1.1-3
1.1
Position of the standards in Europe
The legal position of standards is discussed
again and again. Inside Europe, i.e. within
the scope of the European directives that
are subject to the CE-marking obligation,
a manufacturer is not bound by standards
or other specifi cations. He simply needs to
comply with the health and safety require-
ments of the directive(s). The associated
benefi ts of a division between standards and
legislation are obvious: It is easier for legis-
lators to agree on the essential requirements
than on technical details. Also, the directives
do not regularly have to be adapted to the
state of technology; member states can use
their own legal system for incorporation and
manufacturers are free to select the ways in
which they implement the requirements of
the directive.
So what are the benefi ts of applying the
standards? With so-called harmonised
standards with presumption of conformity,
there is a shifting of the burden of proof, i.e.
if manufacturers apply these standards, it
is presumed that they will also comply with
the specifi c requirements of the European
Standards pyramid
EN ISO 12100 Safety of machinery
EN 1050 Risk assessment
A standards
have priority over all others
and deal with essential safety require-
ments for machinery
A
B1, B2
C
B1 standards
deal with aspects
of safety
B2 standards
deal with safety
devices
EN 954-1 Safety-related parts
EN 574 Two-hand controls
EN 418 Emergency stop equipment
C standards
deal with
specific types or groups
of maschinery
EN 12415 Turning machines
EN 422 Blow moulding machi
EN 692 Mech. presses
Standards and Directives
European directives and position of the standards in Europe
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2008-09
directives. The regulatory authorities would
therefore need to prove that a manufacturer
did not meet the legal requirements.
However, should a manufacturer deviate
from the harmonised standards, he himself
must prove how he has met the essential sa-
fety require-ments. This is generally done via
a hazard analysis. In practice one would en-
deavour to apply the harmonised standards,
unless the products concerned are highly
innovative and no harmonised standards
yet exist. The standards for which this “pre-
sumption effect” applies can be researched
in the Offi cial Journal of the EU (e.g. on the
Internet). Standards in Europe are subdivided
into what are termed A, B and C standards.
