Cobot risk assessment, CE marking and Machinery Regulation 2023 compliance resolved in 3 seconds.

ISO 10218 is a two-part standard with clearly defined scope boundaries. ISO 10218-1:2011 (under revision to ISO 10218-1:2025) applies to the robot manufacturer: it defines the design, construction, and testing requirements for industrial robots as machines. The robot manufacturer must supply the robot with a Declaration of Incorporation (DoI) — not a full CE Declaration of Conformity — because the robot is an incomplete machine not intended to operate independently. ISO 10218-2:2011 applies to the robot system integrator: it defines the safety requirements for the design, installation and integration of robot systems and cells. The integrator is responsible for the risk assessment of the complete robot cell, the safety function design (guards, interlocks, safety controllers), the validation of the integrated system, and the CE marking of the whole machine. A common misunderstanding is that purchasing a CE-marked robot from a manufacturer means the robot cell is CE-marked — it is not. The integrator bears the CE marking obligation for the complete installation. IgeraIndustria retrieves the specific ISO 10218-1 vs ISO 10218-2 requirement split for any component of the robot cell design.

ISO/TS 15066:2016 Annex A defines the biomechanical limits for power-and-force limiting (PFL) collaborative robot operations — the maximum allowable contact forces and pressures for different body regions. The limits are based on pain threshold values from biomechanical research. Key values from Annex A Table A.2: Skull/forehead: 130 N force, 150 N/cm2 pressure; Face (cheek): 65 N, 110 N/cm2; Neck (front): 167 N, 210 N/cm2; Back of head: 130 N, 150 N/cm2; Upper arm/elbow: 170 N, 180 N/cm2; Lower arm: 160 N, 190 N/cm2; Hand/finger: 140 N, 180 N/cm2; Chest: 140 N, 120 N/cm2; Abdomen: 110 N, 100 N/cm2; Pelvis: 180 N, 250 N/cm2; Upper leg/knee: 220 N, 250 N/cm2; Lower leg: 130 N, 220 N/cm2; Foot/toe: 125 N, 200 N/cm2. These limits apply to transient contact (clamping is a separate, more severe condition). The cobot must be configured — via payload, speed, path and force/torque sensor limits — to stay within these values at all points of the collaborative workspace. IgeraIndustria retrieves the specific Annex A limit for any body region and identifies the cobot configuration parameters required to achieve compliance.

EU Machinery Regulation 2023/1230/EU was published in the Official Journal on 29 June 2023 and replaces Machinery Directive 2006/42/EC. Transition period: manufacturers can apply either instrument until 14 January 2027, after which only the Regulation applies. Key changes relevant to robotics and cobots: (1) Regulation is directly applicable in all EU member states without national transposition — eliminates divergence between national implementations; (2) New Annex I includes AI-driven and self-learning machinery — cobots using adaptive control or machine learning algorithms now fall within specific EHSR requirements in Annex III cl.1.1.9 (safety of AI-driven machinery); (3) Digital instructions permitted — physical instructions manual no longer mandatory; (4) Enhanced requirements for remote operation and connectivity — cobots with cloud connectivity or remote programming interfaces must address cybersecurity in the technical file; (5) Annex IV (formerly requiring third-party conformity assessment for high-risk machines) has been restructured. Industrial robots remain in the high-risk category requiring Notified Body involvement unless harmonised standards (ISO 10218-2) are fully applied. IgeraIndustria retrieves the specific EHSR comparison between 2006/42/EC and 2023/1230 for any robot cell design feature.

A cobot risk assessment under ISO 10218-2 and ISO 12100 (machinery risk assessment methodology) follows five steps: (1) DETERMINE THE LIMITS — define the collaborative workspace boundaries, intended tasks, foreseeable misuse, user population (operator training level, physical capabilities), environmental conditions. The collaborative workspace must be defined spatially — not just the robot’s reach, but the zone where human-robot interaction is intended; (2) IDENTIFY HAZARDS — kinematic hazards (impact, crushing, entrapment), tool/end-effector hazards (sharp edges, pinch points, thermal hazards from welding/dispensing cobots), energy hazards (electrical, pneumatic in end-effector), environmental hazards (noise, fume); (3) ESTIMATE RISK — for each hazard: severity of injury (reversible/irreversible, death), frequency of exposure, probability of harm occurrence, probability of avoidance. Use ISO 10218-2 Annex B risk graph or ENISO 13849-1 quantitative methods; (4) EVALUATE RISK — determine whether residual risk is acceptable or requires further risk reduction. ISO/TS 15066 biomechanical limits (Annex A) are the acceptance criteria for contact force risk; (5) REDUCE RISK — apply the hierarchy: inherently safe design → safeguarding (speed/force limits, safety controller, separation monitoring) → information (training, warning labels). Document all measures and verify by validation testing. IgeraIndustria guides through each step with the applicable ISO 10218-2 clause, ISO 12100 method and acceptance criteria.

CE marking a complete robot cell under the Machinery Directive 2006/42/EC (or Machinery Regulation 2023/1230 from January 2027) is the integrator’s responsibility. The process requires: (1) TECHNICAL FILE — must include: description of the machinery and its intended use; assembly drawings with electrical/pneumatic diagrams; risk assessment and risk reduction measures; list of EHSRs (Annex I) addressed, harmonised standards applied (ISO 10218-2, ISO 13849-1, IEC 62061, ISO 10218-2 as EN ISO 10218-2), and standards with full or partial application documented; declarations of incorporation from robot manufacturer and other component suppliers; test reports for safety functions; (2) DECLARATION OF CONFORMITY — signed by the authorised person within the integrator’s organisation (must be legally responsible), identifying the machine, applicable directives/regulations, harmonised standards applied; (3) NOTIFIED BODY — required if the robot cell contains an industrial robot and the integrator does not fully apply harmonised standards (Annex IV MD; Annex I cat. 2 MR). The NB issues an EU Type Examination Certificate; (4) INSTRUCTIONS FOR USE — per Annex I MD cl.1.7.4: must include residual risks, maintenance procedures, noise emission values if applicable, and CE marking obligations for further integration. IgeraIndustria retrieves the complete technical file content requirements and identifies where NB involvement is triggered.

Post-Brexit, robots and robot cells placed on the UK market (England, Wales, Scotland — not Northern Ireland which uses CE) must carry UKCA marking under the UK Supply of Machinery (Safety) Regulations 2008 (as amended by the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019). Key points for importers: (1) UKCA replaces CE for Great Britain market — CE marking was accepted until 31 December 2024; from 1 January 2025, UKCA is mandatory for new machinery placed on the GB market (some categories have further transition periods — check OPSS guidance); (2) UK Approved Bodies replace EU Notified Bodies for conformity assessment of high-risk machinery; (3) UK CA Technical File must reference UK-adopted harmonised standards (BS EN ISO 10218-2 etc.); (4) PUWER (Provision and Use of Work Equipment Regulations 1998) applies to all work equipment including robots used in UK workplaces — requires suitable inspection and maintenance regime, operator training records, and risk assessment. PUWER applies regardless of CE/UKCA marking — it is the employer’s duty under UK health and safety law. HSE guidance L22 covers PUWER compliance for robotic systems. IgeraIndustria retrieves the specific UKCA technical file requirements, UK Approved Body obligations, and PUWER compliance checklist for robotic workstations.