Machinery Safety Standards

EN ISO 12100 Machinery Risk Assessment Review

Risk assessment review for machinery safety, technical files and CE / UKCA compliance.

Mervex Engineering and Inspection supports manufacturers, importers and suppliers with machinery risk assessment review in line with EN ISO 12100. We review hazards, existing protective measures, residual risks, user information and risk reduction evidence before machinery is placed on the market or put into service.

EN ISO 12100 provides the main framework for machinery risk assessment and risk reduction. It supports safer machine design and forms part of the technical documentation required for CE and UKCA compliance.

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What is EN ISO 12100 Risk Assessment?

EN ISO 12100 is a key machinery safety standard covering general principles for design, risk assessment and risk reduction. It provides a structured approach for identifying hazards, estimating and evaluating risk, and reviewing whether risk reduction measures are suitable.

A machinery risk assessment should consider the machine's intended use, reasonably foreseeable misuse, operating conditions, maintenance activities, user interaction and all relevant life cycle stages.

Why Machinery Risk Assessment Matters

Risk assessment is an important part of machinery compliance. It helps identify hazards before machinery is placed on the market, installed or used.

For CE marking, machinery is currently assessed under the Machinery Directive 2006/42/EC. From 20 January 2027, Regulation (EU) 2023/1230 will apply for machinery placed on the EU market. For Great Britain, machinery should be reviewed under the Supply of Machinery (Safety) Regulations 2008.

A clear risk assessment supports technical documentation, instructions, guarding decisions, safety functions, warning labels and Declaration of Conformity evidence.

EN ISO 12100 machinery risk assessment review

What We Review

  • Machine limits and intended use
  • Reasonably foreseeable misuse
  • Mechanical hazards
  • Electrical hazards
  • Thermal hazards
  • Noise and vibration hazards
  • Hydraulic and pneumatic hazards
  • Emergency stop functions
  • Guarding and access openings
  • Safety distances and crushing risks
  • Residual risks and warning labels
  • User information and instructions
  • Existing protective measures
  • Maintenance and cleaning tasks

How We Support the Risk Assessment Process

  • Hazard identification review
  • Risk estimation review
  • Risk reduction hierarchy review
  • Guarding and access opening comments
  • Emergency stop and safety function review
  • Standards mapping
  • Corrective action recommendations
  • Technical file support
  • CE and UKCA documentation guidance

Risk Reduction and Protective Measures

EN ISO 12100 follows a clear risk reduction hierarchy. Risks should first be reduced by inherently safe design measures where possible. If risks remain, safeguarding and protective measures should be considered. Any residual risks should be addressed through user information, warnings and instructions.

We review whether the selected measures are suitable for the identified hazards and whether further action may be needed before the machinery is placed on the market or put into service.

Standards Mapping

EN ISO 12100 often works with other machinery safety standards depending on the hazard.

  • EN ISO 13857: Safety distances and access openings.
  • EN ISO 13854: Minimum gaps to avoid crushing.
  • EN ISO 13850: Emergency stop function.
  • EN 60204-1: Electrical equipment of machinery.
  • EN ISO 13849-1: Safety-related parts of control systems.
  • ISO 4413 and ISO 4414: Hydraulic and pneumatic systems.

Technical File and Deliverables

A machinery risk assessment is normally part of the technical file. It may support design decisions, guarding, safety functions, warning labels, user instructions and Declaration of Conformity documentation.

Deliverables may include:

  • EN ISO 12100 risk assessment review
  • Hazard and risk reduction comments
  • Corrective action recommendations
  • Standards mapping
  • Technical file support
  • CE and UKCA documentation guidance

Risk Assessment, CE and UKCA Compliance

Machinery risk assessment is closely linked with CE marking, UKCA marking and machinery compliance. It should be reviewed with the technical file, user instructions and applicable standards. Related services include Machinery Compliance, CE Marking, UKCA Marking, LVD Testing, EMC Testing, Noise Testing and Documentation Verify.

Important Note

Risk assessment and machinery compliance remain the responsibility of the manufacturer or the party placing the machinery on the market. Mervex supports the process through technical review, documentation support, standards mapping and conformity assessment guidance. Where third-party assessment is required by legislation, this should be completed through an appropriate Notified Body, UK Approved Body or other recognised conformity assessment route.

Frequently Asked Questions

Is EN ISO 12100 required for CE marking?

EN ISO 12100 is widely used as the main framework for machinery risk assessment and risk reduction. It supports the technical documentation required for machinery compliance.

What should a machinery risk assessment include?

It should include machine limits, intended use, foreseeable misuse, hazard identification, risk estimation, risk evaluation, risk reduction measures and residual risk information.

Is risk assessment part of the technical file?

Yes. Machinery risk assessment is normally an important part of the technical file and supports CE or UKCA compliance evidence.

Start Your Machinery Risk Assessment Review

Send us your machine details, drawings, user manual or existing risk assessment and we will review what type of EN ISO 12100 support may be required.

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