Since 1993, the Conformite
Europeene (CE) mandatory mark has signified conformance with legal and
technical directives put forth by the European Union (EU). This CE mark has
served as an entry stamp for many industrial products and services certifying
that the producer of the product or service complies with health, safety,
and/or environmental requirements. Altogether, there are around 25 directives
requiring the CE mark certifying such areas as: safety, machinery, low-voltage
equipment, terminal equipment, and electromagnetic compatibility.
Many manufacturers understand
and comply with existing CE marking, but not all manufacturers are fully aware,
and many more are not prepared, to conform with the looming new Machinery
Directive set to become effective on December 29, 2009. Manufacturers must
understand that there are significant changes from the current directive,
Machinery Directive 89/392/EEC to the new directive, Machinery Directive
For manufacturers planning to
compete with machinery sales into the European marketplace, it will be
essential to become well versed in the new requirements and follow up with
action plans for product compliance.
Machinery Directive: What's New
The evolving requirements
stipulated by the new Machinery Directive provide users and suppliers of
machinery with guidelines for prevention of serious injury.
Some key changes include:
Process of Risk Assessment - Machine manufacturers are obligated to complete a risk
assessment that is now defined within the directive as an iterative process of
hazard identification, risk estimation, hazard elimination or risk reduction.
Safety system requirements - Machine designers are obligated to design control
systems in such a way that a fault in the hardware or software of the control
system and/or reasonably foreseeable human error does not lead to hazardous
Harmonized standards - The standard governing the design and implementation
of the safety related parts of control systems on machinery (EN 954-1) becomes
obsolete on December 29, 2009. Machine builders must use EN ISO 13849 or EN/IEC
62061 to achieve compliance with the new directive.
Administrative and Assessment Procedures - New assessment procedures are defined for machines
listed in Annex IV of the directive and for "partly completed machines". For
manufacturers of Annex IV machines self-certification is now possible.†
Machine builders outside the EU - Machine builders outside the EU must authorize a
person who must be established in the Community to compile the technical file
for the machine. Machine builders without an operation in the EU can appoint an
Structural changes to the new
Machinery Directive expand language to include more detailed instruction,
dictate changes in essential requirements, provide greater scope under
administrative procedures, and even review definitions of machinery.
For example, under 3.1.3 Control
Systems and Devices, the obligations on machine control system designers are
more explicitly and in some cases more stringently defined. In the main these
requirements restate with clarity that a failure of or any other cause in a
machine control system should not lead to a hazardous situation. However the
requirement to consider "foreseeable human error" is new. The design of the
safety system must be considered in a manner where machine operators do not
benefit or gain incentive from bypassing safety systems. Recognizing advances
in technology the new directive introduces the obligation to consider control
systems and protective devices to automatically prevent start-up if it detects a
person in a danger zone.
Or, under 3.3.1. Boundary
with Low Voltage Directive, the interpretation of the "Low Voltage Directive"
("LVD") and the existing "Machinery Directive" resulted in the unintentional
exclusion from the machinery directive of machines on which it could be claimed
that the hazards were primarily electrical. In certain cases such an
interpretation resulted in only the LVD being applied. This "loophole" is now
closed by specifically listing in the new MD the electrical and electronic products
which are covered by the LVD as opposed to the new Machinery Directive.
In addition to final products
or services, assemblies of machines such as robot cells and production lines
also fall under obligations of the new Machine Directive.
Clearly, the new Machine
Directive provides meaningful expansion to existing requirements. Manufacturers
must heed the expanded changes and ensure their products and services fully
comply with the significantly more stringent standards.