Risk Assessment

"The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment." (Machinery Directive 2006/42/EC, Annex I)

Risk assessment is carried out in accordance with the harmonised standard

EN ISO 12100:2010 – Machinery Safety – General Principles for Design – Risk Assessment and Risk Reduction

If a calculated risk exceeds the predefined level of acceptability, technical and organizational measures have to be undertaken in order to bring the risk down to a tolerable level. 


Risk graph

In order to assess the required level of risk reduction in machines, either the risk graph laid down in EN ISO 13849-1 (see illustration below) or the process laid down in EN 62061 is used. Both procedures use the severity of possible injury as a yardstick but also rely on additional parameters for risk assessment such as

  • Frequency of occurrence
  • Possibility of prevention
  • Probability of occurrence



Risk reduction

The required measures for risk reduction are assigned to the single phases of the safety life cycle for the product concerned.

The different phases may be defined as follows:

  • Concept
  • Development
  • Production preparation
  • Production
  • Installation and commissioning
  • Operation
  • Decommissioning


The measures themselves can be classified as follows:

a) Organizational measures

  • Project organization
  • Organization of the Quality Assurance
  • Documentation


b) Technical Measures

The technical measures concern the procedures of development, the provision of tools, the quality assurance as well as the testing of hardware and software components. These core measures in the development process are divided into two fundamentally differing groups.

During the development phase, constructive measures guarantee the preventative avoidance of failures. Analytical measures serve to locate errors. Both constructive and analytical measures are of limited effectiveness. Neither of the two types of measures is sufficiently effectivef to be relied upon exclusively.


Our services

innotec carries out risk assessment procedures for single machines and complex plants according to the relevant standards.

innotec identifies all measures necessary to minimize risk in every single life cycle phase.

innotec supports the most cost-effective and efficient implementation of the measures defined.