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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.

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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.

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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.”

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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.

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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.

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The hazards.yaml pattern

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: 
- 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.

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Suggested patterns

ActivityApproach
Initial risk assessmentOff-platform (Sistema, Pilz, spreadsheet); export hazard list to hazards.yaml
Hazard-to-requirement linkageIn requirements/*.yaml via mitigates_hazards
Risk-reduction verificationEach requirement gets its confirming tests; the platform tracks coverage
IterationRe-run risk assessment after each significant design change; update hazards.yaml; the change-impact analysis surfaces requirements that may need updating

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Pinning

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).

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Next steps

ISO 10218

The product standard for industrial robots that builds on ISO 12100.

ISO/TS 15066

Cobot biomechanical limits that mitigate ISO 12100 mechanical hazards.

EU MR 2023/1230

The Regulation that requires the ISO 12100 risk assessment.