Risk Assessment ISO 12100 For Machinery

Mervex | ISO 12100 Risk Assessment For Machinery

We carry out structured hazard identification, risk evaluation and risk reduction review to help determine whether machinery has been designed, documented and assessed in line with recognised machinery safety principles.

Machinery safety is not only about checking guards, emergency stops or labels. A proper evaluation must consider how the machine is used, who operates it, what hazards may occur, how people may access dangerous areas, and whether the existing protective measures are suitable.

EN ISO 12100 provides the main framework for machinery risk assessment and risk reduction. It sets out a logical process for identifying hazards, estimating risks, evaluating existing controls and applying further protective measures where required.


For machinery placed on the EU market, safety evaluation forms part of the technical documentation required under CE marking under Machinery Directive 2006/42/EC. For machinery placed on the Great Britain market, the same evidence is important for UKCA compliance under the Supply of Machinery (Safety) Regulations 2008.

An ISO 12100 risk assessment helps show that hazards have been considered and that suitable risk reduction measures have been reviewed before machinery is placed on the market, supplied, imported or put into service.

ConformTest assesses different types of machinery and industrial equipment, including production machines, processing equipment, packaging machines, powered machinery, integrated systems, lifting-related equipment and custom-built machinery.


Our machinery safety review considers the machine design, intended use, working environment, operator interaction and foreseeable misuse.

The review may include:

  • – Machine limits and intended use
  • – Foreseeable misuse
  • – Operator access and interaction
  • – Mechanical hazards
  • – Crushing, cutting, drawing-in and entanglement risks
  • – Electrical hazards
  • – Thermal hazards
  • – Noise and vibration hazards
  • – Hydraulic and pneumatic hazards
  • – Stability and structural risks
  • – Guarding and access openings
  • – Emergency stop functions
  • – Safety devices and interlocks
  • – Control system-related safety functions
  • – Maintenance, cleaning and adjustment activities
  • – Residual risks
  • – Warning labels and user information
  • – Installation, operation and maintenance instructions

Each hazard is reviewed against the machine condition, design features, protective measures and available technical documentation. Where safety gaps are identified, corrective actions can be defined.


ISO 12100 follows a clear hierarchy for reducing machinery hazards. The first priority is to remove or reduce hazards through inherently safe design. Where this is not fully possible, safeguarding and protective measures should be used. Any remaining risks should then be communicated through warnings, markings and user instructions.

Our assessment process follows these main steps:

  1. 1- Hazard identification
  2. 2- Risk estimation
  3. 3- Risk evaluation
  4. 4- Review of existing protective measures
  5. 5- Risk reduction recommendations
  6. 6- Residual risk review
  7. 7- Documentation for the technical file

This method helps create a clear and traceable safety record for the machinery technical file.


Machinery safety does not usually rely on ISO 12100 alone. Depending on the machine type, construction and hazards, additional standards may be relevant.

As part of the evaluation, ConformTest identifies applicable machinery safety standards that may support compliance evidence. These may include standards for electrical equipment, guards, interlocking devices, emergency stop functions, safety distances, control systems, lifting equipment, noise, vibration or machine-specific requirements.

Typical standards may include:

  • – EN ISO 12100
  • – EN 60204-1
  • – EN ISO 13849-1
  • – EN ISO 14120
  • – EN ISO 14119
  • – EN ISO 13850
  • – EN ISO 13857
  • – Relevant machine-specific Type C standards

This standards mapping helps connect identified hazards with recognised safety requirements.


The machinery technical file should contain evidence showing how safety requirements have been considered. This may include product descriptions, drawings, electrical diagrams, control system information, inspection records, test reports, applied standards, warning labels, nameplates, user instructions and Declaration of Conformity drafts.

ConformTest prepares clear ISO 12100 risk assessment records that can be used as supporting evidence within the technical file for CE or UKCA compliance.


Our service may include:

  • – ISO 12100 risk assessment report
  • – Hazard identification table
  • – Risk estimation and evaluation records
  • – Risk reduction comments
  • – Corrective action recommendations
  • – Applicable standards mapping
  • – Residual risk review
  • – Technical file evidence review
  • – CE / UKCA compliance comments

If you need ISO 12100 evaluation for machinery risk assessment, CE marking or UKCA marking, ConformTest can assess your machinery, identify safety gaps and prepare structured technical documentation for your compliance file.