> ## Documentation Index
> Fetch the complete documentation index at: https://docs.roboticks.io/llms.txt
> Use this file to discover all available pages before exploring further.
# ISO 12100
> Machinery general principles for design — risk assessment and risk reduction. The foundational standard from which most machinery requirements derive.
# ISO 12100
ISO 12100:2010, *Safety of machinery — General principles for design — Risk assessment and risk reduction*, is the foundational standard for machinery safety design. It establishes the **risk assessment / risk reduction iterative methodology** that every other machinery safety standard assumes as a starting point.
For Roboticks customers, ISO 12100 is rarely the source of derived requirements directly — it provides the methodology that leads to derivations from product-specific standards (ISO 10218, ISO 3691-4, IEC 62061). It is, however, pinned almost universally because the **hazard-and-risk-reduction methodology** itself produces requirements that need traceability.
**Roboticks is audit-readiness tooling, not a certified toolchain.** We assemble the evidence your notified body, certification body, or QA process ingests. We do not replace tool qualification (DO-178C, ISO 26262-8 TCL) and we do not issue conformity assessments. Verify the regulatory interpretations on this page against the standard text and your accredited assessor.
## The three-step method
ISO 12100 prescribes a hierarchy of risk reduction:
1. **Inherently safe design** — eliminate hazards by design (preferred).
2. **Safeguarding and complementary protective measures** — guards, light curtains, interlocks, STO drives.
3. **Information for use** — warnings, instructions, training (last resort).
Each iteration of the cycle: identify hazards → estimate risk → evaluate risk → reduce risk → re-iterate until residual risk is acceptable.
The output of risk assessment is a documented set of hazards and the risk-reduction measures applied to each. Many risk-reduction measures translate into machinery requirements: "the cell shall have a Category 3 PLd light curtain on the entry side," "the manipulator's TCP speed in collaborative mode shall not exceed X mm/s," "the operator interface shall warn before tool change."
## What Roboticks supports
* **Derivation from ISO 12100 clauses** — particularly clauses 5 (risk assessment) and 6 (risk reduction).
* **Hazard-to-requirement traceability** — the project's `hazards.yaml` declares hazards from the risk assessment; requirements link back to the hazards they mitigate.
* **Risk-reduction evidence** — the evidence pack PDF includes a "hazard mitigation" section showing each hazard, the mitigation measure, the derived requirements, and the verification results.
## What Roboticks does not do
* **We do not perform the risk assessment.** The hazard identification, risk estimation, and risk evaluation are human safety-engineering activities. Roboticks consumes the output.
* **We do not replace your risk-assessment software.** Many customers use specialist tools (Pilz PAScal, Sistema, in-house spreadsheets). Roboticks ingests the resulting hazard list and lets you link it to requirements.
## The hazards.yaml pattern
```yaml theme={null}
hazards:
- id: HAZ-007
description: Operator hand crushed between cobot end-effector and workpiece during quasi-static contact
type: mechanical/crushing
severity: S2 # serious, reversible
frequency: F1 # rare to often
avoidability: P2 # scarcely possible
pl_required: PLd
mitigations:
- inherent_design: "Rounded end-effector geometry"
- safeguarding: "PFL operation with TCP force limit per ISO/TS 15066 Annex A"
- information: "Operator training; visible warning lights during cobot motion"
realised_by_requirements:
- REQ-PFL-007
- REQ-PFL-008
- REQ-DOC-014
```
The hazard ID is referenced in requirements:
```yaml theme={null}
- id: REQ-PFL-007
title: Quasi-static contact force on upper arm below TS 15066 Annex A limit
type: safety
asil_pl: PLd
mitigates_hazards: [HAZ-007]
derives_from:
- standard: iso-ts-15066-2016
clause: "Annex A, Table A.2 — upper arm, quasi-static"
edition: "2016"
- standard: iso-12100-2010
clause: "§6.3 Safeguarding and complementary protective measures"
edition: "2010"
text: |
…
```
The evidence pack renders this two ways:
* **Hazard view**: every hazard with its mitigations and the verification status of each.
* **Requirement view**: every requirement, including which hazards it mitigates.
This dual view is exactly what a notified body uses to assess that the risk-reduction strategy is complete.
## Suggested patterns
| Activity | Approach |
| --------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------- |
| **Initial risk assessment** | Off-platform (Sistema, Pilz, spreadsheet); export hazard list to `hazards.yaml` |
| **Hazard-to-requirement linkage** | In `requirements/*.yaml` via `mitigates_hazards` |
| **Risk-reduction verification** | Each requirement gets its confirming tests; the platform tracks coverage |
| **Iteration** | Re-run risk assessment after each significant design change; update `hazards.yaml`; the change-impact analysis surfaces requirements that may need updating |
## Pinning
```bash theme={null}
rbtk standard pin iso-12100-2010 --project acme-robotics/firmware
```
ISO 12100 is part of every machinery bulk template (`industrial-robot-eu`, `cobot-eu`, `amr-eu`).
## Next steps
The product standard for industrial robots that builds on ISO 12100.
Cobot biomechanical limits that mitigate ISO 12100 mechanical hazards.
The Regulation that requires the ISO 12100 risk assessment.