How is a risk assessment template structured?
A risk assessment template to EN ISO 12100 is a table in which every hazard is recorded row by row: consecutive number, life phase, location and hazard zone, type of hazard from Annex B, possible consequence, risk before the measure, measure following the three-step method, risk after the measure and the remaining residual risk with a reference to the instructions for use. An empty template only provides the frame. The substantive evaluation, keeping it current and the link to the instructions for use remain the manufacturer's responsibility.
What a template is for and what it has to deliver
The risk assessment is the mandatory basis of every CE marking. A template makes sure no hazard and no life phase is forgotten.
The risk assessment to EN ISO 12100 is the first and most important step in the CE process. The protective measures on the machine, the warnings and the residual risks in the instructions for use all follow from it. A good template makes sure this process is documented completely and traceably.
A sound template does three things:
- Completeness: it leads systematically through all life phases of the machine and all hazard categories, so nothing is overlooked.
- Traceability: it shows the evaluation before and after the measure for every hazard and makes the risk reduction verifiable.
- Connectivity: it links every residual risk to the matching note in the instructions for use, so the documentation holds together.
A template is a tool, not a result. It replaces neither the technical evaluation of the specific machine nor the upkeep of the assessment over its life cycle.
The columns of a risk assessment template
This is how one row per hazard is built. These columns reflect the three-step method of risk reduction.
| Column | Content |
|---|---|
| No. | Unique number of the hazard for cross-referencing, for example in the instructions for use or in test records. |
| Life phase | Phase in the life cycle: transport, assembly, commissioning, normal operation, setting, cleaning, maintenance, fault clearance, dismantling, disposal. |
| Location / hazard zone | The specific point on the machine where the hazard occurs, for example a drawing-in point, the control cabinet, the tool area. |
| Hazard | Type of hazard following the categories of EN ISO 12100, Annex B: mechanical, electrical, thermal, noise, vibration, radiation, materials and substances, ergonomics, environment, combination. |
| Possible consequence | Conceivable injury or damage to health, for example crushing, electric shock, burns, hearing damage. |
| Risk before measure | Risk estimate from severity of harm and probability of occurrence (frequency, possibility of avoidance), before any protective measure. |
| Measure (three-step method) | The risk reduction decided on, in order of priority: 1. inherently safe design, 2. safeguarding, 3. information for use. |
| Risk after measure | Renewed evaluation once the measure has been implemented. If it is not sufficient, another iteration of risk reduction follows. |
| Residual risk / reference to instructions | The remaining residual risk and the corresponding warning in the instructions for use, with a reference to the chapter or pictogram. |
The hazard categories of EN ISO 12100
Annex B of EN ISO 12100 lists the types of hazard. Working through the template along these categories means fewer hazards are missed.
- Mechanical hazards: crushing, shearing, cutting, drawing-in, impact, stabbing, ejected parts.
- Electrical hazards: direct or indirect contact, arcing, electrostatic charge, thermal effects of current.
- Thermal hazards: hot or cold surfaces, flames, radiated heat, burns, scalding.
- Noise hazards: hearing damage, interference with communication and with the perception of warning signals.
- Vibration hazards: hand-arm vibration and whole-body vibration with long-term health effects.
- Radiation hazards: laser radiation, ionising and non-ionising radiation, electromagnetic fields.
- Hazards from materials and substances: hazardous substances, dusts, gases, mists, fire and explosion risk, biological agents.
- Ergonomic hazards: awkward postures, high forces, poor visibility of controls, mental over- or under-load.
- Hazards from the environment: influences at the place of use such as temperature, humidity, lighting, contamination or slipping.
- Combination of hazards: several hazards acting together and producing a higher risk than each on its own.
Filling in the template in eight steps
This is how to work through a risk assessment template to EN ISO 12100 systematically.
Why a static template reaches its limits
An empty spreadsheet or word processor template is a good start. As a permanent working tool for several machines it soon shows weaknesses.
