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Consultancy - Services:
Machinery Directive Assessments
The Machinery Directive?
- The Machinery Directive 98/37/EC, consolidating the original Machinery Directive
89/392/EEC and its amendment directives (91/ 368/EEC, 93/44/EEC, and 93/68/EEC) into one
Directive.
- Great Britain: The Supply of Machinery (Safety) Regulations 1992 (SI 1992 3070)
- Compliance with directive has been mandatory since 1996
How do We Define Machinery?
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Article 1 of the Machinery Directive specifies its scope as follows. Machinery is:
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An assembly of linked parts or components of which at
least one moves. |
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An assembly of machines which, in order to achieve the
same end, are arranged and controlled so that they function as an integral whole. |
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Interchangeable equipment modifying the function of a
machine. |
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Safety components according to annex IV of the Directive. |
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This means that all machinery products are covered by the Machinery
Directive unless excluded by chapter 3 of Article 1. However, "at least one of
which moves" means that static assemblies such as shelving, racking etc. are
excluded.
Even though the directive says "linked together", machinery which is sold
in dismantled form for the ease of transport has to comply with the Directive, too.
Moreover, machinery where the risks are mainly of electrical origin is excluded by chapter
5 of Article 1. Such machinery is covered by the Low Voltage Directive.
As for other Directives, the Machinery Directive applies for products which are placed on
the EU market for the first time. This definition means that used machines shall comply
with the directive if they are imported from a non-EU member state. Machines that have
already been in service in the EU prior mandatory date of the Directive do not need to
comply.
What are Annex-IV Machines?
The Machinery Directive makes a clear distinction between "ordinary machines"
and machines considered being particularly dangerous (Annex IV-machines). As for both
machine types different conformity assessment procedures are specified, it is important to
find out whether the machine is within the scope of Article IV. Annex IV-machines will
require a Notified Body sign-off. Examples of these (but not exhaustive) are:
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- Circular saws, sawing machines.
- Hand-fed surface planing machines for woodworking.
- Thicknessers for one-side dressing.
- Band saws.
- Combined wood working machines.
- Hand-fed tenoning machines.
- Hand-fed vertical spindle moulding machines.
- Portable chain saws.
- Presses including press breaks for cold working of metals.
- Injection or compression machines for plastics or rubber moulding.
- Machinery for underground work (e.g., machinery on rails, hydraulic-powered roof
supports, or internal combustion engines).
- Manually loaded trucks for collection of household refuse incorporating compression
mechanisms.
- Guards and detachable transmission shafts with universal joints.
- Vehicle-servicing lifts.
- Devices for lifting persons who are at risk of falling more than three meters.
- Machines for the manufacture of pyrotechnics.
- Safety Components:
- Electrosensitive devices (e.g., nonmaterial barriers, sensor mats, electromagnetic
detectors, light curtains, etc.).
- Two-handed controls.
- Automatic movable screens.
- Roll-over protection structures (ROPS).
- Falling-object protective structures (FOPS).
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Depending on the type of machinery and the components, there are other directives
beside the Machinery Directive that may be applied to the product. Some of them are the
EMC Directive, the Low Voltage Directive and the Simple Pressure Vessel Directive,
Pressure Equipment Directive (97/23/EC).
Which Standards are Applicable?
The standards for the Machinery Directive can be split into three main groups:
Type A
Apply to all machinery and are essential reading for machinery builders (e.g. EN
292:Safety of machinery/Terminology).
Type B
Are laterally inter-linked and generally divided into B1 and B2 standards:
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'B1' Standards
Apply to all machinery and are designed to promote the essential factors mentioned in the
Directive |
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'B2' Standards
These are "apply when used" Standards, i.e.., if a particular safety device is
chosen for a machine, then it must be manufactured to the relevant standard |
Type C
These are special to type standards and will identify over 600 different types of
machinery and will inform manufacturers and users of the specific safety precautions and
devices which are required to be used (e.g. EN 201: Injection moulding machines for
plastics)
What are the Three Conformity Assessment Paths to Meet the Requirements of the
Machinery Directive?
Path I
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Annex IV-Determine if equipment falls under it. |
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Equipment does not fall under Annex IV-Create a Hazard
Analysis and Technical Construction file (TCF), as required per Annex V. |
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Declaration of Conformity-Create an Annex IIA Declaration
of Conformity and have it signed by the manufacturer or their EU representative. |
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Affix the CE mark. |
Path II
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Annex IV-Determine if equipment falls under it. |
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Equipment does fall under Annex IV-Were harmonized norms
used when designing, testing, and manufacturing the equipment? |
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Harmonized norms were not observed-Submit product to EU
notified body for EC-type examination. Upon successful completion, the notified body
issues an EC-type examination certificate. |
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Declaration of Conformity-Create an Annex IIA Declaration
of Conformity and have it signed by the manufacturer or their EU representative. |
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5. |
Affix the CE mark. |
Path III
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1. |
Annex IV-Determine if equipment falls under it. |
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Equipment does fall under Annex IV-Were harmonized norms
used when designing, testing, and manufacturing the equipment? |
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3.
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Harmonized norms were observed-either
- Submit the product to EU notified body for EC-type examination. Upon
successful completion, the notified body
issues EC-type examination certificate.
- Manufacturer creates the Hazard Analysis and TCF required per Annex V and
forwards it to a notified body that
will acknowledge receipt of the file and retain it.
- Manufacturer creates the Hazard Analysis and TCF required per Annex V and
forwards it to a notified body that will
simply verify that harmonized norms have been correctly applied and
will issue a certificate of adequacy for the file.
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4.
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Declaration of Conformity-Create an Annex II Declaration
of Conformity and have it signed by the manufacturer or their EU representative. |
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5. |
Affix the CE mark. |
Created By Brett Walton
For more information about how Wemtech can help, please contact Mike Foster on 01527 595066.
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