Basic HTML Version
10
Focusing on risk reduction
This guide is primarily concerned
with the area of risk reduction in
the form of technical safety
measures. We assume that all
possible design measures for
reducing risk have already been
explored.
Risk assessment
Directives and standards describe the risk assessment process.
All manufacturers are obligated to perform a risk assessment.
This is followed by a risk evaluation and appropriate
risk reduction measures must be implemented as required.
Source:
EN ISO 12100
Source:
EN ISO 12100
Source:
EN ISO 12100
Establish the limits of the
machine
Start
Determine the
hazard situation
Risk evaluation
Identifying/examining
the system limits
• Limits of use
• Space limits
• Time limits
Determine/define
states & transitional states
Source: EN ISO 12100
• Preliminary hazard analysis
(PHA)
• “WHAT IF” method
• Failure mode and effects
analysis, failure effects
analysis (FMEA)
• Failure simulation for
control systems
• MOSAR procedure
• Fault tree analysis (FTA)
• Human intervention
• Operating statuses
• Unintentional behaviour or
foreseeable misuse
Risk assessment
of design safety measures –
Is the machine
safe?
No
Yes
Source: Directive 2006/42/EC Appendix I, 1)
Instructive
measures exhausted
End
No
Yes
Risk
assessment
of technical safety
measures –
Is the machine safe?
No
Yes
Risk assessment
Source: EN ISO 14121
Risk analysis
Source: EN ISO 12100
Risk assessment
Source: EN ISO 12100