Definition
ISO 12100 is an A-type standard within machinery safety that specifies basic terminology, principles and a methodology for achieving safe design of machinery.
The standard describes principles for risk assessment and risk reduction of machinery that help designers identify hazards, estimate and evaluate risks, and eliminate hazards or implement measures for sufficient risk reduction - this is one of the requirements for CE marking a machine.
ISO 12100:2010 is published in Europe as EN ISO 12100:2010 - Machinery safety - General principles for design - Risk assessment and risk reduction.
The standard is based on knowledge and experience from:
Design of machinery
Use of machinery
Incidents and accidents
Risks associated with machinery.
ISO 12100 is a central standard within machine safety and is often used as a basis for the design, risk assessment and risk reduction of machinery.
Purpose of ISO 12100
The purpose of ISO 12100 is to provide designers with a methodology for achieving safe design of machinery.
The standard describes methods for:
Identify hazards
Estimate and evaluate risks
Eliminate hazards where possible
Implement measures for sufficient risk reduction
Document and verify the risk assessment process.
ISO 12100 and CE marking of machinery
When CE marking machinery, the manufacturer must demonstrate that the machinery fulfils applicable requirements according to relevant legislation.
Risk assessment is a central part of the work to demonstrate conformity.
The standard supports the manufacturer in:
Identifying hazards associated with the machinery
Assessing risks throughout the machinery lifecycle
Selecting appropriate risk reduction measures
Documenting how risks have been managed.
The standard does not replace legislation and does not mean that the manufacturer transfers its responsibility. The manufacturer always remains responsible for ensuring that the machinery fulfils applicable requirements.
Read more about CE marking of machinery, risk assessment and applicable legislation Machinery Directive 2006/42/EC and the upcoming Machinery Regulation (EU) 2023/1230.
Risk assessment of machinery according to ISO 12100
ISO 12100 describes a methodology for identifying hazards and estimating and evaluating risks during relevant phases of the machinery lifecycle.
The risk assessment helps the designer understand which risks are associated with the machinery and which measures are required to achieve a sufficient safety level.
Identification of hazards
An important part of the risk assessment according to ISO 12100 is identifying hazards that may occur during the machinery lifecycle.
Examples of hazards are:
- Mechanical hazards
- Electrical hazards
- Thermal hazards
- Hazards due to noise
- Hazards due to vibration
- Hazards due to radiation
- Hazards due to materials and substances
- Ergonomic hazards.
Identified hazards are used as the basis for further estimation and evaluation of risks.
Machinery lifecycle in risk assessment
ISO 12100 states that risks shall be considered during relevant phases of the machinery lifecycle.
Examples of lifecycle phases are:
- Design
- Manufacturing
- Transport
- Installation
- Use
- Maintenance
- Dismantling and disposal.
The risk assessment should therefore not only focus on normal operation of the machinery but also consider other situations during the lifetime of the machinery.
ISO 12100 Annex B - Hazards, hazardous situations and injuries
ISO 12100 Annex B contains examples of hazards, hazardous situations and types of injuries as support for the identification and analysis of risks.
The annex can be used as support in the risk assessment process by helping designers identify relevant risk areas associated with the machinery.
Risk reduction according to ISO 12100
ISO 12100 describes principles for eliminating hazards or achieving sufficient risk reduction.
Risk reduction is based on the results from the risk assessment and is carried out according to the principles of ISO 12100.
Measures may include, for example:
- Changes to the machinery design;
- Safeguarding measures;
- Complementary protective measures;
- Information for use.
The objective is to create safer machinery by reducing identified risks in a structured way.
Documentation and verification according to ISO 12100
ISO 12100 provides guidance on documentation and verification of the risk assessment process.
The documentation should provide traceability between:
Identified hazards;
Evaluated risks;
Selected measures;
Verification of implemented measures.
The results from the risk assessment are an important part of the machinery’s technical documentation and a requirement for CE marking of machinery.
Read more about technical documentation.
ISO 12100 in Noex
Through our licensing agreement with SIS (Swedish Institute for Standards), Noex provides access to licensed content from ISO 12100 methodology as well as Annex B as support for hazard identification
Noex supports machinery manufacturers in carrying out, documenting and following up risk assessments according to the principles of ISO 12100.
The platform helps users create traceability and structure the risk assessment process by connecting:
Hazards
Hazardous situations
Possible injuries
Risk reduction measures
Verification
Technical documentation.
ISO 12100 and other safety standards
ISO 12100 is an A-type standard within machinery safety.
The standard is intended to be used as a basis for:
- B-type standards that address specific safety aspects or protective measures
- C-type standards that contain specific safety requirements for specific types of machinery.
ISO 12100 is often used together with other safety standards.
Which standards are relevant depends on the design, function and identified risks of the machinery.
ISO 12100 and ISO/TR 14121-2
ISO 12100 describes the principles and methodology for risk assessment and risk reduction.
ISO/TR 14121-2 describes practical application of a number of methods for different steps in the risk assessment process (Noex uses the hybrid method). If you wish to see more you can find a quick video here.
ISO 12100 revised
The purpose of the revision is to update the standard based on technological development and experience from the use of the standard.
The current version ISO 12100:2010 continues to be the established method for design, risk assessment and risk reduction until the new version is published - ISO 12100:2026.
What is ISO 12100?
ISO 12100 is a type-A safety standard for machinery that specifies basic terminology, principles and a methodology for risk assessment and risk reduction of machinery.
Is ISO 12100 a legal requirement?
No. ISO 12100 is a standard, not legislation. It describes an established methodology for risk assessment and risk reduction.
Do all machines require a risk assessment in accordance with ISO 12100?
Risk assessment is a fundamental part of demonstrating conformity with the Machinery Directive 2006/42/EC and the upcoming Machinery Regulation (EU) 2023/1230. ISO 12100 describes an established methodology for design and risk assessment, but the standard itself is not legislation.
What is the difference between ISO 12100 and risk assessment?
Risk assessment is the process of identifying hazards, estimating and evaluating risks, and determining appropriate risk reduction measures.
ISO 12100 describes the principles and methodology for carrying out this process for machinery.
What does ISO 12100 Annex B contain?
Annex B contains examples of hazards, hazardous situations and types of harm to assist in the identification and analysis of risks.
Is ISO 12100 a harmonised standard?
Yes, ISO 12100 is a harmonised, international safety standard for machinery.
The European version is published as EN ISO 12100 and the Swedish version as SS-EN ISO 12100.
