Professional Documents
Culture Documents
Changes Explained
with Examples
Cumulatively the changes provide a new framework that creates a higher level of safety.
Changes in the new directive include:
o Expanded types of products and machinery covered
o Definitions and statement clarification
o Roles and Responsibilities defined and clarified
o Documentation changes and who is required to retain/provide these documents.
o Introduction and formalizing of the risk assessment procedure
o New certification option—Self Certification—residency requirement for the
Authorized Representative
o Expanded machine shutdown procedures—including a “total system” shutdown
requirement
o CE Tag—Machinery Certifier can now have the company name on the
certification tag
The CE mark Section 1: What is the Machinery Directive and How to Comply
declares that
machines are in
compliance with
either the present
or future
Machinery
Directive
In order for machines exported to Europe to be found in compliance
with both the current and the revised, soon-to-be enacted Machinery
Directive, they must contain the CE Mark. This mark declares that your
machines meet the essential requirements of all relevant EU Directives.
Assemblies of machines such as robot cells and production lines also fall under this
obligation.
The aim of the EU in introducing the Machinery Directive (MD) was to ensure the free
movement of machinery by guaranteeing a high and common level of protection in the
areas of health and safety. In the twenty years since enactment of the original directive,
many economic, political, technology and societal changes impacting European
workplaces have occurred, necessitating a revision to the existing directive.
Thus, there are significant changes from Machinery Directive 89/392/EEC to the current
directive, Machinery Directive 2006/42/EC, to the new Machinery Directive which takes
effect December 29, 2009.
The directive is law in Europe, therefore, failure to build compliant machines will prevent
manufacturers from exporting machinery to European markets.
• Instructions
o Safe operation of machinery depends on clear instructions. The obligations
on machine designers to provide clear information on machine use as well
as the hazards to be expected in operating and using machines are further
elaborated. The contents of the instructions must cover, not only the
intended use of the machinery, but also take into account any reasonably
foreseeable misuse.
• Harmonized Standards
o The new Machinery Directive contains a specific new article relating to
the “presumption of conformity” which emphasizes the benefit of seeking
compliance through standards. The previous standard governing the
design and implementation of the safety-related parts of control systems
on machinery becomes obsolete in December 2009. Consequently
machine builders must use one of the replacement standards—EN ISO
13849 -1 or EN IEC 62061—to achieve compliance with the new
directive. The new standard reflects the increased tendency to use
electronic and programmable systems for safety.
• Definitions of Machinery
o The existing machinery directive has a number of definitions for the
concept of a machine. Those of ‘Machinery’ and ‘Assemblies of
Machines’ (for example in automated production lines) are refined. The
core definition of a machine is now:
§ “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”
o Definitions covering machinery without a drive system, machinery to be
mounted on means of transport, assemblies of machines, lifting machinery
operated by manual effort, interchangeable equipment (no significant
change in this definition) and a revised definition of a Safety Component
are included.
o To clarify essential requirements and eliminate ambiguities, the concept of
“partly completed” machines is introduced. A partly completed assembly
§ “…. 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”
o Manufacturers of “partly completed” machinery such as robots are
required to follow specific CE marking procedures related to the nature of
their machinery as opposed to a completed machine. The placement of a
CE marking on a “partly completed” machine is not allowed.
o Users of production lines and automated production cells must now take
great care in planning the acquisition and installation of their plant and
consider who is taking responsibility to CE mark.
The additions and changes to the Machinery Directive, as you can see can be both
lengthy and add significant requirements for machine builders.
In this section real situations will be presented, what the Machinery Directive says about
this situation, a compliance strategy and how a vendor will help with compliance. Each
scenario will include:
• interpretation of requirements
• compliance strategies
• how a company that has technical competence in the Machinery Directive and
other international standards can help
The company chosen for this exercise is Pilz, a globally known company respected for
safe automation components and services.
Scenario
Compliance Strategy Pilz Service
Machinery Directive
2006/42/EC
Pilz Service
Pilz is qualified by the EU to act as an authorized representative. It can support you with
the assessment and validation of production line safety systems and the creation of the
necessary technical files. New sensing technologies such as SafetyEye® can be
considered.
