ce conformity: md 2006/42/ec - sew eurodrive · directive 2006/42/ec came into effect, stipulating...
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Drive Technology \ Drive Automation \ System Integration \ Services
How to Ensure Machine and Plant Safety:
Standardization and Services
Safety Technology from SEW-EURODRIVE
CE Conformity: MD 2006/42/EC
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Integrated functional safety management
Whoever wants to prove his position as a technological leader and a global innovator has
to provide top-quality products, customer-oriented services and perfectly implemented
process solutions. SEW-EURODRIVE fulfills these requirements in all processes and
products.
According to the international IEC 61508 stan-
dard, the functional safety management drafts
a corporate safety guideline, plans all necessary
activities and implements corres ponding, inte-
grated processes. One of the primary objectives
is to ensure the functional safety of all products
in all phases of development, production and
distribution. For this purpose, an SEW-wide
corporate safety guideline was established.
Tracing the causes
Primary causes for accidents (error distribution)
Each hazard results from a source of danger. This
source can have very different causes and be
infl uenced by a variety of factors. Based on the
“four-eyes principle” and a maximum indepen-
dence of the safety offi cers, existing gaps can
effectively be closed.
21%
15%
15%
43%
6%
Specifi cation 43%
Modifi cation, retrofi tting 21%
Implementation 15%
Operation and maintenance 15%
Installation and startup 6%
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One of the key components of functional
safety management is the qualifi cation of
staff with respect to relevant topics and
standards. SEW-EURODRIVE provides an
extensive product and service portfolio for drive
technology according to the new 2006/42/EC
Machinery Directive.
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On December 29, 2009, the new Machinery
Directive 2006/42/EC came into effect, stipulating
important new conditions for machine and plant
engineering. The new directive replaces the old
98/37/EC directive without a transition phase and
applies to all machines and plants sold on the
European market.
The 2006/42/EC Machinery Directive comprises
several standards that are to improve machine
safety. That includes EN ISO 13849-1 and EN
62061, which regulate the functional safety of
safety-related electric, electronic and program-
mable electronic control systems.
In addition, there is the IEC 61508 standard for
functional safety management, which defi nes
the necessary requirements for processes,
responsibilities and organization. In conjunction
with other specifi c safety standards, a network
is formed that affects all areas of machine and
plant engineering. All those measures are to
increase the machine and plant safety.
Innovations in machines and plants have always been the basis for faster and more
effi cient solutions, and consequently for progress and growth. Especially the European
machine and plant manufacturers set global standards with their products. Apart from
the technical conditions, legal regulations and standards must also be observed when
developing, designing and selling machines and plants.
The 2006/42/EC Machinery Directive for
more machine and plant safety
Functional safety technology not only allows for
safe operation of machines and plants. It can
also increase the efficiency, reduce the safety
zones and thus reduce the overall costs.
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Machinery Directive 2006/42/EC replaces Machinery Directive 98/37/EC
– Compliance confi rmed by CE marking attached by the
machine manufacturer on completion
– Allows for the unrestricted movement of goods within the EU boundaries
EN ISO 13849-1 stipulates the requirements and methods for
calculating the required performance level (PL) for all types of machines
EN 62061 for calculating the safety integrity level (SIL) of
electric/electronic control systems
IEC 61508 defi nes the requirements for
– processes
– activities and responsibilities
– documents
– all other management activities
Affected group of persons Applicable standards/laws
The CE marking is the external indication for the compliance of a product with the
requirements of the Machinery Directive. With the CE marking, the responsible
person confirms that
– the product complies with all applicable Community rules and
– all stipulated conformity evaluation processes have been performed.
The CE marking allows for the unrestricted movement of goods
within the European market.
Component manufacturers
Machine and plant manufacturers
First marketers/importers
Machine operators
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Steps towards a safe machine:
Risk minimization according to EN ISO 12100-1
Schritte zur Risikominimierung laut EN ISO 12100-1:
Starting point
of the
assessment
Defi nition of the machine/plant limits
Limits relating to space, time, or usage
2
1
Identifi cation of hazards, risk assessment, and risk evaluation
Risk evaluation
Achievable PL/SIL = lowest PL/SIL in the chain
S1
S2
F1
F1
F2
F2
a
b
c
d
e
P1
P1
P1
P1
P2
P2
P2
P2
low risk
high riskP
ER
FO
RM
AN
CE
LE
VE
L
EN ISO 13849-1:Determining the required performance level (PLr)
For safety-related parts of controllers and machines of any
type (also hydraulic, pneumatic, mechanical, etc.)
