11
Contrinex Industrial Electronics
MACHINE MANUFACTURER SIDE
The manufacturer side is addressed by the Machinery Directive. This
umbrella document refers to the specific requirements described in EN
standards, and stipulates that each danger zone of a machine must be
made safe. The method used to make different zones safe depends on
the type of hazard.
The Machinery Directive requires that, before placing machinery on
the market and/or putting it into service, the manufacturer ensures that
a technical file is made available. This technical file shall comprise a
construction file including, among others, “the documentation on risk
assessment demonstrating the procedure followed, including:
(i) a list of the essential health and safety requirements which apply to
the machinery,
(ii) the description of the protective measures implemented to eliminate
identified hazards or to reduce risks and, when appropriate, the indi-
cation of the residual risks associated with the machinery.” (Machin-
ery Directive 2006/42/EC, Annex VII, A, 1, a)
Machines that are highly hazardous (as listed in Annex IV of the Ma-
chinery Directive) must conform to special procedures. The manufac-
turer is responsible for obtaining conformity through various procedures
that may require examination of the machine by an EU notified body.
NOTIFIED BODIES
In order to have control over the execution of these directives, veri-
fication of certain steps by certifying bodies may be imposed by the
directives. For example, all safety device concepts must be analyzed,
checked and tested by such a third party organization. In many cases,
this third party organization also audits the production process of a
safety device manufacturer.
A notified (or certified) body is a certification, inspection or testing body
designated by the notifying authority of an EU member state to issue
attestations of conformity for products. Each EU member state has a
list of notified bodies authorized to issue EU-type examination certifi-
cates. The lists include the identification number of each notified body,
as well as the specific areas of activity and the tasks for which it has
been designated.
European notified bodies responsible for carrying out conformity as-
sessment procedures can be found through the NANDO (New Ap-
proach Notified and Designated Organizations) website, where accred-
ited bodies can be searched for by country, product or directive. An
official list of notified bodies responsible for assessing products in com-
pliance with the Machinery Directive can also be found on the relevant
European Union website.