Scenario 2: Machine imported from outside the EU through a parent company.
A medical device producer imports a machine that is designed to apply a proprietary
process in the production of medical devices. The machine, which is not CE marked, is
supplied by a Special Purpose Machine Builder through the parent company of the device
manufacturer. As the machine operator must observe the process carefully—and
intervene regularly to assure product quality—a number of machine operating modes are
required.
The upgrade
designs must be
documented in a
technical file and § What the new Machinery Directive says:
a person
“established in the
o The local company becomes the machine manufacturer and must CE mark
community”
designated to
the machine.
issue a
declaration of
conformance and § Suggested compliance approach:
prepare a CE
marking plate o A risk assessment of the machine should be conducted to:
§ identify the hazards
§ estimate the risks, taking into account the severity of the possible
injury or damage to health and the probability of its occurrence
§ evaluate the risks, with a view to determining whether risk
reduction is required
§ eliminate the hazards or reduce the risks
o If the machine design does not comply with the essential requirements of
the directive it must be upgraded. In doing so, particular attention should
be given to creating intelligent safety concepts for mode selection and to
ensure that operators can observe processes without bypassing the safety
systems.
o The upgrade-designs must be documented in a technical file and a person
established in the community must be designated to issue a declaration of
conformance and prepare a CE marking plate.
Pilz Service
Pilz is qualified to develop and document the upgraded designs and legally act as an
“authorized representative” in order to issue a declaration of conformance and prepare a
CE marking plate.
Scenario 3: Existing machine listed under the Annex IV of the Machinery Directive.
A manufacturer produces a metal-forming machine which is manually loaded and
unloaded. The machine is type-certified through a third-party-notified body in accordance
with the existing machinery directive using harmonized standards including EN 954-1.
Pilz Service
Pilz provides Safety Services, training, and tools such as PAScal to help machine builders
determine if safety-related control systems meet performance levels deemed appropriate
as a result of a machine risk assessment.
Pilz Service
As an authorized representative, Pilz ensures the adequacy of risk assessment, safety
design, and the documentation of hazards that remain despite the inherent safe-design
measures. Pilz can be the authority established in the community qualified to take
responsibility for the required administrative procedures.
Pilz Service
Pilz is qualified to guide you through the above compliance approach.
Pilz Service
Pilz is qualified to conduct a risk assessment and support in both the concept and the
design of the robot to insure that it meets all new MD requirements.
Pilz Service
Pilz is intricately familiar with the international standards mentioned above and can
conduct the risk assessment to ensure machines meet the requirements of the new
Machinery Directive.
Summary
As you can see the changes to the Machinery Directive are extensive. Upon review of
both documents and the changes, it is clear that the scenarios to be covered are almost
limitless. This white paper reviewed:
These changes in 1. What the machinery directive is and how to comply.
the Machinery
Directive become
2. A brief history of the machinery directive with milestones.
mandatory
th
3. Summary of changes in the machinery directive.
December 29 ,
2009 with no 4. Changes in terms of structure, summary of changes in Section Four and
transition period.
examples of changes in before-and-after language.
5. Seven scenarios to show examples of situations machine builders may
encounter, a compliance approach and a recommendation of a company that can
help navigate the process and the directive methodology.
The safety industry is constantly evolving and it is important for safety ambassadors to
design, build and maintain machinery that is safety-compliant. As technology advances,
machinery becomes more complex and machine operators find alternative ways to by-
pass safety systems, change becomes imperative. However, the European Union’s new
safety framework will create a higher level of safety for machinery. This new Machinery
Directive provides greater legal security by providing better definitions, clarifying
statements and ensuring consistent safety-application practices.
These changes in the Machinery Directive become mandatory on December 29, 2009
with no transition period. Furthermore, changes to this directive do not happen often, but
when they do it is important to not only understand them, but to find a trusted source who
can guide you through the changes.