machinery directive and the Low Voltage Directive (now known as 2006/95/EC - LVD).
• This products within 50…1000 VAC and/or 75…1500 V are excluded from the MD
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Specific directives (article 3)
• Where, for machinery, the hazards referred to in Annex I are wholly or partly covered more specifically by other Community Directives, this Directive shall not apply, or shall cease to apply, to that machinery in respect of such hazards from the date of implementation of those other Directives. – See EU guide §§ 90, 91 and 92
• §90 Specific Directives that apply instead of the Machinery Directive to machinery that is in their scope
• §91 Specific Directives that may apply to machinery instead of the Machinery Directive for specific hazards
• §92 Directives that may apply to machinery, in addition to the Machinery Directive, for hazards not covered by the Machinery Directive
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Specific regulations instead of the MD
Reference with respect to § 90
Directive 2009/48/EC On the safety of toys
Directive 89/686/EEC on personal protective equipment (PPED)
Directive 93/42/EEC as amended by Directive 2007/47/EC on medical devices (MDD)
Directive 95/16/EC on lifts (LD)
Directive 2000/9/EC on cableway installations designed to carry persons
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Application of regulations with specific hazards instead of the MD
Reference with respect to § 91
Directive 94/9/EC on equipment and protective systems intended for use in potentially explosive atmospheres (ATEX Directive)
Directive 84/500/EEC on ceramic articles to come into contact with foodstuffs
Directive 2009/105/EC on simple pressure vessels
Directive 2009/142/EC on appliances burning gaseous fuels
Directive 97/23/EC on pressure equipment
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Application of regulations with specific hazards in addition to the MD
Reference with respect to § 92
Directive 89/106/EC on construction products (CPD) New: Regulation (EU) 305/2011 laying down harmonized conditions for the marketing of construction products and repealing Council Directive 89/106/EEC
Directive 97/68/EC as amended by Directives 2002/88/EC43 and 2004/26/EC on the emission of gaseous and particulate pollutants from internal combustion engines to be installed in nonroad mobile machinery (NRMMD)
Directive 1999/5/EC on radio and telecommunications terminal equipment (R&TTED)
New RoHS Directive 2011/65/EU
Directive 2004/108/EC on electromagnetic compatibility (EMCD)
Directive 2009/125/EC establishing a framework for the setting of ecodesign requirements for energy-related products
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Example 1
• Electrical machinery
• No fixed installation
• Applicable regulations
– EMCD 2004/108/EC with partly application of harmonized standards (EMC assessment)
– MD 2006/42/EC with applicable C-Standard
• Sample of an EU declaration of conformity
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DEFINITIONS
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Art. 2 (a) Machinery – 5 definitions
1. an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application
• It is the definition of “machinery stricto sensu”.
• That is the reason that some christmas tree stands shall be CE marked under the MD (power of a spring)
• Legal: no minimum claim limits!
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(a2) and (a3) definition
2. an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion
3. an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure
• Even prior to fitting or installation, these assemblies are already machinery according to the new directive
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Examples
• (a2): only the power sources or interfaces are missing
– brake test stand, test stand for motorcycles
– wood splitter for tractors
• (a3): machinery which is ready-to-install
– Cranes on trains
– Hydraulic platforms on trucks
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(a4) definiton
4. assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole
• Machine installation
• The Federal Ministry of Labour and Social Affairs has published a specific guidance note (2011-05) which was integrated in the EU Guide
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Assessment
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Production process is given?
Only an EU DoC and CE marking of each single machinery and/or declaration of incorporation of each single partly completed machiney is required
Safety-related connection?
Assembly of machinery EU DoC, CE marking (Art. 12)
(a5) definition
5. an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort
• No regulatory changes
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Definition of a manufacturer
• manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer
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Substantial modifications
• Operators are modifying machines during the lifetime
• Key questions: is that a substantial modification?
• If yes, the modified machine falls under the scope of the MD!!!
– The Federal Ministry of Labour and Social Affairs has published a national guidance note for the market surveillance authorities and all stakeholders
– Operator Manufacturer
– Performance of a risk assessment is mandatory!
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COMPLIANCE REQUIREMENTS
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Placing on the market: machinery
a) ensure that it satisfies the relevant essential health and safety requirements set out in Annex I;
b) ensure that the technical file referred to in Annex VII, part A is available
c) provide, in particular, the necessary information, such as instructions EN 82079-1
d) carry out the appropriate procedures for assessing conformity in accordance with Article 12
e) draw up the EC declaration of conformity in accordance with Annex II, part 1, Section A and ensure that it accompanies the machinery;
f) affix the CE marking in accordance with Article 16
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Conformity assessment
Internal production control (Annex VIII)
EU type-examination (Annex IX) and no. 3 of
Annex VIII
Full quality assurance (Annex X)
Procedure 1 Procedure 2 Procedure 3
Procedure 2 OR 3
Art. 12 (2)
Machinery isn´t listed in Annex IV?
Start
Standards applied with all relevant ESH?
Art. 12 (3)
Procedure 1 , 2 OR 3 Procedure 1
End
Art. 12 (4)
yes yes
no no
Placing on the market: partly completed machinery
• Before placing partly completed machinery on the market, the manufacturer or his authorised representative shall ensure that the procedure referred to in Article 13 has been completed
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Partly completed machinery
a) the relevant technical documentation described in Annex VII, part B is prepared;
– Including risk assessment (EN ISO 12100)
b) assembly instructions described in Annex VI are prepared;
c) a declaration of incorporation described in Annex II, part 1, Section B has been drawn up
– See sample
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CONCLUSIONS
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Conclusions
• The new MD includes some new regulatory requirements in detail
• The most machine manufacturers in the EU have problems with the technical documentation including the risk assessment
• Some operators have no knowledge with respect to the MD if they modify the machine substantial!
• Also many operators don´t know that the construction of machinery for ist own use is also within the the scope of the MD!
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Abbreviations
CE Conformité Européenne, meaning "European Conformity"
EEE Electrical and an eletronic equipment
EU DoC EU declaration of conformity
MD Machinery Directive 2006/42/EC
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Contact
• Thank you very much for your participation and attention
• Feel free to contact me if you have any questions
– Michael Loerzer, President GLOBALNORM, Regulatory Affairs Specialist
– Phone: +49 30 3229027-51
– Website http://www.globalnorm.de/en.html
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