Risk parameters:
S = Severity of the injury
S1 = slight (usually reversible) injury
S2 = severe (usually irreversible) injury, including death
F = Frequency and/or duration of the hazard
F1 = rarely or occasionally and/or the duration is short
F2 = often or permanently and/or the duration is long
P = Possibility of preventing the hazard or limiting the damage
P1 = possible under certain conditions
P2 = barely possible
Evaluation of the risk and selection of measures to minimize the risk through safe construction,
functional safety or user information.4
Elimination of the hazard or minimization of the risk. Confi guration of the safety function and calculation of the achieved SIL/PL5
CE marking7
Achievable PFH/MTTF = sum of the individual PFH/MTTF
6 Validation of the results and verifi cation of the implementation of specifi c safety functions:
planning – test/verifi cation – documentation
3 Assessing the risk for each identifi ed hazard and dangerous situation
7
ACHTUNG
fehelende Übersetzung
Actuator
AM = Other measures
Consequences Severity S Frequency and
duration F
Probability W Avoidance P Class K
(F+W+P)
3-4 5-7 8-10 11-13 14-15
Death, losing
an eye or arm 4 ≤ 1 h 5 Very high 5 SIL 2 SIL 2 SIL 2 SIL 3 SIL 3
Irreversible, losing
a fi nger(s)3 > 1 h ≤ Day 5 Likely 4 SIL 1 SIL 2 SIL 3
Reversible, requiring attention
from a medical practitioner 2
> Day
≤ 2 Weeks4 Possible 3 Impossible 5 AM SIL 1 SIL 2
Reversible, requiring fi rst aid 1> 2 Weeks
≤ 1 Year3 Rarely 2 Possible 3 SIL 1
> 1 Year 2 Negligible 1 Probable 1
Determining the required safety integrity level (SIL)
For safety-related electric, electronic and programmable electronic control systems
EN 62061:
Safety chain
Sensor SIL/PL• SIL/PL
PFH/MTTF
Logic SIL/PL• SIL/PL
PFH/MTTF
• SIL SIL
FPFH/MTTF
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360° functional safety management
over the life cycle of your machine or plant
Phase 1:Development and draft of a concept for a machine or plant
Phase 2:Defi nition of the area of application
Phase 3:Execution of the risk analysis and risk evaluation
Phase 4:Determination of all the safety requirements
Phase 13:Overall validation
Phase 14:Overall operation, overall maintenance and repair
Phase 15:Overall modifi cation and retrofi tting
Phase 16:Shutdown or withdrawal from service
Phase 14:
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Safety technology training by
SEW-EURODRIVE
Verifi cation and documentation of
safety-relevant drive systems and
their behavior in the plant
Management and documentation
of risk analyses and risk evaluation
Concept development, calculation
and approval of the safety-relevant
drive system
Descriptions on page 10/11
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Phase 5:Assignment of the safety requirements
Phase 6:Planning of the overall operation and maintenance Phase 7:
Planning of the overall validation
Phase 8:Planning of the overall installation and startup
Phase 9:Realization of safety-relevant systems
Phase 10:Realization of safety-related systems with non-SEW technology
Phase 11:Realization of external devices for risk minimization
Phase 12:Overall installation and startup
Phase 10:Realization of safety-related systems with non-SEW technology
Phase 11:
ggeemmeenntt aass aa bbaassiissyy lliiffee ccyyccllee
Startup of safety-relevant drive
systems
Planning and documentation of
the safety-relevant drive system
Planning and documentation of the
safe operation of the drive system
All processes related to the product life cycle must
be defi ned and monitored by the functional safety
management. The safety-related services offered by
SEW-EURODRIVE ensure that the process requirements are
met and that internal resources are used in an ideal way.
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Safety technology services
by SEW-EURODRIVE
Management and documentation of risk analyses and risk assessment
The risk analysis and the risk assessment represent the basis for all safety-relevant considerations. SEW-EURODRIVE
supports you with comprehensive experience regarding applications, standards and safety. In consultation with the
customer, the limits are defi ned, the applicable standards are compiled, and a list is created with the individual risks
and the resulting measures to reduce the risks. The resulting documentation serves as proof and represents a part of
the required machine and plant documentation.
Concept development, calculation and validation of the safety-relevant drive system
SEW-EURODRIVE assists with the selection of the components and the calculation of the realizable performance level
according to EN 13849-1 by optimally confi guring the components based on the customer safety requirements. Apart
from the documentation, all the components are systematically checked for their safety qualifi cation which represents
the basis for compliance with the safety requirements. SEW-EURODRIVE uses design and selection tools certifi ed by
the German Technical Control Board to help customers to select an effi cient combination.
Planning and documentation of the integration of the safety-related drive system in the machine and plant
For the integration of the drive components, SEW-EURODRIVE dimensions the drivelines and tests the electric wiring
diagrams. In addition, SEW-EURODRIVE defi nes the required conditions and describes the hardware and software
requirements for safety modules together with the customer. This means the customer has one point of contact for
both drive components and safety technology.
Planning and documentation of the safe operation of the drive system
The machine or plant-specifi c operation and maintenance concept provides the customer with a long-term certainty
of action. Apart from the maintenance cycles, SEW also plans the limits of the operating time and an upgrade concept.
This operation and maintenance concept can be integrated in the operating instructions as part of the mandatory
documentation.
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Safety-related services from SEW-EURODRIVE – customer benefits:
– One partner for the entire product life cycle of your machine or plant
– Legal security due to comprehensive functional safety management and
observance of the required steps
– Modular and individually adaptable services for safety technology
– Support from highly qualified SEW experts with years of experience
– Independent consulting reduces the need for modifications or reworks
Startup of safety-relevant drive systems
After having planned the safe integration, the experts from SEW-EURODRIVE also implement the safety-related drive
system in the machine or plant. The professional startup of the components, a perfectly adapted software functionality
and complete documentation allow you to quickly and smoothly use your machines and plants for production.
Verifi cation and documentation of safety-relevant drive systems, individual components and
their behavior in the plant
By verifying and documenting the safety functions in the plant, SEW-EURODRIVE reduces the customer‘s liability risks
to a small inevitable remaining risk. The safety-related functions in the plant are verifi ed and validated. If necessary,
independent external inspection authorities are included, assisted by SEW-EURODRIVE on behalf of the customer.
Thus, the experience of the SEW experts can save valuable time during the startup phase.
+
Safety technology training by SEW-EURODRIVE
The skill level of the staff and the quality of the safety technology processes are essential for safe operation of a plant.
In individually adapted training courses – either on-site or at the DriveAcademy®, the SEW training center – customers
learn about the required contents and procedures either regarding SEW products or the necessary basic conditions
regarding safety management.
SEW-EURODRIVEDriving the world
Drive Technology \ Drive Automation \ System Integration \ Services
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