Currency
Standards and legal bases change. From 20 January 2027 the Machinery Regulation (EU) 2023/1230 applies with no transition period. A static template ages quietly: it points to outdated references without anyone noticing.
Reuse
For a product line or similar machines, many people copy the file and adapt it. That creates version confusion and overlooked changes. A row copied from an old project often does not fit the new machine.
Consistency
If every person evaluates severity and probability by feel, assessments become incomparable. Without stored criteria and standard wording, traceability suffers.
Link to the instructions for use
The residual risk in row 27 of the table and the warning in the instructions for use sit in separate files. If the assessment changes, the warning easily stays as it was. These are exactly the breaks that market surveillance notices.
Common mistakes when filling in the template
These mistakes make a risk assessment vulnerable, even when the table looks complete.
Sources and standards
- EN ISO 12100: risk assessment and risk reduction, in particular Annex B
- Machinery Regulation (EU) 2023/1230, Annex III
- Machinery Directive 2006/42/EC, Annex I
Editions of standards and their harmonised status change continuously. Check standard numbers and editions against the current list in the Official Journal of the EU before applying them. This article is a technical classification and does not replace legal advice.
Frequently asked questions
Is there a legally prescribed template for the risk assessment?
No. Neither the Machinery Directive nor the Machinery Regulation prescribes a particular form. What is prescribed is the procedure to EN ISO 12100: identify hazards, estimate the risk, reduce it and document the result traceably. The tabular template is the form commonly used in practice to do that.
Which columns does a risk assessment template have to contain?
The established set is: consecutive number, life phase, location and hazard zone, type of hazard, possible consequence, risk before the measure, measure following the three-step method, risk after the measure, and residual risk with a reference to the instructions for use. This structure reflects the required chain from hazard to residual-risk information.
Which hazard categories does EN ISO 12100 set out?
Annex B of EN ISO 12100 names mechanical, electrical and thermal hazards among others, as well as hazards from noise, vibration, radiation, materials and substances, ergonomic hazards, hazards from the environment and the combination of several hazards. Working through the template along these categories reduces the risk of missing a hazard.
How do I evaluate the risk in the template?
The risk follows from the severity of the possible harm and the probability of its occurrence. The probability is made up of the frequency and duration of exposure, the probability of the harmful event occurring and the possibilities of avoidance. What matters is applying the same criteria to every row, so the evaluations stay comparable.
What does the three-step method mean in the measures column?
The three-step method of risk reduction to EN ISO 12100 sets the order of measures: first inherently safe design, then safeguarding and complementary protective measures, and last information for use such as warnings and statements in the instructions. The template should make clear which step a given measure belongs to.
Is a spreadsheet template enough for the risk assessment?
For a single, manageable machine a carefully completed table can be enough. With several machines, product lines or frequent changes a static file reaches its limits: currency, version control, consistent evaluation and the link to the instructions for use are all hard to secure.
How are residual risk and instructions for use connected?
Every residual risk that remains after the protective measures has to be communicated to the user in the instructions for use, for example as a warning or a pictogram. In the template, the residual risk column with its reference to the instructions makes sure this connection is documented and updated when things change.
Do I have to set up a separate examination for each life phase?
Yes. EN ISO 12100 requires all life phases of the machine to be considered, from transport, assembly and commissioning through normal operation, setting and cleaning to maintenance, fault clearance, dismantling and disposal. Many serious accidents happen outside normal operation, which is why the life phase column is central.
Does the Machinery Regulation change anything about the risk assessment from 2027?
The procedure to EN ISO 12100 remains the core. The Machinery Regulation (EU) 2023/1230 applies from 20 January 2027 with no transition period and adds requirements, for instance on protection against corruption and on AI and autonomous functions. Templates and references should be updated to the Regulation.
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This article was produced with AI assistance and reviewed for technical accuracy before publication. Editorial responsibility within the meaning of Art. 50(4) of the AI Act (EU) 2024/1689 lies with Heinrich Knutas.
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