Machine Safety EN ISO 12100:2010

Services according to the ISO 12100 standard

The ISO 12100 standard defines the safety conditions under which machinery within the EU must be designed based on its intended use, and subsequently describes how a designer can carry out a correct risk assessment and risk reduction procedure. This ensures the safety of the end user of machinery. Our team of experts can help you implement safety measures according to ISO 12100 so that you will achieve conformity with the required safety requirements.

ISO 12100:210

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What is the NEN EN ISO 12100:2010?

EN ISO 12100:2010 is a European standard that came into force from 9 October 2010, replacing EN ISO 12100-1:2003. This international standard aims to ensure the safety of the intended use of machinery. It does so by regulating the design process of machinery. The standard:

  • sets out specific principles regarding risk assessment and risk reduction during the design process to achieve this safety. Part of this includes how the designer can go through proper risk assessment, and successfully carry out risk reduction.
  • provides the ISO with specific guidance on the documentation and verification of the risk assessment and risk reduction process.
  • provides guidance on the preparation and application of type B (generic safety) and C (machine safety) standards.

ISO 12100 may not be a legal requirement, but it functions as a guide for setting up a safe design and production process. Indeed, you are legally obliged to guarantee the safety of your machine, and by following the ISO 12100, you automatically go through the process that the Machinery Directive prescribes to the designer

How do I correctly implement the ISO 12100?

ISO 12100 is a broad standard that addresses both machine design and risk assessment and reduction during the design phase. This therefore involves multiple, individual processes that you need to go through. This starts with classifying your machines so that it becomes clear which design guidelines apply to your machine. Once the design phase has been carried out according to the guidelines, your machine can be subjected to the risk assessment and risk reduction processes.

Part of risk analysis is risk assessment, and it consists of the following steps:

  • Determination of the limits of the machine
  • Identification of hazards
  • Risk assessment

Based on the risk analysis, a risk assessment follows, indicating whether a risk reduction is needed. If everything is then in order, the construction phase follows, in which your machine goes through another risk assessment. This should show that all risks have been minimised. If this is not the case, adjustments will have to be made again in one of the earlier phases.

When the risk assessment, analysis and possible mitigation have been carried out correctly and completely, your machine conforms to ISO 12100:2010 and you can safely trade or put your machine into service within the EU market. This is on condition that nothing changes in the design of the machine that could affect the safety of its intended use.

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ISO 12100 risk assessment and risk reduction under our guidance

Implementing ISO 12100 is quite an extensive and complex process, let our team help you from start to finish.

Below is an overview of the potential complications you may encounter during implementation, and how Certification Experts can be of assistance.

The challengeOur solution
You need to have knowledge and experience regarding the design, operation, occurrences, accidents and risks associated with machinery.Certification Experts has a team of experts with both knowledge and experience that can support you in understanding and applying the 12100 ISO.
The ISO 12100 describes procedures for identifying, estimating and assessing hazards during multiple phases of a machine’s life cycle.We are familiar with the procedures and can set up and guide them for your machine throughout all phases.
Implementing the risk assessment procedure and risk reduction.We can make a qualitative risk analysis using a risk analysis checklist, and carry it out fully for you. This way, it becomes clear which risks need to be reduced, and we support you in this process.
Conducting a risk assessment requires a lot of documentation and information, including (preliminary) specifications of the machine and the user, information regarding the use of the machine, the relevant and applicable standards and regulations, etc., checking/maintaining this documentation.
Certification Experts can support you in gathering all relevant information, preparing all necessary documentation and checking the documentation so that it is easy for you to maintain.

We can guide you quickly and efficiently, saving you time through our expertise. After reading the above information, are you looking for a partner with international experience who can support you in implementing ISO 12100? Then contact us now and let us help you enter the EU market faster with safe machines.

frequently asked questions

All the answers you might need!

ISO 12100 is not a legal requirement but it functions as a guide for setting up a safe design and production process. However, you are obliged to guarantee safety of your machine and by following the ISO 12100, you go through the process that the Machinery Directive prescribes to the designer.

There are three types of standards: type A, type B, and type C. The EN ISO 12100 defines these three types.

Type A: Generic standard. The standard EN ISO 12100 is a type A standard and addresses general risks for machines and products.

Type B: General standard that addresses issues relevant to multiple aspects, such as the EN 60204-1 concerning electrical installations for machines.

Type C: Product-specific standard. These standards address the ins and outs of the expected aspects for a specific product, such as the EN 619 for conveyors and sorting systems.

The machine risk assessment consists of the following 3 steps:

  1. Determination of the limits of the machine
  2. Identification of potential hazards
  3. Evaluate risks (machine safety risk assessment) and indicate whether a risk reduction is necessary

The ISO 12200:100 is a European standard that aims to ensure the safety of the intended use of the machine. It does so by regulating the design process of machinery.


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